As filed with the Securities and Exchange Commission on November 2, 2017April 20, 2020

No. 333-220898333-235904

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

AMENDMENT NO. 1 2

TO

FORMS-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

Delcath Systems, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 3841 06-1245881

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification No.)

1633 Broadway,

Suite 22C

New York, New York 10019

(212)489-2100

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

 

Jennifer K. Simpson

President and

Chief Executive Officer

Delcath Systems, Inc.

1633 Broadway,

Suite 22C

New York, New York 10019

(212)489-2100

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies of all communications including communications sent to agent for service, should be sent to:

 

Jolie Kahn, Esq.John D. Hogoboom

Wexler, Burkhart, Hirschberg & UngerLowenstein Sandler LLP

377 Oak Street1251 Avenue of the Americas

Garden City, NY 11530New York, New York 10020

(516)(212)222-2230262-6700

 

Robert Charron, Esq.Charles Phillips

Ellenoff Grossman & Schole LLP

1345 Avenue of the Americas

New York, NYNew York 10105

(212)370-1300

 

 

Approximate date of commencement of proposed sale to the public:

As soon as practicable after this Registration Statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,anon-accelerated filer, filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” inRule12b-2 of of the Exchange Act. (Check One):

 

Large accelerated filer   Accelerated filer 
Non-accelerated filer   Smaller reporting company 
   Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

 

 

CALCULATION OF REGISTRATION FEE

 

 

Title of each Class of

Securities to be Registered

 

Proposed

Maximum

Aggregate

Offering Price (1)(2)

 Amount of
Registration Fee

Units, each Unit consisting of one share of Common Stock, par value $0.001 per share, one Series C common warrant to purchase one share of Common Stock, one Series D common warrant to purchase one share of Common Stock, and one Series E common warrant to purchase one share of Common Stock (3)

 $17,250,000 $2147.63

(i) Common Stock included in the Units (4)

 —   —  

(ii) Common warrants included in the Units (4)

 —   —  

Pre-funded Units, eachPre-funded Unit consisting of onepre-funded warrant to purchase one share of Common Stock, one Series C common warrant to purchase one share of Common Stock, one Series D common warrant to purchase one share of Common Stock, and one Series E common warrant to purchase one share of Common Stock (3)

 $15,000,000 $1867.50

(i) Pre-funded warrants included in thePre-funded Units (4)

 —   —  

(ii) Common warrants included in thePre-funded Units (4)

 —   —  

Shares of Common Stock underlyingpre-funded warrants included in thePre-funded Units (3)

 —    

Shares of Common Stock underlying common warrants included in the Units and thePre-funded Units (3)

 $67,000,000 

$8,341.50

Total

 $99,250,000 $12,356.63

 

 

 

Title of each class of

securities to be registered

 

Proposed

maximum

Aggregate

offering price(1)

 Amount of
registration fee

Common stock, par value $0.01 per share(2)(3)

 $25,300,000 $3,284

Series F warrants to purchase common stock(2)

 —   (4)

Common stock issuable upon exercise of the Series F warrants(3)

 $25,300,000 $3,284

Pre-funded warrants to purchase common stock

 (5)  

Common stock issuable upon exercise of thepre-funded warrants

 (5)  

Total

 $50,600,000 $6,568(6)

 

 

(1)

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) ofunder the Securities Act of 1933, solely for purposes of calculatingas amended, or the amount of the registration fee.Securities Act.

(2)Pursuant to Rule 416 of the Securities Act of 1933, this Registration Statement also shall cover any

Includes additional shares of common stock that shall become issuable by reason of any stock dividend, stock split, recapitalization, or other similar transaction byand warrants subject to the registrant.underwriters’ over-allotment option.

(3)

Pursuant to Rule 416 under the Securities Act, there is also being registered hereby such indeterminate number of additional shares of common stock as may be issued or issuable because of stock splits, stock dividends, stock distributions, and similar transactions.

(4)

No fee required pursuant to Rule 457(g).

(5)

The proposed maximum aggregate offering price of the Unitscommon stock will be reduced on adollar-for-dollar basis based on the offering price of anypre-funded warrants sold in the offering, and the proposed maximum aggregate offering price of thepre-funded warrants to be sold in the offering will be reduced on adollar-for-dollar basis based on the offering price of anyPre-funded Units offered and common stock sold in the offering, and as suchoffering. Accordingly, the proposed maximum aggregate offering price of the Unitscommon stock andPre-fundedpre-funded Unitswarrants (including the common stock issuable upon exercise of thepre-funded warrants included in thePre-funded Units)warrants), if any, is $15,000,000, excluding any exercise$25,300,000, including the underwriters’ option to purchase additional shares of the over-allotment option by the underwriter.common stock.

(4)(6)Additional registration

A fee is payable, only above $8030.25 paid with the filing of the original Form S-1 pursuant to Rule 457(i) under the Securities Act of 1933, as amended.$3,732 has been previously paid.

 

 

The registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act, of 1933, as amended, or until this Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED APRIL 20, 2020

PRELIMINARY PROSPECTUS

 

Subject to Completion, Dated November 2, 2017LOGO

LOGO

422,535,211 Units

Each Unit Consisting of One Share1,692,307 Shares of Common Stock

and

One Series C WarrantF Warrants to Purchase One Share of Common Stock, One Series D Warrantup to Purchase One Share of Common Stock, and One Series E Warrant to Purchase One Share1,692,307 Shares of Common Stock

Up to 422,535,211 Units (each Unit consists of 1 Share of Common Stock and 1 Series C Common Warrant to purchase 1 Share of Common Stock, 1 Series D Common Warrant to purchase 1 Share of Common Stock and 1 Series E Common Warrant to purchase 1 Share of Common Stock)

or

Up to 422,535,211Pre-fundedPre-Funded Units (eachPre-funded Unit consists of 1 Pre-funded WarrantWarrants to Purchase 1 Share of Common Stock and 1 Series C Common Warrantup to Purchase 1 Share of Common Stock, 1 Series D Common Warrant to Purchase 1 Share of Common Stock and 1 Series E Common Warrant to Purchase 1 Share of Common Stock

(422,535,2111,692,307 Shares of Common Stock Underlying thePre-funded Warrants) and

(1,267,605,633 Shares of Common Stock Underlying the Series C Common Warrants, Series D Common Warrants and Series E Common Warrants)

 

 

We are offering 1,692,307 shares of common stock and Series F warrants to purchase up to 422,535,211 units (each unit consisting1,692,307 shares of onecommon stock. Each share of our common stock andis being sold with one Series C commonF warrant to purchase one share of our common stock, oneat an assumed combined public offering price of $13.00 per share of common stock and related Series D commonF warrant, to purchase onethe closing sale price per share of our common stock and one Series E common warrant to purchase oneon the OTCQB on April 17, 2020, representing a public offering price of $12.99 per share of our common stock). Eachstock and $0.01 per related Series C common warrant contained in a unit hasF warrant. The Series F warrants are exercisable from and after the date of their issuance and expire on the fifth anniversary of such date, at an exercise price of $             per share each Series Dof common warrant contained in a unit has an exercisestock equal to 100% of the combined public offering price of $ per share of common stock and eachrelated Series EF warrant in this offering. The shares of common warrant contained in a unit has an exercise price of $             per share. The commonstock and Series F warrants contained in the units will be exercisable immediately and the Series C common warrants will expire five years from the date of issuance, the Series D common warrants will expire one year from the date of issuance, and the Series E common warrants will expire one year from the date of issuance. We are also offering the shares of our common stock that are issuable from time to time upon exercise of the common warrants contained in the units. All share numbers included in this prospectus are included on a pre reverse split basis without taking into account the reverse split of the issuer’s issued common stock scheduled to occur on November 6, 2017.separately.

We are also offering to each purchaserthose purchasers, if any, whose purchase of unitscommon stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses,pre-funded units (eachpre-funded unit consisting of onepre-funded warrant to purchase one share of our common stock and one Series C common warrant to purchase one share of our common stock, one Series D common warrant to purchase one share of our common stock and one Series E common warrant to purchase one share of our common stock)warrants in lieu of unitsshares of common stock that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding common stock (or, at the election of the purchaser, 9.99%). of our outstanding common stock. Eachpre-funded warrant is being sold with one Series F warrant to purchase one share of our common stock, at an assumed combined public offering price of $12.99 perpre-funded warrant and related Series F warrant, the closing sale price per share of our common stock on the OTCQB on April 17, 2020, less the $0.01 exercise price of thepre-funded warrant), representing a public offering price of $12.98 perpre-funded warrant and $0.01 per related Series F warrant. The purchasepre-funded warrants and Series F warrants will be issued separately. The exercise price of eachpre-funded unitwarrant will equal $0.01 per share. Eachpre-funded warrant will be exercisable upon issuance and will not expire prior to exercise.

Certain of our existing stockholders have indicated an interest in purchasing at least $4.0 million of our securities in this offering at the combined public offering price per unit beingshare and related warrant and on the same terms as the other purchasers in this offering. See “Prospectus Summary – Support and Conversion Agreement.” However, because indications of interest are not binding agreements or commitments to purchase, such stockholders are not obligated to purchase such securities and the existing stockholders may purchase more, fewer or no securities in this offering. The underwriters will receive the same underwriting discount on these securities as they will on any other securities sold to the public in this offering minus $0.01, and the exercise price of eachpre-funded warrant included in thepre-funded unit will be $0.01 per share. This offering also relates to the shares of common stock issuable upon exercise of anypre-funded warrants contained in thepre-funded units sold in this offering. Each Series C common warrant contained in apre-funded unit has an exercise price of $              per share, each Series D common warrant contained in a pre-funded unit has an exercise price of $             per share, and each Series E common warrant contained in a pre-funded unit has an exercise price of $             per share. The Series C common warrants contained in thepre-funded units will be exercisable immediately and will expire five years from the date of issuance. The Series D common warrants contained in the pre-funded units will be exercisable immediately and will expire one year from the date of issuance. The Series E common warrants contained in the pre-funded units will be exercisable immediately and will expire one year from the date of issuance. We are also offering the shares of our common stock that are issuable from time to time upon exercise of the common warrants contained in thepre-funded units. For eachpre-funded unit we sell, the number of units we are offering will be decreased on aone-for-one basis. Units and thepre-funded units will not be issued or certificated. The shares of common stock orpre-funded warrants, as the case may be, and the common warrants can only be purchased together in this offering but the securities contained in the units orpre-funded units will be issued separately.

Our common stock is quoted on the OTCQB marketplace under the symbol “DCTH.” The last reportedOn December 24, 2019, we effected aone-for-700 reverse split of our common stock, or the Reverse Split. Unless otherwise specified or the context otherwise indicates, the information contained in this prospectus has been adjusted to give effect to the Reverse Split. On April 17, 2020, the closing sale price of our common stock as reported on October 31, 2017the OTCQB was $0.0355 per share.$13.00. Our common stock has been approved for listing on The NASDAQ Capital Market under the symbol “DCTH” contingent on the completion of this offering. The closing sale price of our common stock as reported on the OTCQB may not be indicative of the market price of our common stock on the NASDAQ Capital Market. There is no established public trading market for the Series F warrants or thepre-funded warrants, and we do not expect a market to develop. In addition, we do not intend to apply for listing ofto list the common warrantsSeries F Warrants or thepre-funded warrants on any national securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Series F warrants and thepre-funded warrants will be limited.

The combined public offering price per share and related Series F warrant will be determined between us, the underwriters and investors based on market conditions at the time of pricing, and may be at a discount to the current market price of our common stock. Therefore, the recent market price used throughout this prospectus may not be indicative of the actual combined public offering price.

 

 

Investing in our securities involves risks, including those described in thea high degree of risk. SeeRisk Factorssection beginning on page 88.

Per SharePer
Pre-Funded
Warrant
Per
Series F
Warrant
Total

Public offering price

$$$$

Underwriting discount(1)

$$$$

Proceeds to us (before expenses)

$$$$

(1)

See “Underwriting” beginning on page 72 for additional information regarding the compensation payable to the underwriters.

We have granted the underwriters a30-day option to purchase up to an additional 253,846 shares of this prospectus.common stock and/or Series F warrants to purchase up to 253,846 shares of common stock, in any combination thereof, from us at the public offering price per security, less the underwriting discount, to cover over-allotments, if any.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

Per
Unit (1)
Per
Pre-Funded
Unit (2)
Total

Price to the public

$$$

Underwriting discount(2)

$$$

Proceeds, before expenses, to us(3)

$$$

(1)The public offering price and underwriting discount per unit corresponds to (i) a public offering price per share of common stock of $             and (ii) a public offering price per Series C common warrant of $            , Series D common warrant of $             and Series E common warrant of $            .
(2)The public offering price and underwriting discount per pre-funded unit corresponds to (i) a public offering price per pre-funded warrant of $             and (ii) a public offering price per Series C common warrant of $             , Series D common warrant of $             and Series E common warrant of $            .
(3)We have agreed to reimburse the underwriter for certain of its expenses. See “Underwriting” for a description of the compensation to be received by the underwriter.
(4)Excludes potential proceeds from the exercise of the warrants through this prospectus.

The underwriter expectsDelivery of the shares of common stock, thepre-funded warrants, if any, and the Series F warrants is expected to deliver the securities to the purchasersbe made on or about                 , 2017.

The underwriter has the option to purchase up to an additional (i) 63,380,281 shares of common stock, and/or (ii) additional Series C common warrants to purchase up to 63,380,281 shares of common stock, and/or (iii) additional Series D common warrants to purchase up to 63,380,281 shares of common stock, and/or (iv) additional Series E common warrants to purchase up to 63,380,281 shares of common stock solely to cover over-allotments, if any, at the public offering price per share of common stock and the public offering price per common warrant set forth above less the underwriting discounts and commissions. The over-allotment option may be used to purchase shares of common stock and/or common warrants, in any combination thereof, as determined by the underwriter, but such purchases cannot exceed an aggregate of 15% of the number of shares of common stock and 15% of all of the common warrants sold in the primary offering. The over-allotment option is exercisable for 45 days from the date of this prospectus.2020.

 

 

Oppenheimer & Co.Sole Book-Running Manager

Roth Capital Partners

Co-Lead Managers

Aegis Capital Corp.Laidlaw & Company (UK) Ltd.

The date of this prospectus is                , 20172020

 


TABLE OF CONTENTS

 

   PagePAGE 

Prospectus SummaryPROSPECTUS SUMMARY

   1 

Risk FactorsTHE OFFERING

6

RISK FACTORS

   8 

Cautionary Statement Concerning Forward-Looking StatementsCAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

   28 

Use of ProceedsUSE OF PROCEEDS

   29 

DilutionMARKET FOR OUR COMMON STOCK AND RELATED STOCKHOLDER MATTERS

   30 

CapitalizationCAPITALIZATION

   31 

Price Range Of Common Stock And Dividend PolicyDILUTION

   3233 

Our BusinessMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

   3435 

Security Ownership of Certain Beneficial Owners and ManagementBUSINESS

   5441 

Directors, Executive Officers and Corporate GovernanceMANAGEMENT, EXECUTIVE COMPENSATION AND CORPORATE GOVERNANCE

   5753 

Section 16(a) Beneficial Ownership Reporting ComplianceSECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

   6362 

Executive CompensationCERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

   6365 

Certain Relationships and Related Transactions, and Director IndependenceDESCRIPTION OF SECURITIES

   7066 

Description of Capital StockUNDERWRITING

   7072 

Description of Securities We Are OfferingLEGAL MATTERS

   7476 

Certain U.S. Federal Income Tax ConsiderationsEXPERTS

   77 

UnderwritingWHERE TO FIND MORE INFORMATION

   8378 

Legal MattersFINANCIAL STATEMENTS

   90

Experts

90

Where You Can Find More Information

90

Information Incorporated by Reference

90

Financial Statements and Management’s Discussion and Analysis

91F-2 

i


ABOUT THIS PROSPECTUS

You should rely only onNeither we nor the underwriters have authorized anyone to provide you with information other than that contained in this prospectus. We have not authorizedand the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any person to provide you with different information. If anyone provides you with different or inconsistentother information you should not rely on it.that others may give you. We and the underwriters are not making an offeroffering to sell, theseand seeking offers to buy, the securities offered hereby only in any jurisdictionjurisdictions where the offer or sale is notoffers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front cover page of this document,prospectus, or other earlier date stated in this prospectus, regardless of the time of delivery of this prospectus or the time of issuance orany sale of our securities.

No action is being taken in any securities. Our business, financial condition, results of operations and prospects may have changed since that date. You should read this prospectus in its entirety before making an investment decision. You should also read and consider the information in the documents to which we have referred you in the section of this prospectus entitled “Where You Can Find More Information.”

For investorsjurisdiction outside of the United States neither we nor the underwriter have done anything that wouldto permit thisa public offering of our securities or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other thanjurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States. YouStates are required to inform yourselvesthemselves about and to observe any restrictions relatingas to this offering and the distribution of this prospectus outside of the United States.

Industry and Market Dataapplicable to that jurisdiction.

This prospectus includes industry data and forecasts that we have obtained from industry publications and surveys, public filings and internal company sources. Industry publications and surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but there can be no assurance as to the accuracy or completeness of the included information. Statements as to our market position and market estimates are based on independent industry publications, government publications, third party forecasts, management’s estimates and assumptions about our markets and our internal research. While we are not aware of any misstatements regarding the market, industry or similar data presented herein, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed under the headings “Risk Factors” and “Cautionary Statement Concerning Forward-Looking Statements” in this prospectus.

ii


PROSPECTUS SUMMARY

The following summary highlights information contained elsewhere in this prospectus. It does not contain all of the information you need to consider in making your investment decision. Before making an investment decision, you should read this entire prospectus carefully and you should consider, among other things, the matters set forth under “Risk Factors” and our financial statements and related notes thereto appearing elsewhere in this prospectus or incorporated by reference into this prospectus. In this prospectus, except as otherwise indicated, “Delcath,” “Delcath Systems,” the “Company,” “we,” “our,” and “us” refer to Delcath Systems, Inc., a Delaware corporation, and its subsidiaries. “Delcath” is our registered United States trademark.

Delcath Systems, Inc. isCompany Overview

We are an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product—lead product candidate, Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System, (Melphalan/HDS) —isor Melphalan/HDS, is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our systemMelphalan/HDS is in commercial developmentapproved for sale under the trade name Delcath Hepatic CHEMOSAT® Hepatic Delivery System for Melphalan, (CHEMOSAT®), where it has been used at major medical centers to treat a wide range of cancers of the liver.or CHEMOSAT.

Our primary research focus is on ocular melanoma liver metastases, (mOM)or mOM, and intrahepatic cholangiocarcinoma, (ICC),or ICC, a type of primary liver cancer, andas well as certain other cancers that are metastatic to the liver. We believe that the disease states we are investigating represent a multi-billion dollar global market opportunity and a clearare unmet medical need.needs that represent significant market opportunities.

We are investigating the objective response rate of Melphalan/HDS in patients with mOM in our FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma, or the FOCUS Trial, a global registration clinical trial. For information on the FOCUS Trial, see “Business—Clinical Development Program—The FOCUS Trial”.

We are also conducting the ALIGN Trial, a global Phase 3 clinical trial of Melphalan/HDS in patients with ICC, or the ALIGN Trial. For information on the ALIGN Trial, see “Business—Clinical Development Program—The ALIGN Trial” below.

In addition to the FOCUS Trial and the ALIGN Trial, our commercial development plan also includes a registry for CHEMOSAT cases performed in Europe and sponsorship of select investigator-initiated trials, or IITs.

In the United States, Melphalan/HDS is considered a combination drug and device product and is regulated as a drug by the United States Food and Drug Administration, or the FDA. The drug Melphalan alone and doxorubicin has been previously approved by FDA for various oncologic indications for other sponsors. Although the Melphalan/HDS Kit has not been approved in the U.S., FDA has granted us six orphan drug designations, which apply to the orphan indication for the drug component even though approved as a drug/device, including three orphan designations for the potential use of the drug melphalan for the treatment of patients with mOM, hepatocellular carcinoma (HCC) and ICC. Melphalan/HDS has not been approved for sale in the United States. There are also orphan drug designations for melphalan for neurodendocrine tumors, cutaneous melanoma, and ocular tumors, as well as for the use of doxorubicin for HCC.

In Europe, the current version of our CHEMOSAT product is regulated as a Class IIb medical device and received its CE Mark in 2012. We are in an early phase of commercializing the CHEMOSAT system in select markets in the United Kingdom and the European Union, (EU)or EU, where we believe the prospect of securing adequate reimbursement for the procedure is strongest. In 2015 national reimbursement coverage for the use of CHEMOSAT procedures was awarded in Germany. In 2016, coverage levels were negotiated between hospitals in Germany and regional sickness funds. Coverage levels determined via this process are expected to be renegotiated annually.

Our clinical development program for CHEMOSAT and Melphalan/HDS is comprised, in part, of The FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (The FOCUS Trial), a Global Phase 3 clinical trial that is investigating overall survival in mOM. We have also initiated a separate clinical trial that also uses Melphalan/HDS Kit for intrahepatic cholangiocarcinoma (ICC), which we plan to initiate when financial resources permit. Our clinical development plan (CDP) also includes a commercial registry for CHEMOSATnon-clinical commercial cases performed in Europe and sponsorship of select investigator initiated trials (IITs) in colorectal cancer metastatic to the liver (mCRC) and pancreatic cancer metastatic to the liver.

The direction and focus of our CDP for CHEMOSAT and Melphalan/HDS is informed by prior clinical development conducted between 2004 and 2010,non-clinical, commercial CHEMOSAT cases performed on patients in Europe, and prior regulatory experience with the FDA. Experience gained from this research, development, early European commercial and United States regulatory activity has led to the implementation of several safety improvements to our product and the associated medical procedure.

Currently there are few effective treatment options for certain cancers in the liver. Traditional treatment options include surgery, chemotherapy, liver transplant, radiation therapy, interventional radiology techniques, and isolated hepatic perfusion. We believe that CHEMOSAT and Melphalan/HDS represents a potentially important advancement in regional therapy for primary liver cancer and certain other cancers metastatic to the liver. We believe that CHEMOSAT and Melphalan/HDS is uniquely positioned to treat the entire liver either as a standalone therapy or as a complement to other therapies.strongest.

Cancers in the Liver – Liver—A Significant Unmet Need

Cancers of the liver remain a major unmet medical need globally. According to the American Cancer Society’s, (ACS)or ACS, Cancer Facts & Figures 20172018 report, cancer is the second leading cause of death in the United States, with an estimated 600,920609,640 deaths and 1,688,7801.7 million new cases expected to be diagnosed in 2017.2018. Cancer is one of the leading causes of death worldwide, accounting for approximately 8.29.6 million deaths and 14.118.1 million new cases in 20122018 according to GLOBOCAN.GLOBOCAN, the database of the International Association of Cancer Registries. The financial burden of cancer is enormous for patients, their families and society. The Agency for Healthcare Quality and Research estimates that the direct medical costs (total of all healthcare expenditures) for cancer in the U.S.United States in 20142015 was $87.8$80.2 billion. The liver is often the life-limiting organ for cancer patients and cancer that spreads to the liver is one of the leading causes of cancer death. Cancer that begins in one area of the body often metastasizes to the liver. Patient prognosis is generally poor once cancer has spread to the liver. Consequently, cancers of the liver remain a major unmet medical need globally.

Liver Cancers—Incidence and Mortality

There are two typesCancers of the liver cancers:consist of primary liver cancer and metastatic liver disease.cancer. Primary liver cancer (hepatocellular carcinoma, or HCC, including intrahepatic bile duct cancers or ICC) originates in the liver or biliary tissue and is particularly prevalent in populations where the primary risk factors for the disease, such ashepatitis-B,hepatitis-C, high levels of alcohol consumption, aflatoxin, cigarette smoking and exposure to industrial pollutants, are present. Metastatic liver disease,cancer, also called liver metastasis, or secondary liver cancer, is characterized by microscopic cancer cell clusters that detachresults from the spread or “metastases” of a primary site of disease and travel via the blood stream and lymphatic systemcancer into the liver, where they grow into new tumors.liver. These metastases often continue to grow even after the primary cancer in another

part of the body has been removed. Given the vital biological functions of the liver, including processing nutrients from food and filtering toxins from the blood, it is not uncommon for metastases to settle in the liver. In many cases patients die not as a result of their primary cancer, but from the tumors that metastasize to their liver. In the United States, metastatic liver disease is more prevalent than primary liver cancer.

There are few effective treatment options for certain cancers in the liver. Traditional treatment options include surgery, systemic chemotherapy, immunotherapy, liver transplant, radiation therapy, interventional radiology techniques, and isolated hepatic perfusion. We believe that CHEMOSAT and Melphalan/HDS represent a potentially important advancement in regional therapy for primary liver cancer and certain other cancers metastatic to the liver and are uniquely positioned to treat the entire liver either as a standalone therapy or as a complement to other therapies.

Ocular Melanoma

Ocular melanoma is one of the cancer histologies with a high likelihood of metastasizingfrequently metastasizes to the liver. Based on third party research conductedthat we commissioned in 2016,2018, we estimate that up to 4,700approximately3,700-4,700 cases of ocular melanoma are diagnosed in the United States and Europe annually, and that approximately 55%50-55% of these patients will develop metastatic disease. Of metastatic cases of ocular melanoma, we estimate that approximately 90% of patients will develop liver involvement. OnceAccording to Lane et al.,JAMA Ophthalmol. 2018 Sep1;136(9):981-98, once ocular melanoma has spread to the liver, current evidence suggests median overall survival for these patients is generally six3.9 months (untreated) to eight months. Currently there6.3 months (treated). There is no one standard of care (SOC) for patients with ocular melanoma liver metastases. According to our 2016Based on the research conducted in 2018, we estimate that approximately 2,0001,400-2,150 patients with ocular melanoma liver metastases in the United States, the United Kingdom and Europethe EU may be eligible for treatment with the Melphalan/HDS.HDS annually. Based on our reimbursement experience with CHEMOSAT, we estimate the annual addressable market for this indication in the United States, the United Kingdom and the EU is approximately $200 million per year.

Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC)

HepatobiliaryPrimary liver cancers – includinginclude HCC and ICC – are among the most prevalent and lethal forms of cancer.ICC. According to GLOBOCAN, an estimated 78,500 new cases of primary liver cancers are diagnosed in the United States and Europe annually. According to the ACS, approximately 40,71042,810 new cases of HCC and ICC willthese cancers are expected to be diagnosed in the United States in 2017. Approximately75-90% of these patients are diagnosed with HCC. Excluding patients who are eligible for surgical resection or certain focal treatments, we estimate that2020 leading to approximately 15,000 patients with HCC in the United States and Europe may be eligible for treatment with Melphalan/HDS. We estimate that an additional 9,300 patients diagnosed with ICC may also be eligible for treatment with Melphalan/HDS. According to the ACS, the overall five-year survival rate for liver cancer patients in the United States is approximately 18%. For patients diagnosed with a localized stage of disease, the ACS estimates5-year survival at 31%. The ACS estimates that5-year survival for all cancers is 68%. Globally, with 782,000 new cases in 2012, HCC was the fifth most common cancer in men and the ninth in women according to GLOBOCAN. GLOBOCAN estimates indicate that HCC was responsible for 746,000 deaths in 2012 (9.1% of the total cancer deaths), making it the second most common cause of death from cancer worldwide.

The prognosis for primary liver cancer is very poor, as indicated by an overall ratio of mortality to incidence of 0.95. The American Cancer Society’s Cancer Facts & Figures 2017 outlines the treatment options for HCC as follows: “Early stage liver cancer can sometimes be successfully treated with surgery to remove part of the liver (partial hepatectomy); however, few patients have sufficient healthy liver tissue for this option. Liver transplantation may be possible in individuals with small tumors who are not candidates for partial hepatectomy. Other treatment options include tumor ablation (destruction) or embolization (blocking blood flow). Few options exist for patients diagnosed at an advanced stage. Sorafenib (Nexavar®) is a targeted drug approved for the treatment of HCC in patients who are not candidates for surgery and do not have severe cirrhosis.”

Based on third party research, we estimate that up to 15,000 of the 65,000 patients diagnosed annually in the United States and Europe could be eligible candidates for treatment with the Melphalan/HDS. The FDA has granted orphan drug status to the Melphalan/HDS for treatment of patients with unresectable HCC. We believe that there is a large unmet medical need in first line therapy for patients with HCC, with Sorafenib the only currently approved systemic therapy in the United States, Europe and certain Asian markets.30,160 deaths.

ICC is the second most common form of primary liver tumorcancer and according to Wang et al., 2013 J Clin Oncol 31:1188-1195 accounts for 3%5-30% of all gastrointestinalprimary liver cancers and 15% of HCC cases diagnosed in the United States and Europe annually. Outside of resection, which is the only cure for ICC, there is currently no standard of care. Based on third party research, weWe believe that 90% of ICC patients are not candidates for surgical resection, and that approximately20-30% of these may be candidates for certain focal interventions. WeAccording to third party research that we commissioned in 2018 we estimate that approximately 9,30011,000 ICC patients in the United States, the United Kingdom and Europethe EU annually could be candidates for treatment with Melphalan/HDS, whichHDS. Based on our reimbursement experience with CHEMOSAT, we believe representsestimate the annual addressable market for this indication in the United States, the United Kingdom and the EU is approximately $825 million per year.

According to the ACS, the overall five-year survival rate for primary liver cancers in the United States is approximately 18%. For patients diagnosed with a significant market opportunity.localized stage of disease, the ACS estimates5-year survival at 33%.

About CHEMOSAT and Melphalan/HDS Kit

CHEMOSAT and Melphalan/HDSOur product administers concentrated regional chemotherapy to the liver. This “whole organ” therapy is performed by isolating the circulatory system of the liver, infusing the liver with a chemotherapeutic agent, and then filtering the blood prior to returning it to the patient.patient’s circulatory system. During the procedure, known as percutaneous hepatic perfusion, (PHPPHP® therapy), or PHP therapy, three catheters are placed percutaneously through standard interventional radiology techniques. The catheters temporarily isolate the liver from the body’s circulatory system, allow administration of the chemotherapeutic agent melphalan hydrochloride directly to the liver, and collect blood exiting the liver for filtration by our proprietary filters. The filters absorb chemotherapeutic agent in the blood, thereby reducing systemic exposure to the drug and related toxic side effects, before the filtered blood is returned to the patient’s circulatory system.

PHP therapy is performed in an interventional radiology suite in approximately two to three hours. Patients remain in an intensive care or step-down unit overnight for observation following the procedure. Treatment with CHEMOSAT and Melphalan/HDS is repeatable, and a new disposable CHEMOSAT and Melphalan/HDSsystem is used for each treatment. Patients treated in clinical trial settings are permitted up to six treatments. Innon-clinical commercial treatment settings, patients have received up to eight treatments. In the United States, if we receive FDA approval, melphalan hydrochloride for injection will be included withas part of the system, and marketed as the drug/device melphalan/HDS Kit.if approved. In Europe, the system is sold separately and used in conjunction with melphalan hydrochloride commercially available from a third party. In our clinical trials, melphalan hydrochloride for injection is provided to both European and United States clinical trial sites.

Risks

Recent Developments

On July 11, 2019, we entered into a securities purchase agreement with certain accredited investors pursuant to which we sold to investors an aggregate of Investing20,000 shares of our Series E convertible preferred stock, par value $0.01 per share, or the Series E Preferred Stock, at a price of $1,000 per share and a warrant, or a 2019 E Warrant, to purchase a number of shares of common stock equal to the number of shares of common stock issuable upon conversion of the Series E Preferred Stock purchased by the investor, or the July 2019 Private Placement. In connection with the July 2019 Private Placement, we exchanged $11.8 million of debt, interest and Series D Warrants for 11,500 shares of Series E Preferred Stock and related 2019 Warrants, $0.1 million in accounts payables for 149 shares of Series E Preferred Stock and related 2019 Warrants and issued 923 shares of Series E Preferred Stock and related 2019 Warrants to certain investors in exchange for a waiver of rights under exchange agreements signed in December 2018 and March 2019, or the Debt Exchange.

InvestingOn August 19, 2019, we entered into a securities purchase agreement with certain accredited investors pursuant to which we sold to investors an aggregate of 9,510 shares of SeriesE-1 convertible preferred stock, par value $0.01 per share, or the SeriesE-1 Preferred Stock, at a price of $1,000 per share and a warrant, or a 2019E-1 Warrant, and together with the 2019 E Warrant, the 2019 Warrants, to purchase a number of shares of common stock of the Company equal to the number of shares of common stock issuable upon conversion of the SeriesE-1 Preferred Stock purchased by the investor, or the August 2019 Private Placement, and, collectively with the July 2019 Private Placement, the Private Placements.

Each share of Series E Preferred Stock and SeriesE-1 Preferred Stock, or, collectively, the Preferred Stock, was originally convertible at any time at the option of the holder into the number of shares of common stock determined by dividing the stated value by the conversion price of $42.00, subject to certain limitations and adjustments, or the Conversion Price. Except for certain adjustments, the holders of the Preferred Stock are entitled to receive dividends on shares of Preferred Stock equal (on an “as converted” basis) to and in our securities involves substantial risks. Potential investorsthe same form as dividends paid on shares of the common stock. Any such dividends that are urgednot paid to readthe holders of the Preferred Stock will increase the stated value. No other dividends will be paid on shares of Preferred Stock. Each 2019 Warrant had an original exercise price equal to $42.00, subject to adjustment in accordance with the terms of the 2019 Warrants, or the Exercise Price, and considerbecame exercisable at any time upon the risk factors relatingconsummation of the Reverse Split and will be exercisable until 5:00 p.m. (NYC time) on the date that is five years following the date of the Reverse Split.

Pursuant to the terms of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants were initially subject to adjustment in each of the following circumstances: (i) on the third trading day following the date that the Company effects a reverse stock split, or the Reverse Split Reset Date, (ii) the date that the initial registration statement covering the shares of common stock issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants is declared effective by the Securities and Exchange Commission, or the SEC, or the Registration Reset Date, and (iii) in the event that all of the shares of common stock which we were required to register with the SEC were not then registered on an investment ineffective registration statement, the date that all of the shares underlying the respective Preferred Stock and 2019 Warrants may be sold pursuant to Rule 144, or the Rule 144 Reset Date, each of such reset dates, a Reset Date and, collectively, the Reset Dates. On each Reset Date, the Conversion Price and the Exercise Price were to be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the common stock immediately prior to each Reset Date, or the Reset Formula. In the event of a reduction in the Exercise Price, the aggregate number of Warrant Shares issuable upon the exercise of the 2019 Warrants were to be increased such that the aggregate Exercise Price of the Warrants on the day immediately following such Reset Date equaled the aggregate Exercise Price immediately prior to such adjustment. In addition, from the date of issuance of the Preferred Stock and Warrants until such time that the Company’s common stock is listed or quoted on a national exchange, the Conversion Price and the Exercise Price are subject to price-based anti-dilution protections.

Before giving effect to the Reverse Split, a total of 1,394,478,266 shares of common stock were issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants issued in the Private Placements and the Debt Exchange. If holders of all of the shares issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants had demanded that we honor our obligation to issue such shares, the number of shares of common stock we would have been required to issue would have exceeded the number of shares of common stock we are authorized to issue pursuant to our Amended and Restated Certificate of Incorporation, as amended.

To prevent us from exceeding our common stock authorization and to enable us to complete the registration of the shares issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants, on October 29, 2019, we entered into a Waiver and Forbearance Agreement, or the Waiver, with Rosalind Master Fund LP and Rosalind Opportunities Fund I LP, holders of our Series E and SeriesE-1 Preferred Stock and related 2019 Warrants, or Rosalind, pursuant to which Rosalind agreed, among other things, to waive our obligation to register for resale 321,408,352 shares of common stock issuable to Rosalind (before giving effect to the Reverse Split), or the Rosalind Shares, and to forbear from exercising its right to liquidated damages under the registration rights agreements entered into in connection with the Private Placements and the Debt Exchange until the earlier of (x) December 28, 2019, or the Extension Date, and (y) the date that any of the other holders of the securities issued in the Private Placements became entitled to receive liquidated damages under such registration rights agreements.

On November 7, 2019 the SEC declared effective our registration statement on FormS-1 (FileNo. 333-233396) pursuant to which we registered a total of 980,557,497 shares of our common stock (before giving effect to the Reverse Stock Split) for resale or other disposition by the selling stockholders named therein. In addition, prior to the Reverse Split, an aggregate of 565 shares of Preferred Stock were converted into an aggregate of 9,418,747 shares of common stock.

The Registration Reset Date occurred on November 7, 2019. However, pursuant to the Reset Formula, no reduction in the Conversion Price or the Exercise Price occurred on the Registration Reset Date. The Reverse Split Reset Date occurred on December 30, 2019. Pursuant to the Reset Formula, the Conversion Price and the Exercise Price were reduced to $23.04 per share as of the Reverse Split Reset Date. The Rule 144 Reset Date with respect to the Series E Preferred Stock and the Series E Warrants occurred on January 15, 2020, but no reset in the Conversion Price or the Exercise Price of the Series E Preferred Stock or the Series E Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale. The Rule 144 Reset Date with respect to the SeriesE-1 Preferred Stock and the SeriesE-1 Warrants occurred on February 19, 2020, but no reset in the Conversion Price or the Exercise Price of the SeriesE-1 Preferred Stock or the SeriesE-1 Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale.

As a consequence of the reduction of the Conversion Price on the Reverse Split Reset Date, an additional 813,473 shares of common stock became issuable upon the conversion of the Preferred Stock and, as a consequence of the reduction of the Exercise Price on the Reverse Split Reset Date, an additional 824,587 shares of common stock became issuable upon the exercise of the 2019 Warrants, or collectively the Reset Shares. Pursuant to the terms of the registration rights agreements entered into in connection with the Private Placements and the Debt Exchange we were required to register a number of shares of our common stock that would be issuable assuming that the Conversion Price and the Exercise Price were $16.10 per share, regardless of the actual Conversion Price or the Exercise Price. Pursuant to that requirement, we registered a total of 3,429,680 shares of common stock for sale or other disposition by the Selling Stockholders on our registration statement on FormS-1 (FileNo. 333-235751), or the Second Registration Statement, which included the Rosalind Shares, the Reset Shares and an additional 1,564,085 shares of our common stock, or the Registrable Shares, even though we were obligated to issue only the Reset Shares as a result of the Reverse Split. However, because the Second Registration Statement was not declared effective until January 7, 2020, we are liable to Rosalind for liquidated damages under the terms of the registration rights agreements relating to the Private Placements and the Debt Exchange for the period from December 28, 2019 to January 7, 2020.

Because the combined public offering price per share and related Series F warrant in this offering will be less than $23.04 per share, under the full-ratchet price-protection provisions of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants will be reduced to such public offering price and we will be required to issue 1,389,308 additional shares of common stock upon the conversion of the Preferred Stock, assuming a combined public offering price of $13.00 per share, and related Series F warrant the closing sale price per share of our common stock on the OTCQB on April 17, 2020.

We have filed a registration statement on FormS-1 (FileNo. 333-236100), or the Adjustment Registration Statement, to register additional shares of common stock for sale or other disposition by the holders of the Preferred Stock in an amount representing the difference between the shares of common stock that will become issuable as a result of this offering upon the conversion of the Preferred Stock, and the number of shares of common stock issuable upon the conversion of the Preferred Stock that have been previously registered by us.

Support and Conversion Agreement

We have entered into a support and conversion agreement with Rosalind and our executive officers, which, as amended, we refer to as the support and conversion agreement, pursuant to which, among other things: (i) upon the consummation of this offering, the executive officers have agreed to receive payment of their 2019 annual incentive bonuses aggregating $221,000 in shares of our common stock valued at the combined public offering price per share and related Series F warrant set forth under “Risk Factors”on the cover page of this prospectus, (ii) Rosalind has agreed that from time to time we may require them to convert all or a portion of their 8% senior secured promissory notes in the aggregate principal amount of $2 million into shares of Series E Preferred Stock and Series E Warrants at the contractual conversion price of $1,500 per share of Series E Preferred Stock in certain circumstances described below, or a Rosalind Conversion, and (iii) the executive officers have agreed to receive payment of certain back pay and deferred bonus amounts aggregating $765,000 in shares of our common stock valued at the greater of (x) the last reported sale price per share as of the trading day immediately preceding the Equity Infusion Date (as defined below) and (y) the volume-weighted average price of the common stock for the five trading days immediately preceding the Equity Infusion Date in such circumstances, or an Equitization Transaction.

Pursuant to the support and conversion agreement, we can only effect a Rosalind Conversion and an Equitization Transaction, or collectively, an Equity Infusion, in the event we reasonably determine that an Equity Infusion is reasonably necessary for us to meet Nasdaq’s continued listing requirement that we maintain stockholders’ equity of at least $2.5 million unless an Equity Infusion would not avoid the delisting of our common stock from Nasdaq as a result of our failure to meet Nasdaq’s other continued listing requirements (an “Equity Infusion Determination”). In the event of an Equity Infusion Determination, we will deliver written notice thereof to Rosalind and each executive officer (an “Equity Infusion Notice”), which Equity Infusion Notice will specify our calculation of the amount of the required Equity Infusion required to satisfy the Minimum Stockholders’ Equity Requirement. Any Equity Infusion Notice will specify the date, which will not be less than the third business day after the date of such Equity Infusion Notice or more than five business days after the date of such Equity Infusion Notice, on which the Equity Infusion will occur (such date, the “Equity Infusion Date”). The Equity Infusion will be allocated among Rosalind and the executive officers so that 50% of the Equity Infusion takes the form of a Rosalind Conversion and the remaining 50% of the Equity Infusion takes the form of an Equitization Transaction, subject to certain conditions, until all of the back pay and deferred bonus amounts have been paid pursuant to an Equitization Transaction, and thereafter solely by a Rosalind Conversion.

In the support and conversion agreement, we agreed to provide Rosalind with the right to participate in future financings until the second anniversary of the closing of this offering. The support and conversion agreement will expire on the earlier of (i) the date on which all of the Rosalind notes have been converted or paid in full, or (ii) June 30, 2021, and will terminate prior thereto (x) with respect to an executive officer, upon the effective date of the termination of the executive officer’s employment by us and (y) if we do not receive Nasdaq approval for the listing of the common stock or this offering is not consummated on or before April 30, 2020, other than as a result of Rosalind’s failure to satisfy the participation condition described below. Rosalind’s participation rights will survive any such expiration and or termination.

Pursuant to the terms of the support and conversion agreement, Rosalind has notified us that it intends to participate in this prospectus as well as other information we include or incorporateoffering.

The description of the support and conversion agreement provided above is a summary only, is not intended to be complete, and is qualified in its entirety by reference to the support and conversion agreement, a copy of which has been filed as an exhibit to the registration statement of which this prospectus forms a part. See “Where to Find More Information.”

Board Appointment Agreement

We have entered into a board appointment agreement, or the board appointment agreement, with Rosalind pursuant to which we agreed to provide Rosalind with certain representation rights on our board of directors, or the board. Pursuant to the terms of the board appointment agreement, Rosalind will have the right to nominate, and to cause the removal or replacement of, up to two directors for election to our board, or the Rosalind nominees, in the event that this offering is consummated on or prior to April 30, 2020 and Rosalind invests at least $4.0 million in this prospectus.offering on the same terms as the other investors in this offering, or the participation condition, or in the event that this offering is not consummated on or prior to that date other than as a result of Rosalind’s failure to satisfy the participation condition. The Rosalind nominees must meet all applicable requirements for treatment as independent directors under applicable SEC and Nasdaq rules and regulations. The board has determined that Gil Aharon and Steven Salamon, the principals of Rosalind, would qualify as independent directors under such rules and regulations. One Rosalind nominee would be appointed to the class of directors whose term expires at our 2022 annual meeting of stockholders and the other would be appointed to the class of directors whose term expires at our 2021 annual meeting of stockholders.

If Rosalind exercises its rights to nominate one or more Rosalind nominees, Rosalind will also have the right to designate a Rosalind nominee for service on any committee of the board so long as such Rosalind nominee meets any applicable SEC and Nasdaq requirements for membership on such committee.

If Rosalind exercises its rights to nominate one or more Rosalind nominees, the board will increase the size of the board and elect the Rosalind nominees to fill the vacancies created by such increase. Rosalind’s right to nominate one or more Rosalind nominees as described will expire, if unexercised, at 5:00 p.m. on May 5, 2020 or, prior thereto, if Rosalind ceases to be the beneficial owner of at least 9.99% of our common stock (determined without giving effect to any provision of any security limiting Rosalind’s beneficial ownership).

Until the later of such time as Rosalind exercises its nomination rights and April 30, 2020, the board will not fill any vacancy on the board with a candidate who is not approved by Rosalind. If Rosalind exercises its right to nominate one or more Rosalind nominees, the board has agreed that prior to our 2020 annual meeting of stockholders and, in any event, no later than June 30, 2020, the board will meet to consider and approve a reduction in the size of the board from eight to no fewer than six members. Any director who is asked to step down from the board has agreed to resign at the end of the meeting.

The description of the board appointment agreement provided above is a summary only, is not intended to be complete, and is qualified in its entirety by reference to the board appointment agreement, a copy of which has been filed as an exhibit to the registration statement of which this prospectus forms a part. See “Where to Find More Information.”

Corporate Information

We were incorporated in the State of Delaware in August 1988. Our principal executive offices are located at 1633 Broadway, Suite 22C, New York, New York 10019. Our telephone number is(212)489-2100. Our Our website address is http://www.delcath.com. Information contained in our website does not constitute any part of, and is not a part ofincorporated into, this prospectus.

The OfferingTHE OFFERING

 

UnitsCommon stock offered by us in this offering:  422,535,211 units, each consisting1,692,307 shares of oneour common stock (1,946,153 shares if the underwriters exercise the over-allotment option in full), assuming a combined public offering price of $13.00 per share and related Series F warrant, the closing sale price per share of our common stock and one on the OTCQB on April 17, 2020.
Series C common warrantF warrants offered by usSeries F warrants to purchase oneup to 1,692,307 shares of common stock, which will be exercisable during the period commencing on the date of their issuance and ending five years from such date at an exercise price per share of our common stock one Series D common warrantequal to purchase one100% of the combined public offering price per share of our common stock and onerelated Series EF warrant in this offering. This prospectus also relates to the offering of the shares of common warrant to purchase one sharestock issuable upon exercise of our common stock.the Series F warrants.
Pre-funded unitswarrants offered by us in this offering:  We are also offering to each purchaserthose purchasers, if any, whose purchase of unitscommon stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses,pre-funded units (eachpre-funded unit consisting of onepre-funded warrant to purchase one share of our common stock and one Series C common warrant to purchase one share of our common stock, one Series D common warrant to purchase one share of our common stock, and one Series E common warrant to purchase one share of our common stock)warrants in lieu of unitsshares of common stock that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding common stock (or, at the election of the purchaser, 9.99%). The of our outstanding common stock. Eachpre-funded warrant is being sold with one Series F warrant to purchase one share of our common stock, at an assumed combined public offering price of each$12.99 perpre-funded unitwarrant and related Series F warrant, the closing sale price per share of our common stock on the OTCQB on April 17, 2020, less the $0.01 exercise price of thepre-funded warrant), representing a public offering price of $12.98 perpre-funded warrant and $0.01 per related Series F warrant. Thepre-funded warrants and Series F warrants will equal the price at which the units are being sold to the public in this offering, minus $0.01, and thebe issued separately. The exercise price of eachpre-funded warrant included in eachpre-funded unit will beequal $0.01 per share. ThisEachpre-funded warrant will be exercisable upon issuance and will not expire prior to exercise. We are offering also relatesup to the1,692,307 shares of common stock issuable upon exercise of anyand up to 1,692,307pre-funded warrants, sold in this offering.the aggregate not exceeding more than a total of 1,692,307 shares of common stock andpre-funded warrants. For eachpre-funded unitwarrant we sell, the number of unitsshares of common stock we are offering will be decreased on aone-for-one basis. Because we will issue three common warrants as part of each unit orpre-funded unit, the number of common warrants sold in this offering will not change as a result of a change in the mix of the units andpre-funded units sold.
Common warrants offered by us in the offeringSeries C common warrants to purchase an aggregate of 422,535,211 shares of our common stock, Series D common warrants to purchase an aggregate of 422,535,211 shares of our common stock and Series E common warrants to purchase an aggregate of 422,535,211 shares of our common stock. Each unit and eachpre-funded unit includes a Series C common warrant to purchase one share of our common stock, a Series D common warrant to purchase one share of our common stock, and a Series E common warrant to purchase one share of our common stock. Each Series C common warrant will have an exercise price of $ per share, each Series D common warrant will have an exercise price of $ per share, and each Series E common warrant will have an exercise price of $ per share, will be immediately separable from the common stock orpre-funded warrant, as the case may be, will be immediately exercisable, and each Series C common warrant will expire on the fifth anniversary of the original issuance date, each Series D common warrant and Series E common warrant will expire on the first anniversary of the original issuance date. This prospectus also relates to the offering of the shares of our common stock issuable upon exercise of the commonpre-funded warrants.

Common stock to be

outstanding after

this offering

  912,557,4201,765,080 shares excludingof our common stock(1) (2,018,926 shares if the underwriters exercise the over-allotment option in full) ), assuming we sell only shares underlyingof common stock and assuming no exercise of the Series F warrants.
OverallotmentUnderwriters’ option to purchase additional securities (2)  We have granted the underwriter anunderwriters a30-day option to purchase up to an additional 253,846 shares of common stock equaland/or Series F warrants to 15%purchase up to 253,846 shares of the sharescommon stock, in the offering and/or additional Series C common warrants, Series D common warrants and Series E common warrants equal to 15% of the Series C common warrants, Series D common warrants and Series E common warrants in the offeringany combination thereof, from us at the public offering price per share of common stock and the public offering price per Series C common warrant, Series D common warrant and Series E common warrant set forth on the cover page heretosecurity, less the underwriting discounts and commission. This option is exercisable, in whole or in part, for a period of 45 days from the date of this prospectus
Reverse stock split

Effective on September 21, 2017, the two holders of 590 shares of the Company’s Series C preferred stock, voting with the Company’s common stock with each share of Series C preferred stock having 880,375 votes per share, representing 51% of the outstanding shares of the Company’s Series C preferred stock (on an as voted basis) and common stock as of such date, executed a written consent in lieu of a special meeting of stockholders (the “Majority Stockholder Consent”), approving the following matter, which had previously been approved by the Board of Directors of the Company on September 12, 2017:

•     authority for our Board of Directors, without further stockholder approval,discount, to effect a reverse stock split of all of the outstanding common stock of the Company, by the filing of a Certificate of Amendment to the Company’s Articles of Incorporation with the Secretary of State of Delaware, in a ratio of 1:50, 1:100 or 1:350, with the Company’s Board of Directors having the discretion as to whether or not the reverse split is to be effected, and with the exact exchange ratio of 1:50, 1:100 or 1:350 as determined by the Board of Directors in its sole discretion, at any time before the earlier of (a) September 19, 2018; and (b) the date of the Company’s 2018 annual meeting of stockholders.

On October 4, 2017, we filed a Definitive Information Statement on Schedule 14C with regard to the foregoing, which was mailed to our shareholders on or about October 15, 2017. On the 20th calendar day subsequent to the mailing date, we can file the Certificate of Amendment to our Articles of Incorporation effecting a reverse split of our issued and outstanding common stock in one of the three ratios approved by our majority shareholders, as approved by our Board of Directors. We will not seek to have this Registration Statement declared effective until this reverse split is effected.

cover over-allotments, if any.
Use of proceeds  We expectintend to use the net proceeds fromof this offering (including any resulting from the exercise of the warrants, if any) to fund the clinical and regulatory development of clinical studies, commercialization of our products, obtaining regulatory approvals, as well as for working capital and other general corporate purposes, including funding the costscontinued development of operating as a public company.Melphalan/HDS. See “Use of Proceeds.”
Dividend policyWe have never declared or paid any dividends to the holders of our common stock and we do not expect to pay cash dividends in the foreseeable future. We currently intend to retain any earnings for use in connection with the expansion of our business and for general corporate purposes.
OTCQB symbol for
common stock
DCTHProceeds” beginning on page 29.
Risk factors  Investing in our securities involves a high degree of risk. See “Risk Factors” beginning on page 8.
OTCQB SymbolOur common stock is quoted on the OTCQB under the symbol “DCTH.”

Proposed NASDAQ listing and symbolOur common stock has been approved for listing on The NASDAQ Capital Market under the symbol “DCTH” contingent on the completion of this offering. There is no established public trading market for the Series F warrants or thepre-funded warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list the Series F warrants or thepre-funded warrants on any national securities exchange or other information included or incorporated by reference in this prospectus for a discussionnationally recognized trading system. Without an active trading market, the liquidity of the factors you should carefully consider before deciding to invest in our securitiesSeries F warrants and thepre-funded warrants will be limited.
Transfer agent and registrar  American Stock Transfer and& Trust Company, LLC

(1)

The table and discussion above are based on 72,773 shares of common stock outstanding as of April 17, 2020 and excludes, as of that date, the following:

The number of1,799,093 shares of our common stock outstanding prior to and immediately after this offering, as set forth above, excludes the following potentially dilutive securities as of October 31, 2017:

55,000 shares issuable upon conversion of the exercise of stock options at a weighted average exercise price of $96.99 per share;outstanding Preferred Stock;

 

0.3 million

1,826,608 shares of common stock issuable upon the exercise of outstanding warrants athaving a weighted average exercise price of $12.57$23.04 per share;

 

18,000

1,640 shares reservedof common stock issuable upon the exercise of outstanding options having a weighted average exercise price of $196.70 per share;

63,493 shares of common stock issuable upon the conversion of convertible notes; and

502 shares available for future issuancegrant under our 20092019 Equity Incentive Plan, as amended;or the 2019 Plan.

 

0.1 million unvested restricted shares;
(2)

Because the Series F warrants are not listed on a national securities exchange or other nationally recognized trading market, the underwriters will be unable to satisfy any over-allotment of Series F warrants without exercising the underwriters’ over-allotment option with respect to the Series F warrants. The underwriters have informed us that they intend to exercise their over-allotment option for all of the Series F warrants that are over-allotted, if any, at the time of the initial offering of the our securities. However, because our common stock will be listed on Nasdaq, the underwriters may satisfy some or all of the over-allotment of shares of our common stock, if any, by purchasing shares in the open market and will have no obligation to exercise the over-allotment option with respect to our common stock. Assuming no sale ofpre-funded warrants, if the underwriters exercise their over-allotment option with respect to the Series F warrants in full, but do not exercise their over-allotment option with respect to our common stock, then, the effective warrant coverage for each share of common stock sold in this offering would increase to 115% instead of the 100% stated on the cover of this prospectus.

Except as otherwise indicated herein, all information in this prospectus has been adjusted to give effect to the Reverse Split, and

1,267,605,633 shares issuable upon assumes (i) no investor elects to purchasepre-funded warrants in lieu of common stock in this offering, (ii) no exercise of the Series C common warrants, Series D commonF warrants, and Series E common warrants offered hereby.(iii) no exercise by the underwriters of their over-allotment option to purchase additional securities.

Summary of Historical Financial Data

You should read the summary of historical financial data set forth below in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and the consolidated financial statements and the related notes included in our Annual Report on Form10-K for the year ended December 31, 2016 and our Quarterly Report on Form10-Q for the quarter ended June 30, 2017, each of which is incorporated by reference herein. We derived the following summary historical financial statement of operations data and other data for each of the two years in the period ended December 31, 2016 and the summary historical balance sheet data as of December 31, 2016 from our audited financial statements. We derived the summary historical financial data as of and for the six months ended June 30, 2017 and 2016 from our unaudited financial statements. In our opinion, the unaudited financial statements have been prepared on the same basis as our audited financial statements and include all adjustments (consisting of only normal recurring adjustments) necessary for a fair presentation of the information set forth therein. The results for any interim period are not necessarily indicative of the results that may be expected for a full fiscal year.

   Six Months Ended June 30,  Year Ended December 31, 
   2017  2016  2016  2015    
   (in thousands, except share and per share data)    

STATEMENT OF OPERATIONS DATA:

      

Product revenue

  $1,327  $880  $1,992  $1,747  

Cost of goods sold

   354   261   (550  (462 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Gross profit

   973   619   1,442   1,285  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Operating Expenses:

      

Selling, general and administrative

  $4,947  $4,633  $9,434  $10,009  

Research and development

   4,840   3,289   8,448   6,486  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   9,787   7,952   17,882   16,495  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Operating loss

   (8,814  (7,333  (16,440  (15,210 

Change in fair value of warrant liability, net

   1,200   491   12,780   564  

Interest income (expense)

   (15,282  (1,631  17   9  

Other income (expense) and interest income (expense)

   7   (7  (14,328  (67 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss

  $(13,276 $(8,480 $(17,971 $(14,704 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Common share data:

      

Basic loss per share and diluted*

  $(0.09 $(5.72 $(10.59 $(14.56 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
      
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Weighted average number of basic common shares outstanding*

   148,674,658   1,483,148   1,696,237   1,010,105  

Weighted average number of diluted common shares outstanding*

   148,722,094   1,483,148   1,696,237   1,010,105                  

*Reflects aone-for-sixteen (1:16) reverse stock split effected on July 21, 2016

   As of
June 30,
2017
   As of
December 31,
2016
 

BALANCE SHEET DATA:

    

Cash and cash equivalents

  $1,816    4,409 

Total assets

   18,603    35,239 

Total current liabilities

   17,210    36,095 

Accumulated deficit

   (292,464   (279,188

Stockholders’ equity (deficit)

   867    (1,490

RISK FACTORS

This offering and anAn investment in our securities involve a high degree of risk. You should carefully consider the risks described below, together with the financial and other information contained in this prospectus, before you decide to purchase our securities. If any of the following risks actually occurs, our business, financial condition, results of operations, cash flows and prospects could be materially and adversely affected. If any of these risks actually occur, our business, financial condition and results of operations would suffer. In that event, the trading price of our common stock and the market value of the securities offered hereby could decline, and you may lose all or part of your investment.

Risks Related to Our Business and Financial Condition

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

Our independent registered public accounting firm issued a report dated March 25, 2020 in connection with the audit of our financial statements as of December 31, 2019, which included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. In addition, the notes to our financial statements for the year ended December 31, 2019, included in our Annual Report on Form10-K filed with the Commission on March 25, 2020, contain a disclosure describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. Our consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment.

Drug development is an inherently uncertain process with a high risk of failure at every stage of development. We received a complete response letter from the FDA regarding our Melphalan/HDS Kit system, declining to approve our existing New Drug Application, or NDA, in its current form.

Preclinical testing and clinical trials are long, expensive and highly uncertain processes and failure can unexpectedly occur at any stage of clinical development. Drug development is very risky, and it takes several years to complete clinical trials. The start or end of a clinical trial is often delayed or halted due to changing regulatory requirements, manufacturing challenges, required clinical trial administrative actions, slower than anticipated patient enrollment, changing standards of care, availability or prevalence of use of a comparator treatment or required prior therapy, clinical outcomes including insufficient efficacy, safety concerns, or our own financial constraints.

In response to our New Drug Application (NDA),NDA, which we submitted to FDA in August 2012 seeking approval for use of our Melphalan/HDS Kit for the treatment of patients with ocular melanoma of the liver, in September 2013, the FDA denied approval of the NDA in its current form and issued a complete response letter, (CRL).or CRL. A CRL is issued by the FDA when the review of a filean NDA is completed, and questionsdeficiencies remain that preclude approval of the NDA in its current form. The FDA commentsdeficiencies in the CRL included, but were not limited to, a statement that we must perform additional “well-controlled randomized trial(s) to establish the safety and efficacy of Melphalan/HDS Kit using overall survival as the primary efficacy outcome measure” and which “demonstrates that the clinical benefits of Melphalan/HDS Kit outweigh its risks.” The FDA also required that the additional clinical trial(s) be conducted using the product the company intendswe intend to market. Prior to conducting additional clinical trials, we must satisfy certain other requirements of the CRL, including, but not limited to, product quality testing and human factors. Further, in January 2016 we received agreement on a Special Protocol Assessment (SPA) from the FDA andfactors information.

We have initiated a pivotal Phase 3 overall survival clinical trial in ocular melanoma liver metastases.

A SPA is a process whereby a sponsor and FDA reach agreement on clinical trials and protocol elements, as well as planned analyses. While We had a SPA agreement is notwith FDA for this study, which was initially designed as a guarantee that FDA will acceptrandomized trial with a NDA for filing orprimary endpoint of overall survival. We subsequently amended the protocol so that the clinical trial design andis anon-randomized,single-arm study with a primary endpoint of objective response rate. Although the changes to the protocol invalidated the SPA agreement, FDA stated that it would not object to our conducting a study outside of a SPA agreement. However, we will need to justify how the results will be adequateof the study support a favorable risk-benefit assessment, particularly whether the response rate is sufficient to support approval it is hoped that clinical trial quality will be improved.overcome the toxicity of Melphalan/HDS.

In addition, we conduct and participate in numerous clinical trials with a variety of study designs, patient populations and trial endpoints to support additional indications for Melphalan/HDS Kit and HDS with other drug therapies .therapies. In 2014, we initiated a Phase 2 clinical trial with Melphalan/HDS Kit for hepatocellular carcinoma, or HCC, in both the United States and Europe. In 2015, we expanded the Phase 2 clinical trial for HCC was expanded to include a cohort of patients with intrahepatic cholangiocarcinoma, a type of primary liver cancer, or ICC. The trial for this cohort will bewas conducted at the same centers participating in the Phase 2 HCC trial. Unfavorable or inconsistent clinical data from clinical trials, including the Phase 2 clinical trial for HCC, the market’s perception of thisthese clinical data or FDA’s perception of this clinical data, may adversely impact our ability to obtain approval, and theour financial condition. Additionally, even if the results of our Phase 2 clinical trial for HCC and ICC are positive, there is a substantial risk that it will fail to have positive results in Phase 3 clinical trials with regard to efficacy, safety or other clinical outcomes and may never obtain regulatory approval.

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

Our independent registered public accounting firm issued a report dated March 28, 2017 in connection with the audit of our financial statements as of December 31, 2016, which included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. In addition, our notes to our financial statements for the year ended December 31, 2016 included a disclosure describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment.

We doThe Company does not expect to generate significant revenue for the foreseeable future.

Our entire focus has been on developing, commercializing, and obtaining regulatory authorizations and approvals of CHEMOSAT® and Melphalan/HDS and currently we have only developed this system for the treatment of cancers in the liver. If CHEMOSAT and Melphalan/HDS for the treatment of cancers in the liver failsfail as a commercial product,products, we have no other products to sell. In addition, since CHEMOSAT currently is currently only authorizedapproved for marketingcommercialization solely in the European Economic Area (EEA)Union, or the EU, and limited other jurisdictions, if we aremedac GmbH, or medac, our third-party distributor, is unsuccessful in commercializing the product in the EEA andEU and/or if Melphalan/HDS is not approved in the United States and elsewhere, we will have no means of generating revenue. In September 2013, the FDA issued a CRL with respect to our NDA for our Melphalan/HDS system.HDS. A CRL is issued by the FDA when the review of a file is completed and questions remain that preclude approval of the NDA in its then current form. Accordingly, we do not expect to realize any revenues from product sales in the United States in the next several years, if at all. As a result, our revenue sources are, and will remain, extremely limited unless and until our product candidates are approved by the FDA or other additional foreign regulatory agencies and successfully marketed. CHEMOSAT and Melphalan/HDS may not be successful in clinical trials, approved by the FDA or other additional foreign regulatory agency or marketed at any time in the foreseeable future or at all.

Continuing losses may exhaust our capital resources.

As of December 31, 2016,2019, we had $4.4 million in cash and cash equivalents. At June 30, 2017, we had $1.8$10.0 million in cash and cash equivalents. We have had minimal revenue to date, and we have a substantial accumulated deficit, recurring operating losses and negative cash flow. For the years ended December 31, 20162019 and 2015,2018, we incurred net losses of approximately $18.0$8.9 million and $14.7$19.2 million, respectively and for the three and six months ended June 30, 2017 and 2016, we incurred net losses of approximately, $1.9 million and $13.3 million, and $6.7 million and $8.5 million, respectively, and we expect to continue to incur losses in the second half of 2017 and 2018.2020. To date, we have funded our operations through a combination of private placements and public offerings of ourits securities, including convertible notes. If we continue to incur losses, we may exhaust our capital resources, and as a result may be unable to complete our clinical trials, engage in product development and the regulatory approval process and commercialization of CHEMOSAT and Melphalan/HDS or any other versions of the system.these products. If we are unable to raise capital or generate sufficient revenue, we may not be able to pay its debts when they become due and may have to seek protection under federal bankruptcy law or enter into a receivership.

If we cannot raise additional capital, our potential to generate future revenues will be significantly limited since we may not be able to further commercialize CHEMOSAT and Melphalan/HDS, complete our clinical trials or conduct future product development and clinical trials.

We will require additional substantial financing to complete our clinical trial program or seek other approvals, to conduct future development and clinical trials and to further commercialize our product in the EEAEU and any other markets where we may receive approval for our system. In addition, we are obligated to make payments under long-term research and development obligations and lease agreements.products. If financing is unavailable to make the required payments under these agreements, we could be subject to legal liability and our ability to complete ourproduct development projects or our clinical trials could be impaired. We do not know if additional financing will be available when needed at all or on acceptable terms. If we are unable to obtain additional financing as needed, we may not be able to further commercialize CHEMOSAT and Melphalan/HDS, obtain regulatory approvals or complete our development projects or clinical trials, which would result in a complete loss of an investment in our clinical trials.securities.

Our liquidity and capital requirements will depend on numerous factors, including:

 

clinical studies, including a Phase 3 clinical trial to investigate overall survival in ocular melanoma liver metastases and a registration trial in ICC;

 

the timing and costs of our various United States and foreign regulatory filings, obtaining approvals and complying with regulations;

 

the timing and costs associated with developing our manufacturing operations;

 

the timing of product commercialization activities, including marketing and distribution arrangements overseas;

 

the timing and costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights; and

 

the impact of competing technological and market developments.

Insufficient funds may require us to curtail or stop our commercialization activities, regulatory submissions or ongoing activities for regulatory approval, research and development and clinical trials, which will significantly limit our potential to generate future revenues.

Risks Related to FDA and Foreign Regulatory Approval

Our failure to obtain, or delays in obtaining, regulatory approvals may have a material adverse effect on our business, financial condition and results of operations.

CHEMOSAT and Melphalan/HDS isare subject to extensive and rigorous government regulation by the FDA and other foreign regulatory agencies. The FDA regulates the research,development,pre-clinical and and clinical testing, manufacture, safety, effectiveness, record keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution, import and export of pharmaceutical and medical device products. Failure to comply with FDA and other applicable regulatory requirements may, either before or after product approval, subject us to either civil or criminal administrative or judicially-imposed sanctions and/or other penalties.

In the United States, the FDA regulates drug and device products under the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Melphalan/HDS is subject to regulation by the FDA as a combination product, which means it is composed of both a drug product and device product. If marketed individually, each component would therefore be subject to different regulatory pathways and reviewed by different centers within the FDA. A combination product, however, is assigned to a center that will have primary jurisdiction overitspre-market review review and regulation based on a determination of the product’s primary mode of action, which is the single mode of action that provides the most important therapeutic action. In the case of Melphalan/HDS, the primary mode of action is attributable to the drug component of the product, which means that the Center for Drug Evaluation and Research has primary jurisdiction overitspre-market development development and review.

We are not permitted to market Melphalan/HDS in the United States unless and until we obtain regulatory approval from the FDA. To market the product in the United States, we must submit to the FDA and obtain FDA approval of an NDA. An NDA must be supported by extensive clinical and preclinical data, as well as extensive information regarding chemistry, manufacturing and controls, or CMC, to demonstrate the safety and effectiveness of the applicable product candidate. The number and types of preclinical studies and clinical trials that will be required varies depending on the product candidate, the disease or condition that the product candidate is designed to target and the regulations applicable to any particular product candidate. Despite the time and expense associated with preclinical and clinical studies, failure can occur at any stage, and we could encounter problems that cause usit to repeat or perform additional preclinical studies, CMC studies or clinical trials. The FDA and similar foreign authorities could delay, limit or deny approval of a product candidate for many reasons, including because they:

 

may not deem a product candidate to be adequately safe and effective;

 

may determine that the risk: benefit profile is not favorable;

may not find the data from preclinical studies, CMC studies and clinical trials to be sufficient to support a claim of safety and efficacy;

 

may interpret data from preclinical studies, CMC studies and clinical trials significantly differently than we do;we;

 

may not approve the manufacturing processes or facilities associated with our product candidates;

 

may change approval policies (including with respect to our product candidates’ class of drugs) or adopt new regulations; or

 

may not accept a submission due to, among other reasons, the content or formatting of the submission.

Furthermore, we cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If we or our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may require us to recall our products from distribution or withdraw any potential approvals of an NDA for that product.

Undesirable side effects caused by any product candidate that we develop could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications or cause us to evaluate the future of our development programs. The regulatory review and approval process is lengthy, expensive and inherently uncertain. As part of the U.S. Prescription Drug User Fee Act, the FDA has a goal to review and act on a percentage of all submissions in a given time frame. In August 2012, we submitted the Melphalan/HDS NDA seeking an indication for ocular melanoma liver metastases. In September 2013, the FDA declined to approve ourthe NDA and issued a CRL. The FDA commentsdeficiencies in the CRL included, but were not limited to, a statement that we must perform additional “well-controlled randomized trial(s) to establish the safety and efficacy of Melphalan/HDS using overall survival as the primary efficacy outcome measure” and which “demonstrates that the clinical benefits of Melphalan/HDS outweigh its risks.” The FDA also requires that the additional clinical trial(s) be conducted using the product the companywe intends to market. Prior to conducting additional clinical trials, we must satisfy certain other requirements of the CRL, including, but not limited to, product quality testing and human factors.factors information. However, even if we complete these clinical trials and satisfy all the requirements of the CRL, we may not obtain regulatory approval from the FDA. Continued failure to obtain, or additional delays in obtaining, regulatory approvals may:

 

adversely affect the commercialization of the current version of CHEMOSAT and Melphalan/HDS or any products that we developdevelops in the future;

 

impose additional costs on us;

 

diminish any competitive advantages that may be attained; and

 

adversely affect our ability to generate revenues.

We have obtained the right to affix the CE Mark for the DelcathCHEMOSAT Hepatic CHEMOSAT Delivery System as a medical device for the delivery of melphalan. Since we may only promote the device within this specific indication, if physicians are unwilling to obtain melphalan separately for use with CHEMOSAT, our ability to commercialize CHEMOSAT in the EEAEU will be significantly limited.

In the EEA,EU, CHEMOSAT is regulated as a Class IIb medical device indicated for the intra-arterial administration of a chemotherapeutic agent, melphalan hydrochloride, to the liver with additional extracorporeal filtration of the venous blood return. Our ability to market and promote CHEMOSAT is limited to this approved indication. To the extent that our promotion of CHEMOSAT is found to be outside the scope of ourits approved indication, we may be subject to fines or other regulatory action, limiting our ability to commercialize CHEMOSAT in the EEA.EU.

We are limited to marketing CHEMOSAT in the EEAEU as a medical device for the delivery of melphalan. If physicians are unwilling to obtain melphalan separately for use with CHEMOSAT, our ability to commercialize CHEMOSAT in the EEAEU will be significantly limited. Our product instructions and indication reference the chemotherapeutic agent melphalan. However, no melphalan labels in the EEAEU reference our product, and the labels vary from country to country with respect to the approved indication of the drug and its mode of administration. As a result, the delivery of melphalan with our device may not be within the applicable label with respect to some indications in some Member States of the EEAEU where the drugs are authorized for marketing. Physicians intending to use our deviceCHEMOSAT must obtain melphalan separately for use with CHEMOSAT and must use melphalan independently at their discretion. If physicians are unwilling to obtain melphalan separately from our productCHEMOSAT and/or to prescribe the use of melphalan independently, our sales opportunities in the EEAEU will be significantly impaired.limited.

While we have obtained the right to affix the CE Mark, we will beWe are subject to significant ongoing regulatory obligations and oversight in the EEAEU and will be subject to such obligations in any other country where we receive marketing authorization or approval.

In April 2012, we obtained the required certification from ourits European Notified Body, enabling us to complete an EC Declaration of Conformity with the essential requirements of the EU Medical Devices Directive and affix the CE Mark to the Generation Two CHEMOSAT system.version of CHEMOSAT. In order to maintain the right to affix the CE Mark in the EEA,EU, we are subject to compliance obligations, and any material changes to the approved product, such as manufacturing changes, product improvements or revised labeling, may require further regulatory review. Additionally, we are subject to ongoing audits by our European Notified Body, and the right to affix the CE Mark to the Generation Two version of CHEMOSAT system may be withdrawn for a number of reasons, including the later discovery of previously unknown problems with the product.

To the extent that CHEMOSAT or Melphalan/HDS is approved by the FDA or any other regulatory agency, we will be subject to similar ongoing regulatory obligations and oversight in those countries where we obtain approval.approval is obtained. For example, we may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or requirements for potentially costly post-marketing testing, including Phase IV clinical trials, and surveillance to monitor the safety and efficacy of the product candidate. In addition, if the FDA approves a product candidate, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current good manufacturing practice, or cGMPs, , good clinical practices, (GCPs)or GCPs, , and good laboratory practices, which are regulations and guidelines enforced by the FDA for all products in clinical development, for anypre-clinical or clinical trials that we conductconducts post-approval. In addition, post-marketing requirements for CHEMOSAT and Melphalan/HDS may include implementation of a risk evaluation and mitigation strategies, (REMS)or REMS, program to ensure that the benefits of the product outweigh its risks. A REMS may include a Medication Guide,medication guide, a patient package insert, a communication plan to healthcare professionals, restrictions on distribution or use and/or other elements to assure safe use of the product.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

 

refusals or delays in the approval of applications or supplements to approved applications;

 

refusal of a regulatory authority to review pending market approval applications or supplements to approved applications;

 

restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls or seizures;

 

fines, Warning Letters or untitled letters, or holds on clinical trials;

 

import or export restrictions;

 

injunctions or the imposition of civil or criminal penalties;

restrictions on product administration, requirements for additional clinical trials or changes to product labeling or REMS programs; or

 

recommendations by regulatory authorities against entering into governmental contracts with us.

If we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would have a material adverse effect on our business, results of operations, financial condition and prospects.

The development and approval process in the United States will take many years, require substantial resources and may never lead to the approval of Melphalan/HDS by the FDA for use in the United States.

We cannot sell or market Melphalan/HDS with melphalan or other chemotherapeutic agents in the United States without prior FDA approval of an NDA for Melphalan/HDS. Although melphalan and other drugs have been approved by the FDA for use as chemotherapeutic agents, regulatory approval is required in the United States for the combined medical device component and drug component and the specific indication, dose and route of administration of melphalan or other chemotherapeutic agentagents or compounds used in our system. We are seeking approval of Melphalan/HDS for a substantially higher dose of melphalan than prior approved doses of melphalan and such other drugs.chemotherapeutic agents or other compounds. We must obtain separate regulatory approvals for Melphalan/HDS with melphalan and every other chemotherapeutic agent or other compound used with ourthe system that we intend to market, and all the manufacturing facilities used to manufacture components or assemble our system must be inspected and meet legal requirements. Securing regulatory approval requires the submission ofextensivepre-clinical and and clinical data and other supporting information for each proposed therapeutic indication in order to establish to the FDA’s satisfaction the product’s safety, efficacy, potency and purity for each intended use.Thepre-clinical testing testing and clinical trials of Melphalan/HDS with melphalan or any other chemotherapeutic agent or compound we useuses in ourits system must comply with the regulations of the FDA and other federal, state and local government authorities in the United States. Clinical development is a long, expensive and uncertain process and is subject to delays. We may encounter delays or rejections for various reasons, including our inability to enroll enough patients to complete ourthe clinical trials. Moreover, approval policies or regulations may change. If we do not obtain and maintain regulatory approval for our systemMelphalan/HDS and ourthe use of melphalan or other chemotherapeutic agents, the value ofon our company, ourbusiness, results of operations, financial condition and our ability to raise additional capital willprospects would be harmed.materially and adversely affected.

In August 2012, we submitted a NDA seeking an indication for ocular melanoma liver metastases for our Melphalan/HDS. In September 2013, the FDA issued a CRL. The FDA comments in the CRL included a statementindicating that we must perform additional well-controlled randomized trial(s) to establish the safety and efficacy of Melphalan/HDS using overall survival as the primary efficacy outcome measure and which demonstrates that the clinical benefits of Melphalan/HDS outweigh its risks. Our current Phase 3 trial in ocular melanoma liver metastases, the FOCUS Trial, is not randomized and uses a different primary efficacy outcome measure. Failure to obtain FDA approval will have a material adverse effect on our business, financial condition and results of operations.

Even if we obtain regulatory approval for the Melphalan/HDS system in the United States, our ability to market the Melphalan/HDS system would be limited to those uses that are approved.

The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulationsfordirect-to-consumer advertising, advertising, disseminationofoff-label information, information, industry-sponsored scientific and educational activities and promotional activities involving the Internet. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved label. If the FDA approves an application for the Melphalan/HDS, our ability to market and promote the Melphalan/HDS would be limited to the approved indication, so even with FDA approval, the Melphalan/HDS system may only be promoted in this limited market. Physicians may prescribe legally available drugs for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communicationsregardingoff-label use, use, and FDA approval may otherwise limit our sales practices and our ability to promote, sell and distribute the product. Thus, we may only market the Melphalan/HDS, if approved by the FDA, for its approved indication and we could be subject to enforcement actionforoff-label marketing. marketing. Further, if there are any modifications to the product, including changes in indications, labeling or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new or supplemental NDA, which may require uswe to develop additional data or conduct additional preclinical studies and clinical trials. Failure to comply with these requirements can result in adverse publicity, Warning Letters, corrective advertising and potential civil and criminal penalties.

If future clinical trials are unsuccessful, significantly delayed or not completed, we may not be able to market Melphalan/HDS for other indications.

The clinical trial data on our product is limited to specific types of liver cancer. In 2010, we concluded a Phase 3 clinical trial of Melphalan/HDS in patients with metastatic ocular and cutaneous melanoma to the liver and also completedamulti-arm Phase Phase 2 clinical trial of Melphalan/HDS in patients with primary and metastatic melanoma stratified into four arms.

In January 2016 we received agreement on a SPA from the FDA andWe have initiated a pivotalan open-label Phase 3 overall survival clinical trial in ocular melanoma liver metastases. In March 2017, we received agreement onmetastases called the FOCUS Trial. We also have initiated a SPA from the FDA for aPhase 3 registration trial to treat patients with intrahepatic cholangiocarcinoma (ICC), a trial we expect to initiate when financial resources permit.called the ALIGN trial.

It may take several years to complete the testing of Melphalan/HDS for use in the treatment of these indications, and failure can occur at any stage of development, for many reasons, including:

 

anypre-clinical or or clinical test may fail to produce results satisfactory to the FDA or foreign regulatory authorities;

 

pre-clinical or or clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval;

 

negative or inconclusive results fromapre-clinical study study or clinical trial or adverse medical events during a clinical trial could causeapre-clinical study study or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful;

 

the FDA or foreign regulatory authorities can place a clinical hold on a trial if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant risk of illness or injury;

 

we may encounter delays or rejections based on changes in regulatory agency policies during the period in which we are developing a system or the period required for review of any application for regulatory agency approval;

 

enrollment in our clinical trials may proceed more slowly than expected;

our clinical trials may not demonstrate the safety and efficacy of any system or result in marketable products;

 

the FDA or foreign regulatory authorities may request additional clinical trials, including an additional Phase 3 trial, relating to our NDA submissions;

 

the FDA or a foreign regulatory authoritiesauthority may change its approval policies or adopt new regulations that may negatively affect or delay our ability to bring a system to market or require additional clinical trials; and

 

a system may not be approved for all the requested indications.

The failure or delay of clinical trials could cause an increase in the cost of product development, delay filing of an application for marketing approval or cause uswe to cease the development of Melphalan/HDS for other indications. If we are unable to develop Melphalan/HDS for other indications, the future growth of our business could be negatively impacted. In addition, we have limited clinical data relating to the effectiveness of Melphalan/HDS in certain types of cancer. Such limited data could slow the adoption of CHEMOSAT/CHEMOSAT and Melphalan/HDS and significantly reduce our ability to commercialize CHEMOSAT/CHEMOSAT and Melphalan/HDS.

We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.

FDA has granted us six orphan drug designations and we may seek additional orphan drug designations in the future.

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States.

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing application for the same indication for that drug during that time period. The applicable period is seven years in the United States and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

We cannot assure you that any future application for orphan drug designation with respect to any product candidate will be granted. If we are unable to obtain orphan drug designation in the United States, we will not be eligible to obtain the period of market exclusivity that could result from orphan drug designation or be afforded the financial incentives associated with orphan drug designation. Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

We rely on third parties to conduct certain elements of the clinical trials for CHEMOSAT and Melphalan/HDS, and if they do not perform their obligations to us, we may not be able to obtain regulatory approvals for our system.

We design the clinical trials for Melphalan/HDS, but we rely on academic institutions, corporate partners, contract research organizations and other third parties to assist us in managing, monitoring and otherwise carrying out these trials. We rely heavily on these parties for the execution of our clinical studies and control only certain aspects of their activities. Accordingly, we may have less control over the timing and other aspects of these clinical trials than if we conducted them entirely on ourits own. We rely uponon third parties to conduct monitoring and data collection of our ongoing and future clinical trials, including our Phase 3 ocular melanoma trial and pivotal ICC trial. Although we rely on these third parties to manage the data from these clinical trials, we are responsible for confirming that each of our clinical trials is conducted in accordance with itsour general investigational plan and protocol. Moreover, the FDA and foreign regulatory agencies require us to comply with GCPs for conducting, recording and reporting the results of clinical trials to assure that the data and results are credible and accurate and that the trial participants are adequately protected. The FDA enforces these GCP regulations through periodic inspections of trial sponsors, principal investigators and trial sites. Our reliance on third parties does not relieve us of these responsibilities and requirements and if we or the third parties upon whom we rely for our clinical trials fail to comply with the applicable GCPs, the data generated in our clinical trials may be deemed unreliable and the FDA or other foreign regulatory agencies may require us to perform additional trials before approving our marketing application. We cannot assure you that, upon inspection, the FDA will determine that any of our clinical trials comply or complied with GCPs. In addition, our clinical trials must be conducted with product that complies with the FDA’s cGMP requirements. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process, and we may failresult in a failure to obtain regulatory approval for Melphalan/HDS if these requirements are not met.

Purchasers of CHEMOSAT in the EEAEU may not receive third-party reimbursement or such reimbursement may be inadequate. Without adequate reimbursement, wecommercialization of CHEMOSAT in the EU may not be able to successfully commercialize CHEMOSAT in the EEA.successfuk.

We have obtained the right to affix the CE Mark for CHEMOSAT, and we intendunder the definitive licensing agreement, or the medac License, for CHEMOSAT commercialization in Europe with medac, medac intends to seek third-party or government reimbursement within those countries in the EEAEU where we expectit expects to market and sell CHEMOSAT. In Germany, we havehad received a ZE diagnostic-related group code, or ZE Code, which, beginning in 2016, permits hospitals in Germany to obtain reimbursement for CHEMOSAT procedures beginning in 2016.procedures. Negotiations on the amount of reimbursement to be received under the codeZE Code were concluded in2016in 2016 and the procedure iswas reimbursed under this systemthe ZE Code in 2017. TheReimbursement negotiations under the ZE system is an annual process and negotiations are underway to set reimbursement levels for 2018.conducted annually. Consequently, reimbursement obtained may not be for the full amount sought. In countries where we aremedac is able to obtain reimbursement, local policy could limit our ability to obtain adequate and consistent reimbursement and limit other sales opportunities in those countries. In the United Kingdom, we began seeking a block fund grant in 2014. Ongoing changes to the process and funding streams have resulted in delays that made the award and timing of any block grant funding difficult to predict. Accordingly, we may not receive the grant in a timely manner or at all.

In other countries, until we obtainmedac obtains government reimbursement, weit will rely on private payors orlocalpre-approved funds funds where available. New technology payment programs may provide interim funding, but there are no assurances that we will qualify for such funding. Even if we do qualify, the amount and the duration of this funding may be limited. There are also no assurances that third-party payors or government health agencies of Member States of the EEAEU will reimburse the product’s use of CHEMOSAT in the long term or at all. Further, each country has its own protocols regarding reimbursement, so successfully obtaining third party or government health agency reimbursement in one country does not necessarily translate to similar reimbursement in other EEAEU countries. Physicians, hospitals and other health care providers may be reluctant to purchase CHEMOSAT if they do not receive substantial reimbursement for the cost of using ourthe product from third-party payors or government entities. The lack of adequate reimbursement may significantly limit sales opportunities in the EEA.EU.

The success of our products may be harmed if the government, private health insurers andor other third-party payers do not provide sufficient coverage or reimbursement.

Our ability to commercialize our systemsCHEMOSAT under the medac License and Melphalan/HDS successfully will depend in part on the extent to which reimbursement for the costs of such products and related treatments will be available from government health administration authorities, private health insurers and other third-party payors. Melphalan/HDS is currently not approved by the FDA. Medicare, Medicaid, private health insurance plans and their foreign equivalents will not reimburse the use of Melphalan/HDS since the product is currently not approved outside the EEA.EU. We will seek reimbursement by third-party payors of the cost of Melphalan/HDS after its use is approved, but there are no assurances that adequate third-party coverage will be available for us to establish and maintain price levels sufficient for us to realize an appropriate return on our investment in developing new therapies. Government, private health insurers and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new therapeutic products approved for marketing. Accordingly, even if coverage and reimbursement are provided by government, private health insurers and third-party payors for uses of our products, market acceptance of these products would be adversely affected if the reimbursement available proves to be unprofitable for healthcare providers.

Implementation of healthcare reforms in the United States and in significant overseas markets may limit the ability to commercialize CHEMOSAT/CHEMOSAT and Melphalan/HDS and the demand for CHEMOSAT/CHEMOSAT and Melphalan/HDS. Healthcare providers may respond to such cost-containment pressures by choosing lower cost products or other therapies. In March 2010, the Patient Protection and Affordable

Care Act and Health Care and Education Reconciliation Act of 2010, (ACA) wereor the ACA, was enacted into law in the United States, which included a number of provisions aimed at improving quality and decreasing costs. The PresidentTrump administration has taken executive actions and membershas eliminated the individual shared responsibility penalty portion of Congress have recently introduced legislative proposals to significantly alterACA. A court decision finding that the ACA. ItACA is uncertain if such proposals will be enacted or what consequences these proposals or the implementation of existing provisions will haveunconstitutional is on our efforts to commercialize CHEMOSAT and Melphalan/HDS.appeal.

CHEMOSAT/CHEMOSAT and Melphalan/HDS may not achieve sufficient acceptance by the medical community to sustain our business.

The commercial success of CHEMOSAT and Melphalan/HDS, if approved, will depend upon itstheir acceptance by the medical community and third-party payers as clinically useful, cost effective and safe. Acceptance by the medical community may depend on the extent to which leaders in the scientific and medical communities publish scientific papers in reputable academic journals. If testing and clinical practice do not confirm the safety and efficacy of CHEMOSAT and Melphalan/HDS or even if further testing and clinical practice produce positive results but the medical community does not view these favorably, and CHEMOSAT and Melphalan/HDS as effective and desirable, our efforts to market CHEMOSAT and Melphalan/HDS may fail, which would cause us to cease operation.

We may be subject, directly or indirectly, to federal and state health care fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

If we obtain FDA approval for any of our drug candidates and begin commercializing those products in the United States, our operations will be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. These laws may affect, among other things, our proposed sales, marketing and education programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs;

federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent;

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information;

the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and

state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including exclusion from payment by federal health care programs, civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

Compliance with laws and regulations pertaining to the privacy and security of health information may be time consuming, difficult and costly, particularly in light of increased focus on privacy issues in countries around the world, including the U.S. and the EU.

We are subject to various domestic and international privacy and security regulations. The confidentiality, collection, use and disclosure of personal data, including clinical trial patient-specific information, are subject to governmental regulation generally in the country that the personal data were collected or used. In the United States we are subject to various state and federal privacy and data security regulations, including but not limited to HIPAA and as amended in 2014 by the HITECH Act. HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions, as well as standards relating to the privacy and security of individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect such information. In the EU personal data includes any information that relates to an identified or identifiable natural person with health information carrying additional obligations, including obtaining the explicit consent from the individual for collection, use or disclosure of the information. In addition, we are subject to EU regulation with respect to protection of and cross-border transfers of such data out of the EU, and this regulation will become more stringent in May 2018 when the EU’s General Data Protection Regulation (GDPR) comes into effect. Furthermore, the legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues. The United States and the EU and its member states continue to issue new privacy and data protection rules and regulations that relate to personal data and health information.

Compliance with these laws may be time consuming, difficult and costly. If we fail to comply with applicable laws, regulations or duties relating to the use, privacy or security of personal data we could be subject to the imposition of significant civil and criminal penalties, be forced to alter our business practices and suffer reputational harm.

Changes in health care law and implementing regulations, including government restrictions on pricing and reimbursement, as well as health care policy and other health care payor cost-containment initiatives, may have a material adverse effect on us.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the health care system and efforts to control health care costs, including drug prices, that could have a significant negative impact on our business, including preventing, limiting or delay regulatory approval of our drug candidates and reducing the sales and profits derived from our products once they are approved.

For example, in the United States, the Patient Protection and Affordable Care Act of 2010, or ACA, substantially changed the way health care is financed by both governmental and private insurers and significantly affects the pharmaceutical industry. Many provisions of ACA impact the biopharmaceutical industry, including that in order for a biopharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U.S. government agencies, the manufacturer must extend discounts to entities eligible to participate in the drug pricing program under the Public Health Services Act, or PHS. Since its enactment, there have been judicial and Congressional challenges and amendments to certain aspects of ACA. There is continued uncertainty about the implementation of ACA, including the potential for further amendments to the ACA and legal challenges to or efforts to repeal the ACA.

We cannot be sure whether additional legislative changes will be enacted, or whether government regulations, guidance or interpretations will be changed, or what the impact of such changes would be on the marketing approvals, sales, pricing, or reimbursement of our drug candidates or products, if any, may be.

The “Novel Coronavirus Disease 2019” (“COVID-19”) pandemic has materially and adversely affected our clinical trial operations and may materially and adversely affect our financial results.

The COVID-19 pandemic has affected many countries, including the United States and several European countries, where we are currently conducting our FOCUS Trial and ALIGN Trial. In response to the pandemic, hospitals participating in the trials in affected countries have taken a number of actions, including restricting elective and other procedures that are not deemed to be life-threatening, suspending clinical trial activities and limiting access to data monitoring. As a result, patients enrolled in our clinical trials have had the start of their treatments postponed and ongoing treatment regimens may be delayed. In addition, we do not have sufficient access to monitor trial data on a timely basis. These restrictions have had a materially adverse effect on our clinical operations. For example, as noted under “Business - Clinical Development Program - The FOCUS Trial,” the completion of our FOCUS Trial and the release of the top-line data will be delayed beyond our prior expectations. The extent to which the COVID-19 pandemic may effect our clinical trial operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the spread and severity of COVID-19, and the effectiveness of governmental actions in response to the pandemic. Furthermore, the spread of COVID-19 may materially and adversely effect our ability to recruit and retain patients.

We expect that actions taken in response to the COVID-19 pandemic will also materially and adversely effect sales of CHEMOSAT. As noted above, some hospitals are restricting procedures that are not deemed to be life-threatening at this time. Because CHEMOSAT is not deemed to be a life-threatening procedure, we expect that the number of procedures performed will decline. While we do not expect revenues from CHEMOSAT procedures to be material to us, a decrease in the number of procedures performed will adversely affect our expected revenues and our financial results.

These consequences of the COVID-19 pandemic will delay and could adversely affect our ability to obtain regulatory approval for and to commercialize our products, increase our operating expenses, and could have a material adverse effect on our financial results.

Consolidation in the healthcare industry could lead to demands for price concessions.

The cost of healthcare has risen significantly over the past decade and numerous initiatives and reforms initiated by legislators, regulators and third-party payors to curb these costs have resulted in a consolidation trend in the medical device industry. Group purchasing organizations, independent delivery networks and large single accounts in the United States and foreign markets may result in a consolidation of purchasing decisions for potential healthcare provider customers. We expect that market demand, government regulation, third-party reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances which may exert further downward pressure on the price of CHEMOSAT and Melphalan/HDS and adversely impact our business, financial condition and results of operations.

Further, third-party payors may deny reimbursement if they determine that CHEMOSAT andand/or Melphalan/HDS is not used in accordance with established payor protocols regarding cost effective treatment methods or is used outside its approved indication or for forms of cancer or with drugs not specifically approved by the FDA or other foreign regulatory bodies in the future. Without reimbursement, physicians, hospitals and other health care providers will be less likely to purchase CHEMOSAT andand/or Melphalan/HDS, thereby harming our results of operations.

Risks Related to Manufacturing, Commercialization and Market Acceptance of the

CHEMOSAT and Melphalan/HDS

There is only one approvedare three third-party manufacturermanufacturers of melphalan in certain countries of the EEA.EU of which we are aware. If this manufacturerany of these manufacturers fails toprovideend-users with with adequate supplies of melphalan or fails to comply with the requirements of regulatory authorities, we may be unable to successfully commercialize our product in the EEA.EU.

Under the current regulatory scheme in the EEA,EU, CHEMOSAT is approved for marketing as a device only, and doctors will separately obtain melphalan for use with CHEMOSAT. Although melphalan has been approved in the EEAEU for over a decade, we are aware that there isare currently only onethree approved manufacturermanufacturers of melphalan in certain countries of the EEA, with whom we have no supply arrangements or other affiliation, and therefore we will not have any control over the quality, availability, price or labeling of melphalan in that market.EU. As a result, there may not be sufficient supply of melphalan for use with our system,CHEMOSAT, and any adverse change in the solea manufacturer’s commercial operations or regulatory approval status may seriously impair our sales opportunities in the EEA.EU. Additionally, melphalan is not available in certain foreign countries outside the EEAEU where we may seek to market CHEMOSAT. If supply of melphalan remains limited or unavailable, we will be unable to commercialize our productCHEMOSAT in these markets, thereby limiting future sales opportunities.

If we cannot maintain or enter into acceptable arrangements for the production of melphalan and other chemotherapeutic agents we will be unable to successfully commercialize the Delcath systemMelphalan/HDS in the United States or complete our global Phase 3 trial in ocular melanoma liver metastases, our registration trial in ICC, or any future clinical trials.

We have entered into a manufacturing and supply agreementagreements with Synerx Pharma, LLC (Synerx) and Bioniche Teoranta (Bioniche) an affiliate of Mylan, Inc.,several suppliers for theour supply of our branded melphalan for injection. The agreement with Synerx and Bioniche currently representsinjection for our sole source of branded melphalan in the United States. We intend to use the melphalan supplied by Synerx and Bioniche to conduct our Phase 2 clinical trial for HCC and ICC in the United States and our global Phase 3 trial for ocular melanoma liver metastases.trials. We may pursue agreements with additional contract manufacturers to produce melphalan and other chemotherapeutic agents that we willfor use in the future for our clinical trial program and the commercialization of CHEMOSAT and Melphalan/HDS, as well as for labeling and finishing services. We may not be able to enter into such arrangements on acceptable terms or at all. Every manufacturer is subject to inspection by FDA and must meet all cGMP regulatory requirements. To manufacture melphalan or other chemotherapeutic agents on our own, we would first have to develop a manufacturing facility that complies with FDA requirements and regulations for the production of melphalan and each other chemotherapeutic agent we choose to manufacture for use with our system. Developing these resources would be an expensive and lengthy process and would have a material adverse effect on our revenues and profitability. If we are unable to obtain sufficient melphalan and labeling services on acceptable terms, if weit should encounter delays or difficulties in our relationships with our current and future suppliers or if our current and future suppliers of melphalan do not comply with applicable regulations for the manufacturing and production of melphalan, our business, financial condition and results of operations may be materially harmed.

If we cannot successfully manufacture CHEMOSAT and Melphalan/HDS, our ability to develop and commercialize the system would be impaired.

We manufacture certain components of our products, including our proprietary filter media, and assemble and package CHEMOSAT and Melphalan/HDS for at our facility in Queensbury, New York. We have established our European headquarters and packaging/labeling/distribution worldwidefacility in our Queensbury, NY facility. Galway, Ireland where we intend to conduct final manufacturing and assembly in the future. We currently utilizes third-parties to manufacture some components of CHEMOSAT and Melphalan/HDS.

We have a limited manufacturing history and we may not be able to manufacture the systemour products in sufficient commercial quantities, in a cost-effective manner or in compliance with the regulatory requirements applicable to such manufacturing. Additionally, we may have difficulty obtaining components for the systemour products from our third-party suppliers in a timely manner or at all which may adversely affect our ability to deliver CHEMOSAT and Melphalan/HDS to purchasers.

In addition to limiting sales opportunities, delays in manufacturing CHEMOSAT and Melphalan/HDS may adversely affect our ability to obtain regulatory approval in the United States and other jurisdictions. Our ability to conduct timely clinical trials in the United States and abroad depends on our ability to manufacture the system, including sourcing the chemotherapeutic agents or other compounds through third parties in accordance with FDA and other regulatory requirements. If we are unable to manufacture CHEMOSAT and Melphalan/HDS in a timely manner, we may not be able to conduct the clinical trials required to obtain regulatory approval and commercialize our product.

We have implemented quality systems throughout our organization designed to enable us to satisfy the various international quality system regulations including those of the FDA with respect to products sold in the United States and those established by the International Standards Organization, or ISO, with respect to products sold in the EU. We are required to maintain ISO 13485 certification for medical devices to be sold in the EU, which requires, among other items, an implemented quality system that applies to component quality, supplier control, product design and manufacturing operations. All of our facilities are presently ISO 13485:2016 certified. If our Queensbury, NY facility fails to maintain compliance with ISO 13485 a comprehensive management system for the design and manufacture of medical devices, and FDA cGMP or fails to pass facility inspection or audits, our ability to manufacture at the facility could be limited or terminated. In the future, we may manufacture and assemble CHEMOSAT and Melphalan/HDS in our Galway, Ireland facility or elsewhere in the EEA,EU, and any facilities in the EEAEU would have to obtain and maintain similar approvals or certifications of compliance.

We do not have written contracts with all of our suppliers for the manufacture of components for CHEMOSAT and Melphalan/HDS.

We do not have written contracts with all our suppliers for the manufacture of components for CHEMOSAT and Melphalan/HDS. If we are unable to obtain an adequate supply of the necessary components or negotiate acceptable terms, we may not be able to manufacture the systemCHEMOSAT and Melphalan/HDS in commercial quantities or in a cost-effective manner, and commercialization of CHEMOSAT and Melphalan/HDS in the EEAUnited States, the EU and elsewhere may be delayed. In addition, certain components are available from only a limited number of sources. Components of CHEMOSAT and Melphalan/HDS are currently manufactured for us in small quantities and we may require significantly greater quantities to further commercialize the product. We may not be able to find alternate sources of comparable components. If we are unable to obtain adequate supplies of components from our existing suppliers or need to switch to an alternate supplier and obtain FDA or other regulatory agency approval of that supplier, commercialization of CHEMOSAT and Melphalan/HDS may be delayed.

We have limited experience in marketing and commercializing our products, and as a result, we may not be successful in commercializing CHEMOSAT in the EEA.

We have not previously sold, marketed or distributed any products and have limited experience in building a sales and marketing organization and in entering into and managing relationships with third-party distributors. Even though we have obtained the right to affix the CE Mark, we currently have limited sales, marketing, commercial or distribution capabilities in any countries in the EEA. In order to pursue our strategy to commercialize CHEMOSAT in the EEA, we must acquire or internally develop a sales, marketing and distribution infrastructure and/or enter into strategic alliances to perform these services. The development of sales, marketing and distribution infrastructure is difficult, time consuming and requires substantial financial and other resources. If we cannot successfully develop the infrastructure to market and commercialize CHEMOSAT, our ability to generate revenues in the EEA may be harmed, and we may not generate sufficient revenue to sustain our business or we may be required to enter into strategic alliances to have such activities carried out on our behalf, which may not be on favorable terms.

Competition for sales and marketing personnel is intense, and we may not be successful in attracting or retaining such personnel. Our inability to attract and retain skilled sales and marketing personnel or to reach an agreement with a third party could adversely affect our business, financial condition and results of operations. Further, since our marketing strategy in the EEA includes establishing a network of third-party distributors, we must enter into collaborative arrangements with these third-party distributors. We may not be able to enter into such arrangements on reasonable terms or at all.

Even if we receive FDA or other foreign regulatory approvals, we may be unsuccessful in commercializing CHEMOSAT and Melphalan/HDS in markets outside the EEA,EU, because of inadequate infrastructure or an ineffective commercialization strategy.

Outside the EEA,EU, even if we obtain regulatory approval from the FDA or other foreign regulatory agencies, our ability to commercialize CHEMOSAT and Melphalan/HDS may be limited due to our inexperience in developing a sales, marketing and distribution infrastructure. If we are unable to develop this infrastructure in the United States or elsewhere or to collaborate with an alliance partner to market our products in the United States or foreign countries, particularly in Asia, our efforts to commercialize CHEMOSAT and Melphalan/HDS or any other product outside of the EEAEU may be less successful.

Even if we are successful in commercializing CHEMOSAT and Melphalan/HDS in the EEA,EU, we may not be successful in the United States and other foreign countries. Each country requires a different commercialization strategy, so our EEAEU marketing strategy may not translate to other markets. Without a successful commercialization strategy tailored for each market, our efforts to promote and market CHEMOSAT in each of our target markets may fail in any or all of those markets.

Our plan to use collaborative arrangements with third parties to help finance and to market and sell CHEMOSAT and Melphalan/HDS may not be successful.

We may be unable to enter into collaborative agreements without additional clinical data or unable to continue a collaborative agreement as a result of unsuccessful future clinical trials. Additionally, we may face competition in ourits search for alliances. As a result, we may not be able to enter into any additional alliances on acceptable terms, if at all. Our collaborative relationships may never result in the successful development or commercialization of CHEMOSAT and Melphalan/HDS or any other product. The success of any collaboration will depend upon our ability to perform our obligations under any agreements as well as factors beyond our control, such as the commitment of our collaborators and the timely performance of their obligations. The terms of any such collaboration may permit our collaborators to abandon the alliance at any time for any reason or prevent us from terminating arrangements with collaborators who do not perform in accordance with our expectations or our collaborators may breach their agreements with us. In addition, any third parties with which we collaborate may have significant control over important aspects of the development and commercialization of our products, including research and development, market identification, marketing methods, pricing, composition of sales force and promotional activities. We arewill not able to control or influence the amount and timing of resources that any collaborator may devote to our research and development programs or the commercialization, marketing or distribution of our products. We may not be able to prevent any collaborators from pursuing alternative technologies or products that could result in the development of products that compete with CHEMOSAT and Melphalan/HDS or the withdrawal of their support for our products. The failure of any such collaboration could have a material adverse effect on our business.

If we fail to overcome the challenges inherent in international operations, our business and results of operations may be materially adversely affected.

Currently we have only received authorization to market CHEMOSAT in the EEA,EU, and intend to seek similar authorization or approvals in other foreign countries. As a result, we expect international sales of our productsCHEMOSAT to account for a significant portion of our revenue, which exposes us to risks inherent in international operations. To accommodate our international sales, we will need to further invest financial and management resources to develop an international infrastructure that will meet the needs of our customers. Accordingly, we will face additional risks resulting from our international operations including:

 

difficulties in enforcing agreements and collecting receivables in a timely manner through the legal systems of many countries outside the United States;

 

the failure to satisfy foreign regulatory requirements to market ourits products on a timely basis or at all;

 

availability of, and changes in, reimbursement within prevailing foreign healthcare payment systems;

difficulties in managing foreign relationships and operations, including any relationships that we establish with foreign sales or marketing employees and agents;

 

limited protection for intellectual property rights in some countries;

 

fluctuations in currency exchange rates;

 

the possibility that foreign countries may impose additional withholding taxes or otherwise tax our foreign income, impose tariffs or adopt other restrictions on foreign trade;

 

the possibility of any material shipping delays;

 

significant changes in the political, regulatory, safety or economic conditions in a country or region;

 

protectionist laws and business practices that favor local competitors; and

 

trade restrictions, including the imposition of, or significant changes to, the level of tariffs, customs duties and export quotas.

If we fail to overcome the challenges we encounterit encounters in our international operations, our business and results of operations may be materially adversely affected.

CHEMOSAT has been used a limited number of times in a clinical setting in the EEA, so market acceptance of our product will depend on EEA healthcare professionals’ efforts to learn about our product.

Since all of our prior clinical studies were conducted in the United States and CHEMOSAT has had limited use in a clinical setting in the EEA, physicians in the EEA have no clinical experience with our product. As a result, CHEMOSAT may not gain significant market acceptance among physicians, hospitals, patients and healthcare payors in the EEA until healthcare professionals are properly educated about the procedure. Market acceptance of CHEMOSAT in the EEA will depend upon a variety of factors including:

whether our future clinical trials demonstrate significantly improved patient outcomes;

our ability to educate and train physicians to perform the procedure and drive acceptance of the use of CHEMOSAT;

our ability to obtain adequate reimbursement and convince healthcare payors that use of CHEMOSAT results in reduced treatment costs and improved outcomes for patients;

whether CHEMOSAT replaces and/or complements treatment methods in which many hospitals have made a significant investment; and

whether doctors and hospitals are willing to replace their existing technology with a new medical technology until the new technology’s value has been demonstrated.

We intend to establish clinical training and centers of excellence to educate and train physicians and healthcare payors in the EEA, but the key opinion thought leadership required for initial market acceptance within the healthcare arena may take time to develop. Without effort from healthcare professionals to become educated about our product, the market may not accept CHEMOSAT and our efforts to commercialize CHEMOSAT in the EEA may be unsuccessful.

Similar considerations apply in any other market where we receive approval. Successful commercialization of CHEMOSAT in these markets will depend on market acceptance by healthcare professionals.

Rapid technological developments in treatment methods for liver cancer and competition with other forms of liver cancer treatments could affect our ability to achieve meaningful revenues or profit.

Competition in the cancer treatment industry is intense. CHEMOSAT and Melphalan/HDS competescompete with all forms of liver cancer treatments that are alternatives to the “gold standard” treatment of surgical resection. Many of our competitors have substantially greater resources and considerable experience in conducting clinical trials and obtaining regulatory approvals. If these competitors develop more effective or more affordable products or treatment methods, or achieve earlier product development, our revenues or profitability will be substantially reduced.

Our ability to develop CHEMOSAT and Melphalan/HDS for other indications could affect our orphan drug exclusivity. In November 2008, the FDA granted us two orphan drug designations for the drug melphalan for the treatment of patients with cutaneous melanoma as well as patients with ocular melanoma. In May 2009, the FDA granted us an additional orphan drug designation of the drug melphalan for the treatment of patients with neuroendocrine tumors. In August 2009, the FDA granted us an orphan drug designation of the drug doxorubicin for the treatment of patients with primary liver cancer. The FDA granted us orphan drug designation of the drug melphalan for the treatment of HCC in October 2013 and for the treatment of ICC in July 2015. If CHEMOSAT and Melphalan/HDS is approved for an indication different than the indications for which we have received orphan drug designations, we will not obtain orphan drug exclusivity, which could increase our competition. If another company has orphan drug designations for thesethe same indicationsdrug and indication as us and receives marketing approval before we do, then we will be blocked from marketing approval for seven years from the date of theirits approval for the same indication of use.use unless we can make a showing of the clinical superiority of our drug.

The loss of key personnel could adversely affect our business.

Our success depends upon the efforts of our employees. The loss of a memberany of our senior executive staffexecutives or other key employees could harm ourits business. Competition for experienced personnel is intense.intense and, if key individuals leave us, we could be adversely affected if suitable replacement personnel are not quickly identified and hired. Competition for qualified individuals exists in all functional areas, which makes it difficult to attract and retain the qualified employees we need to operate our business. Our success also depends in part on our ability to attract and retain highly qualified scientific, technical, commercial and administrative personnel. If we cannotare unable to attract new employees and retain our current personnel or attract additional experienced personnel,key employees, our ability to compete could be adversely affected.affected and the development and commercialization of our products could be delayed or negatively impacted.

We rely on the proper function, availability and security of information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business, financial condition or results of operations.

We rely on information technology systems to process, transmit, and store electronic information in ourday-to-day operations. Similar to other companies, the size and complexity of our information technology systems makes them vulnerable to a cyber-attack, malicious intrusion, breakdown, destruction, loss of data privacy, or other significant disruption. Our information systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards. Any failure by us to maintain or protect our information technology systems and data integrity, including from cyber-attacks, intrusions or other breaches, could result in the unauthorized access to personally identifiable information, theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations. Any of these event may cause us to have difficulty preventing, detecting, and controlling fraud, be subject to legal claims and liability, have regulatory sanctions or penalties imposed, have increases in operating expenses, incur expenses or lose revenues as a result of a data privacy breach or theft of intellectual property, or suffer other adverse consequences, any of which could have a material adverse effect on our business, financial condition or results of operations.

Any current or future outbreak of a health epidemic or other adverse public health developments, such as the current outbreak of COVID-19, could disrupt our manufacturing and supply chain, and adversely affect our business and operating results.

Our business could be adversely affected by the effects of health epidemics, specifically COVID-19. For example, our materials suppliers could be disrupted by conditions related to COVID-19, or other epidemics, possibly resulting in disruption to our supply chain. If our suppliers are unable or fail to fulfill their obligations to us for any reason, we may not be able to manufacture our products and satisfy customer demand or our obligations under sales agreements in a timely manner, and our business could be harmed as a result. At this point in time, there is uncertainty relating to the potential effect of COVID-19 on our business. Infections may become more widespread and should that limit our ability to manufacture our products or cause supply disruptions it would have a negative impact on our business, financial condition and operating results. In addition, a significant health epidemic could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that could affect the market for our products, which could have a material adverse effect on our business, operating results and financial condition.

Risks Related to Intellectual Property

Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively.

Our success depends significantly on our ability to maintain and protect our proprietary rights in the technologies and inventions used in or embodied by our product. To protect our proprietary technology, we rely on patent protection, as well as a combination of copyright, trade secret and trademark laws, as well as nondisclosure, confidentiality, license and other contractual restrictions in our manufacturing, consulting, employment and other third party agreements. These legal means may afford only limited protection, however, and may not adequately protect our rights or permit us to gain or keep any competitive advantage.

We have not and may not be able to adequately protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on our product and technologies in any or all countries throughout the world could be prohibitively expensive. The requirements for patentability may differ in certain countries, particularly developing countries, and the breadth of patent claims allowed can be inconsistent. In addition, the laws of some foreign countries may not protect our intellectual property rights to the same extent as laws in the United States. Consequently, we may not be able to prevent third parties from copying our inventions in allforeign countries, outsideto the extent we can in the United States. Competitors may use our technologies in jurisdictions where we have not obtained patent protection that covers the commercial products to develop their own competing products that are the same or substantially the same as our commercial product and, further, may export otherwise infringing products to territories where we have patent protection, but judicial systems do not adequately enforce patents to cause infringing activities to be ceased.

We do not have patent rights in certain foreign countries in which a market for our product and technologies exists or may exist in the future. Moreover, in foreign jurisdictions where we do have patent rights, proceedings to enforce such rights could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Thus, we may not be able to stop a competitor from marketing and selling in foreign countries products that are the same as or similar to our product.product and technologies.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated fornon-compliance with these requirements.

Moreover, the United States Patent and Trademark Office, (USPTO)or the USPTO, and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In addition, periodic maintenance fees on issued patents often must be paid to the USPTO and foreign patent agencies over the lifetime of the patent. While an unintentional lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits,non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents and patent applications covering our product or procedures, we may not be able to stop a competitor from marketing products that are the same as or similar to our product and technologies.

Our success depends in part on our ability to obtain patents, which can be an expensive, time consuming, and uncertain process, and the value of the patents is dependent in part on the breadth of coverage and the relationship between the coverage and the commercial product.

The patent position of medical drug and device companies is generally highly uncertain. The degree of patent protection we require may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us sufficient exclusivity, or to gain or keep our competitive advantage. For example:

 

we might not have been the first to invent or the first to file patent applications on the inventions covered by each of our pending patent applications and issued patents;

 

others may independently develop similar or alternative technologies or duplicate any of our technologies;

 

the patents of others may have an adverse effect on our business;

 

any patents we obtain or license from others in the future may not encompass commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties;

any patents we obtain or license from others in the future may not be valid or enforceable; and

 

we may not develop additional proprietary technologies that are patentable.

patentable The process of applying for patent protection itself is time consuming and expensive and we cannot assure you that we have prepared or will be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is possible that innovation over the course of development and commercialization may lead to changes in the CHEMOSAT/CHEMOSAT and Melphalan/HDS methods and/or devices that cause such methods and/or devices to fall outside the scope of the patent protection we have obtained and the patent protection we have obtained may become less valuable. It is also possible that we will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. In addition, our patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. It

is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example, with respect to proper priority claims, inventorship, claim scope or patent term adjustments. Moreover, we cannot assure you that all of our pending patent applications will issue as patents or that, if issued, they will issue in a form that will be advantageous to us.

Our success depends in part on our ability to commercialize CHEMOSAT and Melphalan/HDS prior to the expiration of our patent protection.

Due to the uncertainty of the patent prosecution process, there are no guarantees that any of our pending patent applications will result in the issuance of a patent. Even if we are successful in obtaining a patent, patents have a limited lifespan. In the United States, the natural expiration of a utility patent typically is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our CHEMOSAT and Melphalan/HDS methods and devices, we may be open to competition from generic versions of such methods and devices.

We may in the future become involved in lawsuits to protect or enforce our intellectual property, or to defend our products against assertion of intellectual property rights by a third party, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents or misappropriate or otherwise violate our intellectual property rights. To stop any such infringement or unauthorized use, litigation may be necessary. Our intellectual property has not been tested in litigation. There is no assurance that any of our issued patents will be upheld if later challenged or will provide significant protection or commercial advantage. A court may declare our patents invalid or unenforceable, may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question, or may interpret the claims of our patents narrowly, thereby substantially narrowing the scope of patent protection they afford. Because of the length of time and expense associated with bringing new medical drugs and devices to the market, the healthcare industry has traditionally placed considerable emphasis on patent and trade secret protection for significant new technologies. Other parties may challenge patents, patent claims or patent applications licensed or issued to us or may design around technologies we have patented, licensed or developed.

In addition, third parties may initiate legal or administrative proceedings against us to challenge the validity or scope of our intellectual property rights, such as inter partes review, post-grant review,re-examinationor opposition proceedings, before the USPTO, the European Patent Office or other foreign counterparts. Third parties may also allege an ownership right in our patents, as a result of their past employment or consultancy with us. Many of our current and potential competitors have the ability to dedicate substantially greater resources to defend their intellectual property rights than we can. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. Competing products may also be sold in other countries in which our patent coverage might not exist or be as strong. If we lose a foreign patent lawsuit, alleging our infringement of a competitor’s patents, we could be prevented from marketing our product in one or more foreign countries.

The medical device industry has been characterized by frequent and extensive intellectual property litigation. Our competitors or other patent holders may assert that our products and the methods employed in our products are covered by their patents. Although we have performed a search for third-party patents and believe we have adequate defenses available if faced with any allegations that we infringe these third-party patents, it is possible that CHEMOSAT and Melphalan/HDS could be found to infringe these patents. It is also possible that our competitors or potential competitors may have patents, or have applied for, will apply for, or will obtain patents that will prevent, limit or interfere with our ability to make, have made, use, sell, import or export our product. If our products or methods are found to infringe, we could be prevented from manufacturing or marketing our product.

Companies in the medical drug/device industry may use intellectual property infringement litigation to gain a competitive advantage. In the United States, patent applications filed in recent years are confidential for 18 months, while older applications are not publicly available until the patent issues. As a result, avoiding patent infringement may be difficult. Litigation may be necessary to enforce any patents issued or assigned to us or to determine the scope and validity of third-party proprietary rights. Litigation could be costly and could divert our attention from our business. There are no guarantees that we will receive a favorable outcome in any such litigation. If a third party claims that we infringed its patents, any of the following may occur:

 

we may become liable for substantial damages for past infringement if a court decides that our technologies infringe upon a competitor’s patent;

a court may prohibit us from selling or licensing our product without a license from the patent holder, which may not be available on commercially acceptable terms or at all, or which may require us to pay substantial royalties or grant cross-licenses to our patents; and

 

we may have to redesign our product so that it does not infringe upon others’ patent rights, which may not be possible or could require substantial funds or time.

Litigation related to infringement and other intellectual property claims such as trade secrets, with or without merit, is unpredictable, can be expensive and time-consuming, and can divert management’s attention from our core business. If we lose this kind of litigation, a court could require us to pay substantial damages, treble damages, and attorneys’ fees, and could prohibit us from using technologies essential to our product, any of which would have a material adverse effect on our business, results of operations, and financial condition. If relevant patents are upheld as valid and enforceable and we are found to infringe, we could be prevented from selling our product unless we can obtain licenses to use technology or ideas covered by such patents. We do not know whether any necessary licenses would be available to us on satisfactory terms, if at all. If we cannot obtain these licenses, we could be forced to design around those patents at additional cost or abandon the product altogether. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could cause the price of our common stock to decline.

If others have filed patent applications with respect to inventions for which we already have patents issued to us or have patent applications pending, we may be forced to participate in interference or derivation proceedings declared by the USPTO to determine priority of invention, which could also be costly and could divert our attention from our business. If the USPTO declares an interference and determines that our patent or application is not entitled to a priority date earlier than that of the other patent application, our ability to maintain or obtain those patent rights will be curtailed. Similarly, if the USPTO declares a derivation proceeding and determines that the invention covered by our patent application was derived from another, we will not be able to obtain patent coverage of that invention.

Because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before CHEMOSAT and Melphalan/HDS or any other product can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thereby reducing any advantages of the patent. Not all of our United States patent rights have corresponding patent rights effective in Europe or other foreign jurisdictions.

Similar considerations apply in any other country where we are prosecuting patent applications, have been issued patents, or have decided not to pursue patent protection relating to our technology. The laws of foreign countries may not protect our intellectual property rights to the same extent as do laws of the United States.

We maintain a patent license arrangement with a third party, and our future business may depend, in part, upon the maintenance of that arrangement.

Certain aspects of our products may be covered by United States patents and United States patent applications owned by a third party and exclusively licensed to us. If we breach the terms of the license agreement, the license may be terminated by the licensor. If we do not meet certain commercialization obligations by 2019, the license may be converted to anon-exclusive license by the licensor. We cannot guarantee that the license will not be terminated or converted in the future. Without the patent license we will not be able to prevent others from practicing the technology covered by the licensed patent. Moreover, without the patent license, we may be subject to allegations of patent infringement by the patent owner. We cannot guarantee that the third party will fulfill its responsibilities under the license arrangement.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product and our technologies.

Recent patent reform legislation couldLegislation introduced earlier this decade increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. On September 16, 2011, the Leahy-Smith America Invents Act (Leahy-Smith Act) was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigation, and switch the United States patent system from a“first-to-invent” system to afirst-to-file”first-inventor-to-file” system. Under afirst-to-file”first-inventor-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The U.S. Patent and Trademark Office (USPTO)USPTO recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, in particular, thefirst-to-filefirst-inventor-to-file provisions, only became effective on March 16, 2013. As case law continues to develop in response to this legislation, it is not yet clear what the full impact of the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

In addition, patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement, and defense of our patents and applications. Furthermore, the United States Supreme Court and the United States Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by United States and foreign legislative bodies. Those changes may materially affect our patents or patent applications and our ability to obtain and enforce or defend additional patent protection in the future.

Our trademarks may be infringed or successfully challenged, resulting in harm to our business.

We rely on our trademarks as one means to distinguish our product from the products of our competitors, and we have registered or applied to register many of these trademarks. The USPTO or foreign trademark offices may deny our trademark applications, however, and even if published or registered, these trademarks may be ineffective in protecting our brand and goodwill and may be successfully opposed or challenged. Third parties may oppose our trademark applications, or otherwise challenge our use of our trademarks. In addition, third parties may use marks that are confusingly similar to our own, which could result in confusion among our customers, thereby weakening the strength of our brand or allowing such third parties to capitalize on our goodwill. In such an event, or if our trademarks are successfully challenged, we could be forced to rebrand our product, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademark rights in the face of any such infringement.

We may rely primarily on trade secret protection for important proprietary technologies in the European Economic Area.Union.

In addition to patent and trademark protection, we also rely on trade secrets, including unpatentedknow-how, technology and other proprietary information, to maintain our competitive position. Specifically in the European Economic Area (EEA),EU, we rely on design patent and trade secret protection for CHEMOSAT and Melphalan/HDS. Without utility patent protection in the EEAEU covering the current version of CHEMOSAT and Melphalan/HDS, CHEMOSAT and Melphalan/HDS will only be covered by design patent and trade secret protection. Unlike patents, trade secrets are only recognized under applicable law if they are kept secret by restricting their disclosure to third parties. We protect our trade secrets and proprietary knowledge in part through confidentiality agreements with employees, consultants and other parties. However, certain consultants and third parties with whom we have business relationships, and to whom in some cases we have disclosed trade secrets and other proprietary knowledge, may also provide services to other parties in the medical device industry, including companies, universities and research organizations that are developing competing products. In addition, some of our former employees who were exposed to certain of our trade secrets and other proprietary knowledge in the course of their employment may seek employment with, and become employed by, our competitors. We cannot be assured that consultants, employees and other third parties with whom we have entered into confidentiality agreements will not breach the terms of such agreements by improperly using or disclosing our trade secrets or other proprietary knowledge. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, we may not be able to obtain adequate remedies for any such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets.

Trade secret protection does not prevent independent discovery of the technology or proprietary information or use of the same. Competitors may independently duplicate or exceed our technology in whole or in part. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If we are not successful in maintaining the confidentiality of our technology, the loss of trade secret protection orknow-how relating to CHEMOSAT and Melphalan/HDS will significantly impair our ability to commercialize CHEMOSAT in the EEA,EU, and our value and results of operations will be harmed. In particular, we rely on trade secret protection for the filter media, which is a key component of our system.

Similar considerations apply in other foreign countries not mentioned above where we receive approval.approval as mentioned in the section “Management’s Discussion and Analysis of Financial Condition and Results of OperationsIntellectual Property and Other Rights”. Since we do not have issued patents for the current version of CHEMOSAT and Melphalan/HDS in these countries, our ability to successfully commercialize CHEMOSAT and Melphalan/HDS will depend on our ability to maintain trade secret protection in these markets.

We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach ofnon-competition ornon-solicitation agreements with our competitors.

We could in the future be subject to claims that we or our employees have inadvertently or otherwise used or disclosed alleged trade secrets or other proprietary information of former employers, competitors, or other third parties. Although we endeavor to ensure that our employees and consultants do not use the intellectual property, proprietary information,know-how or trade secrets of others in their work

for us, we may in the future be subject to claims that we caused an employee to breach the terms of his or hernon-competition ornon-solicitation agreement, or that we or these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a former employer or competitor. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and could

be a distraction to management. If our defense to those claims fails, in addition to paying monetary damages, a court could prohibit us from using technologies or features that are essential to our product, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers or other third parties. An inability to incorporate technologies or features that are important or essential to our product may prevent us from selling our product. In addition, we may lose valuable intellectual property rights or personnel. Moreover, any such litigation or the threat thereof may adversely affect our ability to hire employees or contract with independent sales representatives. A loss of key personnel or their work product could hamper or prevent our ability to commercialize our product.

Risks Related to Products Liability

We may be the subject of product liability claims or product recalls, and we may be unable to maintain insurance adequate to cover potential liabilities.

Our business exposes us to potential liability risks that may arise from clinical trials and the testing, manufacture, marketing, sale and use of CHEMOSAT and Melphalan/HDS. In addition, because CHEMOSAT and Melphalan/HDS isare intended for use in patients with cancer, there is an increased risk of death among the patients treated with our system which may increase the risk of product liability lawsuits related to clinical trials or commercial sales. We may be subject to claims against us even if the injury is due to the actions of others. For example, if the medical personnel that use our system on patients are not properly trained or are negligent in the use of ourthe system, the patient may be injured, through the use of our system, which may subject us to claims. Were such a claim asserted, we would likely incur substantial legal and related expenses even if we prevail on the merits. Claims for damages, whether or not successful, could cause delays in clinical trials and result in the loss of physician endorsement, adverse publicity and/or limit our ability to market and sell the system, resulting in loss of revenue. In addition, it may be necessary for us to recall products that do not meet approved specifications, which would also result in adverse publicity, as well as resulting in costs connected to the recall and loss of revenue. A successful products liability claim or product recall would have a material adverse effect on our business, financial condition and results of operations. WeWhile we currently carry product liability and clinical trial insurance coverage, but it may be insufficient to cover one or more large claims.

Risks Related to this Offering

Our management team will have broad discretion over the use of the net proceeds from this offering.

Our management will use its discretion to direct the net proceeds from this offering. Our management’s judgments may not result in positive returns on your investment and you will not have an opportunity to evaluate the economic, financial or other information upon which our management bases its decisions.

Investors in this offering will experience immediate and substantial dilution.

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the sale by us of up to 422,535,211 units in this offering, at an assumed public offering price of $0.0355 per unit, and after deducting the underwriters discounts and commissions and other estimated offering expenses payable by us, investors in this offering can expect an immediate dilution of approximately $0.0181 per share, or approximately 48.9% at the assumed public offering price. In addition, in the past, we issued options and warrants to acquire shares of common stock. If the holders of our outstanding options or warrants exercise those options or warrants at prices below the public offering price, you will incur further dilution. Further substantial dilution will occur if the “true-up” provision of our warrants issued in conjunction with the amended restructuring agreement is triggered.

The Series C warrants, the Series D warrants and the Series E warrants are each a new issue of securities with no established trading market.

The Series C warrants, Series D warrants and Series E warrants are each a new issue of securities with no established trading market. The warrants will not be listed on any securities exchange or quotation system. A trading market for the warrants may not develop and even if a market develops it may not provide meaningful liquidity. The absence of a trading market or liquidity for the warrants may adversely affect their value.

The exercise price and number of certain outstanding warrants will be adjusted in connection with this and possibly other offerings.

The 0.3 million warrants issued in our February 2015, July 2015 and October 2016 offerings are subject to an exercise price adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock. The exercise price of the warrants is also subject to anti-dilution adjustments for any issuance of common stock or rights to acquire common stock for consideration per share less than the exercise price of the warrants. In addition to the potential dilutive effect of this provision, there is the potential that a large number of the shares may be sold in the public market at any given time, which could place additional downward pressure on the trading price of our common stock.

Risks Related to the Note Financing

Our indebtedness reduces our financial flexibility and could impede our ability to operate.

In October 2016, we issued an aggregate $35 million principal amount of senior secured convertible notes (the “notes”). The notes are payable in fourteen equal installments beginning in January 2017. Although the notes are payable through the issuance of shares of our common stock to the noteholders, our ability to issue stock, instead of paying cash, to satisfy our payment obligations under the notes, is limited and subject to various conditions (including trading volume and stock price conditions for these notes) that we may not be able to meet. If we cannot meet these conditions, we could be required to repay some or all of the amounts due under the notes in cash, and we may not have the funds available to make one or more of such payments when due. Even if we do have funds so available, the use of cash to make such payments could adversely affect our ability to fund operations due to the diversion of necessary cash flow to fund operations to utilization for note payments. Furthermore, the notes impose certain restrictive covenants on us which may impede our ability to operate our business or raise further funds in the capital markets. For example, there are restrictions on incurring additional indebtedness, with exceptions, while the notes are outstanding.

Such payments are based upon a formula which uses as a conversion price a discount to market formula with a floor price of $0.05, thus the amount of shares issued can be significantly dilutive to our stockholders.

As part of the note financing, we are required to repay the principal on the notes in fourteen equal installments in cash or shares of common stock. The issuance of shares of our common stock pursuant to the notes will result in significant dilution to our stockholders.

The notes will be repayable in cash or shares of common stock, at our election, subject to satisfaction of certain conditions. As of the date of this prospectus, we do not believe that we will have the financial ability, nor would it be in the best interests of our stockholders, to make all payments on the notes in cash when due. Thus, we intend, as of the date hereof, to make such payments in shares of our common stock, to the greatest extent possible. The price at which we will be required to make any installment payments in shares of common stock is equal to the lowest of (i) the then prevailing conversion price, and (ii) initially 85% of the arithmetic average of the lower of (x) the three lowest daily weighted average prices of the common stock during the twenty (20) consecutive trading day period ending on the trading day immediately preceding the installment date and (y) the volume weighted average price of the common stock on the trading day immediately preceding the installment date; provided, that the amount determined in this clause (ii) shall in no event be less than $0.05.

This floor price will not adjust upon a further reverse stock split, so the price of our stock is subject to further substantial dilution as a result of the conversion floor on these Notes.

Our obligations to the holders of our notes are secured by a security interest in substantially all of our assets, so if we default on those obligations, the note holders could foreclose on our assets.

Our obligations under the notes and the transaction documents relating to the notes are secured by a first priority security interest in substantially all of our assets. As a result, if we default under our obligations under the notes or the transaction documents, the holders of the notes, acting through their appointed agent, could foreclose on their security interests and liquidate some or all of these assets, which would harm our business, financial condition and results of operations and could require us to reduce or cease operations.

The holders of the notes have certain additional rights upon an event of default under the notes which could harm our business, financial condition and results of operations and could require us to reduce or cease operations.

Under the notes, the holders have certain rights upon an event of default. Such rights include (i) the remaining principal amount of the notes bearing interest at a rate of 15% per annum, (ii) receipt of payment in cash of an amount equal to (x) the remaining principal amount of the notes, accrued and unpaid interest and accrued and unpaid Late Charges (as defined in the notes) on such principal and interest, multiplied by (y) the redemption premium, equal to 118%, in addition to any and all other amounts due thereunder and (iii) the holder having the right to demand redemption of all or a portion of the notes, as described below. At any time after certain notice requirements for an event of default are triggered, a holder of notes may require us to redeem all or any portion of the note by delivering written notice. Each portion of the note subject to redemption would be redeemed by us in cash by wire transfer of immediately available funds at a price equal to the greater of (x) 118% of the principal amount being redeemed or (y) the product of (A) the conversion rate then in effect multiplied by (B) 118% of the volume weighted average price of the common stock on any trading day during the period commencing on the date immediately preceding such event of default and ending on the date such redemption payment is made. We may not have sufficient funds to settle the redemption price and, as described above, this could trigger rights under the security interest granted to the holders and result in the foreclosure of their security interests and liquidation of some or all of our assets.

The exercise of any of these rights upon an event of default could substantially harm our financial condition and force us to reduce or cease operations.

Risks Related to Our Common Stock

The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for investors.

The trading price forof our common stock has been, and we expect it to continue to be, volatile. The price at which our common stock trades depends upon a number of factors, including our historical and anticipated operating results, our financial situation, announcements of technological innovations or new products by us or ourits competitors, ourits ability or inability to raise the additional capital we may needneeded and the terms on which we raise it may be raised, and general market and economic conditions. Some of these factors are beyond our control. Broad market fluctuations may lower the market price of our common stock and affect the volume of trading, in our stock, regardless of our financial condition, results of operations, business or prospects. Among the factors that may cause the market price of ourits common stock to fluctuate are the risks described in this “Risk Factors” section and other factors, including:

 

Failure of our products to achieve or maintain market acceptance or commercial success;

fluctuations in our quarterly operating results or the operating results of our competitors;

 

variance in our financial performance from the expectations of investors;

 

changes in the estimation of the future size and growth rate of our markets;

 

changes in accounting principles or changes in interpretations of existing principles, which could affect our financial results;

 

failure of our products to achieve or maintain market acceptance or commercial success;

conditions and trends in the markets we serve;served;

 

changes in general economic, industry and market conditions;

 

success of competitive products and services;

 

changes in market valuations or earnings of our competitors;

 

changes in our pricing policies or the pricing policies of our competitors;

 

announcements of significant new products, contracts, acquisitions or strategic alliances by us or our competitors;

 

potentially negative announcements, such as a review of any of our filings by the SEC, changes in accounting treatment or restatements of previously reported financial results or delays in our filings with the SEC:

changes in legislation or regulatory policies, practices or actions;

the commencement or outcome of litigation involving our company,us, our general industry or both;

 

our filing for protection under federal bankruptcy laws;

recruitment or departure of key personnel;

 

changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;

 

actual or expected sales of our common stock by our stockholders; and

 

the trading volume of our common stock.

In addition, the stock markets, in general, the OTC and the market for pharmaceutical companies in particular, may experience a loss of investor confidence. Such loss of investor confidence may result in extreme price and volume fluctuations in our common stock that are unrelated or disproportionate to the operating performance of ourits business, financial condition or results of operations. These broad market and industry factors may materially harm the market price of our common stock and expose usit to securities class action litigation. Such litigation, even if unsuccessful, could be costly to defend and divert management’s attention and resources, which could further materially harm our financial condition and results of operations.

Our warrants contain anti-dilution provisions that, if triggered, could cause dilutionUnder certain circumstances, we may become obligated to pay liquidated damages or to issue additional shares of common stock under the terms of certain of our existing stockholders.outstanding securities.

The 0.3 million warrants issued in our February 2015, July 2015As described above under “Prospectus Summary – Recent Developments,” we are liable to Rosalind for liquidated damages under the terms of the registration rights agreements relating to the Private Placements and October 2016 offerings are subject to an exercisethe Debt Exchange for the period from December 28, 2019 and January 7, 2020. Because the public offering price adjustment upon certain equity issuances below $0.14 per share (as mayin this offering will be further adjusted). In additionless than $23.04 per share, under the terms of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Series E Preferred Stock and the Exercise Price of the 2019 Warrants will be reduced to the potential dilutive effectpublic offering price per share upon the consummation of these provisions, there isthis offering which will require us to issue additional shares of common stock upon the potential thatconversion of the Preferred Stock. We will also be liable for liquidated damages if we fail to comply with certain covenants contained in the registration rights agreements relating to the Private Placements and the Debt Exchange.

Sales of a largesubstantial number of the shares may be soldof our common stock in the public market, at any given time, whichor the perception that such sales may occur, could placeadversely affect the market price of our common stock and could impair our ability to raise additional downward pressureequity capital.

Sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could cause the market price of our common stock to decline and could impair our ability to raise capital through the sale of additional equity securities. We cannot predict the effect that future sales of our shares of common stock or other equity-related securities would have on the tradingmarket price of our common stock.

We have a history of reverse splits, which have severely impacted our common stock price.

Since our initial public offering in 2000, we have effected five reverse stock splits, for a cumulative ratio since our IPO of 1:31,360,000,000. Each such reverse split has resulted in an effective decline in the price of our common stock. There can be no assurance that we will not be required to effect one or more additional reverse stock splits which could further impact the market price and liquidity of our common stock.

Anti-takeover provisions in our Amended and Restated Certificate of Incorporation andBy-laws may reduce the likelihood of a potential change of control, or make it more difficult for our stockholders to replace management.

Certain provisions of our Amended and Restated Certificate of Incorporation andBy-laws could have the effect of making it more difficult for our stockholders to replace management at a time when a substantial number of our stockholders might favor a change in management. These provisions include:

 

providing for a staggered board; and

 

authorizing the board of directors to fill vacant directorships or increase the size of ourits board of directors.

Furthermore, our board of directors has the authority to issue up to 10,000,000 shares of preferred stock in one or more series and to determine the rights and preferences of the shares of any such series without stockholder approval. Any series of preferred stock is likely to be senior to the common stock with respect to dividends, liquidation rights and, possibly, voting rights. OurThe board’s ability to issue preferred stock may have the effect of discouraging unsolicited acquisition proposals, thus adversely affecting the market price of our common stock.

We have never declared or paid any dividends to the holders of our common stock and we do not expect to pay cash dividends in the foreseeable future.

We currently intend to retain all earnings for use in connection with the expansion of our business and for general corporate purposes. OurThe board of directors will have the sole discretion in determining whether to declare and pay dividends in the future. The declaration of dividends will depend on our profitability, financial condition, cash requirements, future prospects and other factors deemed relevant by our board of directors. Our ability to pay cash dividends in the future could be limited or prohibited by the terms of financing agreements that we may enter into or by the terms of any preferred stock that we may authorizebe authorized and issue.issued. We do not expect to pay dividends in the foreseeable future. As a result, holders of our common stock must rely on stock appreciation for any return on their investment.

If we engage in acquisitions, reorganizations or business combinations, we will incur a variety of risks that could adversely affect our business operations or our stockholders.

WeFrom time to time, we may consider strategic alternatives, such as acquiring businesses, technologies or products or entering into a business combination with another company. If we do pursue such a strategy, we could, among other things:

 

issue equity securities that would dilute our current stockholders’ percentage ownership;

 

incur substantial debt that may place strains on our operations;

 

spend substantial operational, financial and management resources in integrating new businesses, personnel, intellectual property, technologies and products;

 

assume substantial actual or contingent liabilities;

 

reprioritize our programs and even cease development and commercialization of CHEMOSAT and Melphalan/HDS;

 

suffer the loss of key personnel, or

 

merge with, or otherwise enter into a business combination with, another company in which our stockholders would receive cash or shares of the other company or a combination of both on terms that certain of our stockholders may not deem desirable.

Although we intend to evaluate and consider different strategic alternatives, we have no agreements or understandings with respect to any acquisition, reorganization or business combination at this time.

Risks Related to this Offering

You will suffer immediate and substantial dilution of your investment as a result of this offering.

You will incur immediate and substantial dilution as a result of this offering. The issuancecombined public offering price per share of additionalcommon stock and related Series F warrant, and the combined public offering price of eachpre-funded warrant and related Series F warrant, will be substantially higher than the as adjusted net tangible book value per share of our common stock after giving effect to this offering. Assuming the sale of 1,692,307 shares of our common stock and Series F warrants to purchase up to 1,692,307 shares of common stock at an assumed combined public offering price of $13.00 per share and related Series F warrant, the closing sale price per share of our common stock on the OTCQB on April 17, 2020, assuming no sale of anypre-funded warrants in this offering, no exercise of the Series F warrants being offered in this offering, that no value is attributed to such Series F warrants and that such Series F warrants are classified as and accounted for as equity and after deducting the underwriting discount and estimated offering expenses payable by us, you will incur immediate dilution of approximately $5.27 per share. As a result of the dilution to investors purchasing securities in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything, in the event of the liquidation of our company. See the section entitled “Dilution” below for a more detailed discussion of the dilution you will incur if you participate in this offering. To the extent shares are issued under outstanding options and warrants at exercise prices lower than the public offering price of our common stock in connection with acquisitions or otherwisethis offering, you will dilute all other stockholdings.incur further dilution.

You may experience future dilution as a result of future equity offerings.

We are not restricted from issuingIn order to raise additional capital, we may at any time offer additional shares of our common stock or from issuingother securities that are convertible into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. We may sell shares or other securities in any other offering at a price per share that representis less than the rightpublic offering price per share in this offering, and investors purchasing shares or other securities in the future could have rights superior to receive, common stock. As of October 31, 2017,existing stockholders. The price per share at which we had an aggregate of 500 millionsell additional shares of our common stock, authorized and of that only 0.9 million not issued or outstanding, including 0.3 million shares issuable upon the exercise of the outstanding warrants at a weighted average price of $12.57securities convertible or 55,000 options to purchase warrants at a weighted average exercise price of $96.99. We may issue all of these shares without any action or approval by our shareholders. We may expand our business through

complementary or strategic business combinations or acquisitions of other companies and assets, and we may issue shares ofexchangeable into common stock, in connection with those transactions.future transactions may be higher or lower than the public offering price per share paid by investors in this offering.

We may not be able to maintain the listing of our common stock on Nasdaq.

We must meet certain financial and liquidity criteria to maintain the listing of our common stock on Nasdaq. If we fail to meet any of Nasdaq’s continued listing standards, our common stock may be delisted. In addition, our board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing. A delisting of our common stock from Nasdaq would materially impair our stockholders’ ability to buy and sell our common stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock. A delisting of our common stock would also significantly impair our ability to raise capital.

We have broad discretion in the use of our cash and cash equivalents, including the net proceeds we receive in this offering, and may not use them effectively.

Our management has broad discretion to use our cash and cash equivalents, including the net proceeds we receive in this offering, to fund our operations and could spend these funds in ways that do not improve our results of operations or enhance the value of our common stock, and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. The marketfailure by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock could declineto decline. Pending their use to fund our operations, we may invest our cash and cash equivalents, including the net proceeds from this offering, in a manner that does not produce income or that loses value.

There is no public market for the warrants being offered by us in this offering.

There is no established public trading market for the Series F warrants and thepre-funded warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list the Series F warrants or thepre-funded warrants on any national securities exchange or other nationally recognized trading system. Without an active market, the liquidity of the Series F warrants and thepre-funded warrants will be limited.

Holders of the warrants offered hereby will have no rights as a resultcommon stockholders with respect to the shares our common stock underlying the warrants until such holders exercise their warrants and acquire our common stock, except as otherwise provided in the warrants.

Until holders of the Series F warrants and thepre-funded warrants acquire shares of our issuancecommon stock upon exercise thereof, such holders will have no rights with respect to the shares of our common stock underlying such warrants, except to the extent that holders of such warrants will have certain rights to participate in distributions or dividends paid on our common stock as set forth in the warrants. Upon exercise of the Series F warrants and thepre-funded warrants, the holders will be entitled to exercise the rights of a large number ofcommon stockholder only as to matters for which the record date occurs after the exercise date.

If our shares of common stock particularly ifbecome subject to the per share consideration we receive for thepenny stock we issue isrules, it would become more difficult to trade our shares.

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the per share book valueexchange or system. If we are unable to maintain the listing of our common stock on Nasdaq or another national securities exchange and if we are not expected to be able to generate earnings with the proceeds of the issuance that are as great as the earnings per share we are generating before we issue the additional shares. In addition, any shares issued in connection with these activities, the exercise of warrants or stock options or otherwise would dilute the percentage ownership held by our investors. We cannot predict the size of future issuances or the effect, if any, that they may have on the market price of our common stock is less than $5.00, our common stock will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This prospectus and the documents incorporated by reference into this prospectus containcontains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 with respect to our business, financial condition, liquidity and results of operations. Words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “could,” “would,” “will,” “may,” “can,” “continue,” “potential,” “should,” and the negative of these terms or other comparable terminology often identify forward-looking statements. Statements in this prospectus and the documents incorporated by reference that are not historical facts are hereby identified as “forward-looking statements” for the purpose of the safe harbor provided by Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Section 27A of the Securities Act of 1933, as amended.amended, or the Securities Act. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements, including the risks discussed in this prospectus, in our Annual Report on Form10-K for the fiscal year ended December 31, 2016 in Item 1A understatements. See “Risk Factors” “ as well as in Item 7A “Quantitative and Qualitative Disclosures About Market Risk” and the risks detailed from time to time in our future SEC reports. These forward-looking statements include, but are not limited to, statements about:beginning on page 8.

 

our estimates regarding sufficiency of our cash resources, anticipated capital requirements and our need for additional financing;

 

the commencement of future clinical trials and the results and timing of those clinical trials;

 

our ability to successfully commercialize CHEMOSAT and Melphalan/HDS, generate revenue and successfully obtain reimbursement for the procedure and System;

 

the progress and results of our research and development programs;

 

submission and timing of applications for regulatory approval and approval thereof;

 

our ability to successfully source certain components of the system and enter into supplier contracts;

 

our ability to successfully manufacture CHEMOSAT and Melphalan/HDS;

 

our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners; and

 

our estimates of potential market opportunities and our ability to successfully realize these opportunities.

Many of the important factors that will determine these results are beyond our ability to control or predict. You are cautioned not to put undue reliance on any forward-looking statements, which speak only as of the date of this prospectus or, in the case of documents incorporated by reference, as of the date of such documents.prospectus. Except as otherwise required by law, we do not assume any obligation to publicly update or release any revisions to these forward-looking statements to reflect events or circumstances after such applicable date or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the “Risk Factors” section hereof beginning on page 8 and in reports we will file from time to time with the SEC after the date of this prospectus.

USE OF PROCEEDS

Based on an assumedWe estimate that the net proceeds from this offering will be approximately $20.0 million ($23.0 million if the underwriters exercise their over-allotment option in full), assuming a combined public offering price per share of $0.0355common stock and related Series F warrant of $13.00, the closing sale price per unit, which was the last reported sales priceshare of our common stock on the OTCQB on October 31, 2017, we expect to receive net proceeds fromApril 17, 2020, after deducting the sale of the securities that we are offering to be approximately $13.9 million, after deduction of underwriting discounts, and commissionsdiscount and estimated offering expenses payable by us. This amount does not includeIf the Series F warrants are exercised in full, the estimated net proceeds that we may receive in connection with any exercise of the warrants issued in this offering. We cannot predict when orwill increase to $42.0 million (or $48.3 million if the underwriters’ option to purchase additional securities is exercised in full).

A $0.50 increase or decrease in the assumed combined public offering price per share of common stock and related Series F warrant would increase or decrease the net proceeds to us from this offering by approximately $0.8 million, assuming the number of shares,pre-fundedwarrants will be exercised, however, and it is possible thatSeries F warrants offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discount and estimated offering expenses payable by us. An increase or decrease of 100,000 in the number of shares of common stock (or common stock underlyingpre-funded warrants) and related Series F warrants may expireoffered by us, as set forth on the cover page of this prospectus, would increase or decrease net proceeds to us from this offering approximately by $1.2 million, assuming no change in the assumed combined public offering price per share of common stock and never be exercised.related Series F warrant after deducting the underwriting discount.

We intend to use the net proceeds from this offering (including any resulting from the exercise of the warrants, if any) for:

the clinical and regulatory development of clinical studies, including the Phase 3 Ocular Melanoma liver metastases trial, a registration trial for intrahepatic cholangiocarcinoma, investigator initiated trials mCRC and pancreatic cancer metastatic to the liver, and European Union Commercial Registry;

commercialization of our products,

obtaining regulatory approvals;

research;

capital expenditures and development of joint ventures and licensing arrangements for our products;

working capital; and

the balance, if any, for other general corporate purposes.

We expect that the proceeds of this offering for working capital and general corporate purposes, including the continued development of Melphalan/HDS. We will be sufficient to allow us to continue our ongoing clinical trial programs, however, we are subject to substantial risks that could require us to obtain additional funding in order to achieve these objectives. See “Risk Factors.” We may need substantial additional capital in the future, which could cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights, and if additional capital is not available, we may have to delay, reduce or cease operations.

Our expected use of net proceeds from this offering represents our current intentions based upon our present plans and business condition. The amounts and timing of our actual use of net proceeds will vary depending on numerous factors, including our ability to obtain additional financing, the relative success and cost of clinical and regulatory development programs and the amount and timing of product revenue, if any. In addition, we might decide to postpone or not pursue certain activities if, among other factors, the net proceeds from this offering and our other sources of cash are less than expected. As a result, management will haveretain broad discretion inover the applicationuse of the net proceeds and investors will be relying on our judgment regarding the application of the net proceeds.this offering. Pending the uses described above,such use, we intend to invest the net proceeds in interest-bearing investment-grade securities or deposits.government securities.

DILUTION

If you invest in our common stock and warrants, your interest will be diluted immediately to the extent of the difference between the public offering price per share of our common stock and the adjusted net tangible book value per share of our common stock after this offering.

The net tangible book value of our common stock as of June 30, 2017, was approximately $0.9 million, or approximately $0.00 per share. Net tangible book value per share represents the amount of our total tangible assets, excluding goodwill and intangible assets, less total liabilities divided by the total number of shares of our common stock outstanding.

Dilution per share to new investors represents the difference between the amount per share paid by purchasers for our common stock in this offering and the net tangible book value per share of our common stock immediately following the completion of this offering.

After giving effect to the sale of 422,535,211 units offered by this prospectus at the assumed public offering price of $0.0355 per unit, which was the last reported sales price on October 31, 2017 on the OTCQB, excluding the underwriter’s exercise of the over-allotment option and after deducting the estimated underwriting discount, commissions and our estimated offering expenses and excluding the proceeds, if any from the exercise of the warrants issued pursuant to this offering, our pro forma net tangible book value as of June 30, 2017 would have been approximately $14.7 million or approximately $0.0174 per share. This represents an immediate increase in net tangible book value of approximately $0.0153 per share to our existing stockholders and an immediate dilution in pro forma net tangible book value of approximately $0.0181 per share to purchasers of our common stock in this offering, as illustrated by the following table:

Assumed offering price for one unit consisting of one share of common stock and three warrants

  $0.0355 

Net tangible book value per share as of June 30, 2017

  $0.002 

Increase per share attributable to new investors

  $0.0153 

Pro forma net tangible book value per share as of June 30, 2017 after giving effect to this offering

  $0.0174 

Dilution per share to new investors

  $0.0181 

The discussion of dilution, and the table quantifying it, assume no exercise of any outstanding options or warrants or other potentially dilutive securities. The exercise of potentially dilutive securities having an exercise price less than the offering price would increase the dilutive effect to new investors.

The table above excludes the following potentially dilutive securities as of October 4, 2017:

55,000 shares issuable upon the exercise of stock options at a weighted average exercise price of $96.99 per share;

0.3 million shares issuable upon the exercise of outstanding warrants at a weighted average exercise price of $12.57 per share;

18,000 shares reserved for future issuance under our 2009 Equity Incentive Plan, as amended;

0.1 million unvested restricted shares; and

1,267,605,633 shares issuable upon exercise of the common warrants offered hereby.

To the extent that any of these options or warrants are exercised or the restricted shares vest, these will cause dilution per share to the investors purchasing securities in this offering.

CAPITALIZATION

The following table sets forth our cash and cash equivalents and consolidated capitalization as of June 30, 2017 on: (i) an historical basis; and (ii) an as adjusted basis to give effect to this offering.

You should read the following table in conjunction with the sections entitled “Use of Proceeds,” and “Description of Capital Stock” in this prospectus, and “Selected Historical Combined Consolidated Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our financial statements and related notes thereto in our Annual Report onForm 10-K for the year ended December 31, 2016 and our Quarterly Reports on Form10-Q for the quarters ended March 31, 2017 and June 30, 2017 incorporated by reference into this prospectus.

   June 30, 2017 
   Actual   As
Adjusted
 
   (unaudited) 

Cash and cash equivalents

  $1,816   $15,649 
  

 

 

   

 

 

 

Stockholders’ equity

    

Preferred stock, $.01 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively

   —      —   

Common stock, $.01 par value; 500,000,000 shares authorized; 424,526.067 and 4,131,527 shares issued and 424,408,256 and 4,112,417 shares outstanding at June 30, 2017 and December 31, 2016, respectively*

   4,245    8,471 

Additionalpaid-in capital

   289,186    298,793 

Accumulated deficit

   (292,464   (292,464

Treasury stock, at cost; 110 shares at June 30, 2017 and December 31, 2016, respectively*

   (51   (51

Accumulated other comprehensive income

   (49   (49
  

 

 

   

 

 

 

Total stockholders’ deficit

   867    14,700 
  

 

 

   

 

 

 

Total capitalization

  $18,603   $32,436 
  

 

 

   

 

 

 

*reflects aone-for-sixteen (1:16) reverse stock split effected on July 21, 2016.

Equity Compensation Plans

Summary equity compensation plan data –

The following table sets forth information, as of June 30, 2017, about our equity compensation plans (including the potential effect of debt instruments convertible into common stock) in effect as of that date:

Plan category

  (a)
Number of
securities
to be issued
upon exercise
of outstanding
options, warrants
and rights
(1)(2)
   (b)
Weighted-average
exercise price of
outstanding
options
   (c)
Number of
securities
remaining
available
for future issuance
under equity
compensation
plans
(excluding
securities
reflected in
column
(a))
 

Equity compensation plans approved by security holders (

   55,486   $95.51    17,022 

Equity compensation plans not approved by security holders

   —     $—      —   
  

 

 

   

 

 

   

 

 

 

Totals

   55,486   $95.51    17,022 
  

 

 

   

 

 

   

 

 

 

(1)The description of the material terms ofnon-plan issuances of equity instruments is discussed in Note [5] to the accompanying consolidated financial statements.
(2)Net of equity instruments forfeited, exercised or expired.

PRICE RANGE OFMARKET FOR OUR COMMON STOCK AND DIVIDEND POLICYRELATED STOCKHOLDER MATTERS

Market Information

Our common stock is quoted on the OTCQB under the symbol “DCTH.” The table below sets forth, forQuotations on the periods indicated,OTCQB reflect inter-dealer prices, without retailmark-up, mark-down or commission and may not necessarily represent actual transactions. On December 24, 2019, we effected the quarterly high and lowReverse Split. Unless otherwise specified or the context otherwise indicates, the information contained in this prospectus has been adjusted to give effect to the Reverse Split. On April 17, 2020, the closing sale prices per shareprice of our common stock since 2015.as reported on the OTCQB was $13.00 per share.

Our common stock has been approved for listing on The information inNASDAQ Capital Market under the table below reflects aone-for-sixteen (1:16) reversesymbol “DCTH” contingent on the completion of this offering. The closing sale price of our common stock split effectedas reported on July 21, 2016.

   High   Low 

2015:

    

First Quarter

  $24.93   $15.36 

Second Quarter

   23.04    12.96 

Third Quarter

   14.72    6.38 

Fourth Quarter

   9.96    6.24 

2016:

    

First Quarter

  $8.64   $4.00 

Second Quarter

   5.70    3.68 

Third Quarter

   4.61    2.48 

Fourth Quarter

   2.74    0.90 

2017

    

First Quarter

  $0.87   $0.08 

Second Quarter

  $0.27   $0.02 

The last reported tradingthe OTCQB may not be indicative of the market price of our common stock on October 31, 2017 was $0.0355. the NASDAQ Capital Market.

As of October 31, 2017, we hadApril 17, 2020, there were approximately 10054 holders of record of our common stock.

Dividend Policy

We have never declared or paid any dividends to the holders of our common stock and we do not expect to pay cash dividends in the foreseeable future. We currently intend to retain any earnings for use in connection with the expansion of our business and for general corporate purposes.

OUR BUSINESSCAPITALIZATION

About DelcathThe following table sets forth our cash, derivative liability and capitalization as of December 31, 2019:

Delcath Systems, Inc.

on an actual basis; and

as adjusted to give effect to the assumed sale of 1,692,307 shares of common stock and Series F warrants to purchase up to 1,692,307 shares of common stock at an assumed combined public offering price of $13.00 per share and related Series F warrant, the closing sale price per share of our common stock on the OTCQB on April 17, 2020, assuming no sale of anypre-funded warrants in this offering, no exercise of the Series F warrants being offered in this offering, that no value is attributed to such Series F warrants and that such Series F warrants are classified as and accounted for as equity and after deducting the underwriting discount and estimated offering expenses payable by us.

You should read the forgoing table together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes appearing elsewhere in this prospectus.

   As of December 31, 2019
(in thousands, except for share
numbers)
 
   

Actual

(Unaudited)

   

As Adjusted

(Unaudited)

 

Cash

  $10,002   $29,967 
  

 

 

   

 

 

 

Derivative liability

   3,368    —  (1) 
  

 

 

   

 

 

 

Stockholders’ deficit:

    

Preferred stock, $0.01 par value; 10,000,000 shares authorized; 41,517 shares issued and outstanding as of December 31, 2019

   —      —   
  

 

 

   

 

 

 

Common stock, $0.01 par value; 1,000,000,000 shares authorized; 67,091 shares issued and outstanding as of December 31, 2019, 1,759,398 shares issued and outstanding as adjusted

   —      18 
  

 

 

   

 

 

 

Additional paid in capital

   364,785    388,102 
  

 

 

   

 

 

 

Accumulated deficit

   (371,171   (371,171
  

 

 

   

 

 

 

Accumulated other comprehensive income

   28    28 
  

 

 

   

 

 

 

Total stockholders’ (deficit) equity

   (6,357   16,977 
  

 

 

   

 

 

 

Total capitalization

  $14,212    34,177 
  

 

 

   

 

 

 

(1)

Upon the listing of our common stock on Nasdaq, certain price-adjustment provisions in the 2019 Warrants will terminate. As a result, the 2019 Warrants, which have previously been classified as a liability on our consolidated financial statements, will be reclassified as equity.

A $0.50 increase or decrease in the assumed combined public offering price per share of common stock and related Series F warrant would increase or decrease each of cash, common stock and additionalpaid-in capital, total stockholders’ equity and total capitalization on an as adjusted basis by approximately $0.8 million, assuming that the number of shares,pre-funded warrants and Series F warrants offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discount and estimated offering expenses payable by us. An increase or decrease of 100,000 in the number of shares of common stock (or common stock underlyingpre-funded warrants) and related Series F warrants offered by us, as set forth on the cover page of this prospectus, would increase or decrease each of cash, common stock and additionalpaid-in capital, total stockholders’ equity and total capitalization on an as adjusted basis by approximately $1.2 million, assuming no change in the assumed combined public offering price per share of common stock and related Series F warrant after deducting the underwriting discount and estimated offering expenses payable by us.

The as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined between us and the underwriter at pricing.

The table and discussion above are based on 67,091 shares of common stock outstanding as of December 31, 2019 and excludes, as of that date, the following:

1,802,008 shares of common stock issuable upon conversion of the outstanding Preferred Stock;

1,826,608 shares of common stock issuable upon the exercise of outstanding warrants having a weighted average exercise price of $23.04 per share;

1,640 shares of common stock issuable upon the exercise of outstanding options having a weighted average exercise price of $196.70 per share;

63,493 shares of common stock issuable upon the conversion of convertible notes; and

502 shares available for grant under our 2019 Equity Incentive Plan, or the 2019 Plan.

DILUTION

If you invest in our common stock in this offering, your ownership interest will be diluted immediately to the extent of the difference between the assumed combined public offering price per share and related Series F warrant and the as adjusted net tangible book value per share of our common stock immediately after this offering.

As of December 31, 2019, we had a net tangible book deficit of approximately $(6.4 million), or approximately $(94.75) per share. Net tangible book value (deficit) per share represents our total tangible assets, less total liabilities, divided by the number of shares of common stock outstanding. After giving effect to the assumed sale of 1,692,307 shares of our common stock and Series F warrants to purchase up to 1,692,307 shares of common stock at an assumed combined public offering price of $13.00 per share and related Series F warrant, the closing sale price per share of our common stock on the OTCQB on April 17, 2020, assuming no sale of anypre-funded warrants in this offering, no exercise of the Series F warrants being offered in this offering, that no value is attributed to such Series F warrants and that such Series F warrants are classified as and accounted for as equity and after deducting the underwriting discount and estimated offering expenses payable by us, our as adjusted net tangible book value per share as of December 31, 2019, would have been approximately $13.6 million, or approximately $7.73 per share. This represents an immediate increase in net tangible book value per share of $102.48 to existing stockholders and an immediate dilution of approximately $5.27 per share to new investors purchasing shares of our common stock in this offering.

Assumed combined public offering price per share and related Series F warrant

    $13.00 

Net tangible book deficit per share at December 31, 2019

  $(94.75)   

Increase in book value per share attributable to new investors

   102.48   
  

 

 

   

As adjusted net tangible book value per share at December 31, 2019 after this offering

    $ 7.73 
    

 

 

 

Dilution per share to new investors

    $5.27 
    

 

 

 

If the underwriters exercise their over-allotment option in full, our as adjusted net tangible book value would be approximately $16.6 million, or approximately $8.44 per share, representing an increase in the net tangible book value to existing stockholders of approximately $251.89 per share and immediate dilution of approximately $4.56 per share to new investors purchasing shares of our common stock in this offering.

A $0.50 increase or decrease in the assumed combined public offering price per share of common stock and related Series F warrant, would increase or decrease the as adjusted net tangible book value by approximately $4.24 per share and the dilution to investors participating in this offering by approximately $3.74 per share, assuming the number of shares of common stock,pre-funded warrants and Series F warrants offered by us as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discount and estimated offering expenses payable by us. An increase of 100,000 in the number of shares of common stock (or common stock underlyingpre-funded warrants) and related Series F warrants offered by us, as set forth on the cover page of this prospectus, would increase the as adjusted net tangible book value by approximately $0.23 per share and decrease the dilution to investors participating in this offering by approximately $0.23 per share, assuming the assumed combined public offering price per share of common stock and related Series F warrant remains the same and after deducting the underwriting discount and estimated offering expenses payable by us.

Conversely, a decrease of 100,000 in the number of shares of common stock (or common stock underlyingpre-funded warrants) and related Series F warrants offered by us, as set forth on the cover page of this prospectus, would decrease the as adjusted net tangible book value by approximately $0.25 per share and increase the dilution to investors participating in this offering by approximately $0.25 per share, assuming the assumed combined public offering price per share of common stock and related Series F warrant remains the same and after deducting the underwriting discount and estimated offering expenses payable by us.

The table and discussion above are based on 67,091 shares of common stock outstanding as of December 31, 2019 and excludes, as of that date, the following:

1,802,008 shares of common stock issuable upon conversion of the outstanding Preferred Stock;

1,826,608 shares of common stock issuable upon the exercise of outstanding warrants having a weighted average exercise price of $23.04 per share;

1,640 shares of common stock issuable upon the exercise of outstanding options having a weighted average exercise price of $196.70 per share;

63,493 shares of common stock issuable upon the conversion of convertible notes; and

502 shares available for grant under our 2019 Equity Incentive Plan, or the 2019 Plan.

In addition, we may choose to raise additional capital in the future. To the extent that capital is raised through equity or convertible securities, the issuance of those securities may result in further dilution to the holders of common stock.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this prospectus. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this prospectus.

Overview

We are an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product—lead product candidate, Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System, or Melphalan/HDS—HDS, is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our systemMelphalan/HDS is in commercial developmentapproved for sale under the trade name Delcath Hepatic CHEMOSAT® Hepatic Delivery System for Melphalan, (CHEMOSAT®), where it has been used at major medical centers to treat a wide range of cancers of the liver.or CHEMOSAT.

Our primary research focus is on ocular melanoma liver metastases, (mOM)or mOM, and intrahepatic cholangiocarcinoma, (ICC),or ICC, a type of primary liver cancer, andas well as certain other cancers that are metastatic to the liver. We believe that the disease states we are investigating represent a multi-billion dollar global market opportunity and a clearare unmet medical need.needs that represent significant market opportunities.

Our clinical development program for CHEMOSAT andWe are investigating the objective response rate of Melphalan/HDS is comprised of Thein patients with mOM in our FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma, (Theor the FOCUS Trial),Trial, a Globalglobal registration clinical trial. For information on the FOCUS Trial, see “Business—Clinical Development Program—The FOCUS Trial”.

We are also conducting the ALIGN Trial, a global Phase 3 clinical trial that is investigating overall survivalof Melphalan/HDS in mOM,patients with ICC, or the ALIGN Trial. For information on the ALIGN Trial, see “Business—Clinical Development Program—The ALIGN Trial” below.

In addition to the FOCUS Trial and a registration trial for intrahepatic cholangiocarcinoma (ICC) we plan to initiate when financial resources permit. Our clinicalthe ALIGN Trial, our commercial development plan (CDP) also includes a commercial registry for CHEMOSATnon-clinical commercial cases performed in Europe and sponsorship of select investigator initiatedinvestigator-initiated trials, (IITs) in colorectal cancer metastatic to the liver (mCRC) and pancreatic cancer metastatic to the liver.

The direction and focus of our CDP for CHEMOSAT and Melphalan/HDS is informed by prior clinical development conducted between 2004 and 2010,non-clinical, commercial CHEMOSAT cases performed on patients in Europe, and prior regulatory experience with the FDA. Experience gained from this research, development, early European commercial and United States regulatory activity has led to the implementation of several safety improvements to our product and the associated medical procedure.or IITs.

In the United States, Melphalan/HDS is considered a combination drug and device product and is regulated as a drug by the United States Food and Drug Administration, or the FDA. The FDA has granted us six orphan drug designations, including three orphan designations for the potential use of the drug melphalan for the treatment of patients with mOM, HCChepatocellular carcinoma and ICC. Melphalan/HDS has not been approved for sale in the United States.

In Europe, the current version of our CHEMOSAT product is regulated as a Class IIb medical device and received its CE Mark in 2012. We are in an early phase of commercializing the CHEMOSAT system in select markets in the European Union (EU)United Kingdom and the EU, where we believe the prospect of securing adequate reimbursement for the procedure is strongest. In 2015 national reimbursement coverage for the use of CHEMOSAT proceduresis strongest.

Our Ability to Continue as a Going Concern

The notes to our consolidated financial statements include a disclosure describing the existence of certain conditions that raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. Our consolidated financial statements as of December 31, 2019 have been prepared under the assumption that we will continue as a going concern. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. Our consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. See risk factors relating to our financial condition as well as other risk factors that we face in the Section entitled “Risk Factors” herein.

Our independent registered public accounting firm has issued its report dated March 25, 2020 in connection with the audit of our consolidated financial statements as of December 31, 2019 that includes an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern.

Liquidity and Capital Resources

We received gross proceeds of $29.5 million through two private placements in July and August 2019, providing funding through the second quarter of 2020. We will need to raise additional capital under structures available to us including debt and/or equity offerings. If these sources do not provide the capital necessary to fund our operations, we will need to curtail certain aspects of our operations or consider other means of obtaining additional financing, although there is no guarantee that we could obtain the financing necessary to continue our operations.

Our future results are subject to substantial risks and uncertainties. We have operated at a loss for our entire history and anticipate that losses will continue over the coming years. There can be no assurance that we will ever generate significant revenues or achieve profitability. We expect to use cash, cash equivalents and investment proceeds to fund our clinical and operating activities. Our future liquidity and capital requirements will depend on numerous factors, including the initiation and progress of clinical trials and research and product development programs; obtaining approvals and complying with regulations; the timing and effectiveness of product commercialization activities, including marketing arrangements; the timing and costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights; and the effect of competing technological and market developments.

At December 31, 2019, we had cash, cash equivalents and restricted cash totaling $10.2 million, as compared to cash, cash equivalents and restricted cash totaling $3.6 million at December 31, 2018. During the years ended December 31, 2019 and 2018, the Company used $23.7 million and $14.7 million respectively, of cash in our operating activities.

Our consolidated financial statements as of December 31, 2019 have been prepared under the assumption that we will continue as a going concern for the next twelve months. We expect to incur significant expenses and operating losses for the foreseeable future. These factors raise substantial doubt about our ability to continue as a going concern. Because our business does not generate positive cash flow from operating activities, we will need to obtain substantial additional capital in order to fund clinical trial research and support development efforts relating to ocular melanoma liver metastases, ICC, HCC or other indications, and to fully commercialize the product. We believe we will be able to raise additional capital in the event it is in our best interest to do so. We anticipate raising such additional capital by either borrowing money, selling shares of our capital stock, or entering into strategic alliances with appropriate partners. To the extent additional capital is not available when needed or on acceptable terms, we may be forced to abandon some or all of our development and commercialization efforts, which would have a material adverse effect on the prospects of our business. Further, our assumptions relating to our cash requirements may differ materially from our actual requirements because of a number of factors, including significant unforeseen delays in the regulatory approval process, changes in the timing, scope, focus and direction of clinical trials and costs related to commercializing the product.

We have funded our operations through a combination of private placements and public offerings of its securities in each of 2000, 2003, 2009, 2010, 2011, 2012, 2013, 2015, 2016, 2018 and 2019, including registered direct offerings in 2007, 2009 and 2013, “at the market” equity offering programs in 2012 and 2013, and by the private placement of convertible notes in 2016 and 2018, and, most recently, in July and August 2019, we raised $29.5 million in the closing of two private placements of convertible preferred stock and warrants to purchase common stock. For a detailed discussion of our various sales of debt and equity securities see Notes 10 and 11 to our audited consolidated financial statements.

In October 2018, we filed a registration statement on FormS-3 with the SEC, which was awardeddeclared effective on December 21, 2018 and allowed us to offer and sell, from time to time in Germany.one or more offerings, up to $100.0 million of common stock, preferred stock, warrants, debt securities and stock purchase contracts as it deems prudent or necessary to raise capital at a later date. We lost our FormS-3 eligibility due to the late filing of our Annual Report for the year ended December 31, 2018. Absent prior relief from the SEC, we expect to regainS-3 eligibility on June 1, 2020.

Future Capital Needs; Additional Future Funding

Our future results are subject to substantial risks and uncertainties. We have operated at a loss for our entire history and there can be no assurance that we will ever achieve consistent profitability. Based upon the recent financing activities described above, we believe that we have adequate resources to fund operations through June 2020. Additional working capital will be required to continue operations. There can be no assurance that such working capital will be available on acceptable terms, if at all.

Results of Operations for the Year Ended December 31, 2019; Comparisons of Results of the Years Ended December 31, 2019 and 2018

Revenue

We recorded approximately $1.1 million in product revenue and $0.5 million in other revenue during the year ended December 31, 2019. During the same period in 2018, we recorded $3.4 million in product revenue and $29,000 in other revenue. The decrease in revenue is related to our entering into the licensing agreement with medac which is discussed above in the section titled “Market Access and Commercial Clinical Adoption.” Upon signing the agreement, we transitioned from selling CHEMOSAT directly to centers and recognizing the full selling price of CHEMOSAT as revenue to receiving a royalty on each kit that medac sells. As a result, our revenue has decreased in 2019. This was an anticipated change and is partially offset by the upfront and milestone payments stipulated on our agreement with medac.

Cost of Goods Sold

During the year ended December 31, 2019, we recognized cost of goods sold of approximately $0.7 million related to product revenue of $1.1 million as compared to cost of goods sold of approximately $1.0 million related to product revenue of $3.4 million in the comparable prior period. The decrease in revenue is related to our entering into the licensing agreement with medac which is discussed above in the section titled “Market Access and Commercial Clinical Adoption.” As a result of the transition from direct sales to receiving a royalty, our gross margin on each CHEMOSAT unit sold has decreased significantly in 2019. This was an anticipated change and is partially offset by the upfront and milestone payments stipulated on our agreement with medac.

Selling, General and Administrative Expenses

For the year ended December 31, 2019, selling, general and administrative expenses increased to $11.3 million from $9.8 million for the year ended December 31, 2018. The increase is primarily related to $0.9 million in settlement expenses, which was anon-cash expense discussed further in Note 11 and $0.8 million in expenses related to litigation that was settled in July and August 2019.

Research and Development Expenses

For the year ended December 31, 2019, research and development expenses decreased to $9.5 million from $19.6 million for the year ended December 31, 2018. The decrease was primarily due to a reduced rate of enrollment and related professional services for the FOCUS trial as a result of the cash constraints we experienced during the first half of 2019.

Change in Fair Value of Derivative Liability

For the year ended December 31, 2019,non-cash derivative instrument income decreased to $17.5 million from $19.7 million for the year ended December 31, 2018. In 2016, coverage levels2018, the Company issued the February 2018 Warrants which were negotiated between hospitalsinitially valued at $18.3 million, with almost all of that value being expensed during 2018. In 2019, the Company issued the 2019 Warrants with an initial fair value of $20.8 million. At December 31, 2019, the fair value of the 2019 Warrants was $3.4 million, resulting in Germanya $17.4 million change in the fair value.

Loss on issuance of financial instrument

For the for the year ended December 31, 2019,non-cash loss on issuance of financial instrument decreased to $1.7 million from $2.8 million for the year ended December 31, 2018. In 2019, the $1.7 million loss is related to the issuance of the $2.0 million convertible note which was issued in exchange for the cancellation of the Series D and regional sickness funds. Coverage levels determined via this processPre-Funded Series D Warrants discussed further in Notes 10 and 11. In 2018, the $2.8 million loss was related to the initial fair value of the Series D Warrants discussed further in Notes 10 and 11.

Other Income/Expense and Interest Expense

Other expense and interest expense are primarily related to the amortization of debt discounts discussed in Note 10 of our audited consolidated financial statements, as well as foreign currency exchange gains and losses.

Interest income is from a money market account and interest earned on operating accounts.

Net Loss

We had a net loss for the year ended December 31, 2019 of $8.9 million, a decrease of $10.3 million, or 53.8%, compared to a $19.2 million net loss for the same period in 2018. This decrease is due in part to a $8.7 million decrease in operating expenses and a $1.5 million decrease in gross profits, as well as a $5.4 million decrease in variousnon-cash expense items primarily related to the amortization of debt discounts and other costs related to convertible notes and other instruments issued in 2018 and 2019, and discussed in greater detail in Note 10 of the Company’s audited consolidated financial statements and a $2.2 million decrease in derivative instrument income, also anon-cash item.

Income Taxes

The Company has not recorded expense related to income taxes for the years ending December 31, 2019 and 2018, respectively, due to being in a net tax operating loss position for each of those years.

On December 22, 2017, the 2017 Tax Cuts and Jobs Act (the “Tax Act”) was enacted into law and the new legislation contains several key tax provisions that affected the Company, including aone-time mandatory transition tax on accumulated foreign earnings and a reduction of the corporate income tax rate to 21% effective January 1, 2018, among others. The Company was required to recognize the effect of the tax law changes in the period of enactment, such as determining the transition tax, remeasuring our U.S. deferred tax assets and liabilities as well as reassessing the net realizability of our deferred tax assets and liabilities. In December 2017, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (“SAB 118”), which allowed the Company to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. Since the Tax Act was passed late in the fourth quarter of 2017, and ongoing guidance and accounting interpretation were expected in 2018, the Company considered the accounting of deferred taxre-measurements and the transition tax to be renegotiated annually.incomplete due to the forthcoming guidance and our ongoing analysis of finalyear-end data and tax positions. However, during the year ended December 31, 2017 the Company was able to determine a provisional amount of $143,500 (offset by valuation allowance) and $0, respectively, related to the deferred taxre-measurement andone-time transition tax. See Note 14 to the Company’s audited consolidated financial statements. The Company finalized its accounting of the effects of tax reform in 2018, which resulted in insignificant adjustments.

Currently there

Off-Balance Sheet Arrangements

We do not have anyoff-balance sheet arrangements that have or are few effective treatment options for certain cancersreasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Application of Critical Accounting Policies

Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the liver. TraditionalUnited States of America, or GAAP. Certain accounting policies have a significant impact on amounts reported in the consolidated financial statements. A summary of those significant accounting policies can be found in Note 3 to our audited consolidated financial statements.

We consider the valuation allowance for the deferred tax assets to be a significant accounting estimate. A valuation allowance has been recorded against our deferred tax assets as management believes it is more likely than not that the deferred tax assets will not be realized. In assessing whether it is more likely than not that we will realize the benefits of its deferred tax assets, management considers all forms of available evidence, including our history of cumulative losses, estimates of future taxable income and losses (including reversals of deferred tax liabilities), and available tax planning strategies. Since we are in a cumulative loss position, we cannot rely on future taxable income as a source of taxable income because we view a cumulative loss position as significant objective negative evidence that would be difficult to overcome with the other subjective tests discussed. We do not have taxable income in prior years to absorb the carryback of net operating losses, nor have we implementedtax-planning strategies that would, if necessary, be implemented to allow for the usage of net operating losses.

Prior to ASU2016-16, GAAP prohibited the recognition of current and deferred income taxes for intra-entity asset transfers until the asset has been sold to an outside party. ASU2016-16 eliminates this prohibition for intra-entity transfers of assets other than inventory but retain the prohibition for intra-entity transfers of inventory. This standard is effective for public entities for fiscal years beginning

after December 15, 2017. On January 1, 2012, we sold a portion of our intellectual property to an affiliate, Delcath Holdings Limited, resulting in a taxable gain of $15.8 million in the U.S. based on the fair market value of the intangible that was transferred. The arms-length price, which was determined in accordance with Section 482 of the Internal Revenue Code, is a significant accounting estimate. Prior to ASU 2016-2016, the gain was deferred under GAAP principles until the asset is sold outside of the consolidated financial statements. The remaining deferred gain on the intercompany sale of intangible assets is $2.0 million as of December 31, 2017. We adopted ASU2016-16, effective on January 1, 2018. As a result of adoption, we immediately recognized the $2.0 million deferred gain and none remains as of December 31, 2018.

We have adopted the provisions of Accounting Standard Codification, or ASC, 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for employee services. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders’ requisite service period (generally the vesting period of the equity grant). We expense our share-based compensation under the accelerated method, which treats each vesting tranche as if it were an individual grant.

We have adopted the provisions of ASC505-50, Equity-Based Payments toNon-Employees, which establishes accounting for equity-based payments tonon-employees. Measurement of compensation cost related to common shares issued tonon-employees for services is based on the value of the services provided or the fair value of the shares issued. Each transaction is reviewed to determine the more reliably measurable basis for the valuation. The measurement ofnon-employee stock-based compensation is subject to periodic adjustment as the underlying equity instrument vests.Non-employee stock-based compensation charges are amortized over the vesting period or period of performance of the services.

We have adopted the provisions of ASC 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.

ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy).

Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that we has the ability to access. Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. Our assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. See Note 12 to our audited consolidated financial statements for assets and liabilities we has evaluated under ASC 820.

BUSINESS

Company Overview

We are an interventional oncology company focused on the treatment options include surgery,of primary and metastatic liver cancers. Our lead product candidate, Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System, or Melphalan/HDS, is designed to administer high-dose chemotherapy to the liver transplant, radiation therapy, interventional radiology techniques,while controlling systemic exposure and isolated hepatic perfusion. We believe that CHEMOSAT andassociated side effects. In Europe, Melphalan/HDS representsis approved for sale under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan, or CHEMOSAT.

Our primary research focus is on ocular melanoma liver metastases, or mOM, and intrahepatic cholangiocarcinoma, or ICC, a potentially important advancement in regional therapy fortype of primary liver cancer, andas well as certain other cancers that are metastatic to the liver. We believe that the disease states we are investigating are unmet medical needs that represent significant market opportunities.

We are investigating the objective response rate of Melphalan/HDS in patients with mOM in our FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma, or the FOCUS Trial, a global registration clinical trial. For information on the FOCUS Trial, see “Clinical Development Program—The FOCUS Trial” below.

We are also conducting the ALIGN Trial, a global Phase 3 clinical trial of Melphalan/HDS in patients with ICC, or the ALIGN Trial. For information on the ALIGN Trial, see “Clinical Development Program—The ALIGN Trial” below.

In addition to the FOCUS Trial and the ALIGN Trial, our commercial development plan also includes a registry for CHEMOSAT cases performed in Europe and sponsorship of select investigator-initiated trials, or IITs.

In the United States, Melphalan/HDS is uniquely positioned to treat the entire liver eitherconsidered a combination drug and device product and is regulated as a standalone therapydrug by the United States Food and Drug Administration, or the FDA. The FDA has granted us six orphan drug designations, including three orphan designations for the potential use of the drug melphalan for the treatment of patients with mOM, hepatocellular carcinoma and ICC. Melphalan/HDS has not been approved for sale in the United States.

In Europe, our CHEMOSAT product is regulated as a complement to other therapies.Class IIb medical device and received its CE Mark in 2012. We are commercializing the CHEMOSAT system in select markets in the United Kingdom and the EU, where we believe the prospect of securing reimbursement coverage for the use of CHEMOSAT is strongest.

Cancers in the Liver – Liver—A Significant Unmet Need

Cancers of the liver remain a major unmet medical need globally. According to the American Cancer Society’s, (ACS)or ACS, Cancer Facts & Figures 20172018 report, cancer is the second leading cause of death in the United States, with an estimated 600,920609,640 deaths and 1,688,7801.7 million new cases expected to be diagnosed in 2017.2018. Cancer is one of the leading causes of death worldwide, accounting for approximately 8.29.6 million deaths and 14.118.1 million new cases in 20122018 according to GLOBOCAN.GLOBOCAN, the database of the International Association of Cancer Registries. The financial burden of cancer is enormous for patients, their families and society. The Agency for Healthcare Quality and Research estimates that the direct medical costs (total of all healthcare expenditures) for cancer in the U.S.United States in 20142015 was $87.8$80.2 billion. The liver is often the life-limiting organ for cancer patients and cancer that spreads to the liver is one of the leading causes of cancer death. Cancer that begins in one area of the body often metastasizes to the liver. Patient prognosis is generally poor once cancer has spread to the liver. Consequently, cancers of the liver remain a major unmet medical need globally.

Liver Cancers—Incidence and Mortality

There are two typesCancers of the liver cancers:consist of primary liver cancer and metastatic liver disease.cancer. Primary liver cancer (hepatocellular carcinoma, or HCC, including intrahepatic bile duct cancers or ICC) originates in the liver or biliary tissue and is particularly prevalent in populations where the primary risk factors for the disease, such ashepatitis-B,hepatitis-C, high levels of alcohol consumption, aflatoxin, cigarette smoking and exposure to industrial pollutants, are present. Metastatic liver disease,cancer, also called liver metastasis, or secondary liver cancer,

is characterized by microscopic cancer cell clusters that detach results from the spread or “metastases” of a primary site of disease and travel via the blood stream and lymphatic systemcancer into the liver, where they grow into new tumors.liver. These metastases often continue to grow even after the primary cancer in another part of the body has been removed. Given the vital biological functions of the liver, including processing nutrients from food and filtering toxins from the blood, it is not uncommon for metastases to settle in the liver. In many cases patients die not as a result of their primary cancer, but from the tumors that metastasize to their liver. In the United States, metastatic liver disease is more prevalent than primary liver cancer.

There are few effective treatment options for certain cancers in the liver. Traditional treatment options include surgery, systemic chemotherapy, immunotherapy, liver transplant, radiation therapy, interventional radiology techniques, and isolated hepatic perfusion. We believe that CHEMOSAT and Melphalan/HDS represent a potentially important advancement in regional therapy for primary liver cancer and certain other cancers metastatic to the liver and are uniquely positioned to treat the entire liver either as a standalone therapy or as a complement to other therapies.

Ocular Melanoma

Ocular melanoma is one of the cancer histologies with a high likelihood of metastasizingfrequently metastasizes to the liver. Based on third party research conductedthat we commissioned in 2016,2018, we estimate that up to 4,700approximately3,700-4,700 cases of ocular melanoma are diagnosed in the United States and Europe annually, and that approximately 55%50-55% of these patients will develop metastatic disease. Of metastatic cases of ocular melanoma, we estimate that approximately 90% of patients will develop liver involvement. OnceAccording to Lane et al.,JAMA Ophthalmol. 2018 Sep1;136(9):981-98, once ocular melanoma has spread to the liver, current evidence suggests median overall survival for these patients is generally six3.9 months (untreated) to eight months. Currently there6.3 months (treated). There is no one standard of care (SOC) for patients with ocular melanoma liver metastases. According to our 2016Based on the research conducted in 2018, we estimate that approximately 2,0001,400-2,150 patients with ocular melanoma liver metastases in the United States, the United Kingdom and Europethe EU may be eligible for treatment with the Melphalan/HDS. Based on our reimbursement experience with CHEMOSAT, we estimate the annual addressable market for this indication in the United States, the United Kingdom and the EU is approximately $200 million per year.

Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC)

HepatobiliaryPrimary liver cancers – includinginclude HCC and ICC – are among the most prevalent and lethal forms of cancer.ICC. According to GLOBOCAN, an estimated 78,500 new cases of primary liver cancers are diagnosed in the United States and Europe annually. According to the ACS, approximately 40,71042,810 new cases of HCC and ICC willthese cancers are expected to be diagnosed in the United States in 2017. Approximately75-90% of these patients are diagnosed with HCC. Excluding patients who are eligible for surgical resection or certain focal treatments, we estimate that2020 leading to approximately 15,000 patients with HCC in the United States and Europe may be eligible for treatment with Melphalan/HDS. We estimate that an additional 9,300 patients diagnosed with ICC may also be eligible for treatment with Melphalan/HDS. According to the ACS, the overall five-year survival rate for liver cancer patients in the United States is approximately 18%. For patient diagnosed with a localized stage of disease, the ACS estimates5-year survival at 31%. The ACS estimates that5-year survival for all cancers is 68%. Globally, with 782,000 new cases in 2012, HCC was the fifth most common cancer in men and the ninth in women according to GLOBOCAN. GLOBOCAN estimates indicate that HCC was responsible for 746,000 deaths in 2012 (9.1% of the total cancer deaths), making it the second most common cause of death from cancer worldwide.

The prognosis for primary liver cancer is very poor, as indicated by an overall ratio of mortality to incidence of 0.95. The American Cancer Society’s Cancer Facts & Figures 2017 outlines the treatment options for HCC as follows: “Early stage liver cancer can sometimes be successfully treated with surgery to remove part of the liver (partial hepatectomy); however, few patients have sufficient healthy liver tissue for this option. Liver transplantation may be possible in individuals with small tumors who are not candidates for partial hepatectomy. Other treatment options include tumor ablation (destruction) or embolization (blocking blood flow). Few options exist for patients diagnosed at an advanced stage. Sorafenib (Nexavar®) is a targeted drug approved for the treatment of HCC in patients who are not candidates for surgery and do not have severe cirrhosis.”

Based on third party research, we estimate that up to 15,000 of the 65,000 patients diagnosed annually in the United States and Europe could be eligible candidates for treatment with the Melphalan/HDS. The FDA has granted orphan drug status to the Melphalan/HDS for treatment of patients with unresectable HCC. We believe that there is a large unmet medical need in first line therapy for patients with HCC, with Sorafenib the only currently approved systemic therapy in the United States, Europe and certain Asian markets.30,160 deaths.

ICC is the second most common form of primary liver tumorcancer and according to Wang et al., 2013 J Clin Oncol 31:1188-1195, accounts for 3%5-30% of all gastrointestinalprimary liver cancers and 15% of HCC cases diagnosed in the United States and Europe annually. Outside of resection, which is the only cure for ICC, there is currently no standard of care. Based on third party research, weWe believe that 90% of ICC patients are not candidates for surgical resection, and that approximately20-30% of these may be candidates for certain focal interventions. WeAccording to third party research that we commissioned in 2018 we estimate that approximately 9,30011,000 ICC patients in the United States, the United Kingdom and Europethe EU annually could be candidates for treatment with Melphalan/HDS, whichHDS. Based on our reimbursement experience with CHEMOSAT, we believe representsestimate the annual addressable market for this indication in the United States, the United Kingdom and the EU is approximately $825 million per year.

According to the ACS, the overall five-year survival rate for primary liver cancers in the United States is approximately 18%. For patients diagnosed with a significant market opportunity.localized stage of disease, the ACS estimates5-year survival at 33%.

About CHEMOSAT and Melphalan/HDS

CHEMOSAT and Melphalan/HDSOur product administers concentrated regional chemotherapy to the liver. This “whole organ” therapy is performed by isolating the circulatory system of the liver, infusing the liver with a chemotherapeutic agent, and then filtering the blood prior to returning it to the patient.patient’s circulatory system. During the procedure, known as percutaneous hepatic perfusion, (PHPPHP® therapy), or PHP therapy, three catheters are placed percutaneously through standard interventional radiology techniques. The catheters temporarily isolate the liver from the body’s circulatory system, allow

administration of the chemotherapeutic agent melphalan hydrochloride directly to the liver, and collect blood exiting the liver for filtration by our proprietary filters. The filters absorb chemotherapeutic agent in the blood, thereby reducing systemic exposure to the drug and related toxic side effects, before the filtered blood is returned to the patient’s circulatory system.

PHP therapy is performed in an interventional radiology suite in approximately two to three hours. Patients remain in an intensive care or step-down unit overnight for observation following the procedure. Treatment with CHEMOSAT and Melphalan/HDS is repeatable, and a new disposable CHEMOSAT and Melphalan/HDSsystem is used for each treatment. Patients treated in clinical settings are permitted up to six treatments. Innon-clinical commercial treatment settings, patients have received up to eight treatments. In the United States, melphalan hydrochloride for injection will be included withas part of the system.system, if approved. In Europe, the system is sold separately and used in conjunction with melphalan hydrochloride commercially available from a third party. In our clinical trials, melphalan hydrochloride for injection is provided to both European and United States clinical trial sites.

Risks associated with the CHEMOSAT andEarly development of Melphalan/HDS Procedure

As with many cancer therapies, treatment with CHEMOSAT and Melphalan/HDS is associated with toxic side effects and certain risks, some of which are potentially life threatening. An integrated safety population comprised of patients treated during our prior clinical development using early versions of the Melphalan/HDS showed these risks to include grade 3 or 4 bone marrow suppression and febrile neutropenia, as well as risks of hepatic injury, severe hemorrhage, gastrointestinal perforation, stroke, and myocardial infarction in the setting of an incomplete cardiac risk assessment. Deaths due to certain adverse reactions within this integrated safety population were not observed to occur again during the clinical trials following the adoption of related protocol amendments.

Procedure and Product Refinements

The trials that comprised this integrated safety population used early versions of the device and procedure. As a consequence of these identified risks and experience gained innon-clinical, commercial usage in Europe, we have continued to develop and refine both the CHEMOSAT and Melphalan/HDS and the PHP procedure. The procedure refinements have included modifications to the pre, peri and post procedure patient management and monitoring, as well as the use of the following: prophylactic administration of proton pump inhibitors, prophylactic platelet transfusions, prophylactic hydration at keypre-treatment intervals, use of vasopressor agents coupled with continuous monitoring for maintenance of blood pressure and prophylactic administration of growth factors to reduce risk of serious myelosuppression. In addition, in 2012 we introduced the Generation Two version of the CHEMOSAT system, which offered improved hemofiltration and other product enhancements.

Reports from treating physicians in both Europe and the United States using the Generation Two CHEMOSAT and Melphalan/HDS in anon-clinical, commercial setting have suggested that these product improvements and procedure refinements have improved the safety profile. In 2016, physicians in Europe and the United States also presented the results of research that signaled an improved safety profile as well as efficacy in multiple tumor types at several major medical conferences.

Phase 3—Melanoma Metastases Trial

In February 2010, we concluded a randomized Phase 3 multi-center study for patients with unresectable metastatic ocular or cutaneous melanoma exclusively or predominantly in the liver. In the trial, patients were randomly assigned to receive PHP treatments with melphalan using the Melphalan/HDS, or to a control group providing best alternative care (BAC). Patients assigned to the PHP arm were eligible to receive up to six cycles of treatment at approximately four to eight week intervals. Patients randomized to the BAC arm were permitted to cross-over into the PHP arm at radiographic documentation of hepatic disease progression. A majority of the BAC patients did in fact cross over to the PHP arm. Secondary objectives of the study were to determine the response rate, safety, tolerability and overall survival.

On April 21, 2010, we announced that our randomized Phase 3 clinical trial of PHP with melphalan using Melphalan/HDS for patients with unresectable metastatic ocular and cutaneous melanoma in the liver had successfully achieved the study’s primary endpoint of extended hepatic progression-free survival (hPFS). An updated summary of the results was presented at the European Multidisciplinary Cancer Congress organized by the European Cancer Organization and the European Society of Medical Oncology in September 2011. Data submitted in October 2012 to the System—FDA in Delcath’s New Drug Application (NDA) comparing treatment with the PHP with melphalan (the treatment group) to BAC (the control group), showed that patients in the PHP arm had a statistically significant longer median hPFS of 7.0 months compared to 1.7 months in the BAC control group, according to the Independent Review Committee (IRC) assessment. This reflects a4-fold increase of hPFS over that of the BAC arm, with 50% reduction in the risk of progression and/or death in the PHP treatment arm compared to the BAC control arm. Results of this study were published in Annals of Surgical Oncology, a prestigious medical journal in December 2015.

Phase 2 Multi-Histology, Unresectable Hepatic Tumor Trial

Also in 2010, we concluded a separatemulti-arm Phase 2 clinical trial of PHP with melphalan using an early version of the Melphalan/HDS in patients with primary and metastatic liver cancers, stratified into four arms: neuroendocrine tumors (carcinoid and pancreatic islet cell tumors), ocular or cutaneous melanoma, metastatic colorectal adenocarcinoma (mCRC), and HCC. In the metastatic neuroendocrine (mNET) cohort (n=24), the objective tumor response rate was 42%, with 66% of patients achieving hepatic tumor shrinkage and durable disease stabilization. In the mCRC cohort, there was inconclusive efficacy possibly due to advanced disease status of the patients. Similar safety profiles were seen across all tumor types studied in the trial.

Phase 2 Multi-Histology Clinical Trial—HCC Cohort

In the HCC cohort (n=8) of our Phase 2 Multi-Histology trial, a positive signal in hepatic malignancies was observed in 5 patients. Among these patients, one patient received four treatments, achieved a partial response lasting 12.22 months, and survived 20.47 months. Three other patients with stable disease received3-4 treatments, with hPFS ranging 3.45 to 8.15 months, and overall survival (OS) ranging 5.26 to 19.88 months. There was no evidence of extrahepatic disease progression. The observed duration of hPFS and OS in this limited number of patients exceeded that generally associated with this patient population. We believe these results constitute a promising signal that warrants further clinical investigation.

Prior United States Regulatory ExperienceComplete Response Letter

Based on the results fromclinical trials conducted using an earlier version of our prior clinical developmentMelphalan/HDS system, in August 2012 we submitted an NDA under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, (FFDCA)or FDCA, seeking an indicationFDA approval for use of our Melphalan/HDS system for the percutaneous intra-arterial administration of melphalan for use in the treatment of patients with metastatic melanoma in the liver and, subsequently, amended the indicationapplication to ocular melanoma metastatic to the liver. Data submitted to the Food and Drug Administration (FDA) used the early clinical trial versions of the system along with early clinical procedure techniques. Our NDA was accepted for filing by the FDA on October 15, 2012, and was designated for standard reviewliver with an initial Prescription Drug User Fee Act (PDUFA) goal dateearlier version.

In the Spring of June 15, 2013. On April 3, 2013, the FDA extended its PDUFA goal date to September 13, 2013.

On May 2, 2013 we announced that an Oncologic Drug Advisory Committee, (ODAC) or ODAC panel, convened by the FDA voted 16 to 0, with no abstentions, that the benefits of treatment with the early version of Melphalan/HDS did not outweigh the risks associated with the procedure. A significant portion of FDA’s presentation to the ODAC panel was focused on the FDA’s assessment of treatment related risks, including the analysis of treatment-related deaths that occurred during clinical trials. The FDA also expressed concerns about hypotension, (lowor low blood pressure)pressure, during the procedure, length of hospital stay, as well as risks of stroke, heart attack, renal failure, and bone marrow suppression. We believe that the protocol amendments and other procedure refinements instituted during clinical trials and subsequently in commercial,non-clinical usage in Europe, including changes to the way blood pressure is managed and monitored, may help address these procedure related risks. Collection of adequate safety data on all aspects of the procedure is a major focus of the clinical trials in our current CDP.

Briefing materials presented to the 2013 ODAC panel by both the FDA and Delcath are available on our website at http://delcath.com/clinical-bibliography.

2013 Complete Response Letter

In September 2013, the FDA issued a complete response letter, (CRL) in responseor CRL, relating to our NDA. The FDA issues a CRL after the review of a filean NDA has been completed and questions remain that preclude approval of the NDA in its current form. The deficiencies identified by FDA commentsin the CRL included, but were not limited to, a statement that Delcath mustwe had to perform anotheradditional “well-controlled randomized trial(s) to establish the safety and efficacy of Melphalan/HDS using overall survival as the primary efficacy outcome measure,” and which “demonstrates that the clinical benefits of Melphalan/HDS outweigh its risks.” The FDA also required that the additional clinical trial(s) be conducted using the product the Company intendswe intended to market, and that certain clinical, clinical pharmacology, human factors and product quality elements of the CRL be addressed.

In January 2016, we announced the conclusion ofentered into a Special Protocol Assessment agreement, or SPA, with the FDA on the design of a new Phase 3 clinical trial of Melphalan/HDS to treat patients with hepatic dominant ocular melanoma. This SPA providesrepresented an agreement with FDA that our newa specific Phase 3 trial designwould adequately addressesaddress objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS. However, final determinationsThe primary endpoint was overall survival, and secondary endpoints included progression-free survival, overall response rate andquality-of-life measures. In the summer of 2018, we amended the protocol for marketing application approval are made bythe trial which, after much discussion regarding improvement of the enrollment rate with FDA, after a complete review of a marketing application and are based on the entire dataresulted in the application. The SPA agreement also representstrial protocol design becoming anon-randomized,single-arm study with a different primary endpoint, which effectively terminated the satisfactory resolutionSPA.

We believe that the protocol amendments and other procedure refinements instituted during clinical trials and subsequently in commercial treatment usage in Europe, including changes to the way blood pressure is managed and monitored, may help address these procedure related risks. Collection of a substantial numberadequate safety data on all aspects of the FDA’s CRLnon-clinical trial related requirementsprocedure is a major focus of the clinical trials in our current clinical development program.

Procedure and Product Refinements

In 2012, we introduced the Generation Two version of the CHEMOSAT system, which offered improved hemofiltration and other device component product enhancements. Reports from treating physicians in both Europe and the United States using the Generation Two CHEMOSAT and Melphalan/HDS have indicated that without these successful resolutions,product improvements and procedure refinements have improved the SPA request would notsafety profile of our product. Since 2017, physicians in Europe and the United States have been permitted to be filed.

presented and published the results of research that indicated an improved safety profile by decreasing the percentage of adverse events experienced by treated patients, as well as efficacy in multiple tumor types. Collection of adequate safety data on all aspects of the procedure is a major focus of our clinical trials.

Current Clinical Development Program

The focus of our current CDPclinical development program is to generate clinical data for the CHEMOSAT and Melphalan/HDS in various disease states to demonstrate efficacy and validate the safety profile of the current version of the product and treatment procedure. We believe that the improvements we have made to CHEMOSAT and Melphalan/HDS and to the PHP proceduretherapy have addressed the severe toxicityadverse event profile and procedure-related risks observed duringthat led to the previous Phase 2 and 3issuance of the CRL. Our clinical trials. The CDPdevelopment program is also designed to support clinical adoption of and reimbursement for CHEMOSAT in Europe, and to support regulatory approvals in various jurisdictions, including the United States.

(theThe FOCUS Trial) - NCT02678572Trial

In January 2016,July 2018, we initiated a new pivotal Phase 3commenced an amended clinical trial of Melphalan/HDS, titled ASingle-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in hepatic dominant ocular melanomaPatients with Hepatic-Dominant Ocular Melanoma, or the first patient enrolled in February 2016 looking at overall survival of patients (length of time from treatment to death). CalledFOCUS Trial. Under the revised study protocol, the FOCUS Trial this new global Phase 3 trial will evaluate the safety, efficacy and pharmacokinetic profilestudy a minimum of Melphalan/HDS versus best alternative care in 24080 patients with hepatic dominant OM.ocular melanoma metastatic to the liver. The primary endpoint of the FOCUS Trial is a comparisonobjective response rate, or ORR as measured by RECISTv1.1. Secondary endpoints include duration of response, disease control rate, overall survival between the two study arms. Secondary and progression-free survival. Additional exploratory endpointsoutcome measures include time to objective response, hepatic progression-free survival, overallhepatic objective response, rate and Qualityquality of Life (QoL)life, safety and other pharmacokinetic measures. In the FOCUS trial’s treatment phase, patients randomized toPatients previously enrolled in the Melphalan/HDS arm will receive up to six treatments at intervals of six to eight weeks for up to 12 months. Tumor response will be assessed in both study arms every 12 weeks until evidence of hepatic disease progression. For patients progressing to thefollow-up phase, disease assessment scans original trial will continue every 12 weeks for up to two years.

be treated and statistically evaluated as part of the revised FOCUS Trial. The FOCUS Trial is being conducted at leading cancer centersapproximately 30 sites in the United States and Europe. The Moffitt Cancer Center in Tampa, Florida was activated as a participating center in January 2016 with Jonathan Zager, M.D., FACS, Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments and a Senior Member at Moffitt Cancer Center, serving as the trial’s lead investigator. In October 2016 we announced the addition of several prestigious cancer centers in the United States and Europe. We intend to include approximately 40 leading cancer centers in the United States and Europe in the FOCUS Trial.

The FOCUS Trial is being conductedrarity of ocular melanoma, absence of crossover to the experimental trial arm, and the commercial availability of PHP® Therapy in Europe impeded enrollment in this trial under a SPA we concluded with the FDA in January 2016. Underoriginal protocol. While the termsrevised protocol of the SPA, the FOCUS Trial iswas intended to accelerate the only Phase 3completion of patient enrollment, enrollment of patients in this trial was adversely affected by a lack of capital to fund the trial. Enrollment of the required for submission of an NDA. However, final determinations for marketing application approval are made by FDA after a complete review of a marketing application and are based on the entire data in the application.

There currently is no SOC for the treatment of hepatic dominant ocular melanoma. The Melphalan/HDSpatients has been granted orphan drug status by FDA for treatment ofcompleted. We expected to announce top-line data from this trial in mid-2020. However, the COVID-19 pandemic has impacted our ability to enroll and treat patients with ocular melanoma. Based on the strength of the efficacy data in this disease observed intrial and to monitor data at our prior Phase 3 clinical trial sites. As a result, we will not be able to release the top-line data from the FOCUS Trial within the timeframe we had anticipated. Once our clinical trial sites are able to return to normal operating procedures, we will assess the impact and the reports of an improved safety profile observed innon-clinical trial experience in Europe, we are confident that this program can address the concerns raised by the FDA in its CRL. We believe that ocular melanoma liver metastases represent a significant unmet medical need, and that pursuit of an indication in this disease state represents the fastest path to potential approval of the Melphalan/HDS in the United States.update our expected timing accordingly.

Percutaneous Hepatic Perfusion (PHP) vs. Cisplatin/Gemcitabine in Patients with Intrahepatic Cholangiocarcinoma -The ALIGN TrialNCT03086993

In March 2017April 2018 we announced another SPA agreement with the FDA for the design ofinitiated a new pivotal trial of Melphalan/HDS to treatin patients with intrahepatic cholangiocarcinoma (ICC)ICC, titled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients withIntrahepatic Cholangiocarcinoma (Pivotal ICC Trial). Under, or the ALIGN Trial. The ALIGN Trial is being conducted under an SPA with the Pivotal ICCFDA. The ALIGN Trial will enrollstudy approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The primary endpoint of the ALIGN Trial is overall survival, (OS)or OS, and secondary and exploratory endpoints include safety, progression-free survival, (PFS), overall response rate (ORR)or PFS, ORR andquality-of-life measures. This Pivotal ICC Trial is designed to be cost effective and pursued in a financially prudent manner when financial resources permit. TheUnder the terms of the SPA agreement for this trial indicates thatthe ALIGN Trial, the pivotal trial design adequately addresses objectives that, if met, would support FDA regulatory requirements for approval of Melphalan/HDS in ICC. However, final determinations for marketing application approval are made by FDA after a complete review of a marketing application and are based on the entiretotality of data in the application.

Although, the first patient was enrolled in the ALIGN Trial in October 2018, we have experienced difficulties enrolling trial subjects under the existing trial protocol because patients that have received standard of care treatment outside of the trial are excluded. We intend to seek FDA approval to amend the trial protocol so that such patients are no longer excluded.

Prior Phase 2 Hepatocellular Carcinoma (HCC) & Intrahepatic Cholangiocarcinoma (ICC) ProgramTrials

In 2014 we initiated a Phase 2 clinical trial program in Europe and the United States with the goal of obtaining an efficacy and safety signal for Melphalan/HDS in the treatment of HCC and ICC. Due to differences in treatment practice patterns between Europe and the United States, we established separate European and United States trial protocols for the HCC Phase 2 program with different inclusion and exclusion patient selection criteria:

Protocol 201NCT02406508 – Conducted in the United States, this trial iswas intended to assess the safety and efficacy of Melphalan/HDS followed by sorafenib. This trial was terminated earlier than planned so that we could focus our resources on our ocular melanoma study and is no longer enrolling patients.

Protocol 202 NCT02415036—Conducted in Europe, this trial was intended to assess the safety and efficacy of Melphalan/HDS without sorafenib. The trial willwas also designed to evaluate overall response rate via modified Response Evaluation Criteria in Solid Tumors (mRECIST),mRECIST criteria, progression free survival and to characterize the systemic exposure of melphalan and assess patient quality of life. This trial was terminated earlier than planned so that we could focus our resources on our ocular melanoma study and is now closed to enrollment.

no longer enrolling patients.

Protocol 202NCT02415036 – Conducted in Europe, this trial is intended to assess the safety and efficacy of Melphalan/HDS without sorafenib. The trial will also evaluate overall response rate via mRECIST criteria, progression free survival, characterize the systemic exposure of melphalan and assess patient quality of life. This trial is now closed to enrollment.

ICC Cohort – In 2015 we expandedProtocol 202 to include a cohort of patients with ICC. The trial for this cohort is beingwas conducted at the same centers participating in the Phase 2 HCC trial. This trial has completed enrollment and data collection for the ICC cohort is ongoing. We will announce results forEnrollment of this cohort oncewas completed in 2017; however, analysis of the data are fully mature.has only recently begun due to resource constraints. We expect the results of this trial to be announced before the end of 2020.

ICC Retrospective Data Collection - The original goal to obtain an efficacy signal for—We did not proceed with the Phase 2 ICC cohort has been satisfied by the result oftrial because efficacy data for this indication was obtained from multicenter patient outcomes identified in the retrospective data collection of our commercial ICC cases conducted by our European investigators. These promising outcomes and observations were discussed with Key Opinion Leaders (KOL) at a Delcath-organized medical advisory panel meeting and led to the agreementconclusion that PHP® therapy does indeed, “demonstrate an efficacy signal in ICC and is worthy of full clinical investigation.” Data from this retrospective data collection provided important scientific support during our negotiations with the FDA for our SPA for the Pivotal ICC Trial. Data for the retrospective data collection are being submitted for publication by thewere published in 2018 in “European Radiology” in a paper titled “Percutaneous Hepatic Perfusion (Chemosaturation) with Melphalan in Patients with Intrahepatic Cholangiocarcinoma: European investigators,Multicentre Study on Safety, Short Term Effects and details of these findings will be announced when publicly available.

With the objectives of identifying an efficacy signal worthy of further clinical investigation now met, we have terminated enrollment in our Phase 2 program and will close the Phase 2 trials in order to focus available resources on the FOCUS Trial and the ICC Pivotal trial.

Clinical trials are long, expensive and highly uncertain processes and failure can unexpectedly occur at any stage of clinical development. The start or end of a clinical trial is often delayed or halted due to changing regulatory requirements, manufacturing challenges, required clinical trial administrative actions, slower than anticipated patient enrollment, changing standards of care, availability or prevalence of use of a comparator treatment or required prior therapy.

A substantial portionSurvival”. Details of the Company’s operating expenses consist of research and development expenses incurred in connection with its clinical trials. See the Company’s Consolidated Financial included in Item 8 of our Annual Report on Form10-K for the year ended December 31, 2016, filed with the SEC on March 29, 2017.

European Investigator Initiated Trials

In addition to the clinical trials in our CDP, wefindings from this study are supporting data generation in other areas. We are currently conducting one Investigator Initiated Trial (IITs) in colorectal carcinoma metastatic to the liver (mCRC) at Leiden University Medical Center in the Netherlands. We are planning two additional IITs – one for colorectal carcinoma metastatic to the liver at Heidelberg University in Heidelberg, Germany and one for pancreatic carcinoma metastatic to the liver at Spire Hospital in Southampton, England. We continue to evaluate other IITs as suitable opportunities present in Europe. We believe IITs will serve to build clinical experience at key cancer centers, and will help support efforts to obtain full reimbursement in Europe.discussed below under “Recent Data Presentations”.

European Clinical Data Generation

OnIn April 2, 2015, we announced the activation of ourcreated a prospective patient registry in Europe to collect uniform essential patient safety, efficacy, and QoL information using observational study methods. This registry willis intended to gather data in multiple tumor types from commercial cases performed by participating cancer centers in Europe. A prospective registry is an organized system that uses observational study methods to collect defined clinical data under normal conditions of use to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure. Registry data isnon-randomized, considered to be supportive data and, as such, cannot be used for either registration approval, promotional or competitive claims. However, we believe the patient registry will provide a valuable supportive data repository that contains real-world evidence, from a commercial setting, that can be used to identify further clinical development opportunities, support clinical adoption and reimbursement in Europe. Cancer centers in Germany, the United Kingdom, and the Netherlands are participating in the registry and patient enrollment has begun.

In addition, we also provide support for a number of IITs.

Recent Data Presentations

In September 2017 we announced thatJuly 2019 results from a single-institution retrospective study conducted by University Hospital of Tubingen in Germany on the use of the Delcath CHEMOSAT® Hepatic Delivery System to treat patients with metastatic ocular melanoma with liver metastases were published in the journalCancer Imaging.

The study,Chemosaturation with percutaneous hepatic perfusion of melphalan for liver dominant metastatic uveal melanoma: a single institutioncenter experience, by Dr. Christoph Artzner, et al, evaluated the safety and efficacy of PHP® therapy in 16 patients with unresectable liver metastases from ocular melanoma treated with CHEMOSAT between June 2015 and December 2018. Tumor response was evaluated following each PHP treatment using Response Evaluation Criteria in Solid Tumors, and serious adverse events, or SAEs, were evaluated using Common Criteria for Adverse Events.

The 16 patients underwent a total of 28 PHP treatments. Results of the study in the 15 evaluable patients showed that after the first PHP treatment, nine patients (60%) had a partial response, or PR, five patients (33%) had stable disease, and one patient (7%) had progressive disease for an initial disease control rate of 93%. Median PFS after the first treatment was 11.1 months. Six patients received a second PHP treatment, three patients received three treatments, and a single patient received six treatments. Median overall survival, or OS, was 27.4 months.

Safety analysis showed that grade three SAEs were observed in 14% of treatments, consisting of anemia, leukopenia and thrombocytopenia. The sole grade four SAE observed was in one patient who suffered a cardiac arrest during the first PHP treatment and was removed from the study. Subsequent evaluation determined that this patient had coronary artery occlusion which was successfully treated. Retrospective evaluation of this patient’spre-procedure imaging revealed signs of coronary artery disease, and investigators subsequently modified their screening procedures for cardiovascular risk factors. Investigators stated that most SAEs were grade one or two and that 5% of the reported grade three and four SAEs required additional intervention.

Investigators concluded that for patients with liver-dominant metastatic uveal melanoma, treatment with PHP Therapy had “observed rates for OS and PFS that exceeded the reported outcomes for traditional systemic treatment.” Investigators stated that SAEs were frequent, but most did not require additional intervention, and that care should be taken in patients with suspected coronary heart disease.

In April 2019 results from a prospective Phase 2 study conducted by Leiden University Medical Center, or LUMC, in the Netherlands on the use of CHEMOSAT to treat patients with metastatic ocular melanoma with liver metastases were presented at the Cardiology andEuropean Conference on Interventional Radiology of Europe (CIRSE)Oncology annual meeting, heldmeeting.

The LUMC study titled “Percutaneous hepatic perfusion with melphalan in Copenhagen, Denmark on September16-20, 2017.

The study,Prospective Clinical and Pharmacological Evaluation ofpatients with unresectable liver metastases from ocular melanoma using the Delcath System’s Second Generation (GEN2) Hemofiltration System in Patients Undergoing Percutaneous Hepatic Perfusion (PHP) with Melphalan,second-generation hemofiltration system: a prospective phase II study” was conducted by a team at the Leiden University Medical Center (LUMC) in Leiden, The Netherlandsled and presented by T.S. Meijer, MD.Dr. Mark Burgmans. The study prospectively evaluated filtration efficiency35 patients with unresectable liver metastases from ocular melanoma treated with CHEMOSAT between February 2014 and hematologic side effects in sevenJune 2017. The 35 patients who receivedunderwent a total of ten72 PHP procedures with the GEN2 CHEMOSAT system. Pharmacokinetic samplingtherapy treatments, and tumor response was conducted at several points during the PHP procedure,evaluable in 32 patients. Primary endpoints were overall response, overall survival, and filtration efficiency was calculated at several discrete points. Blood tests were conducted following each procedure to determineprogression free survival. Secondary measures included safety measures and hematologic side effect Grade Levels until the blood values normalized.toxicity.

Results of the study showed the GEN2 CHEMOSAT systemthat one patient had ana complete response and 22 had partial response, for a combined overall efficiencyresponse rate of 86%, with efficiency highest at the time of highest concentration of melphalan in the blood74.1%. Overall survival was 20.3 months and declining as melphalan blood concentration declined. Peak efficiencymean progression free survival was 95.4% in samples taken after 10 minutes of filtration, 85.9% at the end of the drug infusion period, and 77.5% at the end of the saline washout period. Researchers noted these results were superior to and more consistent than prior experience published with the first generation CHEMOSAT system. Hematologic side effects were mainly Grade 1 and 2 with some Grade 3 and 4 side effects emerging post-procedure, including 40% of treatment cycles showing Grade 4 thrombocytopenia, 80% showing Grade 3 or 4 leucopenia, and 70% showing lymphocytopenia. All patients were asymptomatic and all lab results normalized in three weeks. Other adverse events were managed, and there was no mortality, no severe bleeding complications, and no hypotensive cardiac or cerebral events. Researchers concluded that the GEN2 CHEMOSAT system appears to have higher melphalan filter efficiency, more consistent performance, and appears safe but needs further validation.8.1 months.

In July 2017, the Journal of Cancer Research and Clinical Oncology published anSafety analysis of clinical findings from 29 Hannover Medical School patients who were treated with percutaneous hepatic perfusion (PHP®) therapy with Melphalan/HDS as last-line therapy for primary and secondary liver tumors. Hannover Medical School physicians treated 29 patients withshowed a total of 54 PHP procedures. Patients received as many as five treatments each,14 SAEs were recorded. The hematologic toxicities were in a majority of the cases self-limiting and manageable. The investigators concluded that “PHP Therapy with the Generation Two version of CHEMOSAT is an averageeffective and safe treatment for patients with hepatic metastases from ocular melanoma.”

Market Access and Commercial Clinical Adoption

Europe

Our European marketing activities include establishing strategic alliances with partners that include license, supply, sales and marketing arrangements. In December 2018, we entered into a License Agreement, or License, with medac GmbH, or medac, for the commercialization of two per patient. Nineteen patients were diagnosed with unresectable liver metastases that arose from solid tumors, including 11 casesCHEMOSAT in Europe. Under the terms of ocular melanoma,the medac License, medac has the exclusive right to sell and market CHEMOSAT in all member states of the EU, Norway, Liechtenstein, Switzerland, and the remaining 10 patients had hepatocellular or cholangiocarcinoma.

Across all patients,United Kingdom. Under the overall response rate (ORR) was 19.2 percent, with ocular melanoma patients experiencing the highest ORR (33.3 percent). As has been published previously, high tumor volumes negatively impact overall survival (OS). Median OS was 261 days for the entire patient group. Two patients with cholangiocarcinomamedac License, we are entitled to a combination of upfront and one patient with ocular melanoma had the longest survival with 566, 465, and 477 days respectively. Overall, PHP with Melphalan/HDS was well tolerated. Complications including thrombocytopenia, cardiovascular events, ulcerous bleeding, and edema were reported. These results are summarized in the Journal of Cancer Research and Clinical Oncology article, “Safety and Efficacy of Chemosaturation in Patients with Primary and Secondary Liver Tumors.”

In February 2017, we announced that the American Journal of Clinical Oncology published a single-center retrospective review, in which authors found that investigational PHP with Melphalan/HDS offers promising results with a doubling of overall survival and significantly longer progression-free survival (PFS) and hPFS than other targeted therapies. The review, “Hepatic Progression-free and Overall Survival After Regional Therapy to the Liver for Metastatic Melanoma,” was written by a team from the Moffitt Cancer Center who analyzed clinical outcomes of three differentnon-randomized approaches used to treat 30 patients with liver metastases primarily resulting from ocular melanoma and skin melanoma. A third of the patients received PHP using melphalan delivered via the Delcath Hepatic Delivery System (Melphalan/HDS), 12 received chemoembolization (CE) and six received radioembolization withyttrium-90 (Y90). Two patients crossed over once their cancer progressed – one from PHP to Y90 and one from CE to PHP.

The paper’s authors concluded that patients who received PHP with Melphalan/HDS had significantly longer median hPFS at 361 days compared to 54 days for Y90 and 80 days for CE,success-based milestone payments as well as a longer median PFS at 245 days compared to 54 days for Y90 and 52 days for CE. Median overall survival was also longest for PHP at 608 days compared to 295 days for Y90 and 265 days for CE. The authors noted that further studies, including a randomized controlled trial, would be needed to confirm whether clinically superior outcomes can be achieved with PHP compared to other liver-targeted treatments.

Side effects following all treatments were similar, with most complications recorded as anorexia, abdominal pain, fatigue and nausea. Laboratory irregularities, such as thrombocytopenia and abnormal liver function tests, were seen immediately after treatment in some patients, but returned to baseline within a few days.

Also in February 2017, we announced results of a retrospective, multicenter study presented at the Regional Cancer Therapies 12th International Symposium in an oral presentation titled, “Percutaneous Hepatic Perfusion for Unresectable Metastatic Ocular Melanoma to the Liver: A Multi-Institutional Report of Outcomes.” This analysis demonstrated that 45.7 percent of patients with ocular melanoma that metastasized to the liver who underwent PHP using Melphalan/HDS experienced a complete or partial response. The study further showed that among those who responded to treatment, overall survival was projected to be more than three years. The analysis was conducted by teams from Moffitt Cancer Center in Tampa, Fla., and the University of Southampton in the United Kingdom. The presentation was led by Dr. Alexandra Gangi of the Moffitt Cancer Center.

The analysis reviewed outcomes of 49 patients treated between 2008 and 2016 with Melphalan/HDS at either the Moffitt Cancer Center or the University of Southampton. Patients underwent a total of 115 PHP treatments. The median number of treatmentsfixed transfer price per patient was two, with patients receivingone-to-six treatments.

Hepatic response to PHP was evaluable in 46 patients, among whom 45.7 percent showed complete or partial response, and 37.0 percent had stable disease. Median overall survival was not reached, but was projected to be 657 days (1.8 years). Among patients with a complete or partial response, overall survival was projected to be 1,207 days. Most common side effects following treatment were anemia, thrombocytopenia and neutropenia.

Market Access & Commercial Clinical Adoption

European Union

Our market access and clinical adoptions efforts are focused on the key target markets of Germany, United Kingdom and the Netherlands, which represent a majority of the total potential liver cancer market (primary and metastatic) in the EU and where progress in securing reimbursement for CHEMOSAT treatments offers the best near-term opportunities. We also continue to support clinical adoptionunit of CHEMOSAT in Spain, France and Italy. We employ a combination of direct and indirect sales channels to market and sell CHEMOSAT in these markets. Our European Headquarters is in Galway, Ireland.specified royalties.

Since launching CHEMOSAT in Europe, over 500750 commercial treatments have been performed at over 25 leading European cancer centers. Physicians in Europe have used CHEMOSAT to treat patients with a variety of cancers in the liver, primarily ocular melanoma liver metastases, and other tumor types, including cutaneous melanoma, hepatocellular carcinoma, cholangiocarcinoma, and liver metastases from colorectal cancer, breast, pancreatic and neuroendocrine. In 2017, SPIRE Southampton Hospital in the U.K. and the Medical University of Hannover in Germany each surpassed 100 treatments with CHEMOSATsince initiating procedures. In 2017, we announced our first patient to receive eight CHEMOSAT treatments, and have seen the average number of repeat treatments performed on a per patient basis consistently increase.

European Reimbursement

A critical driver of utilization growth for CHEMOSAT in Europe is the expansion of reimbursement mechanisms for the procedure in our priority markets. In Europe, there is no centralizedpan-European medical device reimbursement body. Reimbursement is administered on a regional and national basis. Medical devices are typically reimbursed under Diagnosis Related Groups, (DRG)or DRG, as part of a procedure. Prior to obtaining permanent DRG reimbursement codes, in certain jurisdictions, the Company iswe are actively seeking interim reimbursement from existing mechanisms that include specific interim reimbursement schemes, new technology payment programs as well as existing DRG codes. In most EU countries, the government provides healthcare and controls reimbursement levels. Since the EU has no jurisdiction over patient reimbursement or pricing matters in its member states, the methodologies for determining reimbursement rates and the actual rates may vary by country.

Germany

In October 2015, we announced thatUnder the Institut für das Entgeltsystem im Krankenhaus (InEk),terms of the German federal reimbursement agency, established a national Zusatzentgeld (ZE) reimbursement code for procedures performed with CHEMOSAT in Germany. The ZE diagnostic-related group (DRG) codemedac License, medac is a national reimbursement code that augments existing DRG codes until a specific new DRG code can be created, and will replace the previous Neue Untersuchungs und Behandlungsmethoden (NUB) procedure that required patients in Germany to apply individuallyprovide support for reimbursement of their CHEMOSAT treatment. With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently representedapplications in the DRG catalog in Germany. In 2016, coverage levels were negotiated between hospitals in Germany and regional sickness funds. Coverage levels determined via this process are renegotiated annually.    

United Kingdom

In May 2014, NICE, anon-departmental public body that provides guidance and advice to improve health and social care in the UK, completed a clinical review of CHEMOSAT. The NICE review indicated that as the current body of evidence on the safety and efficacy of PHP withEuropean markets covered by our agreement. CHEMOSAT for primary or metastatic liver cancer is limited, the procedure should be performed within the context of research by clinicians with specific training in its use and techniques. Delcath expects to consult again with the Interventional Procedures Advisory

Committee at the National Institute for Clinical Excellence (NICE) in England, to provide recent clinical evidence with a view to moving existing Interventional Procedural Guidance from research to specialist status. This would enable greater scope for commercialization because it would allow more use by NHS clinicians of the therapy. It might also pave the way for a full Medical Technology Assessment as a way towards longer term reimbursement with the NHS.

In the short term, public patients will continue to be treated in the UK through clinical trials. Private patients will continue to be treated through the established private treatment pathway such as private insurance coverage orself-pay.

Netherlands

In the Netherlands CHEMOSAT has been performed at the Netherlands Cancer Institute in 2013 and at Leiden University Medical Centre since 2014. In June 2017 the Medical Oncology National Treatment Guidelines for Uveal Melanoma were updated and now include recommendations to consider CHEMOSAT in the treatment of liver metastases. An application to the Dutch Health Care Institute (ZIN) to approve CHEMOSAT as a treatment option for ocular melanoma liver metastases and also an applicationapproved for reimbursement Dutch Health Care Authority (NZA) for the formulation of a reimbursement code (DBC) has been made. These applications are currently under review by the respective bodies.

Spain

In April 2016, we announced that the General and Digestive Surgery team at HM Sanchinarro University Hospital had activated the hospital’s CHEMOSAT program. The Sanchinarro team successfully performed three procedures with CHEMOSAT, using the procedure to treat patients with peripheral cholangiocarcinoma and neuroendocrine tumors liver metastases. HM Sanchinarro University Hospital is the second center in Spain to offer CHEMOSAT treatments.

Turkey

In April 2016 we announced the activation of the Hacettepe University Clinic in Ankara, Turkey as a CHEMOSAT treatment center. Hacettepe University Clinic successfully completed its first CHEMOSAT treatments in March 2016, and the center represents the first CHEMOSAT commercial location to be activated outside of the European Union. We believe that Hacettepe University can serve as an important hub for CHEMOSAT treatment to patients in Turkey and throughout the region.

Distribution Partners

As a result of the Company’s strategy to prioritize resources on the key direct markets of Germany, the Netherlands and the United Kingdom the Company expects that its distribution strategy will play a lesser role in its current commercial activities. In Spain, the Company has determined that there was no benefit to continuing with an indirect model and therefore terminated its relationship with its distributor in Spain and is now represented in Spain through a sales agency. The Company is represented in Turkey through a distribution partner.Germany.

Regulatory StatusGovernment Regulation

Our products are subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA. Foreign regulatory agencies, the FDA and comparable regulatory agencies in state and local jurisdictions impose extensive requirements upon the clinical development,pre-market clearance and approval, manufacturing, labeling, marketing, advertising and promotion, pricing, storage and distribution of pharmaceutical and medical device products. Failure to comply with applicable foreign regulatory agency or FDA requirements may result in Warning Letters, fines, civil or criminal penalties, suspension or delays in clinical development, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market.

United States Regulatory Environment

In the United States, the FDA regulates drug and device products under the FFDCA,FDCA, and its implementing regulations. The Delcath Melphalan/HDS is subject to regulation as a combination product, which means it is composed of both a drug product and device product. If marketed individually, each component would therefore be subject to different regulatory pathways and reviewed by different centers within the FDA. A combination product, however, is assigned to a center that will have primary jurisdiction over itspre-market review

and regulation based on a determination of its primary mode of action, which is the single mode of action that provides the most important therapeutic action. In the case of the Melphalan/HDS, the primary mode of action is attributable to the drug component of the product, which means that the Center for Drug Evaluation and Research, has primary jurisdiction over itspre-market development and review.

The process required by the FDA before drug product candidates may be marketed in the United States generally involves the following:

 

submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated periodically, but at least annually;

 

completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;

 

performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;

 

submission to the FDA of an NDA after completion of all pivotal clinical trials;

 

a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review;

 

satisfactory completion of an FDApre-approval inspection of the manufacturing facilities at which the product is produced and tested to assess compliance with current good manufacturing practice, or cGMP, regulations; and

 

FDA review and approval of an NDA prior to any commercial marketing or sale of the drug in the United States.

The development and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product will be granted on a timely basis, if at all.

The results of preclinical tests (which include laboratory evaluation as well as GLP studies to evaluate toxicity in animals) for a particular product candidate, together with related manufacturing information and analytical data, are submitted as part of an IND to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the30-day time period, raises concerns or questions about the conduct of the proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. IND submissions may not result in FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive good clinical practice regulations and regulations for informed consent and privacy of individually identifiable information. Similar requirements to the United States IND are required in the European Economic Area (EEA)EU and other jurisdictions in which we may conduct clinical trials.

Clinical Trials

For purposes of NDA submission and approval, clinical trials are typically conducted in the following sequential phases, which may overlap:

Phase 1 Clinical Trials. Studies are initially conducted in a limited population to test the product candidate for safety, dose tolerance, absorption, distribution, metabolism and excretion, typically in healthy humans, but in some cases in patients.

Phase 2 Clinical Trials. Studies are generally conducted in a limited patient population to identify possible adverse effects and safety risks, explore the initial efficacy of the product for specific targeted indications and to determine dose range or pharmacodynamics. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

Phase 3 Clinical Trials. These are commonly referred to as pivotal studies. When Phase 2 evaluations demonstrate that a dose range of the product is effective and has an acceptable safety profile, Phase 3 clinical trials are undertaken in large patient populations to further evaluate dosage, provide substantial evidence of clinical efficacy and further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial centers.

Phase 4 Clinical Trials. The FDA may approve an NDA for a product candidate, but require that the sponsor conduct additional clinical trials to further assess the drug after NDA approval under a post-approval commitment. In addition, a sponsor may decide to conduct additional clinical trials after the FDA has approved an NDA. Post-approval trials are typically referred to as Phase 4 clinical trials.

Sponsors of clinical trials may submit proposals for the design, execution, and analysis for their pivotal trials under a SPA. A SPA is an evaluation by the FDA of a protocol with the goal of reaching an agreement that the Phase 3 trial protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval of the drug product candidate with respect to effectiveness for the indication studied. Under a SPA, the FDA agrees to not later alter its position with respect to adequacy of the design, execution or analyses of the clinical trial intended to form the primary basis of an effectiveness claim in an NDA, without the sponsor’s agreement, unless the FDA identifies a substantial scientific issue essential to determining the safety or efficacy of the drug after testing begins.

Prior to initiating our currently ongoing Phase 3 clinical trial(s), we submitted a proposal for the design, execution and analysis under a SPA.

New Drug Applications

The results of drug development, preclinical studies and clinical trials are submitted to the FDA as part of an NDA. NDAs also must contain extensive chemistry, manufacturing and control information. An NDA must be accompanied by a significant user fee, which may be waived in certain circumstances. Once the submission has been accepted for filing, the FDA’s goal is to review applications within ten months of submission or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months from submission. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. For new oncology products, the FDA will often solicit an opinion from an ODAC, a panel of expert authorities knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions. The ODAC panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer, and makes appropriate recommendations to the

Commissioner of Food and Drugs. The FDA is not bound by the recommendation of an advisory committee. The FDA may deny approval of an NDA by issuing a Complete Response Letter, or CRL, if the applicable regulatory criteria are not satisfied. A CRL may require additional clinical data and/or an additional pivotal Phase 3 clinical trial(s), and/or other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we or our collaborators interpret data. Approval may be contingent on a Risk Evaluation and Mitigation Strategy, or REMS, that limits the labeling, distribution or promotion of a drug product. Once issued, the FDA may withdraw product approval if ongoing regulatory requirements are not met or if safety problems occur after the product reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the safety effects of approved products which have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs or other information.

There are three primary regulatory pathways for a New Drug Application under Section 505 of the FDCA: Section 505 (b)(1), Section 505 (b)(2) and Section 505(j). A Section 505 (b)(1) application is used for approval of a new drug (for clinical use) whose active ingredients have not been previously approved. A Section 505 (b)(2) application is used for a new drug that relies on data not developed by the applicant. Section 505(b)(2) of the FDCA was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This statutory provision permits the approval of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. The Hatch-Waxman Act permits the applicant to rely in part upon the FDA’s findings of safety and effectiveness for previously approved products. Section 505(j) application, also known as an abbreviated NDA, is used for a generic version of a drug that has already been approved.

Orphan Drug Exclusivity

Some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs. Pursuant to the Orphan Drug Act, the FDA grants orphan drug designation to drugs intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. The orphan designation is granted for a combination of a drug entity and an indication and therefore it can be granted for an existing drug with a new (orphan) indication. Applications are made to the Office of Orphan Products Development at the FDA and a decision or request for more information is rendered in 60 days. NDAs for designated orphan drugs are exempt from user fees, obtain additional clinical protocol assistance, are eligible for tax credits up to 50% of research and development costs, and are granted a seven-year period of exclusivity upon approval. The FDA cannot approve the same drug for the same condition during this period of exclusivity, except in certain circumstances where a new product demonstrates superiority to the original treatment. Exclusivity begins on the date that the marketing application is approved by the FDA for the designated orphan drug, and an orphan designation does not limit the use of that drug in other applications outside the approved designation in either a commercial or investigational setting.

The FDA has granted DelcathWe have received six orphan drug designations. In November 2008, the FDA granted Delcathdesignations: two orphan drug designations for the drug melphalan for the treatment of patients with cutaneous melanoma, as well as patients with ocular melanoma. In May 2009, the FDA granted Delcath an additional orphan drug designation of the drugmelanoma; one for melphalan for the treatment of patients with neuroendocrine tumors. In August 2009, the FDA granted Delcath an orphan drug designation of the drugtumors; one for doxorubicin for the treatment of patients with primary liver cancer. In October 2013, the FDA granted Delcath an orphan drug designation of the drugcancer; one for melphalan for the treatment of HCC. In July 2015, the FDA granted Delcath an orphan drug designation of the drugHCC; and one for melphalan for the treatment of cholangiocarcinoma, which includes ICC.

The granting of orphan drug designations does not mean that the FDA has approved a new drug. Companies must still pursue the rigorous development and approval process that requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product will be granted at all, or on a timely basis.

Intellectual Property and Other Rights

Our success depends in part on our ability to obtain patents and trademarks, maintain trade secret andknow-how protection, enforce our proprietary rights against infringers, and operate without infringing on the proprietary rights of third parties. Because of the length of time and expense associated with developing new products and bringing them through the regulatory approval process, the health care industry places considerable emphasis on obtaining patent protection and maintaining trade secret protection for new technologies, products, processes,know-how, and methods. The Company currently holds eight U.S. utility patents, one U.S. design patent, six pending U.S. utility patent applications (one of which has been allowed), four issued foreign counterpart utility patents (including the validation of one European patent in two European countries, and the validation of another European patent in four European countries), six issued foreign counterpart design patents, and eight pending foreign counterpart patent applications (one of which has been allowed). The company holds U.S. and some foreign trademarks for DELCATH, CHEMOSAT, CHEMOFUSE, ISOFUSE, PHP, and THE DELCATH PHP SYSTEM.

In July 2017, one of our pending patent applications for our chemotherapy filtration system was approved by the U.S. Patent Office. When appropriate, the Company actively pursues protection of our proprietary products, technologies, processes, and methods by filing United States and international patent and trademark applications. We seek to pursue additional patent protection for technology invented through research and development, manufacturing, and clinical use of the CHEMOSAT and Melphalan/HDS that will enable us to expand our platform beyond the treatment of cancers in the liver.

There can be no assurance that the pending patent applications will result in the issuance of patents, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that these patents will be found to be valid or sufficiently broad to protect our technology or provide us with a competitive advantage.

To maintain our proprietary position, we also rely on trade secrets and proprietary technological experience to protect proprietary manufacturing processes, technology, andknow-how relating to our business. We rely, in part, on confidentiality agreements with our marketing partners, employees, advisors, vendors and consultants to protect our trade secrets and proprietary technological expertise. In addition, we also seek to maintain our trade secrets through maintenance of the physical security of the premises where our trade secrets are located. There can be no assurance that these agreements will not be breached, that we will have adequate remedies for any breach, that others will not independently develop equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets and proprietary knowledge.

Certain of our United States and foreign patents have already expired and other patents relating to the CHEMOSAT and Melphalan/HDS will expire in the future. In certain circumstances, United States patent law allows for the extension of a patent’s duration for a period of up to five years after FDA approval. The Company intends to seek extension for one of our patents after FDA approval if it has not expired prior to the date of approval. In addition to our proprietary protections, the FDA has granted Delcath five orphan drug designations that provide us a seven-year period of exclusive marketing beginning on the date that our NDA is approved by the FDA for the designated orphan drug. While the exclusivity only applies to the indication for which the drug has been approved, the Company believes that it will provide us with added protection once commercialization of an orphan drug designated product begins.

There has been and continues to be substantial litigation regarding patent and other intellectual property rights in the pharmaceutical and medical device areas. If a third party asserts a claim against Delcath, the Company may be forced to expend significant time and money defending such actions and an adverse determination in any patent litigation could subject us to significant liabilities to third parties, require us to redesign our product, require us to seek licenses from third parties, and, if licenses are not available, prevent us from manufacturing, selling or using our system. Additionally, Delcath plans to enforce its intellectual property rights vigorously and may find it necessary to initiate litigation to enforce our patent rights or to protect our trade secrets orknow-how. Patent litigation can be costly and time consuming and there can be no assurance that the outcome will be favorable to us.

Delcath Systems, Inc. Patents and Patent Applications

Patents Issued in the United States

Patent No.

Title

Issuance Date

Owned or
Licensed

Expiration
Date
7,022,097Method For Treating Glandular Diseases and Malignancies04/04/2006Owned06/24/2023
9,707,331Apparatus For Removing Chemotherapy Compounds from Blood07/18/2017Owned09/17/2034
D708749Dual Filter07/08/2014Owned07/08/2028
9,314,561Filter and Frame Apparatus and Method of Use04/19/2016Owned02/07/2034
9,541,544A Method of Selecting Chemotherapeutic Agents for an Isolated Organ or Regional Therapy01/10/2017Owned08/28/2033
8,679,057Recovery Catheter Assembly03/25/2014Licensed03/04/2031
9,265,914Recovery Catheter Assembly02/23/2016Licensed04/05/2031
9,108,029Recovery Catheter Assembly and Method08/18/2015Licensed02/09/2034

Patent Applications in the United States

Application No.

Application Title

Filing Date

Owned or Licensed

15/651,141Apparatus For Removing Chemotherapy Compounds from Blood07/17/2017Owned
15/071,896Filter and Frame Apparatus and Method of Use03/16/2016Owned
15/346,239A Method of Selecting Chemotherapeutic Agents for an Isolated Organ or Regional Therapy11/08/2016Owned
14/995,677Recovery Catheter Assembly01/14/2016Licensed
14/797,108Recovery Catheter Assembly and Method07/11/2015Licensed
15/728,296Recovery Catheter Assembly and Method10/09/2015Licensed

Foreign Patents

Patent No.

Title

Issuance DateOwned or
Licensed
Expiration
Date
84.098Dual Filter (Argentina)06/29/2012Owned06/29/2027
343454Dual Filter (Australia)07/23/2012Owned06/25/2022
146201Dual Filter (Canada)05/15/2013Owned05/15/2023
ZL 201230277905.5Dual Filter (China)03/20/2013Owned06/22/2022
001333173Dual Filter (Europe)06/27/2012Owned06/25/2037
1456186Dual Filter Cartridge for Fluid Filtration (Japan)10/26/2012Owned10/26/2032
2797644Filter and Frame Apparatus and Method of Use (Albania)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Austria)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Belgium)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Bulgaria)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Croatia)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Cyprus)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Czech Republic)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Denmark)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Estonia)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Finland)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (France)04/12/2017Owned12/29/2032
602012031191.6Filter and Frame Apparatus and Method of Use (Germany)04/12/2017Owned12/29/2032

2797644Filter and Frame Apparatus and Method of Use (Great Britain)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Greece)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Hungary)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Iceland)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Ireland)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Italy)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Latvia)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Lithuania)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Luxembourg)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Macedonia)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Malta)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Monaco)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Netherlands)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Norway)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Poland)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Portugal)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Romania)04/12/2017Owned12/29/2032

2797644Filter and Frame Apparatus and Method of Use (San Marino)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Serbia)Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Slovakia)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Slovenia)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Spain)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Sweden)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Switzerland)04/12/2017Owned12/29/2032
2797644Filter and Frame Apparatus and Method of Use (Turkey)04/12/2017Owned12/29/2032
2011224640Recovery Catheter Assembly (Australian)08/20/2015Licensed03/04/2031
ZL201180022704.3Recovery Catheter Assembly (China)08/26/2015Licensed03/04/2031
1183257Recovery Catheter Assembly (Hong Kong)08/12/2016Licensed03/04/2031
5982081Recovery Catheter Assembly (Japan)08/05/2016Licensed03/04/2031

Foreign Patent Applications

Application No.

Title

Filing Date

Owned or
Licensed

12847108.3Apparatus For Removing Chemotherapy Compounds from Blood (Europe)11/07/2012Owned
17176952.4Apparatus For Removing Chemotherapy Compounds from Blood (Europe)11/07/2012Owned
17165333.0Filter and Frame Apparatus and Method of Use (Europe)12/29/2012Owned
15104220.7Filter and Frame Apparatus and Method of Use (Hong Kong)07/07/2017Owned
2015210390Recovery Catheter Assembly (Australia)03/04/2011Licensed
2793561Recovery Catheter Assembly (Canada)09/05/2012Licensed
201510452193.9Recovery Catheter Assembly (China)11/06/2012Licensed
11709548.9Recovery Catheter Assembly (Europe)03/04/2011Licensed
2016-081587Recovery Catheter Assembly (Japan)09/06/2012Licensed

Other Regulatory Requirements

Products manufactured or distributed pursuant to FDA approvals are subject to continuing regulation by the FDA, including recordkeeping, annual product quality review and reporting requirements. Adverse event experience with the product must be reported to the FDA in a timely fashion and pharmacovigilance programs to proactively look for these adverse events are mandated by the FDA. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Following such inspections, the FDA may issue notices on Form 483 and Untitled Letters or Warning Letters that could cause us or our third-party manufacturers to modify certain activities. A Form 483 Notice, if issued at the conclusion of an FDA inspection, can list conditions the FDA investigators believe may have violated cGMP or other FDA regulations or guidelines. In addition to Form 483 Notices and Untitled Letters or Warning Letters, failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as suspension of manufacturing, seizure of product, injunctive action or possible civil penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If we or our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may require us to recall our products from distribution or withdraw any potential approvals of an NDA for that product.

The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations fordirect-to-consumer advertising, dissemination ofoff-label information, industry-sponsored scientific and educational activities and promotional activities involving the Internet. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to the drug, including changes in indications, labeling, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new or supplemental NDA, which may require us to develop additional data or conduct additional preclinical studies and clinical trials. Failure to comply with these requirements can result in adverse publicity, Warning Letters, corrective advertising and potential civil and criminal penalties.

Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Suchoff-label uses are common across medical specialties, in particular in oncology. Physicians may believe that suchoff-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communications regardingoff-label use.

European Regulatory Environment

In the EEA,EU, the CHEMOSAT system is subject to regulation as a medical device. The EEAEU is composed of the 27 Member States of the EU plus Norway, Iceland and Liechtenstein. Under the EU Medical Devices Directive (Directive No 93/42/ECC of 14 June 1993, as last amended), drug delivery products such as the CHEMOSAT system is governed by the EU laws on pharmaceutical products only if they are (i) placed on the market in such a way that the device and the pharmaceutical product form a single integral unit which is intended exclusively for use in the given combination, and (ii) the product is not reusable. In such cases, the drug delivery product is governed by the EU Code on Medicinal Products for Human Use (Directive 2001/83/EC, as last amended), while the essential requirements of the EU Medical Devices Directive apply to the safety and performance-related device features of the product. Because we do not intend to place the CHEMOSAT system on the EEAEU market as a single integral unit with melphalan, the product is governed solely by the EU Medical Devices Directive, while the separately marketed drug is governed by the EU Code relating to Medicinal Products for Human Use and other EU legislation applicable to drugs for human use.

Before we may commercialize a medical device in the EEA,EU, we must comply with the essential requirements of the EU Medical Devices Directive. Compliance with these requirements entitles a manufacturer to affix a CE conformity mark, without which the products cannot be commercialized in the EEA.EU. To demonstrate compliance with the essential requirements and obtain the right to affix the CE conformity mark, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. In April 2011, we obtained authorization to affix a CE Mark for the Generation One CHEMOSAT system and began European commercialization with this version of the CHEMOSAT system in early 2012. In April 2012, the Company obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT system, and since this time all procedures in Europe have been performed with this version of the systemsystem.

The Medical Devices Directive establishes a classification system placing devices into Class I, IIa, IIb, or III, depending on the risks and characteristics of the medical device. For certain types of low risk medical devices (i.e., Class I devices which arenon-sterile and do not have a measuring function), the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the EU Medical Devices Directives. Other devices are subject to a conformity assessment procedure requiring the intervention of a Notified Body, which is an organization designated by a Member State of the EEAEU to conduct conformity assessments.

CHEMOSAT is regulated as a Class IIb medical device. As a Class IIb medical device, the Notified Body is not required to carry out an examination of the product’s design dossier as part of its conformity assessment prior to commercialization. The Company must continue to comply with the essential requirements of the EU Medical Devices Directive (Directive 93/42 EC) and is subject to a conformity assessment procedure requiring the intervention of a Notified Body. The conformity assessment procedure for Class IIb medical devices requires the manufacturer to apply for the assessment of its quality system for the design, manufacture and inspection of its medical devices by a Notified Body. The Notified Body will audit the system to determine whether it conforms to the provisions of the Medical Devices Directive. If the Notified Body’s assessment is favorable, it will issue a Full Quality Assurance Certificate, which enables the manufacturer to draw a Declaration of Conformity and affix the CE mark to the medical devices covered by the assessment. Thereafter, the Notified Body will carry out periodic audits to ensure that the approved quality system is applied by the manufacturer.

A manufacturer without a registered place of business in a Member State of the European UnionEU which places a medical device on the market under its own name must designate an authorized representativeAuthorized Representative established in the European UnionEU who can act before, and be addressed by, the Competent Authorities on the manufacturer’s behalf with regard to the manufacturer’s obligations under the EU Medical Devices Directive. We appointed such a representative prior to establishing our infrastructure in the EEAEU. With the Delcath Systems Ltd. infrastructure now firmly in place, the Authorized Representative responsibilities have been formally transferred internally and expect that we will notthere is no longer a need for a third party representative in the future.third-party representative.

In the EEA,EU, we must also comply with the Medical Device Vigilance System, which is designed to improve the protection of health and safety of patients, users and others by reducing the likelihood of recurrence of incidents related to the use of a medical device. Under this system, incidents are defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health. When a medical device is suspected to be a contributory cause of an incident, its manufacturer or authorized representative in the EU must report it to the Competent Authority of the Member State where the incident occurred. Incidents are generally investigated by the manufacturer. The manufacturer’s investigation is monitored by the Competent Authority, which may intervene, or initiate an independent investigation if considered appropriate. An investigation may conclude in the adoption of a Field Safety Corrective Action, (FSCA).or FSCA. An FSCA is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. An FSCA may include device recall, modification exchange and destruction.

FSCAs must be notified by the manufacturer or its authorized representative to its customers and/or the end users of the medical device via a Field Safety Notice.

In the EEA,EU, theoff-label promotion of a pharmaceutical product is strictly prohibited under the EU Community Code on Medicinal Products, which provides that all information provided within the context of the promotion of a drug must comply with the information contained in its approved summary of product characteristics. Our product instructions and indication reference the chemotherapeutic agent melphalan hydrochloride. However, no melphalan labels in the EEAEU reference our product, and the labels vary from country to

country with respect to the approved indication of the drug and its mode of administration. In the exercise of their professional judgment in the practice of medicine, physicians are generally allowed, under certain conditions, to use or prescribe a product in ways not approved by regulatory authorities. Physicians intending to use our device must obtain melphalan separately for use with the CHEMOSAT system and must use melphalan independently at their discretion.

In the EEA,EU, the advertising and promotion of our products is also subject to EEAEU Member States laws implementing the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, as well as other EEAEU Member State legislation governing the advertising and promotion of medical devices. These laws may further limit or restrict the advertising and promotion of our products to the general public and may also impose limitations on our promotional activities with health care professionals.

Failure to comply with the EEAEU Member State laws implementing the Medical Devices Directive, with the EU and EEAEU Member State laws on the promotion of medicinal products or with other applicable regulatory requirements can result in enforcement action by the EEAEU Member State authorities, which may include any of the following: fines, imprisonment, orders forfeiting products or prohibiting or suspending their supply to the market, or requiring the manufacturer to issue public warnings, or to conduct a product recall.

The European Commission recently reviewed the Medical Device Directive legislative framework and promulgated REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, legislative frameworkamending Directive 2001/83/EC, Regulation EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. This new Medical Device Regulation became effective on May 25, 2017, marking the start of a3-year transition period for manufacturers selling medical device in 2012Europe to comply with the aimnew medical device regulation, or MDR, which governs all facets of simplifying itmedical devices. The transition task is highly complex and ensuringtouches every aspect of product development, manufacturing production, distribution and post marketing evaluation.

Effectively addressing these changes will require a more uniform applicationcomplete review of the provisions contained in the medical devices directives across the EEA.our device operations to determine what is necessary to comply. We do not believe the adoptedMDR regulatory changes will impact our business at this time, though future changes toimplementation of the medical device legislation may adversely affect our business, financial condition and results of operations or restrict our operations.

Other International Regulations

The CHEMOSAT device has received registrations in the following countries: Australia, New Zealand, Argentina, Taiwan, and Singapore. With limited resources and our attention focused on European commercial and clinical adoption efforts, pursuing other markets at this time is not practical. We will continue to evaluate commercial opportunities in these and otherselect markets when resources are available and at an appropriate time.

Competition

The healthcare industry is characterized by extensive research, rapid technological progress and significant competition from numerous healthcare companies and academic institutions. Competition in the cancer treatment industry is intense. We believe that the primary competitive factors for products addressing cancer include safety, efficacy, ease of use, reliability and price. We also believe that physician relationships, especially relationships with leaders in the medical and surgical oncology communities, are important competitive factors. We also believe that the current global economic conditions and new healthcare reforms could put competitive pressure on us, including reduced selling prices and potential reimbursement rates, and overall procedure rates. Certain markets in Europe are experiencing the effects of continued economic weakness, which is affecting healthcare budgets and reimbursement.

The CHEMOSAT and Melphalan/HDS competes with all forms of liver cancer treatments, including surgery, systemic chemotherapy, focal therapies and palliative care. In the disease states we are targeting there are also numerous clinical trials sponsored by third-parties, which can compete for potential patients in the near term and may ultimately lead to new competitive therapies.

For ocular melanoma liver metastases, there are currently no approved or effective treatment options, and patients are generally treated with a variety of local and regional techniques. There are numerous companies developing and marketing devices for the performance of focal therapies, including Covidian, Biocompatibles, Merit, CeleNova, SirTex, AngioDynamics, and many others.

For HCC, sorafenib (Nexavar, Onyx Pharmaceuticals) remains the only targeted drug approved for the treatment of HCC in patients who are not candidates for surgery.

Several therapies have been recently approved for unresectable or metastatic cutaneous melanoma, which may encompass liver metastases. Dabrafenib (Tafinlar™, GlaxoSmithKline), is indicated as single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, and in combination with trametinib in unresectable or metastatic melanoma with BRAF V600E or V600K mutations. Furthermore, trametinib (MEKINIST™, GlaxoSmithKline) is indicated as single agent (in addition to in combination with dabrafinib) for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. Previously approved melanoma therapies such as the biologic ipilimumab (Yervoy™, Bristol Myers Squibb) and theB-RAF targeted drug vemurafenib (Zelboraf™, Genentech) may also make up the competitive landscape for the treatment of metastatic liver disease.

Many of these treatments are approved in Europe and other global markets.

Many of our competitors have substantially greater financial, technological, research and development, marketing and personnel resources. In addition, some of our competitors have considerable experience in conducting clinical trials, regulatory, manufacturing and commercialization capabilities. Our competitors may develop alternative treatment methods, or achieve earlier product development, in which case the likelihood of us achieving meaningful revenues or profitability will be substantially reduced.

Manufacturing and Quality Assurance

We manufacture certain components including our proprietary filter media, and assemble and package the CHEMOSAT and Melphalan/HDS at our facility in Queensbury, New York. We have established our European headquarters and distribution facility in Galway, Ireland where we intend to conduct final manufacturing and assembly in the future. Delcath currently utilizes third-parties to manufacture some components of the CHEMOSAT and Melphalan/HDS. The CHEMOSAT and Melphalan/HDS and its components must be manufactured and sterilized in accordance with approved manufacturing andpre-determined performance specifications. In addition, certain components will require sterilization prior to distribution and Delcath relies on third-party vendors to perform the sterilization process.

We are committed to providing high quality products to our customers. To honor this commitment, Delcath has implemented updated quality systems throughout our organization. Delcath’s quality system starts with the initial product specification and continues through the design of the product, component specification process and the manufacturing, sale and servicing of the product. These systems are designed to enable us to satisfy the various international quality system regulations including those of the FDA with respect to products sold in the United States and those established by the International Standards Organization (ISO) with respect to products sold in the EEA. The Company is required to maintain ISO 13485 certification for medical devices to be sold in the EEA, which requires, among other items, an implemented quality system that applies to component quality, supplier control, product design and manufacturing operations. On February 17, 2011, we announced that we had achieved ISO 13485 certification for our Queensbury manufacturing facility. On December 28, 2011, we announced that we had achieved ISO 13485 certification for our Galway, Ireland facility.

Intellectual Property and Other Rights

Our success depends in part on our ability to obtain patents and trademarks, maintain trade secret andknow-how protection, enforce our proprietary rights against infringers, and operate without infringing on the proprietary rights of third parties. Because of the length of time and expense associated with developing new products and bringing them through the regulatory approval process, the health care industry places considerable emphasis on obtaining patent protection and maintaining trade secret protection for new technologies, products, processes,know-how, and methods. The Company currently holds nine United StatesWe hold rights in eight U.S. utility patents, one United StatesU.S. design patent, five pending United StatesU.S. utility patent applications, elevensix issued foreign counterpart utility patents (including the validation of a European

patent directed to our filter apparatus in eight European countries, six issued foreign counterpart design patents, and eight pending foreign counterpart patent applications (oneapplications. In July 2017, a patent directed to our chemotherapy filtration system was issued by the U.S. Patent and Trademark Office. In October 2018 and February 2019 patents directed to our chemotherapy filtration system and a method of which has been allowed). We presently haveusing our filter and frame apparatus were issued utility and design patents with claims related to certain features of the current version of CHEMOSAT and Melphalan/HDS inby the United States Patent and JapanTrademark Office. A Notice of Allowance was obtained from the United States Patent and Trademark Office for the patent application entitled “Apparatus For Removing Chemotherapy Compounds from Blood” with allowed claims to a kit of parts capable of being assembled for delivering a small molecule chemotherapeutic agent to a subject. The allowed claims are directed to CHEMOSAT. A Hong Kong patent directed to our Filter and Frame Apparatus was issued in March of 2018. A European patent was granted for our chemotherapy filtration system in November 2018 and a designEuropean patent protectionapplication directed to a method of using our filter and frame apparatus was granted in Argentina, Australia, Canada, China and Europe.April 2019 by the European Patent Office.

When appropriate, the Companywe actively pursuespursue protection of our proprietary products, technologies, processes, and methods by filing United States and international patent and trademark applications. We seek to pursue additional patent protection for technology invented through research and development, manufacturing, and clinical use of the CHEMOSAT and Melphalan/HDS that will enable us to expand our platformpatent portfolio around advances to our current systems, technology, and methods for our current applications as well as beyond the treatment of cancers in the liver.

There can be no assurance that the pending patent applications will result in the issuance of patents, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that these patents will be found to be valid or sufficiently broad to protect our technology or provide us with a competitive advantage.

To maintain our proprietary position, we also rely on trade secrets and proprietary technological experience to protect proprietary manufacturing processes, technology, andknow-how relating to our business. We rely, in part, on confidentiality agreements with our marketing partners, employees, advisors, vendors and consultants to protect our trade secrets and proprietary technological expertise. In addition, we also seek to maintain our trade secrets through maintenance of the physical security of the premises where our trade secrets are located. There can be no assurance that these agreements will not be breached, that we will have adequate remedies for any breach, that others will not independently develop equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets and proprietary knowledge.

Certain of our United States and foreign patents have already expired [and other patents relating to the CHEMOSAT and Melphalan/HDS will expire in 2017]. In certain circumstances, United States patent law allows for the extension of a patent’s duration for a period of up to five years after FDA approval. The Company intendsWe intend to seek extension for one of our patents after FDA approval if it has not expired prior to the date of approval. In addition to our proprietary protections, the FDA has granted Delcath fiveus six orphan drug designations that provide us a seven-year period of exclusive marketing beginning on the date that our NDA is approved by the FDA for the designated orphan drug. While the exclusivity only applies to the indication for which the drug has been approved, the Company believeswe believe that itthis exclusivity will provide us with added protection once commercialization of an orphan drug designated product begins.

There has been and continues to be substantial litigation regarding patent and other intellectual property rights in the pharmaceutical and medical device areas. If a third party asserts a claim against Delcath, the Companyus, we may be forced to expend significant time and money defending such actions and an adverse determination in any patent litigation could subject us to significant liabilities to third parties, require us to redesign our product, require us to seek licenses from third parties, and, if licenses are not available, prevent us from manufacturing, selling or using our system. Additionally, Delcath planswe plan to enforce itsour intellectual property rights vigorously and may find it necessary to initiate litigation to enforce our patent rights or to protect our trade secrets orknow-how. Patent litigation can be costly and time consuming and there can be no assurance that the outcome will be favorable to us.

EmployeesCompetition

During 2016, Delcath added 7 employeesThe healthcare industry is characterized by extensive research, rapid technological progress and significant competition from numerous healthcare companies and academic institutions. Competition in the cancer treatment industry is intense. We believe that the primary competitive factors for products addressing cancer include safety, efficacy, ease of use, reliability and price. We also believe that physician relationships, especially relationships with leaders in the medical and surgical oncology communities, are important competitive factors. We also believe that the current global economic conditions and new healthcare reforms could put competitive pressure on us, including reduced selling prices and potential reimbursement rates, and overall procedure rates. Certain markets in Europe are experiencing the effects of continued economic weakness, which is affecting healthcare budgets and reimbursement.

CHEMOSAT competes and, if approved by the FDA Melphalan/HDS will compete, with all forms of liver cancer treatments, including surgery, systemic chemotherapy, focal therapies and palliative care. In the disease states we are targeting there are also numerous clinical trials sponsored by third-parties, which can compete for potential patients in the near term and may ultimately lead to supportnew competitive therapies.

For ocular melanoma liver metastases, there are currently no approved or effective treatment options, and patients are generally treated with a variety of local and regional techniques. There are numerous companies developing and marketing devices for the performance of focal therapies, including Boston Scientific Corporation, the Covidien Products division of Medtronic plc, Merit Medical Systems, Inc., Celenova BioSciences Inc., Sirtex Medical Limited, AngioDynamics, Inc., and many others.

For ICC, gemcitabine plus cisplatin remains the standard of care for the treatment of ICC in patients who are not candidates for surgery.

Several therapies have been recently approved for unresectable or metastatic cutaneous melanoma, which may encompass liver metastases. Dabrafenib (Tafinlar, GlaxoSmithKline plc), is indicated as single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, and in combination with trametinib in unresectable or metastatic melanoma with BRAF V600E or V600K mutations. Furthermore, trametinib (MEKINIST, GlaxoSmithKline plc) is indicated as single agent (in addition to in combination with dabrafinib) for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. Previously approved melanoma therapies such as the biologic ipilimumab (Yervoy, Bristol Myers Squibb Company) and theB-RAF targeted drug vemurafenib (Zelboraf, Genentech, Inc.) may also make up the competitive landscape for the treatment of metastatic liver disease.

Many of these treatments are approved in Europe and other global markets.

Many of our competitors have substantially greater financial, technological, research and development, marketing and personnel resources. In addition, some of our competitors have considerable experience in conducting clinical trial implementationstrials, regulatory, manufacturing and commercialization capabilities. Our competitors may develop alternative treatment methods, or achieve earlier product development, in which case the likelihood of us achieving meaningful revenues or profitability will be substantially reduced.

Manufacturing and Quality Assurance

We manufacture certain critical medical device components including our proprietary filter media and assemble and package the CHEMOSAT and Melphalan/HDS at our facility in Queensbury, New York. We have established our European headquarters and distribution facility in Galway, Ireland where we conduct final manufacturing, processing and assembly. We use third-parties to manufacture some components of the CHEMOSAT and Melphalan/HDS. The CHEMOSAT and Melphalan/HDS and its components must be manufactured and sterilized in accordance with approved manufacturing andpre-determined performance specifications. In addition, certain components will require sterilization prior to distribution and we use third-party vendors to perform the sterilization process.

We are required to comply with the FDA’s cGMP regulations and international quality system regulations including those established by the International Standards Organization (ISO) with respect to products sold in the EU. We are required to maintain ISO 13485 certification for medical devices to be sold in the EU, which requires, among other items, an implemented quality system that applies to component quality, supplier control, product design and manufacturing operations. Our facilities are ISO 13485:2016 certified.

Employees

As of April 17, 2020, we had approximately 33 full time employees located in the United States and to meet the demands of commercial sales. As of September 25, 2017, Delcath had 46 full-time employees.in Europe. None of our employees isare represented by a labor union and weor covered by a collective bargaining agreement. We believe relationshipsour relationship with our employees areis good.

Properties

Our corporate offices currently occupy 6,877 square feet of office space at 1633 Broadway, Suite 22C, New York, New York under asub-lease agreement that expires in March 2019. The Company leases twoFebruary 2021. We lease additional spacesspace in the United States includingcomprised of approximately 6,000 square feet at95-97 Park Road in Queensbury, New York and 17,320 square feet of office space at 810 Seventh Avenue, New York, New York. Theunder a lease agreements expirethat expires in October 2018 and March 2021 respectively. The Company has subleased the office space at 810 Seventh Avenue to unaffiliated third-parties. Delcath ownsNovember 2020. We also own a building containingcomprised of approximately 10,320 square feet at 566 Queensbury Avenue in Queensbury, NY.New York. These facilities house manufacturing, quality assurance and quality control, research and development, and office space. The Company also ownsspace functions. We own approximately four acres of land at 12 and 14 Park Road in Queensbury, New York. In addition, the Company leaseswe lease a facility for office and manufacturing containingcomprised of approximately 19,200 square feet at 19 Mervue, Industrial Park in Galway, Ireland under a lease agreement that expires in August 2, 2021. The Company hasWe have sublet 5,662 square feeta portion of this facility to an unaffiliated third-party. The Company believes substantially allWe believe that our facilities are adequate for our operations.

Legal Proceedings

From time to time, we are engaged in various legal actions, claims and proceedings arising in the ordinary course of our property and equipment is in good condition and that we have sufficient capacitybusiness, none of which are expected to meet our current operational needs.be material.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERSMANAGEMENT, EXECUTIVE COMPENSATION AND MANAGEMENTCORPORATE GOVERNANCE

The following tables containBelow are the names and certain information regarding the beneficial ownership of our common stock as of October 31, 2017, held by: (i) each of our directors; (ii) each of our namedCompany’s executive officers in the Summary Compensation Table; (iii) all of ourand directors and executive officers as a group; and (iv) each person or group known by us to own beneficially more than 5% of the outstanding common stock. We are not aware of any 5% or more holders of our Common Stock as of October 31, 2017 except as set forth below. The information set forth in the table below excludes shares issuable upon exercise of our outstanding warrants held by certain investors that are presently exercisable, subject to limitations on exercisability for more than 4.9% or 9.9% of our outstanding shares of common stock, depending upon the particular investor. Except as indicated in the footnotes below, the address of the persons or groups named below is c/o Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019.

Directors and Officers:

 

Shares
Beneficially
Owned (1)

Name of Beneficial Owner:

NumberPercent

Named Executive Officers and Directors:

Jennifer K. Simpson, Ph.D.(2)

46,987*

John Purpura, M.S.(3)

38,827*

Barbra C. Keck, M.B.A.(4)

26,158*

Harold S. Koplewicz, M.D.(5)

4,688*

Roger G. Stoll, Ph.D.(6)

6,637*

William D. Rueckert(7)

6,250*

Marco Taglietti, M.D.(8)

17,500*

All directors and executive officers as a group (7 people)(9):

147,047*

*Less than 1%
(1)Except as indicated in these footnotes: (i) the persons named in this table have sole voting and investment power with respect to all shares of common stock beneficially owned; (ii) the number of shares beneficially owned by each person as of September 19, 2017, includes any vested and unvested shares of restricted stock and any shares of common stock that such person or group has the right to acquire within 60 days of September 19, 2017, upon the exercise of stock options; and (iii) for each person or group included in the table, percentage ownership is calculated by dividing the number of shares beneficially owned by such person or group by the sum of the 490,022,209 shares of common stock outstanding on September 19, 2017, plus the number of shares of common stock that such person or group has the right to acquire within 60 days of September 19, 2017.
(2)Includes 5,079 shares of common stock, which Dr. Simpson has the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017.
(3)Includes 3,429 shares of common stock, which Mr. Purpura has the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017.
(4)Includes 2,271 shares of common stock, which Ms. Keck has the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017, and 4 shares held in a joint account with her spouse.
(5)Includes 1,875 shares of common stock, which Dr. Koplewicz has the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017. Mr. Koplewicz resigned as a director effective September 15, 2017.
(6)Includes 3,688 shares of common stock, which Dr. Stoll has the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017
(7)Includes 3,125 shares of common stock, which Mr. Rueckert has the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017.
(8)Includes 3,125 shares of common stock, which Dr. Taglietti has the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017.
(9)Includes 22,592 shares of common stock, which certain directors and executive officers have the right to acquire upon exercise of outstanding options exercisable within 60 days of September 19, 2017.

FIVE PERCENT HOLDERS

Title of

Class

Address of

Beneficial

Owner

Amount
and
nature of
beneficial
ownership
(Series C
Preferred Stock)
Percent
of Class
(Series C
Stock)

Hudson Bay Master Fund Ltd.

Common Stock, Series C Preferred Stock

777 Third Avenue,

30th Floor

New York, NY 10017

Attention: George Antonopoulos

501.5(1)85%

Alto Opportunity Master Fund, SPC- Segregated Master Portfolio A.

Series C Preferred Stock

1180 Avenue

of the Americas,

Suite 842

New York, NY 10036

Attn: Waqas Khatri

88.5(2)15%

(1)Hudson Bay Capital Management, L.P., the investment manager of Hudson Bay Master Fund Ltd., has voting and investment power over these securities. Sander Gerber is the managing member of Hudson Bay Capital GP LLC, which is the general partner of Hudson Bay Capital Management, L.P. The Preferred Stock votes along with the common stock with 880,375 votes.
(2)Ayrton Capital LLC serves as the investment manager of Alto Opportunity Master Fund,SPC- Segregated Master Portfolio A and has voting and investment power over these securities. Waqas Khatri is the manager of Ayrton Capital LLC. Each of Alto Opportunity Master Fund, SPC—Segregated Master Portfolio A and Waqas Khatri disclaims beneficial ownership over the securities, except to the extent of its pecuniary interest therein. The Series C Preferred Stock votes along with the common stock with 880,375 votes.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Information About Directors. The following table sets forth certain information about our director who successfully stood forre-election and about our directors whose terms will continue after the Annual Meeting.

Name

  Age   Position with Delcath   Director
Since
 

Class I Directors—Term expiring at the 2019 Annual Meeting

      

William D. Rueckert

   64    Director    2014 

Marco Taglietti, M.D.

   57    Director    2014 

Class III Directors—Terms expiring at the 2018 Annual Meeting

      

Roger G. Stoll, Ph.D.

   74    Chairman    2008 

Jennifer K. Simpson, Ph.D.

   48    Director    2015 

Class I Directors—Terms Expiring at the 2019 Annual Meeting.

William D. Rueckert was appointed as a Director in December 2014. Mr. Rueckert has served on many public and private corporate boards in both the life science and banking industries. He is currently President of Oyster Management Group, LLC, an investment partnership specializing in community banking. From 2007 until 2012 he served on the board of Novogen Ltd. (ASX, NASDAQ) a biotechnology company based in Sydney, Australia. He acted as Chairman from 2010 until 2012, and as acting CEO led the restructuring of the company, spinning off its major subsidiary, Marshall Edwards, Inc. (now MEI Pharma, Inc. NASDAQ.) He is currently a director of MEI Pharma, Inc. (NASDAQ), a San Diego based company that is developing novel oncology therapies. Until its sale to H. Lundbeck A/S, he was a director of Chelsea Therapeutics International, Ltd. (NASDAQ) whose drug candidate, Northera, was approved by the FDA in 2014. He has also served on the boards of several banks including Westport Bank and Trust, Lafayette American Bank and Hudson United Bank (all NASDAQ.) He currently serves on the board of Fairfield County Bank, a mutually owned, community bank based in Ridgefield, Connecticut, and Bleachers, Inc., a privately held company that streams live and archived sports and entertainment events from independent schools. Among his civic associations, Mr. Rueckert is a Director and President of the Cleveland H. Dodge Foundation,Co-Chairman of the Board of Trustees of Teachers College, Columbia University, a Director of the Y Retirement Fund, a Trustee of International House, an Emeritus Director of the YMCA of Greater New York, a Trustee of the American University of Beirut and a Director of Wave Hill, Inc. He earned a BA in Spanish in 1977 from the University of New Hampshire. The Nominating Committee considered Mr. Rueckert’s experience and qualifications, in addition to his relevant executive management and operational pharmaceutical experience, as well as the overall composition of the Board, in making the determination that Mr. Rueckert should serve as director of Delcath.

Dr. Marco Taglietti, M.D. was appointed as a Director in December 2014. Dr. Taglietti serves as CEO and on the Board of Directors of NASDAQ-listed SCYNEXIS, Inc., a pharmaceutical company committed to the discovery, development and commercialization of novel anti-infectives; and NephroGenex, Inc., a pharmaceutical company focused on the development of therapeutics to treat kidney disease. Prior to its acquisition in February 2014, Dr. Taglietti served as Executive Vice President, Research and Development, and Chief Medical Officer of Forest Laboratories. He also served as President of the Forest Research Institute. Prior to joining Forest Labs in 2007, Dr. Taglietti held the position of Senior Vice President, Head of Global Research and Development, at Stiefel Laboratories, Inc. for three years. He joined Stiefel after 12 years at Schering-Plough Corporation where he last held the position of Vice President, Worldwide Clinical Research for Anti-Infectives, Oncology, CNS, Endocrinology and Dermatology. Dr. Taglietti began his career at Marion Merrell Dow Research Institute. He received his medical degree and board certifications from the University of Pavia in Italy. The Nominating Committee considered Dr. Taglietti’s experience and qualifications, in addition to his relevant executive management and operational pharmaceutical experience, as well as the overall composition of the Board, in making the determination that Dr. Taglietti should serve as director of Delcath.

Class III Directors—Terms Expiring at the 2018 Annual Meeting.

Roger G. Stoll, Ph.D. was appointed as a Director in December 2008, Executive Chairman in September 2014 and has served as our Chairman since October 1, 2015. From 2002 to 2008, he served as Chairman, Chief Executive Officer and President of Cortex Pharmaceuticals, Inc. (OTCBB: CORX). In August 2008, he was appointed Executive Chairman of its board. He retired from Cortex Pharmaceuticals in August, 2012. From 2001 to 2002, he was a consultant to several east coast venture capital firms and startup ventures. From 1998 to 2001, he was Executive Vice President of Fresenius Medical Care-North America, in charge of the dialysis products division and the diagnostic systems business units, which included hemodialysis machines and dialysis filters equipment. From 1991 to 1998, Dr. Stoll was Chief Executive of Ohmeda, a global leader in anesthetic agents, critical care drugs and related operating room equipment and devices. He also served on the boards of directors of St. Jude Medical and the BOC Group, plc. From 1986 to 1991, Dr. Stoll held several executive management positions at Bayer, AG, including Executive Vice-President and General Manager for its worldwide Diagnostic Business Group. Prior to that, Dr. Stoll worked for American Hospital Supply Corp., where he rose from Director of Clinical Pharmacology to President of its American Critical Care Division. He began his pharmaceutical career at the Upjohn Company in 1972. Dr. Stoll obtained his B.S. in Pharmacy from Ferris State University, obtained a Ph.D. in Biopharmaceutics and Drug Metabolism at the University of Connecticut and was a post-doctoral fellow for two years at the University of Michigan. From 2008 and until its sale to H. Lundbeck A/S, Dr. Stoll served on the board of directors of Chelsea Therapeutics (NASDAQ: CHTP) and was a member of that board’s audit and compensation committees. Dr. Stoll in the past also served on the boards of Questcor and Agensys, HIMA and PMA (now PhRMA). Dr. Stoll also serves on the School of Pharmacy Advisory Board of the University of Connecticut. The Nominating Committee considered Dr. Stoll’s experience and qualifications, in addition to his relevant executive management and operational pharmaceutical and medical device experience, as well as the overall composition of the Board, in making the determination that Dr. Stoll should serve as director of Delcath.

In addition, information concerning Jennifer K. Simpson, one of our Directors and our President and Chief Executive Officer, is provided under “—Information About Executive Officers”

Information About our Executive Officers

The following table provides information concerning the current executive officers of Delcath.

Name

  

Age

  

Office CurrentlyPosition Held

Jennifer K. Simpson, Ph.D.

  4851 Director, President and Chief Executive Officer

Barbra C. Keck M.B.A.

  3942  Chief Financial Officer and Secretary

John Purpura

  5558  Executive Vice President, Global Head of Operations

Elizabeth Czerepak

64Director

William D. Rueckert

67Director

Roger G. Stoll, Ph.D.

77Director, Chairman

John R. Sylvester

56Director

Marco Taglietti, M.D.

60Director

The following is a brief description of the business experience of the following officers:

Jennifer K. Simpson was appointed as a Director in October 2015. Dr. Simpson joined Delcath as Executive Vice President, Global Marketing in March 2012 and was promoted to Executive Vice President, Global Head of Business Operations in April 2013 andInterimCo-President andCo-Chief Executive Officer, Executive Vice President, Global Head of Business Operations in September 2013. In September 2014, Dr. Simpson was named Interim President and Chief Executive Officer and named President and Chief Executive Officer in OctoberMay 2015. From May 2011 to March 2012, Dr. Simpson served as the Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. (a wholly owned subsidiary of Eli Lilly and Company), where she was responsible for all product commercialization activities and launch preparation for one of the late-stage assets. From June 2009 to May 2011, Dr. Simpson served as the Vice President, Product Champion and from 2008 to 2009 as the Associate Vice President, Product Champion for ImClone’s product Ramucirumab. From 2006 to 2008, Dr. Simpson served as Product Director, Oncology Therapeutics Marketing at Ortho Biotech (now Janssen Biotech), a Pennsylvania-based biotech company that focuses on innovative solutions in immunology, oncology and nephrology. Earlier in her career, Dr. Simpson spent over a decade as a hematology/oncology nurse practitioner and educator. Dr. Simpson has served on the Board of Directors and Nominating and Corporate Governance Committee of Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) since 2019. Dr. Simpson earned a Ph.D. in Epidemiology from the University of Pittsburgh, an M.S. in Nursing from the University of Rochester, and a B.S. in Nursing from the State University of New York at Buffalo.

Barbra C. Keck joined Delcath as Controller in January 2009, was promoted to Vice President in October 2009, to Senior Vice President in March 2015 and to Chief Financial Officer in February 2017. Prior to joining Delcath, she was an audit assistant with Deloitte & Touche, LLP from August 2008 to December 2008. From June 2006 to August 2008, Ms. Keck was the Assistant to the Vice President and Dean of Baruch College, Zicklin School of Business, and from September 2005 to May 2006 she was the Donor Relations and Communications Manager for Young Audiences New York. From 2002 to 2005, Ms. Keck was the Manager, UD Arts Series at the University of Dayton, where she also served as the Manager, Arts and Cultural Events from 1999 to 2002. Between those positions, from 2002 to 2003, she was the Director of Teacher Programs at the Muse Machine. Ms. Keck served as the General Manager of Dayton Bach Society and the Manager of UD Arts Series from 1999 to 2002. She earned her M.B.A. in Accountancy from Baruch College and Bachelor of Music in Music Education from the University of Dayton.

John Purpura joined Delcath as Executive Vice President, Regulatory Affairs and Quality Assurance in November 2009 and was promoted to Executive Vice President, Global Head of Operations on July 19, 2016. Prior to joining Delcath, he was with Bracco Diagnostics (formerly(formerly E-Z-EM,Inc.) as Vice President and then Executive Director of International Regulatory Affairs from 2007 to 2008 and Head of Regulatory Affairs for North America and Latin America from 2008 to 2009. PriortoE-Z-EM, Inc., Mr. Purpura hadan11-year career career with Sanofi-Aventis, ultimately serving as Associate Vice President for Regulatory CMC from 2005 to 2007. From 1985 to 1995, he had various quality and regulatory management roles with Bolar Pharmaceuticals, Luitpold Pharmaceuticals and Eon Labs Manufacturing. He earned his M.S. in Management & Policy and B.S. degrees in Chemistry and Biology at the State University of New York at Stony Brook.

Elizabeth Czerepak was appointed as a Director in February 2020. Ms. Czerepak served as Chief Financial Officer and Chief Business Officer at Genevant Sciences, Inc., a development stage mRNA start-up based in Cambridge, MA, from May 2018 until January 2020. From 2015 until 2018, she served as Chief Financial Officer and Executive Vice President, Corporate Development at Altimmune, Inc. (NASDAQ:ALT), a clinical stage immunotherapeutics biotechnology company. She served as Chief Financial Officer and Chief Business Officer of Isarna Therapeutics Inc., which developed selective TGFb inhibitors to fight cancer and to treat ophthalmic and fibrotic diseases, from 2014 to 2015. Prior to that she served as Chief Financial Officer, Secretary, Principal Accounting Officer and Head of Human Resources at Cancer Genetics, Inc. (NASDAQ:CGIX), a company that develops, commercializes and provides molecular and biomarker-based tests, from 2011 until 2014. From 2000 to 2009, she served as a Managing Director at JPMorgan Chase & Co. and Bear Stearns & Co., and a General Partner at Bear Stearns Health Innoventures L.P., a venture capital fund. From 1982 to 2000, she served in senior and executive level position at BASF (Knoll) Pharma, Hoffmann-La Roche, Inc. and Merck & Co., Inc. (NASDAQ:MRK).

William D. Rueckert was appointed as a Director in December 2014. Mr. Rueckert has served on many public and private corporate boards in both the life science and banking industries. He is currently President of Oyster Management Group, LLC, an investment partnership specializing in community banking. From 2007 until 2012 he served on the board of Novogen Ltd. (ASX, NASDAQ) a biotechnology company based in Sydney, Australia. He acted as Chairman from 2010 until 2012, and as acting CEO led the restructuring of the company, spinning off its major subsidiary, Marshall Edwards, Inc. (now MEI Pharma, Inc. NASDAQ.) He is currently a director of MEI Pharma, Inc. (NASDAQ), a San Diego based company that is developing novel oncology therapies. Until its sale to H. Lundbeck A/S, he was a director of Chelsea Therapeutics International, Ltd. (NASDAQ) whose drug candidate, Northera, was approved by the FDA in 2014. He has also served on the boards of several banks including Westport Bank and Trust, Lafayette American Bank and Hudson United Bank (all NASDAQ.) He currently serves on the board of Fairfield County Bank, a

mutually owned, community bank based in Ridgefield, Connecticut, and Bleachers, Inc., a privately held company that streams live and archived sports and entertainment events from independent schools. Among his civic associations, Mr. Rueckert is a Director and President of the ClevelandH. Dodge Foundation, Co-Chairman of the Board of Trustees of Teachers College, Columbia University, a Director of the Y Retirement Fund, a Trustee of International House, an Emeritus Director of the YMCA of Greater New York, a Trustee of the American University of Beirut and a Director of Wave Hill, Inc. He earned a BA in Spanish in 1977 from the University of New Hampshire. The Nominating Committee considered Mr. Rueckert’s experience and qualifications, in addition to his relevant executive management and operational pharmaceutical experience, as well as the overall composition of the Board, in making the determination that Mr. Rueckert should serve as director of Delcath.

Roger G. Stoll, PhD. was appointed as a Director of the Company in December 2008. He became Executive Chairman in September, 2014 and has served as Chairman of the Board since October 1, 2015. From 2002 to 2008 he served as Chairman and Chief Executive Officer of Cortex Pharmaceuticals, Inc. (now RespireRx Pharmaceuticals Inc.). In August of 2008 he was appointed Executive Chairman of the board of directors of Cortex and retired in 2012. From 2001 to 2002 he was a consultant to several east coast venture capital firms and startup ventures. From 1998 to 2001, he was Executive Vice President of Fresenius Medical Care-North America, in charge of the dialysis products division and the diagnostic business units, which included hemodialysis machines, dialysis filters, dialysate solutions, and attendant devices used in the dialysis procedure. From 1991 to 1998, Dr. Stoll was Chief Executive of Ohmeda, a global leader in anesthetic agents, critical care drugs and related operating room devices with sales of $1 billion annually. From 1986 to 1991, Dr. Stoll held several positions of increasing responsibility at Bayer, AG including, Chief Administrative Office, President of Consumer Healthcare business unit, and Executive Vice-President and General Manager for its worldwide Diagnostic Business Group which included the acquisition of The Tecnicon Company and globally integrating the Bayer and Techincon business units. This resulted in a global diagnostic business in excess of $1 billion in sales annually. Prior to that he worked for American Hospital Supply Corporation, where he rose from Director of Clinical Pharmacology to President of the American Critical Care drug division of AHSC. He began his pharmaceutical career at the Upjohn Company working in drug metabolism and pharmacokinetic studies in a clinical development unit in 1972. Dr. Stoll obtained his BS in Pharmacy degree at Ferris State University, his PhD in Biopharmaceutics and drug metabolism at the University of Connecticut and was a post-doctoral fellow for two years at the University of Michigan. He served on the board of Agensys, Inc from 2003 until its sale to Astellas in late 2007 and on the board of director of Questcor Pharmaceuticals from 1999 to 2004, and Chelsea Therapeutics until it was acquired in 2008 by Lundbeck A/S. Dr. Stoll also serves on the University of Connecticut School of Pharmacy Advisory Board. The nominations committee considered Dr. Stoll’s experience and qualifications in both pharmaceuticals and medical devices and equipment in addition to his relevant executive management experience. as well as, the overall composition of the Board, in making the determination that Dr. Stoll should serve as a director of Delcath.

John R. Sylvesterwas appointed as a Director in July 2019. He served as Chief Commercial Officer of BTG plc, from 2011 to 2019 and has had roles leading both their Interventional Oncology and Interventional Vascular businesses as well as a period as Chief Development Officer accountable for Strategy, M&A and Market access since 2005. Prior to BTG, Mr. Sylvester was Managing Director of Biocompatibles plc, building their Interventional Oncology business which led to a successful exit to BTG for £166.0 million. Mr. Sylvester joined Biocompatibles following a period as the Vice President of Marketing for Baxter Healthcare’s $750.0 million European Medication Delivery business based in Brussels then Zurich accountable for six strategic business units incorporating drugs, devices and drug device combinations. Before this, Mr. Sylvester held a number of senior commercial roles in the industrial sector. Immediately prior to Baxter Healthcare, he was the General Manager of a Minerals company with $4.0 billion of assets on three continents, $500.0 million of sales and 1,500 employees. Mr. Sylvester graduated with joint honors in Biochemistry and Applied Molecular Biology from the University of Manchester Institute of Science and Technology (U.M.I.S.T.)

Dr. Marco Taglietti, M.D.was appointed as a Director in December 2014. Dr. Taglietti serves as President and CEO and is on the Board of Directors of SCYNEXIS, Inc. (NASDAQ:SCYX), a pharmaceutical company committed to the discovery, development and commercialization of novel anti-infectives. Prior to its acquisition in February 2014, Dr. Taglietti served as Executive Vice President, Research and Development, and Chief Medical Officer of Forest Laboratories. He also served as President of the Forest Research Institute. Prior to joining Forest Laboraties in 2007, Dr. Taglietti held the position of Senior Vice President, Head of Global Research and Development, at Stiefel Laboratories, Inc. for three years. He joined Stiefel after 12 years at Schering-Plough Corporation where he last held the position of Vice President, Worldwide Clinical Research for Anti-Infectives, Oncology, CNS, Endocrinology and Dermatology. Dr. Taglietti began his career at Marion Merrell Dow Research Institute. Dr. Taglietti served on the Board of Directors and as a member of the Compensation Committee of NephroGenex, Inc., a pharmaceutical company focused on the development of therapeutics to treat kidney disease, from 2014 to 2016. He received his medical degree and board certifications from the University of Pavia in Italy. The Nominating Committee considered Dr. Taglietti’s experience and qualifications, in addition to his relevant executive management and operational pharmaceutical experience, as well as the overall composition of the Board, in making the determination that Dr. Taglietti should serve as director of Delcath.

Executive Compensation

Our Compensation Committee is responsible for formulating and establishing our overall compensation philosophy with respect to our executive officers. The Company believes that a strong executive management team comprised of talented individuals in key positions at the Company is critical to the development and growth of our business and to increasing stockholder value. Accordingly, a key objective of executive compensation is to attract and retain talented and experienced individuals, while motivating them to perform and make decisions consistent with the Company’s business objectives, goals and culture. We emphasizepay-for-performance by linking executive compensation to Company performance. For each executive, the amount of pay that is actually realized is primarily driven by the Company’s performance and each executive’s contribution to that performance.

Our Compensation Committee considers the input it receives from our stockholders when designing and evaluating our executive compensation practices.Compensation Components. The three primary components of executive compensation are base salary, annual incentive cash awards and long-term equity incentive awards:

Base Salary. We pay our executive officers a base salary, which our Compensation Committee reviews and determines annually. Base salaries are used to compensate our executive officers for performing the core responsibilities of their positions and to provide them with a level of security with respect to a portion of their total compensation. Base salaries are set in part based on the executive’s unique skills, experience and expected contribution to the Company, as well as individual performance, including the impact of such performance on our business results, and the period of the executive’s performance. Decisions regarding base salary increases take into account the executive’s current base salary, third-party benchmark and survey data, and the salary compensation paid to executive officers within and outside the Company, as well as the Company’s overall performance, its ability to afford such increases, its success in achieving its operational and strategic goals and objectives, and the executive officer’s contribution to Company performance.

Annual Incentive Cash Awards. Annual incentive compensation is intended to establish a direct correlation between annual cash awards and the performance of the Company. The Company’s Annual Incentive Plan, or AIP, is an annual incentive cash bonus plan designed to align the interests of participants with the interests of the Company and its stockholders. The AIP is designed to strengthen the link between a participant’s pay and his or her overall performance and the Company’s performance, focus participants on critical individual and corporate objectives, offer a competitive cash incentive, and encourage and reward performance and competencies critical to the Company’s success.

Long-Term Incentive Compensation. In addition to using base salaries and annual incentive cash bonuses, which our Compensation Committee views as short-term compensation, a portion of our executive compensation is in the form of long-term equity compensation. Our Long-Term Incentive Plan, or LTIP, is an annual equity-based incentive plan designed to align participants’ interests with those of the Company and its stockholders by rewarding participants for their contributions to the long-term success of the Company. The LTIP is designed to incentivize Company leaders to focus on the long-term performance of the Company, offer participants competitive, market-based long-term incentive award opportunities, and strengthen the link between a participant’s compensation and his or her overall performance and the Company’s overall long-term performance. We believe the LTIP assists us in achieving an appropriate balance between short- and long-term executive compensation.

Base Salary. The following table summarizes the amount of base salary and year-over-year increase for each of our named executive officers for 2018 and 2019:

Executive

  Hire Date   2017
Base
Salary
   Percent
Increase
in 2018
  2018
Base
Salary
   Percent
Increase
in 2019
  2019
Base
Salary
 

Jennifer K. Simpson, Ph.D.

   3/23/2012   $453,004    3.0 $466,594    0 $466,594 

Barbra C. Keck, M.B.A.

   1/5/2009   $300,000    8.0 $324,000    0 $324,000 

John Purpura, M.S.

   11/16/2009   $316,210    5.9 $335,000    0 $335,000 

Annual Incentive Plan. Under the AIP, annual incentive target award opportunities are expressed as a percentage of a participant’s actual base salary for the performance year, beginning January 1. The following table sets forth, for each executive, the applicable target bonus percentage of base salary to which each executive is entitled.

Executive

  Target
Bonus
Expressed
as
% of Base
Salary
  Dollars ($)  Actual
Payout as
% of Base
Salary
  Dollars ($) 

Jennifer K. Simpson, Ph.D.

   50.0 $233,297   42.5 $198,302 

Barbra C. Keck, M.B.A.

   45.0 $145,800   38.3 $123,930 

John Purpura, M.S.

   45.0 $150,750   38.3 $128,138 

For 2019, AIP goals were based entirely on Company performance to focus all the executives on the same critical challenges facing the Company. Company performance in 2019 will be measured based upon achievement of objectives in the following areas: (1) Clinical Trials and (2) Capital. The Board is reviewing the Company’s performance for 2019 and no decisions have been made at this time.

Long Term Incentive Plan. Grants under the LTIP are typically comprised of a mix of restricted stock and stock option awards granted in the first quarter of each year with the number of shares subject to the awards designed to deliver a competitive valuetargeted at the mid-market of the executive compensation comparison group.

These guidelines are reviewed periodically based on prevailing compensation comparison group levels, however, and the Compensation Committee then uses these guidelines to determine long-term equity incentive awards for our named executive officers based upon a holistic assessment of Company and individual performance for the prior year and its view of the appropriate incentives to best help achieve the Company’s business objectives. Our ability to provideawards at the mid-market level has been difficult to do in the past few years due to share availability. Such awards in the past few years have typically been at or below the market 25th percentile.

Summary Compensation Table

The following table sets forth the total compensation awarded to, earned by or paid to: (i) each person who served as a principal executive officer during 2019, and (ii) our two other most highly-compensated executive officers who were serving as executive officers on December 31, 2019. We refer to these individuals as our “named executive officers.”

Name and Position

  Year   Salary
($)(1)
   Bonus
($)(2)
   Stock
Awards
($)(3)
   Options
Awards
($)
   Non-Equity
Incentive Plan
Compensation
($)
   All Other
Compensation
($)
   Total ($) 

Jennifer K. Simpson, Ph.D.

   2019   $466,594   $198,302   $—    $90,706   $—    $—    $663,641 

President and Chief Executive Officer

   2018    466,594    75,000    —      —      —      —      541,594 

Barbra C. Keck, M.B.A.

   2019    324,000    123,930    —      64,790    —      —      441,309 

Chief Financial Officer and Secretary

   2018    324,000    50,000    —      —      —      —      374,000 

John Purpura, M.S.

   2019    335,000    128,138    —      64,790    —      —      417,508 

Executive Vice President, Global Head of Operations

   2018    335,000    50,000    —      —      —      —      385,000 

(1)

For 2019, Dr. Simpson was paid $393,703, Ms. Keck was paid $274,875 and Mr. Purpura was paid $284,042. For 2018, Dr. Simpson was paid $172,142, Ms. Keck was paid $116,500 and Mr. Purpura was paid $135,669. The balance of their salaries has been accrued. See “Prospectus Summary—Support and Conversion Agreement” for additional information.

(2)

For 2018 and 2019, all bonus amounts have been accrued and not yet paid. For 2019, each NEO was awarded a bonus related to the Private Placements. See “Prospectus Summary—Support and Conversion Agreement” for additional information.

(3)

Due to the lack of available shares for issuance under the Company’s 2009 Stock Incentive Plan, the Board of Directors did not grant any long-term equity awards to our named executive officers in 2018 which in no way should create any negative inference concerning the Compensation Committee’s evaluation of their performance.

Grants of Plan-Based Awards—2019

The following table sets forth grants of plan-based awards made during the fiscal year ended December 31, 2019 to the named executive officers. All equity grants were made pursuant to the Company’s 2019 Equity Incentive Plan, or the 2019 Plan. Under the 2019 Plan, 2,142 shares of common stock of the Company are available for grants through February 1, 2029 to the Company’s employees, directors and consultants. The stock options are vesting over a period of one year commencing from the date of grant in twelve equal monthly increments commencing on the one month anniversary of the grant date. The stock options carry a ten year term and expire on February 1, 2029.

Name

  Grant
Date
   All Other Option
Awards; Number
of Securities
Underlying
Options
   Exercise or
Base
Price of
Option
Awards
   Grant Date
Fair Value of
Option
Awards
 

Jennifer K. Simpson, Ph.D.

   2/1/2019    500   $196.70   $90,706 

Barbra C. Keck, M.B.A.

   2/1/2019    357   $196.70   $64,790 

John Purpura, M.S.

   2/1/2019    357   $196.70   $64,790 

Outstanding EquityAwards at Fiscal Year-End Table—2019.

The following table sets forth information relating to unexercised options and unvested restricted shares held by the named executive officers as of December 31, 2019.

Name

  Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
   Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
   Option
Exercise
Price
   Option
Expiration
Date
   Number of
Shares of
Stock
That
Have Not
Vested (#)
   Market
Value of
Shares of
Stock
That
Have Not
Vested
($)
 

Jennifer K. Simpson, Ph.D.

   458    42   $196.70    2/1/2029    42   $—  

Barbra C. Keck, M.B.A.

   327    30   $196.70    2/1/2029    30   $—  

John Purpura, M.S.

   327    30   $196.70    2/1/2029    30   $—  

Potential Payments upon Termination or Change of Control.

The following table shows the potential incremental value transfer to each named executive officer under various termination orchange-in-control scenarios as of December 31, 2019, the last business day of 2019. Unvested, unexercised stock options and unvested restricted stock awards are valued at the closing market price of our common stock on that date. The actual amounts to be paid out in respect of the named executive officers can only be determined at the time of such named executive officer’s actual separation from our company.

Name

  Retirement
or Voluntary
Termination
Without
“Good
Reason”
   Termination
for “Cause”
   Involuntary
Termination
(Termination
Without
Cause, or
Termination
for Good
Reason)
   Upon a
Change in
Control
   Death or
Disability
Termination
 

Jennifer K. Simpson, Ph.D.

   —      —     $730,661   $ 730,661    —   

Barbra C. Keck, M.B.A.

   —      —     $536,029   $ 536,029    —   

John Purpura, M.S.

   —      —     $520,733   $ 520,733    —   

Severance Arrangements

The Company has entered into an Executive Security Agreement with each of the named executive officers. The Executive Security Agreements provide for the payment of severance to each of our named executive officers upon a qualifying termination (a termination which is involuntary but not “for cause” or a termination for “good reason” as defined therein) to be paid within 10 days of such event as follows: (i) all base salary owed to the date of the qualifying event, (ii) aone-time lump sum fee equal to the named executive officer’s monthly base salary for a term of two years for Jennifer Simpson and 18 months for Barbra Keck and John

Purpura, and (iii) COBRA payments should the named executive officer remain on the Company’s health benefit plans. The named executive officer would also be entitled to apro-rata portion of any AIP payment for the fiscal year in which termination of employment occurs due by March 15th of the following year. The term of the Executive Security Agreements continues until terminated by mutual agreement of each named executive officer and the Company.

Director Compensation—2019

The Compensation Committee reviews and recommends to the Board of Directors appropriate director compensation programs for service as directors, committee chairs, and committee members.

In lieu ofper-meeting fees,non-employee directors of the Company are paid an annual retainer of $43,000 and certain additional annual retainers for chairing or serving as a member of the committees of the Board as follows:

Name  Annual Retainer 

Board Service

  $43,000 

Chair of Audit Committee

  $20,000 

Member of Audit Committee

  $8,000 

Chair of Compensation and Stock Option Committee

  $12,000 

Member of Compensation and Stock Option Committee

  $5,000 

Chair of Nominating and Corporate Governance Committee

  $8,000 

Member of Nominating and Corporate Governance Committee

  $4,000 

Dr. Stoll receives an annual retainer fee as Director and Chairman of the Board of $68,000. Additionally, we reimburseall non-employee directors for theirreasonable out-of-pocket travel expenses incurred in attending meetings of our Board of Directors or any committees of the Board.

The following table sets forth the compensation awarded to, earned by or paid toeach non-employee director who served on our Board of Directors in 2019.

Name

  Fees
Earned
or Paid in
Cash(2)
   Stock
Awards
   Option
Awards
   Non-Equity
Incentive Plan
Compensation
($)
   All Other
Compensation
   Total 

Simon Pedder, Ph.D.(1)

  $14,000   $—    $—     $—    $—    $14,000 

William D. Rueckert

   72,000    —      25,916    —      —      97,916 

Roger G. Stoll, Ph.D.

   87,750    —      25,916    —      —      113,666 

John Sylvester

   21,161    —      —      —      —      21,161 

Marco Taglietti, M.D.

   65,000    —      25,916    —      —      90,916 

(1)

Dr. Pedder resigned as a director effective April 10, 2019. John R. Sylvester was appointed director effective July 24, 2019 to fill the vacancy created.

(2)

Nonon-employee director was paid his 2018 fees. Certain amounts were invested by directors in the July 2019 Private Placement. Mr. Rueckert and Dr. Taglietti have not been paid their 2019 fees. Their fees have been accrued.

Corporate Governance

Board of Directors. We have currently have fourfive directors serving on the Board of Directors. The Board of Directors oversees the business affairs of the Company and monitors the performance of management. In accordance with our corporate governance principles, our Board does not involve itselfinday-to-day operations. operations. The directors keep themselves informed through discussions with the Chairman of the Board, Roger G. Stoll, Jennifer K. Simpson, in her capacity as Director and Chief Executive Officer, or CEO, and other key executives, and by reading the reports and other materials that management sends them and by participating in Board and committee meetings. Our directors hold office until their successors have been elected and qualified unless the director resigns or is removed or by reason of death or other cause is unable to serve in the capacity of director.

Board Independence. The Board has determined that threefour of our fourfive directors (each of Roger G. Stoll, William D. Rueckert, John R. Sylvester and Marco Taglietti) are “independent” directors within the meaning of the NASDAQ listing rules.

Attendance. The Board of Directors met 1719 times in 20162019 (including regularly scheduled and annualspecial meetings). During 2016,2019, each director attended at least 75% of the aggregate of: (i) the total number of meetings of the Board (held during the period for which he or she served as a director) and (ii) the total number of meetings held by all committees of the Board of Directors on which he or she served (held during the period that he or she served). It is Delcath’s policy that, absent unusual or unforeseen circumstances, all directors are expected to attend annual meetings of stockholders, and all attended our 2016 Annual Meeting.stockholders.

Board Leadership Structure. Roger G. Stoll, Ph.D. was appointed Executive Chairman effective September 2014 and designated Chairman in connection with the appointment of Dr. Simpson as director effective October 2015. Dr. Stoll has been a member of the Board of Directors since 2008.

It is our policy to separate the Chairman and Chief Executive Officer roles. We believe this structure is appropriate for Delcathour company because it allows our President and CEO to concentrate on Delcath’sour day-to-day operations, operations, while providing for effective oversight by the Chairman, who is involved in strategic and key matters, such as business strategy, major transactions and the broader business of Delcath.our company. For a company like Delcathours that is focused on the development, approval and commercialization of a specialized product in an extremely technical, highly regulated and intensely competitive industry, we believe our President and CEO is in the best position to lead our management team, in part because of the depth of her experience in conducting clinical trials in oncology, and to respond to the current pressures and needs of a company in the stage of growth and development of Delcath,our company, with assistance from our Chairman who also focuses the Board’s attention on the broader issues of corporate business strategy and corporate governance. We believe that splitting the roles between Chairman, on the one hand, and President and CEO, on the other hand, minimizes any potential conflicts that may result from combining the roles of CEO, President and Chairman, and maximizes the effectiveness of our management and governance processes to the benefit of our stockholders. Our President and CEO and Chairman regularly consult with each other as part of this structure.

Board’s Role in Risk Oversight. The Board as a whole is responsible for risk oversight, with reviews in certain areas being conducted by the relevant Board committees. Each of the Board’s committees oversees the management of risks associated with their respective areas of responsibility. In performing this oversight function, the committees are assisted by management which provides visibility about the identification, assessment and monitoring of potential risks and management’s strategy to mitigate such risks. Key members of management responsible for a particular area report directly to the Board committee charged with oversight of the associated function and, if the circumstances require, the whole Board. The Board committees review various risk exposures with the full Board and otherwise keep the full Board abreast of the committees’ risk oversight activities throughout the year, as necessary or appropriate.

Risk Assessment of Compensation Programs. Our Compensation and Stock Option Committee annually evaluates whether our compensation programs encourage excessive risk-taking by employees at the expense of long-term Company value.value of our company. Based upon its assessment, including a review of the overall annual award limitations and individual annual limitations in the Delcath 2009 Stock Incentive Planour stock incentive plans and the Compensation Committee’s role in the consideration and approval of certain awards, the Compensation and Stock Option Committee does not believe that our compensation programs encourage excessive or inappropriate risk-taking, motivate imprudent risk-taking or create risks that are reasonably likely to have a material adverse effect on the Company.our company.

Director Continuing Education. We require our directors to attend, at least annually, educational programs provided by various universities, stock exchanges and other regulatory agencies to assist our directors in maintaining or enhancing their skills and abilities as directors and to update their knowledge and understanding of the pharmaceutical, medical device and biopharma industries and the regulatory environment in which Delcath operates and to which it is subject.

Board Committees. Our Board has three standing committees: an Audit Committee, a Compensation and Stock Option Committee and a Nominating and Corporate Governance Committee. No individual director is the chairman of more than one committee. Mr. Sylvester joined the board in July 2019 and has not been appointed to any committee yet.

Audit Committee. The Audit Committee provides assistance to the Board in fulfilling its oversight responsibilities with respect to the Company’sour financial statements, the Company’sour system of internal accounting and financial controls and the independent audit of the Company’sour financial statements. Functions of the Audit Committee include:

 

the selection, evaluation and, where appropriate, replacement of our outside auditors;

 

an annual review and evaluation of the qualifications, performance and independence of our outside auditors;

 

the approval of all auditingservices and permittednon-audit services provided by our outside auditors;

 

the review of the adequacy and effectiveness of our accounting and internal controls over financial reporting; and

 

the review and discussion with management and with our outside auditors of the Company’s financial statements to be filed with the SecuritiesCommission.

The current members of the Audit Committee are William D. Rueckert (Chair), Elizabeth Czerepak and Exchange Commission (the “SEC”).

Roger G. Stoll. The Board has determined that each member of the Audit Committee, William D. Rueckert (Chair), and Marco Taglietti (since April 6, 2016)Roger G. Stoll qualifies as an “audit committee financial expert” as defined by SEC rules. During 2016,2019, the Audit Committee met four times. Each member of the Audit Committee is “independent” within the meaning of the NASDAQ listing rules and otherwise meets the financial statement proficiency requirements of the NASDAQ listing rules. The Audit Committee has a written charter, which is available on our website; go towww.delcath.com, click on “Investors,” then “Corporate Governance.”

Compensation and Stock Option Committee. The Compensation and Stock Option Committee, (the “Compensation Committee”)or the Compensation Committee, assists the Board of Directors in the discharge of the Board’s responsibilities with respect to the compensation of Delcath’sour directors, executive officers, and other key employees and consultants. The Compensation Committee establishes our overall compensation philosophy and is authorized to approve the compensation payable to our executive officers, including our named executive officers, and other key employees, including all perquisites, equity incentive awards, cash bonuses, and severance packages. The Compensation Committee also administers certain of our employee benefit plans, including its equity incentive plans, and is responsible for assessing the independence of compensation consultants and legal advisors. The Compensation Committee has concluded that each of Wexler, Burkhart,

Hirschberg & Unger,Lowenstein Sandler LLP, outside legal counsel to the Compensation Committee and the Company as well as Pearl Meyer & Partners, compensation consultant to the Compensation Committee, qualified as independent. The Compensation Committee exercises sole power to retain compensation consultants and advisors and to determine the scope of the associated engagements.

The current members of the Compensation and Stock Option Committee are Marco Taglietti (Chair) and William D. Rueckert, (since April 6, 2016),and Roger G. Stoll, each of whom is “independent” within the meaning of the NASDAQ listing rules. During 2016,2019, the Compensation and Stock Option Committee met nine times.one time. The Compensation and Stock Option Committee has a written charter, which is available on our website; go towww.delcath.com, click on “Investors,” then “Corporate Governance.”

Nominating and Corporate Governance Committee. The Nominating and Corporate Governance Committee, (the “Nominating Committee”)or the Nominating Committee, is responsible for identifying individuals qualified to become Board members, and recommends to the Board the director nominees to be proposed by the Board for election by the stockholders (as well as any director nominees to be appointed by the Board to fill interim vacancies). The Nominating Committee also recommends the directors to be selected for membership on each Board committee.

The Nominating Committee is also responsible for developing and recommending to the Board appropriate corporate governance guidelines and policies, and for leading the Board in its annual review of the Board’s performance.

The current members of the Nominating Committee are Roger G. Stoll (Chairman), William D. Rueckert and Marco Taglietti,John Sylvester, each of whom is “independent,” within the meaning of the NASDAQ listing rules. During 2016,2019, the Nominating Committee met one time.two times. The Nominating Committee has a written charter, which is available on our website; go towww.delcath.com, click on “Investors,” then “Corporate Governance.”

The Nominating Committee, with, when it deems it necessary, the assistance of a third-party search firm, identifies candidates for director nominees. In considering candidates for the Board, the Nominating Committee considers each candidate’s credentials as a whole, including, but not necessarily limited to, outstanding achievement in a candidate’s personal career, broad and relevant experience, integrity, sound and independent judgment, experience and knowledge of the business environment and markets in which the Company operates,we operate, business acumen, and willingness and ability to devote adequate time to Board duties. The Nominating Committee considers the diversity of its members in the context of the Board as a whole, including the personal characteristics, experience and background of directors and nominees to facilitate Board deliberations that reflect a broad range of perspectives.

Recommendations by Stockholders of Director Nominees.Nominees. The Nominating Committee will consider any recommendation by a stockholder of a candidate for nomination as a director. If a stockholder wants to recommend a director candidate for consideration by the Nominating Committee, the stockholder should submit the name of the proposed nominee, together with the reasons why the stockholder believes the election of the candidate would be beneficial to the Companyour company and itsour stockholders and the information about the nominee that would be required in a proxy statement requesting proxies to vote in favor of the candidate. The stockholder’s submission must be accompanied by the written consent of the proposed nominee to being nominated by the Board and the candidate’s agreement to serve if nominated and elected. Any such submission should be directed to the Nominating Committee at Delcath’sour principal office, 1633 Broadway, Suite 22C, New York, New York 10019. If a stockholder intends to nominate a person for election to the Board of Directors at an annual meeting, the stockholder must provide Delcathus with written notice of his or her intention no later than the deadline for receiving a stockholder proposal for inclusion in Delcath’sour proxy statement for such meeting (as described below under the heading “Stockholder Proposals For the 2018 Annual Meeting”) and must otherwise comply with our amended and restated certificate of incorporation. Copies of any recommendation received in accordance with these procedures will be distributed to each member of the Nominating Committee. One or more members of the Nominating Committee may contact the proposed candidate to request additional information.

Stockholder Communications with the Board of Directors.Directors. Any stockholder wishing to communicate with the Board or with any specified director should address his or her communication to the Board of Directors or to the particular director(s) in care of the Corporate Secretary, Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019. All such written communication, other than items determined by our legal counsel to be inappropriate for submission to the intended recipient(s), will be submitted to the Board or to the particular director(s). Any stockholder communication not so delivered, will be made available upon request to any director. Examples of stockholder communications that would be considered inappropriate for submission include, without limitation, customer complaints, business solicitations, product promotions, job inquiries, junk mail and mass mailings, as well as material that is unduly hostile, threatening, illegal or similarly unsuitable.

Compensation Committee Interlocks and Insider Participation. During 2019, Marco Taglietti, Roger G. Stoll and William D. Rueckert served as members of our Compensation and Stock Option Committee. None of the current members or members serving during 2019 of the Compensation and Stock Option Committee is a current or former officer or employee of our company at the time of their service on the Compensation and Stock Option Committee, nor did any Compensation and Stock Option Committee member engage in any “related person” transaction that would be required to be disclosed underItem 404 of Regulation S-K. During 2019, none of our executive officers served on the compensation committee (or equivalent) or on the board of directors of another entity whose executive officers served on the Compensation and Stock Option Committee or our Board of Directors.

Code of Ethics. We maintain a Code of Business Conduct and Ethics (Code) that applies to all employees, including our principal executive officer, principal financial officer, principal accounting officer, controller and persons performing similar functions, and including our independent directors, who are not our employees, of the Company, with regard to their Delcath-relatedcompany-related activities. The Code incorporates guidelines designed to deter wrongdoing and to promote honest and ethical conduct and compliance with applicable laws, rules and regulations. The Code also incorporates our expectations of our employees that enable us to provide accurate and timely disclosure in our filings with the SEC and other public communications. In addition, the Code incorporates guidelines pertaining to topics such as complying with applicable laws, rules, and regulations; insider trading; reporting Code violations; and maintaining accountability for adherence to the Code. The full text of our Code is published on our web sitewebsite at http://delcath.com/investors/governance. We intend to disclose future amendments to certain provisions of our Code, or waivers of such provisions granted to our principal executive officer, principal financial officer or principal accounting officer and persons performing similar functions on our web site.website.

REPORT

SECURITY OWNERSHIP OF THE AUDIT COMMITTEECERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND

The Audit Committee reviewed and discussed the Company’s audited financial statements for the fiscal year ended December 31, 2016, with management and Grant Thornton, the Company’s independent registered public accounting firm for the fiscal year ended December 31, 2016. The Audit Committee also discussed with Grant Thornton the matters required to be discussed by the Statement on Auditing Standards No. 16, as amended, as adopted by the Public Company Accounting Oversight Board in Rule 3200T regarding “Communication with Audit Committees.” The Audit Committee has received and reviewed the written disclosures and the letter from Grant Thornton required by applicable requirements of the Public Company Accounting Oversight Board regarding Grant Thornton’s communications with the Audit Committee concerning independence, and has discussed with Grant Thornton its independence from the Company.RELATED STOCKHOLDER MATTERS

Based onsolely upon information made available to us, the review and discussions referred to above, the Audit Committee recommended to the Board of Directors that the Company’s audited financial statements be included in the Company’s Annual Report on Form10-K for the fiscal year ended December 31, 2016, for filing with the Securities and Exchange Commission.

Submitted by the Audit Committee of the Board of Directors,

William Rueckert (Chair)

May 9, 2017

SECTION 16(A) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE

Section 16(a) of the Securities Exchange Act of 1934, as amended, requires our directors and officers, and persons who are beneficial owners of more than 10% of our common stock to file with the Securities and Exchange Commission reports of holdings and changes in beneficial ownership of Delcath’s equity securities. Based on a review of copies of reports furnished to Delcath or written representations that no reports were required, we believe that all reports were timely filed in 2016.

EXECUTIVE COMPENSATION

Our Compensation and Stock Option Committee is responsible for formulating and establishing our overall compensation philosophy with respect to our executive officers. The Company believes that a strong executive management team comprised of talented individuals in key positions at the Company is critical to the development and growth of our business and to increasing stockholder value. Accordingly, a key objective of executive compensation is to attract and retain talented and experienced individuals, while motivating them to perform and make decisions consistent with the Company’s business objectives, goals and culture. We emphasizepay-for-performance by linking executive compensation to Company performance. For each executive, the amount of pay that is actually realized is primarily driven by the Company’s performance and each executive’s contribution to that performance.

Our Compensation Committee engaged an independent compensation consulting firm, Pearl Meyer, to assist with the formulation of our executive compensation programs for 2016.

Our Compensation Committee considers the input it receives from our stockholders when designing and evaluating our executive compensation practices. At our 2016 annual meeting of stockholders, our stockholders approved, on an advisory basis, the 2015 compensation of our executive officers described in our 2016 proxy statement. Approximately 74% of the votes present or represented and entitled to vote on the matter were voted “For” such advisory“say-on-pay” approval.

Compensation Components. The three primary components of executive compensation are base salary, annual incentive cash awards and long-term equity incentive awards:

Base Salary. We pay our executive officers a base salary, which our Compensation Committee reviews and determines annually. Base salaries are used to compensate our executive officers for performing the core responsibilities of their positions and to provide them with a level of security with respect to a portion of their total compensation. Base salaries are set in part based on the executive’s unique skills, experience and expected contribution to the Company, as well as individual performance, including the impact of such performance on our business results, and the period of the executive’s performance. Decisions regarding base salary increases take into account the executive’s current base salary, third-party benchmark and survey data, and the salary compensation paid to executive officers within and outside the Company, as well as the Company’s overall performance, its ability to afford such increases, its success in achieving its operational and strategic goals and objectives, and the executive officer’s contribution to Company performance.

Annual Incentive Cash Awards. Annual incentive compensation is intended to establish a direct correlation between annual cash awards and the performance of the Company. The Company’s Annual Incentive Plan (“AIP”) is an annual incentive cash bonus plan designed to align the interests of participants with the interests of the Company and its stockholders. The AIP is designed to strengthen the link between a participant’s pay and his or her overall performance and the Company’s performance, focus participants on critical individual and corporate objectives, offer a competitive cash incentive, and encourage and reward performance and competencies critical to the Company’s success.

Long-Term Incentive Compensation. In addition to using base salaries and annual incentive cash bonuses, which our Compensation and Stock Option Committee views as short-term compensation, a portion of our executive compensation is in the form of long-term equity compensation. Our Long-Term Incentive Plan (“LTIP”) is an annual equity-based incentive plan designed to align participants’ interests with those of the Company and its stockholders by rewarding participants for their contributions to the long-term success of the Company. The LTIP is designed to incentivize Company leaders to focus on the long-term performance of the Company, offer participants competitive, market-based long-term incentive award opportunities, and strengthen the link between a participant’s compensation and his or her overall performance and the Company’s overall long-term performance. We believe the LTIP assists us in achieving an appropriate balance between our short- and long-term.

Base Salary. Effective February 21, 2017, Barbra Keck, previously the Senior Vice President of Finance, Principal Accounting Officer and Principal Financial Officer of the Company, became the Chief Financial Officer of the Company. In connection with her promotion to Chief Financial Officer, Ms. Keck’s annual base salary was increased from $247,200 in 2016 to $300,000 in 2017.

The following table summarizes the amount of base salary and year-over-year increase for each of our named executive officers for 2015 and 2016.

Executive

  Hire Date   2015 Base
Salary
   Percent
Increase
in 2016
  2016 Base
Salary
 

Jennifer K. Simpson, Ph.D.

   3/23/2012   $427,000    3.0 $439,810 

Barbra C. Keck, M.B.A.

   1/5/2009   $240,000    3.0 $247,200 

John Purpura, M.S.

   11/16/2009   $270,569    13.5 $307,000 

Annual Incentive Plan. Under the AIP, annual incentive target award opportunities are expressed as a percentage of a participant’s actual base salary for the performance year, beginning January 1. The following table sets forth, for each executive, the applicable target bonus percentage of base salary to which each executive could have been entitled, as well as the actual bonus earned based on company performance in 2016:

   Target Incentive
Bonus Opportunity
   2016 Incentive Award
Earned
 

Executive

  Target Bonus
Expressed as %
of Base Salary
  Dollars
($)
   Actual Payout
as a % of
Target Bonus
  Dollars
($)
 

Jennifer K. Simpson, Ph.D.

   50.0 $219,905    68.0 $149,535 

Barbra C. Keck, M.B.A.

   35.0 $86,520    68.0 $58,834 

John Purpura, M.S.

   45.0 $138,150    68.0 $93,942 

For 2016, AIP goals were based entirely on Company performance as noted in the table below to focus all the executives on the same critical challenges facing the Company.

Company performance in 2016 was measured based upon achievement of objectives in the following areas: (1) Clinical Trials; (2) Capital; and (3) Sales. The table below summarizes the corporate performance in 2016, the assigned weighting and the actual achievement for each area:

Performance

Measure

  Weighting  

Summary of Target Goals

  

Actual Performance

  Percentage
Earned
(as% of
Target
Goals)
 

Clinical Trials

   45.0 

•       Treatment of patients and completion of preliminary activities to support a new regulatory path

  

•       FOCUS Trial initiated, accrual/treatment of patients ongoing; preliminary activities for ICC development completed

   19.50

Cash Management

   5.0 

•       Achieve average quarterly cash burn rate in accordance with approved budget.

  

•       Actual operating cash spend of $4.4 - $5.0 per quarter exceeded our target goal.

   5.00

Capital

   45.0 

•       Raise sufficient, unrestricted funds to meet the Company’s needs through 2Q 2017.

  

•       Actual cash balance was $4.4 million at December 31, 2016.

   38.50

Sales

   5.0 

•       Achieve sales for 2016 of at least $2.1 million.

  

•       Actual sales were $2.0 million for 2016.

   5.00
       

 

 

 

Total Percentage Earned (as a % of Target Goals)

   68.00
       

 

 

 

Long Term Incentive Plan. Grants under the LTIP are typically comprised of a mix of restricted stock and stock option awards granted in the first quarter of each year with the number of shares subject to the awards designed to deliver a competitive value targeted at themid-market of the executive compensation comparison group. These guidelines are reviewed periodically based on prevailing compensation comparison group levels, however, and the Compensation and Stock Option Committee then uses these guidelines to determine long-term equity incentive awards for our named executive officers based upon a holistic assessment of Company and individual performance for the prior year and its view of the appropriate incentives to best help achieve the Company’s business objectives. Our ability to provide awards at themid-market level has been difficult to do in the past few years due to share availability. Such awards in the past few years have typically been at or below the market 25th percentile.

There were no long-term equity awards to our named executive officers in 2016. Due to the lack of available shares for issuance under the Company’s Delcath 2009 Stock Incentive Plan, the Board of Directors did not grant any long-term equity awards to our named executive officers in 2016 which in no way should create any negative inference concerning the Compensation and Stock Option Committee’s evaluation of their performance.

Summary Compensation Table.

The following table sets forth the total compensation awarded to, earned by or paid to: (i) each person who served as a principal executive officer during 2016, and (ii) our two other most highly-compensated executive officers who were serving as executive officers on December 31, 2016, including our principal financial officer, during 2016. We refer to these individuals as our “named executive officers.”

Name & Position

  Year   Salary
($)
   Bonus
($)
   Stock
Awards
($)(2)
   Option
Awards
($)
   Non-Equity
Incentive Plan
Compensation
($)
   All Other
Compensation
($)
   Total
($)
 

Jennifer K. Simpson, Ph.D.

   2016    439,810    149,535    —      —      —      —      589,345 

President and Chief Executive Officer

   2015    427,000    108,885    239,636    60,729    —      —      836,251 

Barbra C. Keck, M.B.A.

   2016    247,200    58,834    —      —      —      —      306,034 

Chief Financial Officer and
Secretary(1)

   2015    240,000    42,840    87,019    22,105    —      —      391,964 

John Purpura, M.S.

   2016    291,442    93,942    —      —      —      —      385,384 

Executive Vice President Global Head of Operations

   2015    270,569    55,196    119,595    30,325    —      —      475,685 

(1)Effective February 21, 2017, Ms. Barbra C. Keck, previously the Senior Vice President of Finance, Principal Accounting Officer and Principal Financial Officer of the Company, became the Chief Financial Officer of the Company.
(2)Due to the lack of available shares for issuance under the Company’s Delcath 2009 Stock Incentive Plan, the Board of Directors did not grant any long-term equity awards to our named executive officers in 2016 which in no way should create any negative inference concerning the Compensation and Stock Option Committee’s evaluation of their performance.

Outstanding Equity Awards at FiscalYear-End Table—2016.

The following table sets forth information relating to unexercised optionsregarding the beneficial ownership of our common stock, Series E Preferred Stock and unvested restricted sharesSeriesE-1 Preferred Stock as of April 17, 2020, held byby: (i) each director and director nominees; (ii) each of the named executive officers; (iii) all of our directors and executive officers as a group; and (iv) each additional person or group who is known by us to own beneficially more than 5% of December 31, 2016.our common stock or Series E and SeriesE-1 Preferred Stock. Except as indicated in the footnotes below, the address of the persons or groups named below is c/o Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019.

 

Name

  Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
   Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
   Option
Exercise Price
($)
   Option
Expiration
Date
   Number of
Shares of Stock
That Have Not
Vested (#)
   Market Value
of Shares of
Stock That
Have Not
Vested ($)
 

Jennifer K. Simpson, Ph.D.

   234    —      811.52    3/23/2022    —      —   
   156    —      545.28    3/11/2023    —      —   
   726    —      76.80    11/14/2023    —      —   
   1,982    3,963    19.04    6/10/2025    8,390    7,719 

Barbra C. Keck, M.B.A.

   292    —      1,397.76    10/12/2019    —      —   
   39    —      1,643.52    3/10/2021    —      —   
   54    —      1,177.60    2/28/2022    —      —   
   54    —      545.28    3/11/2023    —      —   
   388    —      76.80    11/14/2023    —      —   
   723    1,441    19.04    6/10/2025    3,047    2,803 

John Purpura, M.S.

   585    —      1,090.56    11/16/2019    —      —   
   109    —      1,643.52    3/10/2021    —      —   
   156    —      1,177.60    2/28/2022    —      —   
   156    —      545.28    3/11/2023    —      —   
   443    —      76.80    11/14/2023    —      —   
   989    1,979    19.04    6/10/2025    4,188    3,853 

Director Compensation—2016

The Compensation and Stock Option Committee reviews and recommends to the Board of Directors appropriate director compensation programs for service as directors, committee chairs, and committee members.

In lieu ofper-meeting fees,non-employee directors of the Company are paid an annual retainer of $43,000 and certain additional annual retainers for chairing or serving as a member of the committees of the Board as follows:

      Shares Beneficially Owned(1)        
         Series E     Series E-1     
   Common     Preferred     Preferred     

Name of Beneficial Owner

  Stock  Percent  Stock  Percent  Stock   Percent 

Named Executive Officers and Directors:

        

Jennifer K. Simpson, Ph.D.

   6,892 (2)   9.5  147 (3)   *   —      —   

Barbra C. Keck, M.B.A.

   3,322 (4)   4.4  68 (5)   *   —      —   

John Purpura, M.S.

   3,187 (6)   4.2  65 (7)   *   —      —   

William D. Rueckert

   2,761 (8)   3.7  60 (9)   *   —      —   

Roger G. Stoll, Ph.D.

   4,189 (10)   5.4  93 (11)   *   —      —   

Marco Taglietti, M.D.

   2,748 (12)   3.6  60 (13)   *   —      —   

Elizabeth Czerepak

   —     *   —     *   —      —   

John Sylvester

   —     *   —     *   —      —   
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

   

 

 

 

All directors and executive officers as a group (8people):

   23,099 (14)   30.8  493 (15)   1.5  —      —   
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

   

 

 

 

5% Stockholders

        

Altium Capital Management, LP(16)

        

Altium Growth Fund, LP

        

Altium Growth GP, LLC

        

551 Fifth Ave, FL 19

        

New York, NY 10176

   7,204   9.9  2,300   7.2  1,100    11.7

Rosalind Master Fund L.P.(17)

        

Rosalind Opportunities Fund I L.P.

        

77 Bloor St W, 3rd FL

        

Toronto, Ontario M5S 1M2

   7,204   9.9  16,800   52.4  2,875    30.6

Hudson Bay Master Fund Ltd(18)

        

777 Third Avenue, 30th Floor

        

New York, NY 10017

   7,204   9.9  2,187   6.8  —      0.0

 

Name

  Annual Retainer 

Board Service

  $43,000 

Chair of Audit Committee

  $20,000 

Member of Audit Committee

  $8,000 

Chair of Compensation and Stock Option Committee

  $12,000 

Member of Compensation and Stock Option Committee

  $5,000 

Chair of Nominating and Corporate Governance Committee

  $8,000 

Member of Nominating and Corporate Governance Committee

  $4,000 

Dr. Stoll receives an annual retainer fee as Director and Chairman of the Board of $68,000. Additionally, we reimburse allnon-employee directors for their reasonableout-of-pocket travel expenses incurred in attending meetings of our Board of Directors or any committees of the Board. Due to the low number of shares remaining available for issuance under the Company’s Delcath 2009 Stock Incentive Plan, the Board of Directors did not grant any equity awards tonon-employee directors during 2016 which in no way should create any negative inference concerning the Compensation and Stock Option Committee’s evaluation of their performance.

The following table sets forth the compensation awarded to, earned by or paid to eachnon-employee director who served on our Board of Directors in 2016.
*

Less than 1%

 

Name

  Fees Earned or
Paid in Cash
   Stock
Awards
   Option
Awards
   All Other
Compensation
   Total 

Harold S. Koplewicz. M.D.

  $60,750   $—     $—      —     $60,750 

Dennis H. Langer, M.D., J.D.

  $14,000   $—     $—      —     $14,000 

Laura A. Philips, Ph.D., M.B.A.

  $15,750   $—     $—      —     $15,750 

William D. Rueckert

  $70,750   $—     $—      —     $70,750 

Roger G. Stoll, Ph.D.

  $68,000   $—     $—      —     $68,000 

Marco Taglietti, M.D.

  $63,250   $—     $—      —     $63,250 

(1)

(i) except as otherwise indicated in these footnotes, each stockholder named in the table above possesses sole voting and investment power with respect to all shares of common stock, Series E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock beneficially owned by him, her or it, (ii) the number of shares of common stock beneficially owned by each stockholder shown above has been determined in accordance with Rule13d-3 under the Exchange Act and includes, for such purpose, shares of common stock that such stockholder has the right to acquire within 60 days of April 17, 2020 after giving effect to any applicable limitations on beneficial ownership described in the footnotes below, or Beneficial Ownership Limitation, and (iii) the beneficial ownership percentages shown above are based on 72,773 shares of common stock, 32,061 shares of Series E Preferred Stock, and 9,385 shares of SeriesE-1 Preferred Stock outstanding as of April 17, 2020, respectively. Shares of Series E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock vote together with the common stock on anas-converted basis, subject to any applicable Beneficial Ownership Limitation, on all matters submitted to holders of common stock for approval.

(2)

Includes 500 shares of common stock, which Dr. Simpson has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 17, 2020.

(3)

The 147 shares of Series E Convertible Preferred Stock are convertible into 6,381 shares of common stock subject to the Beneficial Ownership Limitation and does not include the 6,381 shares of common stock that may be obtained by Dr. Simpson upon the exercise of a warrant held by her, which is subject to the Beneficial Ownership Limitation.

(4)

Includes 357 shares of common stock, which Ms. Keck has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 17, 2020.

(5)

The 68 shares of Series E Convertible Preferred Stock are convertible into 2,952 shares of common stock subject to the Beneficial Ownership Limitation and does not include the 2,952 shares of common stock that may be obtained by Ms. Keck upon the exercise of a warrant held by her, which is subject to the Beneficial Ownership Limitation.

(6)

Includes 357 shares of common stock, which Mr. Purpura has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 17, 2020.

(7)

The 65 shares of Series E Convertible Preferred Stock are convertible into 2,822 shares of common stock subject to the Beneficial Ownership Limitation and does not include the 2,822 shares of common stock that may be obtained by Mr. Purpura upon the exercise of a warrant held by him, which is subject to the Beneficial Ownership Limitation.

(8)

Includes 142 shares of common stock, which Dr. Stoll has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 17, 2020.

(9)

The 93 shares of Series E Convertible Preferred Stock are convertible into 4,037 shares of common stock subject to the Beneficial Ownership Limitation and does not include the 4,037 shares of common stock that may be obtained by Mr. Stoll upon the exercise of a warrant held by him, which is subject to the Beneficial Ownership Limitation.

(10)

Includes 142 shares of common stock, which Mr. Rueckert has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 17, 2020.

(11)

The 60 shares of Series E Convertible Preferred Stock are convertible into 2,605 shares of common stock subject to the Beneficial Ownership Limitation and does not include the 2,605 shares of common stock that may be obtained by Mr. Rueckert upon the exercise of a warrant held by him, which is subject to the Beneficial Ownership Limitation.

(12)

Includes 142 shares of common stock, which Dr. Taglietti has the right to acquire upon exercise of outstanding options exercisable within 60 days of April 17, 2020.

(13)

The 60 shares of Series E Convertible Preferred Stock are convertible into 2,605 shares of common stock subject to the Beneficial Ownership Limitation and does not include the 2,605 shares of common stock that may be obtained by Mr. Taglietti upon the exercise of a warrant held by him, which is subject to the Beneficial Ownership Limitation.

(14)

Includes 1,640 shares of common stock, which certain directors and executive officers have the right to acquire upon exercise of outstanding options exercisable within 60 days of April 17, 2020.

(15)

The aggregate 493 shares of Series E Convertible Preferred Stock are convertible into an aggregate of 21,402 shares of common stock subject to the Beneficial Ownership Limitation and does not include the aggregate 21,402 shares of common stock that may be obtained by such persons upon the exercise of warrants held by them, subject to the Beneficial Ownership Limitation.

(16)

The information provided is based on a Statement on Schedule 13G/A jointly filed on February 14, 2020 by and on behalf of each of Altium Growth Fund, LP, Altium Capital Management, LP, and Altium Growth GP, LLC which acquired shares of Series E Preferred Stock and warrants in our July 2019 PIPE Financing. Altium Growth Fund, LP is the record and direct beneficial owner of the securities referenced. Altium Capital Management, LP is the investment adviser of, and may be deemed to beneficially own securities, owned by, Altium Growth Fund, LP. Altium Growth GP, LLC is the general partner of, and may be deemed to beneficially own securities owned by, Altium Growth Fund, LP. The reporting persons hold shared voting and dispositive power with respect to 2,300 shares of Series E Convertible Preferred Stock and 1,100 shares of SeriesE-1 Convertible Preferred Stock which could be converted into 134,069 shares of common stock or that may be voted pursuant to theas-converted voting provisions of the Series E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock subject to the Blockers described below. The referenced securities do not include 134,069 shares of common stock that may be obtained upon the exercise of warrants held by the reporting persons subject to the Blockers described below. Each reporting person disclaims beneficial ownership of the securities referenced. Each of the reporting persons may be deemed to be a member of a group with respect to Delcath or securities of Delcath for the purposes of Section 13(d) or 13(g) of the Securities Act of 1933, as amended. Pursuant to the terms of (i) the certificate of designations of Delcath containing the terms of the Series E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock, the reporting persons cannot convert their shares of Series E Convertible Preferred Stock or SeriesE-1 Convertible Preferred Stock to the extent the reporting persons would beneficially own, after any such conversion, more than 9.99% of the outstanding shares of common stock, or the Preferred Stock Blockers, and (ii) the as to the warrants referenced, the reporting persons cannot exercise such warrants to the extent the reporting persons would beneficially own, after any such exercise, more than 4.99% of the outstanding shares of common stock, or the Warrant Blockers, and collectively with the Preferred Stock Blockers, the Blockers, and the percentage set forth above gives effect to the Blockers. Consequently, as of April 17, 2020, the reporting persons were not able to exercise all of the reported Series E Convertible Preferred Stock, the SeriesE-1 Convertible Preferred Stock or any of the reported warrants due to the Blockers.

(17)

The information provided is based on a Statement on Schedule 13D/A jointly filed on April 10, 2020 by and on behalf of Rosalind Advisors, Inc., Rosalind Opportunities Fund I L.P., Rosalind Master Fund L.P. and Steven Salamon with respect to beneficial ownership of shares of Series E Convertible Preferred Stock and warrants acquired in our July 2019 PIPE Financing. Rosalind Advisors, Inc., or the Advisor, is the investment advisor to Rosalind Opportunities Fund I L.P. and Rosalind Master Fund L.P. and may be deemed to be the beneficial owner of shares held by Rosalind Opportunities Fund I L.P. and Rosalind Master Fund L.P. Steven Salamon is the portfolio manager of the Advisor and may be deemed to be the beneficial owner of

shares of Series E Convertible Preferred Stock and underlying warrants for common stock held by Rosalind Master Fund L.P. The Rosalind Opportunities Fund I L.P. holds shared voting and dispositive power with respect to 10,400 shares of Series E Convertible Preferred Stock and 2,260 shares of SeriesE-1 Convertible Preferred Stock that can be converted into 549,479 shares of common stock or that may be voted pursuant to theas-converted voting provisions of the Series E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock subject to the Blockers described below. The Rosalind Master Fund L.P. holds shared dispositive and voting power with respect to 6,400 shares of Series E Convertible Preferred Stock and 615 shares of SeriesE-1 Convertible Preferred Stock that could be converted into 304,471 shares of common stock or that may be voted pursuant to theas-converted voting provisions of the Series E Convertible Preferred Stock subject to the Blockers described below. The Advisor and Steven Salamon hold shared voting and dispositive power with respect to 19,675 shares of Series E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock that could be converted into 853,950 shares of common stock or that may be voted pursuant to theas-converted voting provisions of the Series E Convertible Preferred Stock or SeriesE-1 Convertible Preferred Stock subject to the Blockers described below. Notwithstanding the foregoing, the Advisor and Mr. Salamon disclaim beneficial ownership of any such shares. The referenced securities do not include 853,950 shares of common stock that may be obtained upon the exercise of warrants held by the reporting persons subject to the Blockers described below. Each reporting person disclaims beneficial ownership of the securities referenced. Each of the reporting persons may be deemed to be a member of a group with respect to Delcath or securities of Delcath for the purposes of Section 13(d) or 13(g) of the Securities Act of 1933, as amended. Pursuant to the terms of (i) the certificate of designations of Delcath containing the terms of the Series E Convertible Preferred Stock or the SeriesE-1 Convertible Preferred Stock, the reporting persons cannot convert their shares of Series E Convertible Preferred Stock or SeriesE-1 Convertible Preferred Stock to the extent the reporting persons would beneficially own, after any such conversion, more than 9.99% of the outstanding shares of common stock, or the Preferred Stock Blockers, and (ii) as to the warrants referenced, the reporting persons cannot exercise such warrants to the extent the reporting persons would beneficially own, after any such exercise, more than 4.99% of the outstanding shares of common stock, or the Warrant Blockers, and collectively with the Preferred Stock Blockers, the Blockers, and the percentage set forth above gives effect to the Blockers. Consequently, as of April 17, 2020, the reporting persons were not able to exercise all of the reported Series E Convertible Preferred Stock or SeriesE-1 Convertible Preferred Stock or any of the reported warrants due to the Blockers.
(18)

Based on the information available to the Company, Hudson Bay Master Fund Ltd, which acquired shares of Series E Convertible Preferred Stock, SeriesE-1 Convertible Preferred Stock, Series E Warrants and SeriesE-1 Warrants in our July and August 2019 PIPE financings. Hudson Bay Master Fund Ltd is the record and direct beneficial owner of the securities referenced. Hudson Bay Capital Management LP, the investment manager of Hudson Bay Master Fund Ltd., has voting and investment power over these securities. Sander Gerber is the managing member of Hudson Bay Capital GP LLC, which is the general partner of Hudson Bay Capital Management LP. Hudson Bay Capital Management LP may be deemed to be the beneficial owner of all shares of common stock underlying the securities held by Hudson Bay Master Fund Ltd. Mr. Gerber disclaims beneficial ownership of these securities. Hudson Bay Capital Management LP holds sole voting and dispositive power with respect to 2,187 shares of Series E Convertible Preferred Stock could be converted into 94,927 shares of common stock or that may be voted pursuant to theas-converted voting provisions of the Series E Convertible Preferred Stock or SeriesE-1 Convertible Preferred Stock subject to the Blockers described below. The referenced securities do not include 106,866 shares of common stock that may be obtained upon the exercise of warrants held by the reporting persons subject to the Blockers described below. Each reporting person disclaims beneficial ownership of the securities referenced. Pursuant to the terms of (i) the certificate of designations of Delcath containing the terms of the Series E Convertible Preferred Stock or SeriesE-1 Convertible Preferred Stock, the reporting persons cannot convert their shares of Series E Convertible Preferred Stock to the extent the reporting persons would beneficially own, after any such conversion, more than 9.99% of the outstanding shares of common stock, or the Preferred Stock Blockers, and (ii) as to the warrants referenced, the reporting persons cannot exercise such warrants to the extent the reporting persons would beneficially own, after any such exercise, more than 9.99% of the outstanding shares of common stock, or the Warrant Blockers, and collectively with the Preferred Stock Blockers, the Blockers, and the percentage set forth above gives effect to the Blockers. Consequently, as of April 17, 2020, the reporting persons were not able to exercise all of the reported Series E Convertible Preferred Stock, SeriesE-1 Convertible Preferred Stock or any of the reported warrants due to the Blockers.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

Transactions with Related Persons. We have adopted a written policy for the review and approval or ratification of transactions between Delcathour company and Related Parties (as defined below). Under the policy, our Nominating Committee will review the material facts of proposed transactions involving Delcath in which a Related Party will have a direct or indirect material interest. The Nominating Committee will either approve or disapprove Delcath’sour entry into the transaction or, if advance approval is not feasible, will consider whether to ratify the transaction. The Nominating Committee may establish guidelines for ongoing transactions with a Related Party, and will review such transactions at least annually. If the aggregate amount of the transaction is expected to be less than $200,000, such approval or ratification may be made by the Chair of the Committee. In determining whether to approve or ratify a transaction with a Related Party, the Nominating Committee (or Chair) will consider, among other factors, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated third-party and the extent of the Related Party’s interest in the transaction.

Certaintransactions are deemedpre-approved under the policy, including compensation of executive officers and directors (except that employment of an immediate family member of an executive officer requires specific approval), and transactions with a company at which the Related Party’s only relationship is as anon-officer employee, director, or less than 10% owner if the aggregate amount involved does not exceed 2% of such company’s total annual revenues (or, in the case of charitable contributions by Delcath,us, 2% of the charity’s total annual receipts).Pre-approval is not required if the amount involved in the transaction is not expected to exceed $120,000 in any calendar year.

For purposes of the policy, a Related Party is generally anyone who since the beginning of the last full fiscal year is or was an executive officer, director or director nominee, owner of more than 5% of theour common stock, or immediate family member of any of such persons.

No related personExcept for the participation of certain Related Parties in the Private Placements and the Debt Exchange, no Related Party transactions occurred during 2016.

Compensation Committee Interlocks2019 and Insider Participation. During 2016, Marco Taglietti2018. See “Prospectus Summary—Support and William D. Rueckert served as membersConversion Agreement” and “Prospectus Summary — Board Appointment Agreement” for descriptions of our Compensationcertain agreements we have entered into with Rosalind and Stock Option Committee. Laura A. Philips and Dennis H. Langer, former directors, each served on the Compensation and Stock Option Committee until their resignations on April 3, 2016 and April 4, 2016, respectively. None of the current members or members serving during 2016 of the Compensation and Stock Option Committee is a current or former officer or employee of Delcath at the time of their service on the Compensation and Stock Option Committee, nor did any Compensation and Stock Option Committee member engage in any “related person” transaction that would be required to be disclosed under Item 404 of RegulationS-K. During 2016, none of Delcath’sour executive officers served on the compensation committee (or equivalent) or on the board of directors of another entity whose executive officers served on the Compensation and Stock Option Committee or our Board of Directors.in connection with this offering.

Board Independence. The Board has determined that three of our five directors (each of William D. Rueckert and Marco Taglietti) are “independent” directors within the meaning of the NASDAQ listing rules.

Certain Anti-Takeover Provisions of Delaware Law and our Certificate of Incorporation and Bylaws

We are not subject to Section 203 of the Delaware General Corporation Law, which prohibits Delaware corporations from engaging in a wide range of specified transactions with any interested stockholder, defined to include, among others, any person other than such corporation and any of its majority owned subsidiaries who own 15% or more of any class or series of stock entitled to vote generally in the election of directors, unless, among other exceptions, the transaction is approved by (i) our board of directors prior to the date the interested stockholder obtained such status or (ii) the holders of two thirds of the outstanding shares of each class or series of stock entitled to vote generally in the election of directors, not including those shares owned by the interested stockholder.

Staggered Board of Directors

Our certificate of incorporation andby-laws provide that our board of directors be classified into three classes of directors of approximately equal size. As a result, in most circumstances, a person can gain control of our board only by successfully engaging in a proxy contest at two or more annual meetings.

Authorized But Unissued Shares

Our authorized but unissued shares of common stock and preferred stock are available for future issuances without stockholder approval and could be utilized for a variety of corporate purposes, including future offerings to raise additional capital, corporate acquisitions, employee benefit plans and stockholder rights plans. The existence of authorized but unissued and unreserved common stock and preferred stock could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Transactions with Related Persons. We have adopted a written policy for the review and approval or ratification of transactions between Delcath and Related Parties (as defined below). Under the policy, our Nominating Committee will review the material facts of proposed transactions involving Delcath in which a Related Party will have a direct or indirect material interest. The Nominating Committee will either approve or disapprove Delcath’s entry into the transaction or, if advance approval is not feasible, will consider whether to ratify the transaction. The Nominating Committee may establish guidelines for ongoing transactions with a Related Party, and will review such transactions at least annually. If the aggregate amount of the transaction is expected to be less than $200,000, such approval or ratification may be made by the Chair of the Committee. In determining whether to approve or ratify a transaction with a Related Party, the Nominating Committee (or Chair) will consider, among other factors, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated third-party and the extent of the Related Party’s interest in the transaction.

Certain transactions are deemed pre-approved under the policy, including compensation of executive officers and directors (except that employment of an immediate family member of an executive officer requires specific approval), and transactions with a company at which the Related Party’s only relationship is as a non-officer employee, director, or less than 10% owner if the aggregate amount involved does not exceed 2% of such company’s total annual revenues (or, in the case of charitable contributions by Delcath, 2% of the charity’s total annual receipts). Pre-approval is not required if the amount involved in the transaction is not expected to exceed $120,000 in any calendar year.

For purposes of the policy, a Related Party is generally anyone who since the beginning of the last full fiscal year is or was an executive officer, director or director nominee, owner of more than 5% of the common stock, or immediate family member of any of such persons.

No related person transactions occurred during 2016.

Compensation Committee Interlocks and Insider Participation. During 2016, Marco Taglietti and William D. Rueckert served as members of our Compensation and Stock Option Committee. Laura A. Philips and Dennis H. Langer, former directors, each served on the Compensation and Stock Option Committee until their resignations on April 3, 2016 and April 4, 2016, respectively. None of the current members or members serving during 2016 of the Compensation and Stock Option Committee is a current or former officer or employee of Delcath at the time of their service on the Compensation and Stock Option Committee, nor did any Compensation and Stock Option Committee member engage in any “related person” transaction that would be required to be disclosed under Item 404 of Regulation S-K. During 2016, none of Delcath’s executive officers served on the compensation committee (or equivalent) or on the board of directors of another entity whose executive officers served on the Compensation and Stock Option Committee or our Board of Directors.

Board Independence. The Board has determined that three of four of our directors (each of Roger Stoll, William D. Rueckert and Marco Taglietti) are “independent” directors within the meaning of the NASDAQ listing rules.

DESCRIPTION OF CAPITAL STOCKSECURITIES

The following description of our common stock and preferred stock together with the additional information incorporated by reference and in any related free writing prospectuses, summarizes the material terms and provisions of our common stock and preferred stock. The following description of our capital stock does not purport to be complete and is subject to, and qualified in its entirety by, our Amended and Restated Certificate of Incorporation, as amended, and our Amended andRestatedBy-Laws, which which are exhibits to the registration statement of which this prospectus forms a part, and by applicable law. We refer in this section to our Amended and Restated Certificate of Incorporation, as amended, as our certificate of incorporation, and we refer to our Amended andRestatedBy-Laws asour by-laws. The as ourby-laws. The terms of our common stock and preferred stock may also be affected by Delaware law.

Authorized Capital Stock

Our authorized capital stock consists of 500,000,0001,000,000,000 shares of our common stock, $0.01 par value per share, and 10,000,000 shares of undesignated preferred stock, $0.01 par value per share. As of November 2, 2017,April 17, 2020, we had 490,022,20972,773 shares of common stock outstanding and no32,061 shares of preferred stockSeries E Convertible Preferred Stock and 9,385 shares of SeriesE-1 Convertible Preferred Stock outstanding. As of November 2, 2017,April 17, 2020, we had 0.3 million1,826,608 shares of common stock issuable upon the exercise of outstanding warrants, including (i) 29 Common Stock Warrants and (ii) 1,826,579 Series E and SeriesE-1 Warrants at a weighted average exercise price of $12.57$23.04 per share, 55,000 shares issuable upon the exercise of stock options at a weighted average exercise price of $96.99 per share, and 0.1 million shares of unvested restricted stock.share.

Common Stock

Voting

Holders of our common stock are entitled to one vote per share on matters to be voted on by stockholders and also are entitled to receive such dividends, if any, as may be declared from time to time by our board of directors in its discretion out of funds legally available therefor. Holders of our common stock have exclusive voting rights for the election of our directors and all other matters requiring stockholder action, except with respect to amendments to our certificate of incorporation that alter or change the powers, preferences, rights or other terms of any outstanding preferred stock if the holders of such affected series of preferred stock are entitled to vote on such an amendment or filling vacancies on the board of directors.

Dividends

Holders of common stock are entitled to share ratably in any dividends declared by our board of directors, subject to any preferential dividend rights of any outstanding preferred stock. Dividends consisting of shares of common stock may be paid to holders of shares of common stock. We do not intend to pay cash dividends in the foreseeable future.

Liquidation and Dissolution

Upon our liquidation or dissolution, the holders of our common stock will be entitled to receive pro rata all assets remaining available for distribution to stockholders after payment of all liabilities and provision for the liquidation of any shares of preferred stock at the time outstanding.

Other Rights and Restrictions

Our common stock has no preemptive or other subscription rights, and there are no conversion rights or redemption or sinking fund provisions with respect to such stock. Our common stock is not subject to redemption by us. Our certificate of incorporation and bylaws do not restrict the ability of a holder of common stock to transfer the stockholder’s shares of common stock. If we issue shares of common stock under this prospectus, the shares will be fully paidandnon-assessable and and will not have, or be subject to, any preemptive or similar rights.

Pre-Funded Warrants

The following summary of certain terms and provisions of thepre-funded warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions ofthe pre-funded warrant, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form ofpre-funded warrant for a complete description of the terms and conditions of thepre-funded warrants.

ListingDuration and Exercise Price

OurEach pre-funded warrant offered hereby will have an initial exercise price per share equal to $0.01.The pre-funded warrants will be immediately exercisable and will not expire prior to exercise. The exercise price and number of shares of common stock issuable upon exercise is quoted onsubject to appropriate adjustment in the OTCQBevent of stock dividends, stock splits, reorganizations or similar events affecting our common stock.

Exercisability

Thepre-funded warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion ofthe pre-funded warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of beneficial ownership of outstanding stock after exercising the holder’spre-funded warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of thepre-funded warrants and Delaware law. Purchasers ofpre-funded warrants in this offering may also elect prior to the issuance of thepre-funded warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock.

Cashless Exercise

If, at the time a holder exercisesits pre-funded warrants, a registration statement registering the issuance of the shares of common stock underlyingthe pre-funded warrants under the symbol “DCTH.”Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in thepre-funded warrants.

Transfer AgentTransferability

Subject to applicable laws, apre-funded warrant may be transferred at the option of the holder upon surrender of thepre-funded warrant to us together with the appropriate instruments of transfer.

Fractional Shares

No fractional shares of common stock will be issued upon the exercise of thepre-funded warrants. Rather, the number of shares of common stock to be issued will be rounded to the nearest whole number.

Trading Market

There is no established public trading market for thepre-funded warrants, and Registrarwe do not expect a market to develop. In addition, we do not intend to apply to list thepre-funded warrants on any national securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of thepre-funded warrants will be limited.

Right as a Stockholder

Except as otherwise provided in thepre-funded warrants or by virtue of such holder’s ownership of shares of our common stock, the holders ofthe pre-funded warrants do not have the rights or privileges of holders of our common stock with respect to the shares of common stock underlying thepre-funded warrants, including any voting rights, until they exercisetheir pre-funded warrants. Thepre-funded warrants will provide that holders have the right to participate in distributions or dividends paid on our common stock.

Fundamental Transaction

In the event of a fundamental transaction, as described inthe pre-funded warrants and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders ofthe pre-funded warrants will be entitled to receive upon exercise ofthe pre-funded warrants the kind and amount of securities, cash or other property that the holders would have received had they exercisedthe pre-funded warrants immediately prior to such fundamental transaction.

Series F Warrants

The following summary of certain terms and provisions of the Series F warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the Series F warrant, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of Series F warrant for a complete description of the terms and conditions of the Series F warrants. The Series F warrants will be issued in book-entry form and will initially be represented only by one or more global warrants deposited with the warrant agent, as custodian on behalf of The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.

Duration and Exercise Price

The transfer agentSeries F warrants are exercisable from and registrarafter the date of their issuance and expire on the fifth anniversary of such date, at an exercise price per share of common stock equal to 100% of the combined public offering price per share of common stock and related Series F warrant in this offering. The Series F warrants will be governed by the terms of a global warrant held in book-entry form. The holder of a Series F warrant will not be deemed a holder of our underlying common stock until the Series F warrant is exercised. No fractional shares of common stock will be issued in connection with the exercise of a Series F warrant. Instead, for any such fractional share that would have otherwise been issued upon exercise of Series F warrants, we will round such fraction down to the next whole share.

Exercisability

The Series F warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the Series F warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of beneficial ownership of outstanding stock after exercising the holder’s Series F warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Series F warrants and Delaware law. Purchasers of Series F warrants in this offering may also elect prior to the issuance of the Series F warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock.

Cashless Exercise

If, at the time a holder exercises its Series F warrants, a registration statement registering the issuance of the shares of common stock underlying the Series F warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the Series F warrants.

Transferability

Subject to applicable laws, a Series F warrant may be transferred at the option of the holder upon surrender of the Series F warrant to us together with the appropriate instruments of transfer.

Fractional Shares

No fractional shares of common stock will be issued upon the exercise of the Series F warrants. Rather, the number of shares of common stock to be issued will be rounded to the nearest whole number.

Trading Market

There is no established public trading market for the Series F warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list the Series F warrants on any national securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Series F warrants will be limited.

Right as a Stockholder

Except as otherwise provided in the Series F warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the Series F warrants do not have the rights or privileges of holders of our common stock with respect to the shares of common stock underlying the Series F warrants, including any voting rights, until they exercise their Series F warrants. The Series F warrants will provide that holders have the right to participate in distributions or dividends paid on our common stock.

Fundamental Transaction

In the event of a fundamental transaction, as described in the Series F warrants and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the Series F warrants will be entitled to receive upon exercise of the Series F warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the Series F warrants immediately prior to such fundamental transaction. Additionally, as more fully described in the Series F warrants, in the event of certain fundamental transactions, the holders of the Series F warrants will be entitled to receive consideration in an amount equal to the Black Scholes value of the Series F warrants determined according to a formula set forth in the Series F warrants.

Warrant Agent

The Series F warrants will be issued pursuant to the terms of a warrant agency agreement between us and American Stock Transfer & Trust Company.Company, LLC, as warrant agent. The warrant agent may resign upon 30 days’ written notice to us, our transfer agent and the holders of any warrant certificates. We have the right to remove the warrant agent upon 30 days’ prior written notice to the warrant agent, our transfer agent and the holders of any warrant certificates. If the warrant agent resigns or is removed, we will appoint a successor warrant agent. If we do not do so within 30 days, then any holder of a warrant certificate may petition a court of competent jurisdiction to appoint a successor warrant agent and we will be deemed to be the warrant agent pending such appointment. In the warrant agency agreement, we have agreed to indemnify the warrant agent against certain liabilities.

Amendments

The warrant agency agreement may be amended by the warrant agent and us without the approval of the holders of Series F warrants to cure any ambiguity, to correct or supplement any defective or inconsistent provisions or to make such other provisions as we and the warrant agent deem necessary or desirable and which do not adversely affect the interest of the holders. In addition, with the consent of the holders of a majority of the outstanding Series F warrants, we and the warrant agent may modify the warrant agency agreement and the Series F warrants for the purpose of adding any provisions to or changing in any manner or eliminating any of the provisions of the warrant agency agreement or modifying in any manner the rights of the holders of the Series F warrants; provided, however, that no modification of the terms (including but not limited to the adjustments provisions) upon which the Series F warrants are exercisable or reducing the percentage required for consent to modification of the warrant agency agreement may be made without the consent of each holder of the then-outstanding Series F warrants.

The description of the warrant agency agreement contained herein is not complete and is qualified in its entirety by the provisions of the warrant agency agreement, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the warrant agency agreement for a complete description of the terms and conditions thereof.

Preferred Stock

Our board of directors has the authority to issue up to 10,000,000 shares of preferred stock in one or more series and to determine the rights and preferences of the shares of any such series without stockholder approval, none of which areSeries E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock or, collectively, the Preferred Stock, is outstanding. Our board of directors may issue preferred stock in one or more series and has the authority to fix the designation and powers, rights and preferences and the qualifications, limitations, or restrictions with respect to each class or series of such class without further vote or action by the stockholders. The ability of our board of directors to issue preferred stock without stockholder approval could have the effect of delaying, deferring or preventing a change of control of us or the removal of existing management.

RecentIn connection with the July 11, 2019 Private Placement, the Company filed a certificate of designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock with the Secretary of State of the State of Delaware, or the Delaware SOS, for the purpose of amending its Amended and Restated Certificate of Incorporation to classify and designate 40,000 authorized but unissued shares of the Company’s preferred stock as shares of Series E Preferred Stock. The preferences, conversion and other rights, voting powers, restrictions, limitations as to dividends and other distributions, qualifications and terms and conditions of redemption of the Series E Convertible Preferred Stock are set forth in the Certificate of Designation and are described below. The certificate of designation became effective on July 11, 2019 upon acceptance for filing by the Delaware SOS.

In connection with the August 15, 2019 Private Placement, the Company filed a certificate of designation of Preferences, Rights and Limitations of SeriesE-1 Convertible Preferred Stock with Delaware SOS, for the purpose of amending its Amended and Restated Certificate of Incorporation to classify and designate 12,960 authorized but unissued shares of the Company’s preferred stock as shares of SeriesE-1 Convertible Preferred Stock. The preferences, conversion and other rights, voting powers, restrictions, limitations as to dividends and other distributions, qualifications and terms and conditions of redemption of the SeriesE-1 Convertible Preferred Stock are set forth in the certificate of designation and are described below. The certificate of designation became effective on August 15, 2019 upon acceptance for filing by the Delaware SOS.

Each share of the Series E Convertible Preferred Stock and SeriesE-1 Convertible Preferred Stock has a par value of $0.01 per share and a stated value equal to $1,000, or the Stated Value, and is convertible at any time at the option of the holder into the number of shares of common stock determined by dividing the stated value by the conversion price of $23.04, subject to certain limitations and

adjustments, or the Conversion Price. Except for certain adjustments, the holders of Preferred Stock will be entitled to receive dividends on shares of Preferred Stock equal (on an as if converted basis) to and in the same form as dividends paid on shares of the common stock. Any such dividends that are not paid to the holders of Preferred Stock will increase the Stated Value. No other dividends will be paid on shares of Preferred Stock. The Preferred Stock will vote on an as converted basis on all matters submitted to the holders of common stock for approval, subject to certain limitations and exceptions. The affirmative vote of the holders of a majority of the then outstanding shares of Preferred Stock is required to increase the number of authorized shares of Preferred Stock or to alter or change adversely the powers, preferences or rights given to the Preferred Stock, or to amend the Company’s organizational documents in any manner that adversely affects the rights of the holders of the Preferred Stock. Upon any liquidation of the Company, the holders of Preferred Stock will be entitled to receive out of the assets of the Company an amount equal to the Stated Value plus any accrued and unpaid dividends thereon for each share of Preferred Stock before any distribution or payment will be made to the holders of the common stock.

Reset Provisions

Pursuant to the terms of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants were initially subject to adjustment in each of the following circumstances: (i) on the third trading day following the date that the Company effects a reverse stock split, or the Reverse Split Reset Date, (ii) the date that the initial registration statement covering the shares of common stock issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants is declared effective by the SEC, or the Registration Reset Date, and (iii) in the event that all of the shares of common stock which we were required to register with the SEC were not then registered on an effective registration statement, the date that all of the shares underlying the respective Preferred Stock and 2019 Warrants may be sold pursuant to Rule 144, or the Rule 144 Reset Date, each of such reset dates, a Reset Date and, collectively, the Reset Dates. On each Reset Date, the Conversion Price and the Exercise Price were to be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the common stock immediately prior to each Reset Date, or the Reset Formula. In the event of a reduction in the Exercise Price, the aggregate number of Warrant Shares issuable upon the exercise of the 2019 Warrants were to be increased such that the aggregate Exercise Price of the Warrants on the day immediately following such Reset Date equaled the aggregate Exercise Price immediately prior to such adjustment. In addition, from the date of issuance of the Preferred Stock and Warrants until such time that the Company’s common stock is listed or quoted on a national exchange, the Conversion Price and the Exercise Price are subject to price-based anti-dilution protections.

The Registration Reset Date occurred on November 7, 2019. However, pursuant to the Reset Formula, no reduction in the Conversion Price or the Exercise Price occurred on the Registration Reset Date. The Reverse Split Reset Date occurred on December 30, 2019. Pursuant to the Reset Formula, the Conversion Price and the Exercise Price were reduced to $23.04 per share as of the Reverse Split Reset Date. The Rule 144 Reset Date with respect to the Series E Preferred Stock and the Series E Warrants occurred on January 15, 2020, but no reset in the Conversion Price or the Exercise Price of the Series E Preferred Stock or the Series E Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale. The Rule 144 Reset Date with respect to the SeriesE-1 Preferred Stock and the SeriesE-1 Warrants occurred on February 19, 2020, but no reset in the Conversion Price or the Exercise Price of the SeriesE-1 Preferred Stock or the SeriesE-1 Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale.

Because the combined public offering price per share and related Series F warrant in this offering will be less than $23.04 per share, under the full-ratchet price-protection provisions of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants will be reduced to such public offering price and we will be required to issue 1,389,308 additional shares of common stock upon the conversion of the Preferred Stock, assuming a combined public offering price of $13.00 per share and related Series F warrant, the closing sale price per share of our common stock on the OTCQB on April 17, 2020.

Prior Warrants

The following is a brief summary of material provisions of the 2019 Warrants.

Pursuant to the Securities Purchase Agreements dated July 11, 2019 and August 15, 2019, the Company issued warrants, or the 2019 Warrants, to purchase a number of shares of common stock equal to the number of shares of common stock issuable upon conversion of the Preferred Stock purchased. Each 2019 Warrant has an exercise price equal to $23.04, subject to adjustment in accordance with the terms of the 2019 Warrants, or the Exercise Price, and will be exercisable at any time beginning on the date that the Company effects a reverse stock split until 5:00 p.m. (NYC time) on the date that is five years following the Reverse Split Reset Date.

As noted above under “Description of Securities—Preferred Stock—Reset Provisions”, the 2019 Warrants are also subject to reset and full-ratchet price-based antidiution protections in certain circumstances.

Market Information

Our common stock is quoted the OTCQB under the symbol “DCTH”. Our common stock has been approved for listing on The NASDAQ Capital Market under the symbol “DCTH” contingent on the completion of this offering. There is no established public trading market for the Series F warrants or the pre-funded warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list the Series F Warrants or the pre-funded warrants on any national securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Series F warrants and the prefunded warrants will be limited.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is American Stock Transfer & Trust Company, LLC.

Anti-Takeover Provisions of Delaware Law and our Certificate of Incorporation and Bylaws

We are not subject to Section 203 of the Delaware General Corporation Law, which prohibits Delaware corporations from engaging in a wide range of specified transactions with any interested stockholder, defined to include, among others, any person other than such corporation and any of its majority owned subsidiaries who own 15% or more of any class or series of stock entitled to vote generally in the election of directors, unless, among other exceptions, the transaction is approved by (i) our board of directors prior to the date the interested stockholder obtained such status or (ii) the holders oftwo-thirds of the outstanding shares of each class or series of stock entitled to vote generally in the election of directors, not including those shares owned by the interested stockholder.

Staggered Board of Directors

Our certificate of incorporation andby-laws provide that our board of directors be classified into three classes of directors of approximately equal size. As a result, in most circumstances, a person can gain control of our board only by successfully engaging in a proxy contest at two or more annual meetings.

Authorized But Unissued Shares

Our authorized but unissued shares of preferred stock are available for future issuances without stockholder approval and could be utilized for a variety of corporate purposes, including future offerings to raise additional capital, corporate acquisitions, employee benefit plans and stockholder rights plans. The existence of authorized but unissued and unreserved preferred stock could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.

UNDERWRITING

We have entered into an underwriting agreement with Roth Capital Partners, LLC, acting as the representative of the several underwriters named below, with respect to the shares of common stock,pre-funded warrants and Series F warrants subject to this offering. Subject to certain conditions, we have agreed to sell to the underwriters, and the underwriters have severally agreed to purchase, the number of shares of common stock,pre-funded warrants and Series F warrants provided opposite their respective names.

Underwriter

Number of
Shares
Number of
Pre-Funded
Warrants
Number of
Series F
Warrants

Roth Capital Partners, LLC

Aegis Capital Corp.

Laidlaw & Company (UK) Ltd.

Total

The underwriters are offering the shares of common stock,pre-funded warrants and Series F warrants subject to their acceptance of the shares of common stock,pre-funded warrants and Series F warrants from us and subject to prior sale. The underwriting agreement provides that the obligations of the several underwriters to pay for and accept delivery of the shares of common stock,pre-funded warrants and Series F warrants offered by this prospectus are subject to the approval of certain legal matters by their counsel and to certain other conditions. The underwriters are obligated to take and pay for all of the shares of common stock,pre-funded warrants and Series F warrants if any such securities are taken. However, the underwriters are not required to take or pay for the securities covered by the underwriters’ over-allotment option described below.

Certain of our existing stockholders have indicated an interest in purchasing at least $4.0 million of our securities in this offering at the combined public offering price per share and related warrant and on the same terms as the other purchasers in this offering. See “Prospectus Summary – Support and Conversion Agreement.” However, because indications of interest are not binding agreements or commitments to purchase, such stockholders are not obligated to purchase such securities and the existing stockholders may purchase more, fewer or no securities in this offering. The underwriters will receive the same underwriting discount on these securities as they will on any other securities sold to the public in this offering.

Over-Allotment Option

We have granted the underwriters an option, exercisable for 30 days from the date of this prospectus, to purchase up to an aggregate of 253,846 additional shares of common stock at a purchase price of $13.00 per share and/or additional Series F warrants to purchase up to 253,846 shares of common stock at a purchase price of $0.01 per Series F warrant, in any combination thereof, to cover over-allotments, if any, of the securities offered by this prospectus. If the underwriters exercise this option, each underwriter will be obligated, subject to certain conditions, to purchase the number of additional shares and/or warrants, proportionate to that underwriter’s initial purchase commitment as indicated in the table above for which the option has been exercised.

Because the Series F warrants are not listed on a national securities exchange or other nationally recognized trading market, the underwriters will be unable to satisfy any over-allotment of Series F warrants without exercising the underwriters’ over-allotment option with respect to the Series F warrants. The underwriters have informed us that they intend to exercise their over-allotment option for all of the Series F warrants that are over-allotted, if any, at the time of the initial offering of our securities. However, because our common stock will be listed on Nasdaq, the underwriters may satisfy some or all of the over-allotment of shares of our common stock, if any, by purchasing shares in the open market and will have no obligation to exercise the over-allotment option with respect to our common stock. Assuming no sale ofpre-funded warrants, if the underwriters exercise their over-allotment option with respect to the Series F warrants in full, but do not exercise their over-allotment option with respect to our common stock, then, the effective warrant coverage for each share of common stock sold in this offering would increase to 115% instead of the 100% stated on the cover of this prospectus.

Discount, Commissions and Expenses

The underwriters have advised us that they propose to offer the shares of common stock, thepre-funded warrants and the Series F warrants to the public at the combined public offering prices set forth on the cover page of this prospectus and to certain dealers at those prices less a concession not in excess of $                 share orpre-funded warrant, as applicable, and related Series F warrants. After this offering, the combined public offering prices and concession to dealers may be changed by the underwriters. No such change will change the amount of proceeds to be received by us as set forth on the cover page of this prospectus. The shares of common stock,pre-funded warrants and Series F warrants are offered by the underwriters as stated herein, subject to receipt and acceptance by them and subject to their right to reject any order in whole or in part. The underwriters have informed us that they do not intend to confirm sales to any accounts over which they exercise discretionary authority.

The following table shows the underwriting discount payable to the underwriters by us in connection with this offering. Such amounts are shown assuming both no exercise and full exercise of the underwriters’ over-allotment option to purchase additional shares of common stock and Series F warrants.

Per
Share and Related
Series F Warrant
Per
Pre-Funded
Warrant and
Related Series F
Warrant
Total Without
Exercise of
Over-Allotment
Option
Total With
Exercise of
Over-Allotment
Option

Public offering price

$$$$

Underwriting discount (8%)

$$$$

We have agreed to reimburse the underwriters for certainout-of-pocket expenses, including the fees and disbursements of their counsel, up to an aggregate of $75,000. We estimate that the total expenses payable by us in connection with this offering, other than the underwriting discount referred to above, will be approximately $275,000.

Indemnification

We have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or the Securities Act, and liabilities arising from breaches of representations and warranties contained in the underwriting agreement, or to contribute to payments that the underwriters may be required to make in respect of those liabilities.

Lock-Up Agreements

We and our officers and directors have agreed, subject to limited exceptions, for a period of 90 days after the date of the underwriting agreement, not to offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise dispose of, directly or indirectly any shares of common stock or any securities convertible into or exchangeable for our common stock either owned as of the date of the underwriting agreement or thereafter acquired without the prior written consent of the representative. The representative may, in its sole discretion and at any time or from time to time before the termination of thelock-up period, without notice, release all or any portion of the securities subject tolock-up agreements.

Other Relationships

If we decide to make an offering of our equity or equity-linked securities at any time prior to the first anniversary of the closing date of this offering, we have granted Roth Capital Partners, LLC the right to act as a placement agent or underwriter, as applicable.

Price Stabilization, Short Positions and Penalty Bids

In connection with the offering the underwriters may engage in stabilizing transactions, over-allotment transactions, syndicate covering transactions and penalty bids in accordance with Regulation M under the Exchange Act:

Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum.

Over-allotment involves sales by the underwriters of shares in excess of the number of shares the underwriters are obligated to purchase, which creates a short position. The short position may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the over-allotment option. In a naked short position, the number of shares involved is greater than the number of shares in the over-allotment option. The underwriters may close out any covered short position by either exercising their over-allotment option and/or purchasing shares in the open market.

Syndicate covering transactions involve purchases of shares of the common stock in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares through the over-allotment option. If the underwriters sell more shares than could be covered by the over-allotment option, a naked short position, the position can only be closed out by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.

Penalty bids permit a syndicate representative to reclaim a selling concession from a syndicate member when the common stock originally sold by the syndicate member is purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.

These stabilizing transactions, syndicate covering transactions and penalty bids, to the extent applicable, may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of the common stock. As a result, the price of our securities may be higher than the price that might otherwise exist in the open market. Neither we nor the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our common stock. In addition, neither we nor the underwriters make any representations that the underwriters will engage in these stabilizing transactions or that any transaction, once commenced, will not be discontinued without notice.

NASDAQ Listing

Our shares of common stock are quoted on the OTCQB under the symbol “DCTH.” Our common stock has been approved for listing on The NASDAQ Capital Market under the symbol “DCTH” contingent on the completion of this offering. There is no established public trading market for the Series F warrants or thepre-funded warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list the Series F warrants or thepre-funded warrants on any national securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Series F warrants and thepre-funded warrants will be limited.

Electronic Distribution

This preliminary prospectus in electronic format may be made available on websites or through other online services maintained by the underwriters, or by their affiliates. Other than this preliminary prospectus in electronic format, the information on any underwriter’s website and any information contained in any other website maintained by such underwriter is not part of this preliminary prospectus or the registration statement of which this preliminary prospectus forms a part, has not been approved and/or endorsed by us or any underwriter in its capacity as underwriter, and should not be relied upon by investors.

Other

From time to time, the underwriters and/or their affiliates have provided, and may in the future provide, various investment banking and other financial services for us for which services they have received and, may in the future receive, customary fees. In the course of their businesses, the underwriters and their affiliates may actively trade our securities or loans for their own account or for the accounts of customers, and, accordingly, the underwriters and their affiliates may at any time hold long or short positions in such securities or loans. Except for services provided in connection with this offering and except as described below, no underwriter has provided any investment banking or other financial services to us during the180-day period preceding the date of this prospectus and we do not expect to retain any underwriter to perform any investment banking or other financial services for at least 90 days after the date of this prospectus. In connection with the August 2019 Private Placement, we paid the representative a commission of $580,434.

Selling Restrictions

No action may be taken in any jurisdiction other than the United States that would permit a public offering of the common stock or the possession, circulation or distribution of this prospectus in any jurisdiction where action for that purpose is required. Accordingly, the securities offered hereby may not be offered or sold, directly or indirectly, and neither the prospectus nor any other offering material or advertisements in connection with such securities may be distributed or published in or from any country or jurisdiction except under circumstances that will result in compliance with any applicable laws, rules and regulations of any such country or jurisdiction.

Notice to Prospective Investors in Canada

The securities offered hereby may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities offered hereby must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars of these rights or consult with a legal advisor.

Pursuant to section 3A.3 (or, in the case of securities issued or guaranteed by the government of anon-Canadian jurisdiction, section 3A.4) of National Instrument33-105 Underwriting Conflicts (NI33-105), the underwriters are not required to comply with the disclosure requirements of NI33-105 regarding underwriter conflicts of interest in connection with this offering.

Notice to Prospective Investors in the European Union

In relation to each Member State of the European Union, or a Relevant Member State, no offer of the securities offered hereby may be made to the public in that Relevant Member State other than:

to any legal entity which is a qualified investor as defined in the Prospectus Directive;

to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the underwriters; or

in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of the securities offered hereby shall require us or the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.

Each person in a Relevant Member State who initially acquires any of the securities offered hereby or to whom any offer is made will be deemed to have represented, acknowledged and agreed that it is a “qualified investor” within the meaning of the law in that Relevant Member State implementing Article 2(1)(e) of the Prospectus Directive. In the case of any security being offered to a financial intermediary as that term is used in Article 3(2) of the Prospectus Directive, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the securities acquired by it in the offer have not been acquired on anon-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any of the securities offered hereby to the public other than their offer or resale in a Relevant Member State to qualified investors as so defined or in circumstances in which the prior consent of the underwriters has been obtained to each such proposed offer or resale.

We, the underwriters and their affiliates will rely upon the truth and accuracy of the foregoing representations, acknowledgements and agreements.

This prospectus has been prepared on the basis that any offer of the securities offered hereby in any Relevant Member State will be made pursuant to an exemption under the Prospectus Directive from the requirement to publish a prospectus for offers of such securities. Accordingly, any person making or intending to make an offer in that Relevant Member State of the securities which are the subject of the offering contemplated in this prospectus may only do so in circumstances in which no obligation arises for us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Directive in relation to such offer. Neither we nor the underwriters have authorized, nor do they authorize, the making of any offer of the securities offered hereby in circumstances in which an obligation arises for us or the underwriters to publish a prospectus for such offer.

Notice to Prospective Investors in the United Kingdom

In the United Kingdom, this prospectus supplement is being distributed only to, and is directed only at, and any offer subsequently made may only be directed at persons who are “qualified investors” (as defined in the Prospectus Directive) (i) who have professional experience in matters relating to investments falling within Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the Order) and/or (ii) who are high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”).

Any person in the United Kingdom that is not a relevant person should not act or rely on the information included in this prospectus or use it as basis for taking any action. In the United Kingdom, any investment or investment activity that this prospectus relates to may be made or taken exclusively by relevant persons. Any person in the United Kingdom that is not a relevant person should not act or rely on this prospectus or any of its contents.

LEGAL MATTERS

The validity of the securities offered hereby will be passed upon by Lowenstein Sandler LLP, New York, New York. Ellenoff Grossman & Schole LLP, New York, New York, is acting as counsel for the underwriters in connection with this offering.

EXPERTS

The consolidated financial statements as of December 31, 2019 and 2018 and for the years then ended included in this prospectus and in the registration statement have been so included in reliance on the report of Marcum LLP, an independent registered public accounting firm, (the report on the financial statements contains an explanatory paragraph regarding the Company’s ability to continue as a going concern) appearing elsewhere herein and in the registration statement, given on the authority of said firm as experts in auditing and accounting.

WHERE TO FIND MORE INFORMATION

We have filed with the SEC a registration statement on FormS-1, as amended by Amendment No. 1 to FormS-1, under the Securities Act with respect to the securities offered by this prospectus. This prospectus, which constitutes a part of the registration statement, does not contain all the information set forth in the registration statement, some of which is contained in exhibits to the registration statement as permitted by the rules and regulations of the SEC. For further information with respect to us and our securities, we refer you to the registration statement, including the exhibits filed as a part of the registration statement. Statements contained in this prospectus concerning the contents of any contract or any other document are not necessarily complete. If a contract or document has been filed as an exhibit to the registration statement, please see the copy of the contract or document that has been filed. Each statement in this prospectus relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. You may obtain copies of this information by mail from the Public Reference Section of the SEC, 100 F Street, N.E., Room 1580, Washington, D.C. 20549, at prescribed rates. You may obtain information on the operation of the public reference rooms by calling the SEC at1-800-SEC-0330. The SEC also maintains an internet website that contains reports and other information about issuers, like us, that file electronically with the SEC. The address of that website is www.sec.gov. You may also request a copy of these filings, at no cost, by writing us at:

Delcath Systems, Inc.

1633 Broadway, Suite 22C

New York, New York 10019

Attn: Barbra C. Keck, Corporate Secretary

E-Mail: investorrelations@delcath.com

Telephone: (212)489-2100

We are subject to the information and reporting requirements of the Exchange Act and, in accordance with this law, file periodic reports, proxy statements and other information with the SEC. These periodic reports, proxy statements and other information are available for inspection and copying at the SEC’s public reference facilities and the website of the SEC referred to above. We also maintain a website at www.delcath.com. Information contained in, or accessible through, our website is not a part of this prospectus, and the inclusion of our website address in this prospectus is only as an inactive textual reference. You may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC.


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and Board of Directors of

Delcath Systems, Inc. and Subsidiaries

Opinion on the Financial Statements

We have audited the accompanying consolidatedbalance sheets of Delcath Systems, Inc. and Subsidiaries (the “Company”) as of December 31, 2019 and 2018, the related consolidatedstatements of operations and comprehensive loss, stockholders’ deficit and cash flows for the years ended December 31, 2019 and 2018, and the related notes(collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for the years ended December 31, 2019 and 2018,in conformity with accounting principles generally accepted in the United States of America.

Explanatory Paragraph – Going Concern

The accompanying consolidatedfinancial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 1, the Company has a significant working capital deficiency, has incurred significant recurring losses and needs to raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidatedfinancial statements do not include any adjustments that might result from the outcome of this uncertainty.

Change in Accounting Principle

As discussed in Note 3 to the consolidated financial statements, the Company has changed its method of accounting for leases in 2019 due to the adoption of ASUNo. 2016-02 (Topic 842), as amended, effective January 1, 2019, using the modified retrospective approach.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ MarcumLLP

MarcumLLP

We have served as the Company’s auditors since 2018.

New York, New York

March 25, 2020

DELCATH SYSTEMS, INC.

Consolidated Balance Sheets

(in thousands, except share and per share data)

   December 31,  December 31, 
   2019  2018 

Assets

   

Current assets

   

Cash and cash equivalents

  $10,002  $2,516 

Restricted cash

   181   1,062 

Accounts receivables, net

   21   585 

Inventories

   654   858 

Prepaid expenses and other current assets

   1,759   898 
  

 

 

  

 

 

 

Total current assets

   12,617   5,919 

Property, plant and equipment, net

   735   925 

Right-of-use assets

   860   —   
  

 

 

  

 

 

 

Total assets

  $14,212  $6,844 
  

 

 

  

 

 

 

Liabilities and Stockholders’ Deficit

   

Current liabilities

   

Accounts payable

  $4,533  $7,715 

Accrued expenses

   6,947   7,964 

Convertible notes payable, net of debt discount

   —     2,038 

Lease liabilities, current portion

   664   —   

Warrant liability

   3,368   33 
  

 

 

  

 

 

 

Total current liabilities

   15,512   17,750 

Deferred revenue

   2,860   3,405 

Lease liabilities, long-term portion

   197   —   

Convertible notes payable, net of debt discount

   2,000   —   

Othernon-current liabilities

   —     628 
  

 

 

  

 

 

 

Total liabilities

   20,569   21,783 
  

 

 

  

 

 

 

Commitments and contingencies

   

Stockholders’ Deficit

   

Preferred stock, $.01 par value; 10,000,000 shares authorized; 41,517 and 101 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively

   —     —   

Common stock, $.01 par value; 1,000,000,000 shares authorized; 67,091 and 14,715 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively*

   1   —   

Additionalpaid-in capital

   364,785   329,065 

Accumulated deficit

   (371,171  (344,054

Accumulated other comprehensive loss

   28   50 
  

 

 

  

 

 

 

Total stockholders’ deficit

   (6,357  (14,939
  

 

 

  

 

 

 

Total liabilities and stockholders’ deficit

  $14,212  $6,844 
  

 

 

  

 

 

 

*

reflects, aone-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and aone-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.

See Accompanying Notes to these Consolidated Financial Statements.

DELCATH SYSTEMS, INC.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

   Year ended December 31, 
   2019  2018 

Product revenue

  $1,101  $3,378 

Other revenue

   479   29 

Cost of goods sold

   (719  (1,009
  

 

 

  

 

 

 

Gross profit

   861   2,398 

Operating expenses:

   

Research and development expenses

   9,490   19,650 

Selling, general and administrative expenses

   11,279   9,819 
  

 

 

  

 

 

 

Total operating expenses

   20,769   29,469 
  

 

 

  

 

 

 

Operating loss

   (19,908  (27,071

Change in fair value of the warrant liability, net

   17,493   19,706 

Loss on debt extinguishment

   —     (1,123

Loss on issuance of financial instrument

   (1,720  (2,826

Interest expense

   (4,746  (7,959

Other income

   2   51 
  

 

 

  

 

 

 

Net loss

  $(8,879 $(19,222
  

 

 

  

 

 

 

Other comprehensive loss:

  ��

Foreign currency translation adjustments

  $(22 $8 
  

 

 

  

 

 

 

Comprehensive loss

  $(8,901 $(19,214
  

 

 

  

 

 

 

Common share data:

   

Basic and diluted loss per share*

  $(1,047 $(504
  

 

 

  

 

 

 

Weighted average number of basic and diluted shares outstanding*

   25,900   38,151 
  

 

 

  

 

 

 

*

reflects, aone-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and aone-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.

See Accompanying Notes to these Consolidated Financial Statements.

DELCATH SYSTEMS, INC.

Consolidated Statements of Stockholders’ Deficit

(in thousands, except share data)

   Common Stock   Preferred Stock              
   $0.01 Par Value   $0.01 Par Value              
   No. of Shares   Amount   No. of
Shares
  Amount   Additional
Paid
in Capital
  Accumulated
Deficit
  Accumulated
Other
Comprehensive
Income
  Total 

Balance at January 1, 2019

   14,715   $—      101  $—     $329,065  $(344,054 $50  $(14,939

Compensation expense for issuance of stock options

   —      —      —     —      273   —     —     273 

Compensation expense for issuance of restricted stock

   20    —      —     —      4   —     —     4 

Issuance of Series D Preferred Stock

   —      —      15   —      150   —     —     150 

Retirement of Series D Preferred Stock

   —      —      (116  —      (1,160  —     —     (1,160

Exercise ofPre-Funded Series D Warrants

   11,285    —      —     —      —     —     —     —   

Exchange of warrants

   92    —      —     —      13   —     —     13 

Issuance of Series E Preferred Stock

   —      —      32,572   —      42,876   (13,340  —     29,536 

Issuance of SeriesE-1 Preferred Stock

   —      —      9,510   —      14,408   (4,898  —     9,510 

Fair value of warrants issued

   —      —      —     —      (20,844  —     —     (20,844

Conversion of Preferred stock into common stock

   13,455    —      (565  —      1   —     —     1 

Shares issued due to fractional rounding upon reverse stock split

   27,524    1    —     —      (1  —     —     —   

Net loss

   —      —      —     —      —     (8,879  —     (8,879

Total comprehensive loss

   —      —      —     —      —     —     (22  (22
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2019

   67,091   $1    41,517  $—      364,785  $(371,171  28  $(6,357
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

  

 

 

  

 

 

  

 

 

 

   Common Stock Issued   Preferred Stock                     
   $0.01 Par Value   $0.01 Par Value   Treasury Stock              
   No. of
Shares
   Amount   No. of
Shares
   Amount   No. of
Shares
  Amount  Additional
Paid
in Capital
  Accumulated
Deficit
  Accumulated
Other
Comprehensive
Income (Loss)
   Total 

Balance at January 1, 2018

   377   $—      —     $—      (1 $(51 $325,519  $(324,832 $42   $678 

Compensation income related to cancellation of stock options

   —      —      —      —      —     —     (40  —     —      (40

Compensation expense for issuance of restricted stock

   236    —      —      —      —     —     98   —     —      98 

Sale of common stock, net of expenses

   7,624    —      —      —      —     —     10,916   —     —      10,916 

Fair value of warrants issued

   —      —      —      —      —     —     (18,306  —     —      (18,306

Cashless exercise of warrants

   49    —      —      —      —     —     —     —     —      —   

Issuance ofpre-funded warrants

   —      —      —      —      —     —     520   —     —      520 

Exercise ofpre-funded warrants

   5,250    —      —      —      —     —     —     —     —      —   

Fair value of warrants issued with Convertible Notes

   —      —      —      —      —     —     5,007   —     —      5,007 

Fair value of warrants reclassified from liability to equity

   —      —      —      —      —     —     4,210   —     —      4,210 

Beneficial conversion feature of convertible note

   —      —      —      —      —     —     44   —     —      44 

Issuance of Series D Preferred Stock

   —      —      101    —      —     —     1,004   —     —      1,004 

Exchange of warrants for Common Stock

   1,179    —      —      —      —     —     —     —     —      —   

Fair value of warrants exchanged for Common Stock

   —      —      —      —      —     —     144   —     —      144 

Retirement of Treasury Stock

   —      —      —      —      1   51   (51  —     —      —   

Net income

   —      —      —      —      —     —     —     (19,222  —      (19,222

Total comprehensive loss

   —      —      —      —      —     —     —     —     8    8 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

   

 

 

 

Balance at December 31, 2018

   14,715   $—      101   $—      —    $—    $329,065  $(344,054 $50   $(14,939
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

   

 

 

 

*

reflects, aone-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and aone-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.

See Accompanying Notes to these Consolidated Financial Statements.

DELCATH SYSTEMS, INC.

Consolidated Statements of Cash Flows

(in thousands)

   Year ended December 31, 
   2019  2018 

Cash flows from operating activities:

   

Net loss

  $(8,879 $(19,222

Adjustments to reconcile net loss to net cash used in operating activities:

   

Stock option compensation expense (income)

   273   (40

Restricted stock compensation expense

   4   98 

Depreciation expense

   212   444 

Amortization of Right of Use Asset

   1,577   —   

Warrant liability fair value adjustment

   (17,493  (19,706

Non-cash interest income

   (11  (1

Equitization of expenses

   1,474   —   

Loss on issuance of financial instrument

   1,715   402 

Interest expense accrued related to convertible notes

   74   7,572 

Debt discount amortization

   4,467   2,826 

Loss on debt settlements

   —     1,123 

Changes in assets and liabilities:

    —   

Prepaid expenses and other assets

   (367  (218

Accounts receivable

   497   (293

Inventory

   204   385 

Accounts payable and accrued expenses

   (4,791  8,163 

Deferred revenue

   (479  3,503 

Interest payments on financing lease

   (3  —   

Operating lease liability

   (1,537  —   

Othernon-current liabilities

   (627  232 
  

 

 

  

 

 

 

Net cash used in operating activities

   (23,690  (14,732
  

 

 

  

 

 

 

Cash flows from investing activities:

   

Purchase of property, plant and equipment

   (24  (76
  

 

 

  

 

 

 

Net cash used in investing activities

   (24  (76
  

 

 

  

 

 

 

Cash flows from financing activities:

   

Repayment of convertible note debt

   —     (4,870

Net proceeds from the issuance of debt

   3,719   —   

Net proceeds from the sale of Series E andE-1 Preferred Stock and warrants

   26,475   —   

Net proceeds from sale of Series D preferred shares

   150   1,005 

Principal payments of financing leases

   (39  —   

Net proceeds from convertible note debt financing

   —     5,664 

Net proceeds from sale of stock

   —     10,917 

Net proceeds from exercise of warrants

   —     520 
  

 

 

  

 

 

 

Net cash provided by financing activities

   30,305   13,236 
  

 

 

  

 

 

 

Foreign currency effects on cash, cash equivalents and restricted cash

   14   (174
  

 

 

  

 

 

 

Net increase (decrease) in cash, cash equivalents and restricted cash

   6,605   (1,746

Cash, cash equivalents and restricted cash:

   

Beginning of period

   3,578   5,324 
  

 

 

  

 

 

 

End of period

  $10,183  $3,578 
  

 

 

  

 

 

 

Supplementalnon-cash activities:

   

Fair value of warrants issued

  $20,844  $28,539 
  

 

 

  

 

 

 

Reclassification of Series D Warrants from liability to equity

  $—    $4,210 
  

 

 

  

 

 

 

Equitization of debt, interest and expenses into July 2019 Private Placement

  $12,572  $—   
  

 

 

  

 

 

 

Adoption of ASC 842 lease standard

  $1,652  $—   
  

 

 

  

 

 

 

Right of use assets obtained in exchange for lease obligations

  $874  $—   
  

 

 

  

 

 

 

Financing of insurance

  $548  $—   
  

 

 

  

 

 

 

See Accompanying Notes to these Consolidated Financial Statements.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

(1)

Description of Business

We are an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our lead product candidate, Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System, or Melphalan/HDS, is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, Melphalan/HDS is approved for sale under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan, or CHEMOSAT.

Our primary research focus is on ocular melanoma liver metastases, or mOM, and intrahepatic cholangiocarcinoma, or ICC, a type of primary liver cancer, as well as certain other cancers that are metastatic to the liver. We believe that the disease states we are investigating are unmet medical needs that represent significant market opportunities.

In the United States, Melphalan/HDS is considered a combination drug and device product and is regulated as a drug by the United States Food and Drug Administration, or the FDA. The FDA has granted us six orphan drug designations, including three orphan designations for the potential use of the drug melphalan for the treatment of patients with mOM, hepatocellular carcinoma and ICC. Melphalan/HDS has not been approved for sale in the United States.

In Europe, our CHEMOSAT product is regulated as a Class IIb medical device and received its CE Mark in 2012. We are commercializing the CHEMOSAT system in select markets in the United Kingdom and the European Union, or EU, where we believe the prospect of securing reimbursement coverage for the use of CHEMOSAT is strongest.

Liquidity and Going Concern

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements during the year ended December 31, 2019, the Company incurred net operating losses of $8.9 million and used $23.7 million of cash for its operating activities. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time.

The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to us on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.

The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. At December 31, 2019, management believed that its capital resources were adequate to fund operations through June 2020. Additional working capital will be required to continue operations. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product development and clinical trial results; uncertainty regarding regulatory approval; technological uncertainty; uncertainty regarding patents and proprietary rights; comprehensive government regulations; limited commercial manufacturing, marketing or sales experience; and dependence on key personnel.

(2)

Basis of Consolidated Financial Statement Presentation

The accounting and financial reporting policies of the Company conform to generally accepted accounting principles in the United States of America (“GAAP”). The preparation of consolidated financial statements in conformity with GAAP requires management to make assumptions and estimates that impact the amounts reported in the Company’s consolidated financial statements. The consolidated financial statements include the accounts of all entities controlled by Delcath. All significant inter-company accounts and transactions are eliminated.

Reverse Stock Splits

All share numbers presented in these financial statements, including these footnotes reflect aone-for-five hundred (1:500) reverse stock split effected on May 2, 2018 and aone-for seven hundred (1:700) reverse stock split effected on December 24, 2019.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

(3)

Summary of Significant Accounting Policies

Use of Estimates

The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for derivative instrument liabilities, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates.

Cash Equivalents and Concentrations of Credit Risk

The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation (“FDIC”), however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution.

Restricted Cash

Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets.

Accounts Receivable

Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified.

Inventories

Inventories are valued at the lower of cost or net realizable value using thefirst-in,first-out method. The reported net value of inventory includes finished saleable products,work-in-process, and raw materials that will be sold or used in future periods. The Company reserves for expired, obsolete, and slow-moving inventory.

Property, Plant and Equipment

Property, plant and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. Maintenance and repairs are charged to operations as incurred. Expenditures which substantially increase the useful lives of the related assets are capitalized.

Derivative Instrument Liability

The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. Accounting for changes in the fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At December 31, 2019 and 2018, the Company did not have any derivative instruments that were designated as hedges.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

Fair Value Measurements

The Company adheres to ASC 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances.

ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy).

Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access.

Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals.

Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity.

In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability.

Revenue Recognition

Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied.

We may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing and commercialization components. These arrangements are often complex and we may receive various types of consideration over the life of the arrangement, including:up-front fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

Our results of operations for reporting periods beginning on or after January 1, 2018 are presented under ASC 606, Revenue from Contracts with Customers, while prior period amounts, as reported, are not adjusted. The effects of the adoption of the new standard in 2018 were not material to our consolidated financial statements. In assessing our revenue arrangements in accordance with ASC 606, Revenue from Contracts with Customers, we must identify the contract, determine the transaction price including an estimation of any variable consideration we expect to receive in connection with the contract, identify the promises of goods or services to the customer and each distinct performance obligation, allocate the transaction price to each of the performance obligations, and recognize revenue when or as the performance obligations are satisfied. Each of these steps in the revenue recognition process requires management to make judgements and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount we believe is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. We believe this provides a reasonable basis for recognizing revenue, however, actual results could differ from estimates and significant changes in estimates could impact our results of operations in future periods.

Deferred Revenue

License fees and milestones received in exchange for the grant of a license for the commercialization of CHEMOSAT are generally recognized over the development period, as the license is considered distinct from the delivery of product. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved.

Selling, General and Administrative

Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred.

Research and Development

Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred.

Stock Based Compensation

The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for employee services and ASC505-50, Equity-Based Payments toNon-Employees, which establishes accounting for equity-based payments tonon-employees. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders’ requisite service period (generally the vesting period of the equity grant). The Company is required to record compensation cost for all share-based payments granted to employees based upon the grant date fair value, estimated in accordance with the provisions of ASC 718. Under the provisions of ASC505-50, measurement of compensation cost related to common shares issued tonon-employees for services is based on the value of the services provided or the fair value of the shares issued. The measurement ofnon-employee stock-based compensation is subject to periodic adjustment as the underlying equity instrument vests. The Company expenses its share-based compensation for share-based payments granted under the accelerated method, which treats each vesting tranche as if it were an individual grant.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors andnon-employee contractors, with an exercise price greater than or equal to the fair market value of Delcath’s common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the award, the expected post-vesting option life, the expected volatility of Delcath’s stock over the option’s expected term, the risk-free interest rate over the option’s expected term, and Delcath’s expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards.

Income Taxes

The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740, Income Taxes. Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 14 for additional information.

Net Loss per Common Share

Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which the exercise price of the warrants was less than the last reported sales price of Delcath’s common stock on the final trading day of the period and there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, the impact of gains related to themark-to-market adjustment of the warrants outstanding at the end of the period is reversed and the treasury stock method is used to determine diluted earnings per share. As discussed in Note 11, the Series E Preferred Stock and the SeriesE-1 Preferred Stock were each determined to have a beneficial conversion feature which was accounted for as a deemed dividend.

For the years ended December 31, 2019 and 2018 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive:

   2019   2018 

Common stock warrants - equity

   —      6,005 

Common stock warrants - liability

   1,826,608    271 

Assumed conversion of Series E and SeriesE-1 Preferred Stock

   1,802,008    —   

Assumed conversion of convertible notes

   63,493    3,681 

Stock options

   1,640    —   
  

 

 

   

 

 

 

Total

   3,693,749    9,957 
  

 

 

   

 

 

 

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

Segment Information

The Company currently operates in one business segment, which is the development and commercialization of Melphalan/HDS and CHEMOSAT. A single management team that reports to the CEO and President comprehensively manages the business. Accordingly, the Company does not have separately reportable segments.

Foreign Currency and Currency Translation

Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations.

The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States Dollar (“USD”). Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions.

Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income.

Recently Adopted Accounting Pronouncements

In February 2018, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”)2018-02, Income Statement—Reporting Comprehensive Income (Topic 220). ASU2018-02 allows a company to elect a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU2018-02 is effective for periods beginning after December 15, 2018. Upon adoption of ASU2018-02, the Company did not elect to reclassify the tax effects of the Tax Cuts and Jobs Act from accumulated other comprehensive income to retained earnings, as the stranded tax effects were insignificant.

In February 2016, the FASB issued Accounting Standards Update(“ASU”) No. 2016-02, Leases (Topic 842)(“ASC 842”). In July 2018, the FASB issuedASU No. 2018-10, Codification Improvements to Topic 842, Leases(“ASU 2018-10”), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, andASU No. 2018-11, Leases (Topic 842)—Targeted Improvements(“ASU 2018-11”), which addressed implementation issues related to the new lease standard. These and certain other lease-related ASUs have generally been codified in ASC 842. ASC 842 supersedes the lease accounting requirements in ASC Topic 840,Leases (“ASC 840”). ASC 842 establishesa right-of-use model that requires a lessee to recorda right-of-use (“ROU”) asset and a lease liability on the balance sheet for all leases. Under ASC 842, leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The standard also requires disclosures to help investors and other financial statement users better understand the amount, timing and uncertainty of cash flows arising from leases. ASU2016-02 was effective for annual reporting periods beginning after December 15, 2018 and interim periods within that reporting period. The Company adopted ASC 842 on January 1, 2019 using the effective date transition method. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods.

The Company has elected certain practical expedients permitted under the transition guidance within ASC 842 to leases that commenced before January 1, 2019, including the package of practical expedients. The election of the package of practical expedients resulted in the Company not reassessing prior conclusions under ASC 840 related to lease identification, lease classification and initial direct costs for expired and existing leases prior to January 1, 2019. The Company did not elect the practical expedient to not record short-term leases on its consolidated balance sheet. The adoption ofASU 2016-02 did not have a significant impact on the Company’s consolidated results of operations or cash flows. See Note 9 for additional information.

SEC Disclosure Update and Simplification

In August 2018, the SEC adopted the final rule under SEC ReleaseNo. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. This final rule was effective on November 5, 2018. The adoption did not have a material impact on the Company’s consolidated financial statements.

(4)

Restricted Cash

Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded inRestricted Cash on the balance sheet. Restricted cash does not include required minimum balances.

                      
(in thousands)  December 31,
2019
   December 31,
2018
 

Cash and cash equivalents

  $10,002   $2,516 

Convertible Notes

   —      —   

Letters of credit

   131    1,012 

Security for credit cards

   50    50 
  

 

 

   

 

 

 

Total cash, cash equivalents and restricted cash shown in the statement of cash flows

  $10,183   $3,578 
  

 

 

   

 

 

 

(5)

Inventories

Inventories consist of:

                      
(in thousands)  December 31,
2019
   December 31,
2018
 

Raw materials

  $375   $358 

Work-in-process

   279    500 

Finished goods

   —      —   
  

 

 

   

 

 

 

Total Inventory

  $654   $858 
  

 

 

   

 

 

 

(6)

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets include the following:

                      
(in thousands)  December 31,
2019
   December 31,
2018
 

Clinical trial expenses

   725    —   

Insurance premiums

   589    140 

Security deposit

   51    51 

Income tax and VAT receivable

   31    579 

Other1

   363    128 
  

 

 

   

 

 

 

Total prepaid expenses and other current assets

  $1,759   $898 
  

 

 

   

 

 

 

1

Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% at December 31, 2019 and 2018.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

(7)

Property, Plant, and Equipment

Property, plant, and equipment consists of:

(in thousands)  December 31,
2019
   December 31,
2018
   

Estimated Useful Life

Buildings and land

  $589   $589   30 years - Buildings

Enterprise hardware and software

   1,739    1,742   3 years

Leaseholds

   1,695    1,701   Lesser of lease term or estimated useful life

Equipment

   1,025    1,002   7 years

Furniture

   198    198   5 years
  

 

 

   

 

 

   

Property, plant and equipment, gross

   5,246    5,232   

Accumulated depreciation

   (4,511   (4,307  
  

 

 

   

 

 

   

Property, plant and equipment, net

  $735   $925   
  

 

 

   

 

 

   

Depreciation expense for the years ended December 31, 2019 and 2018 was $0.2 million and $0.4 million, respectively.

(8)

Accrued Expenses

Current accrued expenses include the following:

(in thousands)  December 31,
2019
   December 31,
2018
 

Clinical trial expenses

  $2,497   $4,530 

Compensation, excluding taxes

   3,525    1,785 

Professional fees

   263    190 

Short-term portion of lease restructuring

   —      184 

Other1

   662    1,275 
  

 

 

   

 

 

 

Total accrued expenses

  $6,947   $7,964 
  

 

 

   

 

 

 

1

Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at December 31, 2019 and 2018.

(9)

Leases

The Company recognizesright-of-use (“ROU”) assets and lease liabilities when it obtains the right to control an asset under a leasing arrangement with an initial term greater than twelve months. The Company leases its facilities undernon-cancellable operating and financing leases.

The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

The following table summarizes the Company’s operating and financing leases as of December 31, 2019:

(in thousands)  US  Ireland  Total 

Lease Cost

    

Operating lease cost

  $710  $210  $920 

Financing lease cost

   42   —     42 

Sublease income

   (215  (175  (390
  

 

 

  

 

 

  

 

 

 

Total

  $537  $35  $572 
  

 

 

  

 

 

  

 

 

 

Other information

    

Operating cash flows out from operating leases

   (755  (210  (965

Operating cash flows in from operating leases

   215   175   390 

Operating cash flows out from financing leases

   (39  —     (39

Right-of-use assets exchanged for new operating lease liabilities

   874   —     874 

Weighted average remaining lease term

   1.1   1.8  

Weighted average discount rate - operating leases

   8  8 

Maturities of the Company’s operating leases, excluding short-term leases, are as follows:

(in thousands)  US   Ireland   Total 

Year ended December 31, 2020

  $498   $210   $708 

Year ended December 31, 2021

   79    122    201 
  

 

 

   

 

 

   

 

 

 

Total

   577    332    909  

Less present value discount

   (27   (21   (48
  

 

 

   

 

 

   

 

 

 

Operating lease liabilities included in the condensed consolidated balance sheet at December 31, 2019

  $550   $311   $861 
  

 

 

   

 

 

   

 

 

 

(10)

Outstanding Debt

On June 6, 2019, the Company entered into an agreement with two institutional investors, pursuant to which the investors agreed to transfer and surrender warrants to purchase 5,605 shares of the Company’s common stock (the “Series D Warrants”) and warrants to purchase 0.1 million shares of the Company’s common stock (the“Pre-Funded Series D Warrants”) for cancellation by the Company. Under the terms of the Purchase Agreement, the Company agreed to sell and issue to the investors 8% Senior Secured Promissory Notes in an aggregate principal amount of $2.0 million in full payment and satisfaction of the purchase price for the Series D Warrants andPre-Funded Series D Warrants. This agreement was effective on July 15, 2019, upon the closing of the Company’s Private Placement discussed further in Note 11. Following the closing of the Private Placement, the Company entered into an agreement under which the 8% Senior Secured Promissory Notes became convertible into shares of Series E Preferred Stock and Warrants at the price of $1,500 per Unit. The principal is recognized in Convertible notes payable, long-term on the consolidated balance sheet.

On April 19, 2019, April 26, 2019, May 9, 2019 and May 23, 2019, the Company issued 8% senior secured notes (collectively, the “2019 Notes”) in the aggregate principal amount of $3.3 million, to two institutional investors. The 2019 Notes bore interest at the rate of 8% per annum and were to mature on thesix-month anniversary of issuance in each case. The 2019 Notes were not convertible. The 2019 Notes contained standard events of default and remedies and are secured by a lien on the Company’s assets. The 2019 Notes were exchanged as part of the recent equity financing discussed further in Note 11 and are no longer outstanding.

In March 2019, the Company exchanged all issued and outstanding shares of its Series D Preferred Stock (having an aggregate stated value of $1,160,000) and received $400,000 in cash proceeds in exchange for a senior secured promissory note (the “March 2019 Note”) in the principal amount of $1,560,000. The March 2019 Note bore interest at the rate of 8% per annum, and were to mature on April 1, 2020, and was not convertible. The March 2019 Note was exchanged as part of the recent equity financing discussed further in Note 9 and is no longer outstanding.

On June 4, 2018, July 21, 2018, August 29, 2018, and September 21, 2018, the Company issued 8% senior secured convertible notes (collectively, the “2018 Notes”) in the aggregate principal amount of $9.4 million to several institutional investors. The

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

2018 Notes bore interest at the rate of 8% per annum and had maturity dates between December 2018 and March 2021. The 2018 Notes were initially convertible and secured pursuant to a Security Agreement which created a first priority security interest in all of the personal property (other than Excluded Collateral as defined in the Security Agreement) of the Company of every kind and description, tangible or intangible, whether currently owned and existing or created or acquired in the future. In March 2019, the Company amended the June 2018, July 2018 and August 2018 Notes to make themnon-convertible. There was no impact to the financial statements. In April 2019, the Company received notices of default from the investors in the 2018 Notes which resulted in a 25%, or $1.1 million, increase in principal and an increase in the interest rates from 8% to 18%. The 2018 Notes were exchanged as part of the recent equity financing discussed further in Note 9 and are no longer outstanding.

The following table provide a summary of the outstanding Note at December 31, 2019:

(in millions)  Conversion
price
   Current
interest

rate
  Principal 

Long term convertible notes payable

     

8.0% July 2019 Notes

  $1,500    8 $2.0 

The following table provides a summary of the Notes by their maturity dates (absent provisions of default) at December 31, 2018:

(in millions)  Interest
rate
  Conversion
price
   Principal   Unamortized
Discount
  Carrying
value
 

December 4, 2018

   8.0 $1.75   $1.7   $—    $1.7 

March 1, 2019

   8.0  1.75    0.6    (0.5  0.1 

March 21, 2019

   8.0  1.75    0.4    (0.2  0.2 

December 4, 2019

   8.0  1.75    0.9    (0.9  —   

March 1, 2020

   8.0  1.75    0.8    (0.8  —   

March 21, 2020

   8.0  1.75    0.1    (0.1  —   
     

 

 

   

 

 

  

 

 

 

Total Convertible Notes Payable, net

     $4.5   $(2.5 $2.0 
     

 

 

   

 

 

  

 

 

 

(11)

Stockholders’ Equity

Preferred Stock Issuances

Series AE and SeriesE-1 Preferred Stock

On July 11, 2019, the Company entered into a securities purchase agreement with certain accredited investors pursuant to which Delcath sold to investors an aggregate of 20,000 shares of our Series E convertible preferred stock, par value $0.01 per share, or the Series E Preferred Stock, at a price of $1,000 per share and a warrant, or a 2019 E Warrant, to purchase a number of shares of common stock equal to the number of shares of common stock issuable upon conversion of the Series E Preferred Stock purchased by the investor, or the July 2019 Private Placement. In connection with the July 2019 Private Placement, the Company exchanged $11.8 million of debt, interest and Series D Warrants for 11,500 shares of Series E Preferred Stock and related 2019 Warrants, $0.1 million in accounts payables for 149 shares of Series E Preferred Stock and related 2019 Warrants and issued 923 shares of Series E Preferred Stock and related 2019 Warrants to certain investors in exchange for a waiver of rights under exchange agreements signed in December 2018 and March 2019, or the Debt Exchange.

On August 19, 2019, the Company entered into a securities purchase agreement with certain accredited investors pursuant to which Delcath sold to investors an aggregate of 9,510 shares of SeriesE-1 convertible preferred stock, par value $0.01 per share, or the SeriesE-1 Preferred Stock, at a price of $1,000 per share and a warrant, or a 2019E-1 Warrant, and together with the 2019 E Warrant, the 2019 Warrants, to purchase a number of shares of common stock of the Company equal to the number of shares of common stock issuable upon conversion of the SeriesE-1 Preferred Stock purchased by the investor, or the August 2019 Private Placement, and, collectively with the July 2019 Private Placement, the Private Placements.

Each share of Series E Preferred Stock and SeriesE-1 Preferred Stock, or, collectively, the Preferred Stock, was originally convertible at any time at the option of the holder into the number of shares of common stock determined by dividing the stated

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

value by the conversion price of $42.00, subject to certain limitations and adjustments, or the Conversion Price. Except for certain adjustments, the holders of the Preferred Stock are entitled to receive dividends on shares of Preferred Stock equal (on an “as converted” basis) to and in the same form as dividends paid on shares of the common stock. Any such dividends that are not paid to the holders of the Preferred Stock will increase the stated value. No other dividends will be paid on shares of Preferred Stock. Each 2019 Warrant had an original exercise price equal to $42.00, subject to adjustment in accordance with the terms of the 2019 Warrants, or the Exercise Price, and became exercisable at any time upon the consummation of the Reverse Split and will be exercisable until 5:00 p.m. (NYC time) on the date that is five years following the date of the Reverse Split.

Pursuant to the terms of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants were initially subject to adjustment in each of the following circumstances: (i) on the third trading day following the date that the Company effects a reverse stock split, or the Reverse Split Reset Date, (ii) the date that the initial registration statement covering the shares of common stock issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants is declared effective by the SEC, or the Registration Reset Date, and (iii) in the event that all of the shares of common stock which we were required to register with the SEC were not then registered on an effective registration statement, the date that all of the shares underlying the respective Preferred Stock and 2019 Warrants may be sold pursuant to Rule 144, or the Rule 144 Reset Date, each of such reset dates, a Reset Date and, collectively, the Reset Dates. On each Reset Date, the Conversion Price and the Exercise Price were to be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the common stock immediately prior to each Reset Date, or the Reset Formula. In the event of a reduction in the Exercise Price, the aggregate number of Warrant Shares issuable upon the exercise of the 2019 Warrants were to be increased such that the aggregate Exercise Price of the Warrants on the day immediately following such Reset Date equaled the aggregate Exercise Price immediately prior to such adjustment. In addition, from the date of issuance of the Preferred Stock and Warrants until such time that the Company’s common stock is listed or quoted on a national exchange, the Conversion Price and the Exercise Price are subject to price-based anti-dilution protections.

The Registration Reset Date occurred on November 7, 2019. However, pursuant to the Reset Formula, no reduction in the Conversion Price or the Exercise Price occurred on the Registration Reset Date. The Reverse Split Reset Date occurred on December 30, 2019. Pursuant to the Reset Formula, the Conversion Price and the Exercise Price were reduced to $23.04 per share as of the Reverse Split Reset Date. The Rule 144 Reset Date with respect to the Series E Preferred Stock and the Series E Warrants occurred on January 15, 2020, but no reset in the Conversion Price or the Exercise Price of the Series E Preferred Stock or the Series E Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale. The Rule 144 Reset Date with respect to the SeriesE-1 Preferred Stock and the SeriesE-1 Warrants occurred on February 19, 2020, but no reset in the Conversion Price or the Exercise Price of the SeriesE-1 Preferred Stock or the SeriesE-1 Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale.

As a consequence of the reduction of the Conversion Price on the Reverse Split Reset Date, an additional 813,473 shares of common stock became issuable upon the conversion of the Preferred Stock and, as a consequence of the reduction of the Exercise Price on the Reverse Split Reset Date, an additional 824,587 shares of common stock became issuable upon the exercise of the 2019 Warrants, or collectively the Reset Shares. Pursuant to the terms of the registration rights agreements entered into in connection with the Private Placements and the Debt Exchange we were required to register a number of shares of our common stock that would be issuable assuming that the Conversion Price and the Exercise Price were $16.10 per share, regardless of the actual Conversion Price or the Exercise Price. Pursuant to that requirement, we registered a total of 3,429,680 shares of common stock for sale or other disposition by the Selling Stockholders on our registration statement on FormS-1 (FileNo. 333-235751), or the Second Registration Statement, which included the Rosalind Shares, the Reset Shares and an additional 1,564,085 shares of our common stock, or the Registrable Shares, even though we were obligated to issue only the Reset Shares as a result of the Reverse Split. However, because the Second Registration Statement was not declared effective until January 7, 2020, the Company is liable to Rosalind for liquidated damages under the terms of the registration rights agreements relating to the Private Placements and the Debt Exchange for the period from December 28, 2019 and January 7, 2020.

The Company received net proceeds after expenses of $26.6 million. As discussed above, the Company exchanged $11.8 million of debt, interest and Series D Warrants for 11,500 shares of Series E Preferred Stock and related warrants. The Company also exchanged $0.1 million in accounts payables for 149 shares of Series E Preferred Stock and related warrants and issued 923 shares of Series E Preferred Stock and related Warrants to certain investors in exchange for a waiver of rights under exchange agreements signed in December 2018 and March 2019. Of the net proceeds and equitized value received, the Company allocated an estimated fair value of $20.8 million to the 2019 Warrants. As a result of the Series E Preferred Stock and SeriesE-1

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

Preferred Stock having an effective conversion price that was lower than the market price on the date of issuance, the Company has recognized a beneficial conversion feature of $18.3 million. Due to the Series E Preferred Stock and SeriesE-1 Preferred Stock being immediately convertible, the beneficial conversion feature was recognized in full as a deemed dividend.

Series D Preferred Stock

On November 5, 2018, the Company’s Board authorized the establishment of a new series of preferred stock designated as Series D Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock. On March 29, 2019, the Company exchanged all issued and outstanding shares of its Series D Preferred Stock (having an aggregate stated value of $1,160,000) and received $400,000 in cash proceeds in exchange for the issuance of the March 2019 Notes. Please see the discussion under Notes 10 and 11 above.

Common Stock Issuances

Series E and SeriesE-1 Convertible Preferred Stock Conversions

565 shares of Series E and SeriesE-1 Convertible Preferred Stock were converted into 13,455 shares of common stock, $0.01 par value per share, during 2019.

Pre-Funded Series D Warrant Exercises

5,379Pre-Funded Series D Warrants were exercised during 2018.

December 2018 Warrant Exchange

In December 2018, the Company entered into exchange agreements with several institutional investors with respect to their November 2017 Warrants and February 2018 Warrants. The Company issued to the investors 1,179 shares of Common Stock (the “Exchange Shares”) in exchange for the Existing Warrants (the “Exchange”). The Exchange was made in reliance upon the exemption from registration provided by Section 3(a)(9) of the Securities Act of 1933, as amended.

September 2018 Rights Offering

In September 2018, the Company completed the sale of 6,669 shares of its common stock, with net proceeds after expenses of approximately $7.0 million. The rights offering was made pursuant to a Registration Statement on FormS-1 that was made effective on August 3, 2018.

February 2018 Financing

In February 2018, the Company completed the sale of 606 shares of its Common Stock, 109pre-funded warrants and the issuance of warrants to purchase 1,429 common shares (the “February 2018 Warrants”) pursuant to a placement agent agreement, with net proceeds after expenses of $4.3 million. The February 2018 Warrants are exercisable one year after the anniversary date of their issuance. At December 31, 2018, the February 2018 Warrants were exercisable at $7,000 per share with 273 warrants outstanding. The Company allocated an estimated fair value of $18.3 million to the February 2018 Warrants. The Company valued the February 2018 Warrants using the following inputs: exercise price of $7,000; contractual term of six years; volatility of 122.68% and risk-free rate of approximately one percent. Due to certain price protection features in the agreement, the February 2018 Warrants were accounted for as a derivative liability at issuance and will be subsequently marked to market through the statement of operations.

In October 2018, the Company filed a registration statement on FormS-3 with the SEC, which was declared effective on December 21, 2018 and allows the Company to offer and sell, from time to time in one or more offerings, up to $100.0 million of common stock, preferred stock, warrants, debt securities and stock purchase contracts as it deems prudent or necessary to raise capital at a later date. The Company has lost its FormS-3 eligibility due to the late filing of its Form10-K for the year ended December 31, 2018. Absent prior relief from the SEC, we expect to regainS-3 eligibility on June 1, 2020.

Stock Incentive Plans

The Company’s 2019 Equity Incentive Plan (the “Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers,

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

directors, employees, consultants and advisors are eligible to receive grants under the Plan. The maximum number of shares reserved for issuance under the Plan is 2,142. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair value on the dates of grant. As of December 31, 2019, the Plan had approximately 502 shares available for grant.

The following is a summary of stock option activity under the Plan for the year ended December 31, 2019:

   Number of
Shares
   Weighted Average
Exercise Price
   Weighted Average
Remaining
Contractual Term
(Years)
   Aggregate
Intrinsic
Value
 

Outstanding at January 1, 2019

   —         

Granted

   1,782   $196.70     

Exercised

   —         

Cancelled/Forfeited

   (142  $196.70     
  

 

 

       

Outstanding at December 31, 2019

   1,640   $196.70    9.1   $—   
  

 

 

   

 

 

   

 

 

   

 

 

 

Exercisable at December 31, 2019

   1,502   $196.70    9.1   $—   
  

 

 

   

 

 

   

 

 

   

 

 

 

At December 31, 2019, there was approximately $25,000 of total unrecognized compensation expense related tonon-vested share-based compensation awards under the plans for employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 0.1 year. For the years ended December 31, 2019 and 2018, the Company recognized compensation expense $0.3 million and compensation income of $0.04 million, respectively, related to stock options granted to employees and board members.

For the year ended December 31, 2019 the Company did not recognize any restricted stock compensation expense. For the year ended December 31, 2018, the Company recognized compensation expense of approximately $0.1 million related to restricted stock granted to employees and consultants.

(in thousands)  Twelve months ended
December 31, 2019
   Twelve months ended
December 31, 2018
 

Selling, general and administrative

  $213,807   $120,850 

Research and development

   59,391    (61,867
  

 

 

   

 

 

 

Total

  $273,198   $58,983 
  

 

 

   

 

 

 

Warrants

The following is a summary of warrant activity for the years ended December 31, 2019 and 2018:

   Warrants   Exercise Price per
Share
  Weighted Average
Exercise Price
   Weighted Average
Remaining Life
(Years)
 

Outstanding at January 1, 2018

   20   $857,500 -

 $13,798,400,000

  $4,868,205,366    4.88 

Warrants issued

   100,352      222   

Warrants exercised

   (6,536     1,252   

Warrants expired

   (1     13,798,400,000   
  

 

 

       

Outstanding at December 31, 2018

   93,835   $7 - $7,000  $151    5.75 

Warrants issued

   1,826,579      42   

Warrants exercised

   (11,285     7   

Warrants exchanged

   (82,521     170   
  

 

 

       

Outstanding at December 31, 2019

   1,826,608   $7 - $23  $23    4.99 
  

 

 

       

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

(12)

Fair Value Measurements

The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2019:

Fair Value Measurements Using Significant Unobservable

Inputs (Level 3)

(in thousands)  Warrant Liability 

Balance at January 1, 2018

  $560 

Fair value of warrants issued

   23,533 

Total change in the liability included in earnings

   (19,706

Reclass from liability to equity

   (4,210

Fair value of warrants exchanged

   (144
  

 

 

 

Balance at December 31, 2018

   33 
  

 

 

 

Total change in the liability included in earnings

   (17,498

Reclass from liability to equity

   (11

Fair value of warrants issued

   20,844 
  

 

 

 

Balance at December 31, 2019

   3,368 
  

 

 

 

At December 31, 2018, the Company had a total of 179 February 2018 Warrants outstanding, which were surrendered pursuant to a settlement agreement entered into between the Company and the holders of the February 2018 Warrants on April 18, 2019 and final payment under the settlement was made on July 16, 2019.

The fair value of the Warrants at December 31, 2019 was determined by using option pricing models assuming the following:

   December 31,  December 31, 
   2019  2018 

Expected life (in years)

   4.6   1.1 - 5.1 

Expected volatility

   207.5  145.7% - 265.3

Risk-free interest rates

   1.7  2.5% - 2.6

The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2019 and 2018, aggregated by the level in the fair value hierarchy within which those measurements fall.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

   Assets and Liabilities Measured at Fair Value on a Recurring Basis 
   Level 1   Level 2   Level 3   Balance at
December 31,
 
(in thousands)  2019   2018   2019   2018   2019   2018   2019   2018 

Liabilities

                

Derivative instrument liabilities

  $—     $—     $—     $—     $3,368   $33   $3,368   $33 

For the twelve months ended December 31, 2019 and 2018 there were no transfers in or out of Level 1, 2 or 3 inputs.

(13)

Commitments

Financing Lease

In January 2019, the Company entered into an amendment (the “Park Road Lease Amendment”) to a lease agreement entered into in October 2018 (the “Park Road Lease”) for approximately 6,000 square feet of space located at95-97 Park Road in Queensbury, New York. Under the terms of the Park Road Lease Amendment, the original two year term which began on October 31, 2018 was extended through November 2020 and provides for total annual base rent of $50,000 per year.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

Operating Leases

In September 2018, the Company entered into an amendment (the “1633 Sublease Amendment”) to asub-lease agreement executed in March 2016 (the “1633 Sublease) for approximately 6,877 square feet of office space at 1633 Broadway, New York, NY. The term began in April 2016 and under the terms of the 1633 Sublease Amendment is extended through February 2021 and provides for total annual base rent of $0.5 million.

In August 2011, Delcath Systems Ltd. entered into an agreement of lease for an office and manufacturing facility located in the city of Galway, Ireland. This facility is approximately 19,200 square feet and is intended to be the location of Delcath’s European headquarters. The Lease is for a term of ten years, commencing August, 2011. The Lease provides for fixed annual lease amounts payable in advance in equal quarterly installments. The remaining annual lease amount is $0.2 million. Delcath Systems Ltd. is also required to pay for customary building operating expenses. Delcath Systems Ltd.’s payment obligations and performance of the Lease are guaranteed by Delcath. The Company hassub-leased a portion of this facility.

Future minimum lease payments, net of receipts due under the terms of subleases, under all operating leases at December 31, 2019 are as follows:

(in thousands)  Future Lease Payments 

2020

   635 

2021

   79 
  

 

 

 
  $714 
  

 

 

 

For the years ended December 31, 2019 and 2018 rent expense, net of receipts under the terms of subleases, totaled approximately $0.5 million and $0.6 million, respectively.

Letters of Credit

Under the terms of asub-lease agreement for office space at 1633 Broadway, New York, NY, the Company is required to maintain a letter of credit in the amount of $0.1 million which will expire with the sublease in February 2021.

(14)

Income Taxes

There is no income tax expense recognized for the years ended December 31, 2019 and 2018, respectively.

Loss before taxes consists of:

(in thousands)  December 31, 2019   December 31, 2018 

Domestic

  $(4,882  $(12,961

Foreign

   (3,997   (6,261
  

 

 

   

 

 

 

Income (loss) before taxes

  $(8,879  $(19,222
  

 

 

   

 

 

 

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

The provision for income taxes differs from the amount computed by applying the statutory rate as follows:

(in thousands)  December 31, 2019   December 31, 2018 

Income taxes using U.S federal statutory rate

  $(1,865  $(4,037

Tax Cuts and Jobs Act

   —      —   

Nondeductible interest

   994    2,273 

Loss on extinguishment of debt

   361    236 

Loss of tax benefit of federal net operating loss carryforwards

   —      (588

Loss of tax benefit of state net operating loss carryforwards

   1,477    1,040 

Loss of tax benefit of federal tax credit carryforwards

   324    495 

Amortization of gain on IP migration

   —      —   

State income taxes, net of federal benefit

   (1,461   (2,355

Foreign rate differential

   664    1,166 

Valuation allowance

   3,512    6,323 

Derivative charge

   (3,674   (4,138

Stock option exercises and cancellations

   —      215 

Research and development costs

   (316   (636

Other

   (16   6 
  

 

 

   

 

 

 
  $—     $—   
  

 

 

   

 

 

 

Significant components of the Company’s deferred tax assets are as follows:

(in thousands)  December 31, 2019   December 31, 2018 

Deferred tax assets:

    

Equity compensation

  $84   $—   

Accrued liabilities

   —      519 

Research tax credits

   135    161 

Lease obligation

   206   

Other

   72    60 

Net operating losses

   14,502    10,624 
  

 

 

   

 

 

 

Total deferred tax assets

  $14,999   $11,364 
  

 

 

   

 

 

 

Deferred tax liabilities:

    

Beneficial conversion feature

   —      —   

Right of use asset

   206    —   

Other

   —      —   
  

 

 

   

 

 

 

Total deferred tax liabilities

   206    —   
  

 

 

   

 

 

 

Valuation allowance

   14,793    11,364 
  

 

 

   

 

 

 

Net deferred tax assets

  $—     $—   
  

 

 

   

 

 

 

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

As of December 31, 2019 and 2018 the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately $246.3 million and $230.0 million, respectively. A significant portion of the federal amount is subject to an annual limitation as low as $27,500 as a result of changes in the Company’s ownership in May 2003, November 2016, and multiple dates throughout 2017, 2018 and 2019, as defined by Federal Internal Revenue Code Section 382 and the related income tax regulations. As a result of the limitations caused by the May 2003, November 2016 and multiple 2017, 2018 and 2019 ownership changes, approximately $207.0 million of the total net operating loss carryforwards is expected to expire unutilized and will be unavailable to offset future federal taxable income. Approximately $39.3 million of net operating loss carryforwards remains available to offset future federal taxable income, of which $1.7 million will expire between 2020 and 2037 and $37.6 million will have an unlimited carryforward period as a result of the Tax Cuts and Jobs Act.

In addition, the Company’s state net operating losses are also subject to annual limitations that generally follow the federal Section 382 provisions (with the exception of Connecticut), adjusted for each state’s respective income apportionment percentages. As of December 31, 2019 and 2018, the Company had net operating loss carryforwards for state and city income tax purposes between approximately $27.3 million and $180.6 million and between approximately $27.3 million and $167.3 million, respectively, which expire through 2039. As a result of the 382 limitations, approximately $169.4 million and $153.7 million of New York State and New York City net operating losses are expected to expire unutilized and will be unavailable to offset future taxable income. Approximately $11.2 million and $11.2 million of net operating loss carryforwards, respectively, will be available to offset future state and city taxable income. As of December 31, 2019 and 2018 the Company had a net operating loss carryforward for foreign income tax purposes of $26.1 million and $25.2 million, respectively, which have indefinite carryforward periods. As of December 31, 2019 and 2018, the Company had federal research and development tax credit carryforwards of approximately $5.3 million and $5.0 million respectively, which expire through 2039. As a result of the section 382 limitations, all but $0.1 million of the tax credit carryforwards is expected to expire unutilized.

Management has established a 100% valuation allowance against the deferred tax assets as management does not believe it is more likely than not that these assets will be realized. The Company’s valuation allowance increased by approximately $3.4 million and increased by $5.4 million in 2019 and 2018, respectively. The change in valuation is as follows:

(in thousands)  December 31, 2019   December 31, 2018 

Beginning balance

  $11,364   $5,972 

Charged to costs and expenses

   3,512    6,323 

Charged to additionalpaid-in capital

   —      —   

Charged to retained earnings

   —      (834

Charged to other comprehensive income

   (83   (97
  

 

 

   

 

 

 

Ending balance

  $14,793   $11,364 
  

 

 

   

 

 

 

On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (the “Act”). The Act, which is also commonly referred to as “U.S. tax reform”, significantly changes U.S. corporate income tax laws by, among other provisions, reducing the maximum U.S. corporate income tax rate from 35% to 21% starting in 2018. During the year ended December 31, 2017, the Company reduced deferred tax assets by a provisional amount of $143,500, offset by a corresponding reduction to its valuation allowance, as a result of there-measurement of deferred tax assets and liabilities from its 34% effective rate under existing law to the new lower statutory rate of 21%. The Company finalized its accounting of the effects of tax reform in 2018, which resulted in insignificant adjustments.

The Act also requires a mandatoryone-time inclusion of the deferred foreign income of controlled foreign corporations. Theone-time transition tax is based on Delcath’s total post-1986 earnings and profits (E&P) for which the Company has previously deferred from U.S. income taxes. During the year ended December 31, 2017, the Company’s reasonable estimate resulted in no provisional amount for theone-time transition tax liability, as the Company’s international subsidiaries are expected to have a cumulative deficit in E&P. As the Company’s international subsidiaries have a cumulative deficit in earnings and profits, the Company did not anticipate being affected by the mandatory inclusion provisions of the Act. The Company finalized its calculation of the total post-1986 foreign E&P (including deficits) for these foreign subsidiaries during 2018 and was not impacted by the mandatory inclusion provisions of the Act.

On December 22, 2017, Staff Accounting Bulletin 118 was issued due to the complexities involved in accounting for the recently enacted Act. SAB 118 requires the Company to include in its financial statements a reasonable estimate of the impact of the Act on earnings to the extent such estimate has been determined. Accordingly, the U.S. provision for income tax for December 31, 2017 was based on the reasonable estimate guidance provided by SAB 118. The Company finalized the impact from the Act during 2018 and recorded insignificant adjustments.

DELCATH SYSTEMS, INC.

Notes to Consolidated Financial Statements

for the Years Ended December 31, 2019 and 2018

The Company complies with the provisions of ASC740-10, Income Taxes, in accounting for its uncertain tax positions. ASC740-10 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC740-10, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The Company has determined that the Company has no significant uncertain tax positions requiring recognition under ASC740-10 and therefore has not included a tabular rollforward of unrecognized tax benefits. As there are no uncertain tax positions recognized, interest and penalties have not been accrued.

The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The Company has not been audited by any state tax authorities in connection with income taxes. The Company has not been audited by international tax authorities or any states in connection with income taxes. The Company’s New York State tax returns have been subject to annual desk reviews which have resulted in insignificant adjustments to the related franchise tax liabilities and credits. The Company is no longer subject to federal and state examination for tax years ending prior to December 31, 2016; tax years ending December 31, 2016 through December 31, 2019 remain open to examination. The Republic of Ireland is the Company’s only significant foreign jurisdiction. The Company is no longer subject to Ireland tax examination for tax years ending prior to December 31, 2015 (as Ireland has not initiated an audit of 2014 as of December 31, 2019); tax years ending December 31, 2014 through December 31, 2018 remain open to examination. However, the Company’s tax years December 31, 1998 through December 31, 2019 generally remain open to adjustment for all federal, state and foreign tax matters until its net operating loss and tax credit carryforwards are utilized or expire prior to utilization, and the applicable statutes of limitation have expired in the utilization year. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations.

Delcath recognizes interest accrued related to unrecognized tax benefits and penalties, if incurred, as a component of income tax expense.

(15)

Subsequent Events

Since January 1, 2020, the Company has issued 2,915 shares pursuant to conversions of Series E and SeriesE-1 Convertible Preferred Stock.

In May 2018, the Company received a Demand Letter from a vendor for an outstanding balance owed at that time of $2.1 million. At that time, the Company agreed with the vendor on a payment plan for the balance owed. Subsequent to December 31, 2019, the vendor issued a notice of default relating to the Demand Letter. As a result, the Company paid $0.9 million, representing the remaining balance owed.

In February 2020, we issued 2,717 shares of restricted common stock in relation to certain advisory services received by us. In connection with the foregoing, we relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, for transactions not involving a public offering.

In connection with our proposed public offering (the “Proposed Offering”) of our securities pursuant to our registration statement on Form S-1 (File No. 333-235904), and the potential listing of the Company’s common stock, par value $0.01 per share (the “Common Stock”) on the Nasdaq Capital Market in connection therewith, on March 11, 2020, the Company entered into a support and conversion agreement (the “Support and Conversion Agreement”) with Rosalind Master Fund L.P. and Rosalind Opportunities Fund I L.P. (collectively, “Rosalind”) and our executive officers. The Support and Conversion Agreement provides that, among other things, the executive officers have agreed to receive payment of the net after-tax amount of their 2019 annual incentive bonuses aggregating $221,000 in unregistered shares of Common Stock, valued at the public offering price of the securities sold in the Proposed Offering, upon the consummation of the Proposed Offering. In addition, following the consummation of the Proposed Offering, (i) Rosalind has agreed that from time to time the Company may require them to convert all or a portion of their 8% senior secured promissory notes in the aggregate principal amount of $2 million (the “Notes”) into shares of the Company’s Series E convertible preferred stock (the “Series E Preferred Stock”) and Series E warrants at the contractual conversion price of $1,500 per share of Series E Preferred Stock in certain circumstances described below (a “Rosalind Conversion”), and (ii) the Company’s executive officers have agreed to receive payment of the net after-tax amounts of back pay and deferred bonuses aggregating $765,000 in unregistered shares of Common Stock (an “Equitization Transaction,” and together with a Rosalind Conversion, an “Equity Infusion”). The shares of Common Stock issuable in an Equitization Transaction would have a value equal to the greater of (x) the last reported sale price per share as of the trading day immediately preceding the Equity Infusion Date (as defined below) and (y) the volume-weighted average price of the Common Stock for the five trading days immediately preceding the Equity Infusion Date.

The recent outbreak of a novel strain of coronavirus (COVID-19) has had an impact on our ability to monitor data at our clinical trial sites and is likely to cause a decline in product revenue for the forseeable future as many hospitals are prioritizing the treatment of patients diagnosed with COVID-19. This situation is rapidly changing and additional impacts to the business may arise that we are not aware of currently. The ultimate impact of the pandemic on the Company’s results of operations, financial position, liquidity or capital resources cannot be reasonably estimated at this time.

Unaudited

On April 8, 2020, we, Rosalind and our executive officers entered into an amendment (the “Amendment”) to the Support and Conversion Agreement. Pursuant to the Amendment, we agreed to, among other things, extend the expiration date of the Support and Conversion Agreement. As so amended, the Support and Termination Agreement will expire on the earlier of (i) the date on which all of Rosalind’s 8% senior secured promissory notes in the aggregate principal amount of $2 million have been converted or paid in full, or (ii) June 30, 2021; provided, however, that the Support and Conversion Agreement will terminate and be of no further force and effect (x) with respect to an executive officer, upon the effective date of the termination of the executive officer’s employment by us and (y) if Nasdaq approval is not obtained or the Proposed Offering is not consummated on or prior to the April 30, 2020 (the “Closing Deadline”) other than as a result of a failure by Rosalind to satisfy the Participation Condition (as such term is defined in the Board Appointment Agreement described below). In the Amendment, Rosalind notified us that it intends to participate in the Proposed Offering pursuant to the participation rights provided to it in the Support and Conversion Agreement.

We have also entered into a Board Appointment Agreement (the “Board Appointment Agreement”) with Rosalind pursuant to which we agreed to provide Rosalind with certain representation rights on our Board of Directors (the “Board”). Pursuant to the terms of the Board Appointment Agreement, Rosalind will have the right to nominate, and to cause the removal or replacement of, up to two directors for election to the Board (the “Rosalind Nominees”) in the event that the Proposed Offering is consummated on or prior to the Closing Deadline and Rosalind invests at least $4.0 million in the Proposed Offering on the same terms as the other investors in the Proposed Offering (the “Participation Condition”), or in the event that the Proposed Offering is not consummated on or prior to the Closing Deadline other than as a result of Rosalind’s failure to satisfy the Participation Condition. The Rosalind Nominees must meet all applicable requirements for treatment as independent directors under applicable SEC and Nasdaq rules and regulations. The Board has determined that Gil Aharon and Steven Salamon, the principals of Rosalind, would qualify as independent directors under such rules and One Rosalind Nominee would be appointed to the class of directors whose term expires at our 2022 annual meeting of stockholders and the other would be appointed to the class of directors whose term expires at our 2021 annual meeting of stockholders.

If Rosalind exercises its rights to nominate one or more Rosalind Nominees, Rosalind will also have the right to designate a Rosalind Nominee for service on any committee of the Board so long as such Rosalind Nominee meets any applicable SEC and Nasdaq requirements for membership on such committee.

If Rosalind exercises its rights to nominate one or more Rosalind Nominees, the Board will increase the size of the Board and elect the Rosalind Nominees to fill the vacancies created by such increase. Rosalind’s right to nominate one or more Rosalind Nominees as described above will expire, if unexercised, at 5:00 p.m. on May 5, 2020 or, prior thereto, if Rosalind ceases to be the beneficial owner of at least 9.99% of our common stock (determined without giving effect to any provision of any security limiting Rosalind’s beneficial ownership).

Until the later of such time as Rosalind exercises its nomination rights and April 30, 2020, the Board will not fill any vacancy on the Board with a candidate who is not approved by Rosalind. If Rosalind exercises its right to nominate one or more Rosalind Nominees, the Board has agreed that prior to our 2020 annual meeting of stockholders and, in any event, no later than June 30, 2020, the Board will meet to consider and approve a reduction in the size of the Board from eight to no fewer than six members. Any director who is asked to step down from the Board has agreed to resign at the end of the meeting.

LOGO

1,692,307 Shares of Common Stock

Series F Warrants to Purchase up to 1,692,307 Shares of Common Stock

Pre-Funded Warrants to Purchase up to 1,692,307 Shares of Common Stock

PROSPECTUS

Sole Book-Running Manager

Roth Capital Partners

Co-Lead Managers

Aegis Capital Corp.Laidlaw & Company (UK) Ltd.

The date of this prospectus is             , 2020


PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13.

Other Expenses of Issuance and Distribution.

The following table sets forth the costs and expenses, other than underwriter fees to be paid by us in connection with the sale of the shares of our common stock being registered hereby. All amounts are estimates except for the SEC registration fee, the FINRA filing fee and the NASDAQ listing fee. All such expenses will be borne by the Company.

SEC registration fee

  $6,568 

FINRA filing fee

   8,090 

NASDAQ listing fee

   50,000 

Legal fees and expenses

   100,000 

Accounting fees and expenses

   75,000 

Printing and engraving expenses

   5,000 

Transfer agent and registrar fees and expenses

   10,000 

Warrant agent fees and expenses

   5,000 

Other expenses

   15,342 
  

 

 

 

Total

  $275,000 
  

 

 

 

Item 14.

Indemnification of Directors and Officers.

Section 102(b)(7) of Delaware’s General Corporation Law (“DGCL”) allows a corporation to provide in its certificate of incorporation that a director of the corporation will not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except where the director breached the duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our amended and restated certificate of incorporation provides for this limitation of liability.

Section 145 of the DGCL, or Section 145, provides that a Delaware corporation may indemnify any person who was, is or is threatened to be made, party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person is or was an officer, director, employee or agent of such corporation or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who are, were or are a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person is or was a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit, provided such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporation’s best interests, provided that no indemnification is permitted without judicial approval if the officer, director, employee or agent is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him against the expenses which such officer or director has actually and reasonably incurred.

Section 145 further authorizes a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise, against any liability asserted against him and incurred by him in any such capacity, or arising out of his or her status as such, whether or not the corporation would otherwise have the power to indemnify him under Section 145.

Our amended and restated bylaws provides that we must indemnify our directors and officers to the fullest extent permitted by the DGCL and must also pay expenses incurred in defending any such proceeding in advance of its final disposition upon delivery of an undertaking, by or on behalf of an indemnified person, to repay all amounts so advanced if it should be determined ultimately that such person is not entitled to be indemnified.

II-1


We have entered into indemnification agreements with certain of our executive officers and directors pursuant to which have agreed to indemnify such persons against all expenses and liabilities incurred or paid by such person in connection with any proceeding arising from the fact that such person is or was an officer or director of our company, and to advance expenses as incurred by or on behalf of such person in connection therewith.

The indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter acquire under any statute, provision of our certificate of incorporation, our bylaws, agreement, vote of stockholders or disinterested directors or otherwise.

We maintain standard policies of insurance that provide coverage (1) to our directors and officers against loss rising from claims made by reason of breach of duty or other wrongful act and (2) to us with respect to indemnification payments that we may make to such directors and officers.

Item 15.

Recent Sales of Unregistered Securities

In connection with each of the following unregistered sales and issuances of securities, except as otherwise provided below, the Company relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated thereunder for transactions not involving a public offering.

On June 6, 2016, the Company completed a private placement, exempt for registration purposes under Section 4(a)(2) of the Securities Act, of $35 million aggregate principal amount of senior secured convertible notes (the “Notes”) pursuant to a Securities Purchase Agreement dated June 6, 2016 (the “SPA”) between the Company and certain institutional investors as set forth in the Schedule of Buyers attached to the SPA, as described in the Company’s Form8-K filed with the Securities and Exchange Commission on June 7, 2016.

The Notes were issued at an 8 percent original issue discount to the principal amount of Notes (a purchase price of $920 for each $1,000 principal amount of Notes and related warrants) for aggregate proceeds of $32.2 million. The Notes did not bear any ordinary interest and provided that the Company repay the principal amount of the Notes in equal monthly installments beginning seven months after the original date of issuance.

The Company also issued warrants to purchase one additional share of common stock to such institutional investors concurrently with the issuance of the Notes. The Company repurchased all of such warrants for cash, effective as of March 31, 2017.

On June 29, 2017, our Board authorized the establishment of a new series of preferred stock designated as Series A Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock (the “Series A Certificate of Designations”) which waswere filed with the State of Delaware on June 30, 2017 (together with any preferred shares issued in replacement thereof in accordance with the terms thereof, the “Series A Preferred Stock”). On July 2, 2017, we entered into an exchange agreement (the “Exchange”) with one of our investors which had purchased certain senior secured convertible notes (the “Notes”), convertible into shares of our common stock pursuant to a certain June 6, 2016 securities purchase agreement, of $4.2 million aggregate principal amount of such Notes for 4,200 shares of Series A Preferred Stock (the “Series A Preferred Shares”). The Exchange was made in reliance upon the exemption from registration provided by Rule 3(a)(9) of the Securities Act of 1933, as amended. The Series A Preferred Shares were entitled to the whole number of votes equal to $4.2 million divided by $3.68$901,600 (the closing bid price on June 13, 2016, the date of issuance of the Notes as adjusted for the reverse stock split effected in July 2016,) or 1,141,3045 votes. The Series A Preferred Stock had no dividend, liquidation or other preferential rights to our common stock, and each share of Series A Preferred Stock was redeemed for the amount of $0.001, paid in cash pursuant to the Restructuring Agreement signed$0.01 on August 28, 2017 and discussed in further detail below.2017.

Series B Preferred Stock

On June 29, 2017, our Board authorized the establishment of a new series of preferred stock designated as Series B Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock (the “Series B Certificate of Designations”) which was filed with the State of Delaware on June 30, 2017 (together with any preferred shares issued in replacement thereof in accordance with the terms thereof, the “Series B Preferred Stock”). On July 11, 2017, we entered into a securities purchase agreementan Amended and Restated Securities Purchase Agreement (the “Amended Purchase Agreement”) with existing holderscertain institutional investors for the sale by the Company of Notes pursuant to which

the investors purchased $2,360,0002,360 shares of Series B Preferred Stock for(the “Series B Preferred Stock”) at a cash purchase price of $2,000,000$1,000 per share, in a private placement. The aggregate gross proceeds for the sale of the Series B Preferred Stock was $2.0 million. The Company used the proceeds from the transaction for general corporate purposes. The restricted shares of Series B Preferred Stock had no registration rights and were not be eligible for legend removal for a period of at least six months from the date of closing. This Amended Purchase Agreement amends the July 5, 2017 Securities Purchase Agreement (the “Purchase Agreement”) into which we entered with certain institutional investors (the “Investors”) for the sale by the Company of 2,360 shares of Series B Preferred Stock in a registered direct offering. The Series B Preferred Stock was entitled to the whole number of votes equal to $2.0 million divided by $0.1867$45,745 (the closing bid price on July 5, 2017, the date of the original securities purchase agreement forsale of the Series B Preferred Stock), or 10,712,37244 votes. The Series B Preferred Stock had no dividend, liquidation or other preferential rights (but had the redemption rights described below)which are preferential to our common stock and could have been converted into shares of our common stock at a price equal to $0.153 per share upon the earlier of the date of closing to the extent that the holder thereof reallocated shares of our common stock reserved for issuance under its Notes to conversion of the Series B Preferred Shares and otherwise upon receipt of shareholder approval of the Reverse Stock Split.stock. The Series B Preferred Stock was redeemed for $2,360,000 pursuant to the Restructuring Agreement signed onin August 28, 2017 and discussed in further detail below.2017.

II-2


On August 28, 2017, wethe Company entered into a Restructuring Agreement (the “Agreement”) with one of the institutional investors (the “Investor”) who was a party to the Securities Purchase Agreement, dated June 6, 2016, by and among us, the Investor and certain other buyers signatory thereto (the “Securities Purchase Agreement”), pursuant to which the Investor and such other buyers acquired (i) certain senior secured convertible notes (the “Notes”), convertible into shares of our common stock, par value $0.01 per share (the “Common Stock”) and (ii) warrants to acquire shares of the Common Stock.SPA. As of the date the Agreement was entered into, the Investor held $11,444,637 aggregate principal amount of Notes of which there was $10,092,857 aggregate Restricted Principal, (as defined in the Notes) of Notes (the “Restricted Notes”), secured by such aggregate cash amount held in a collateral account of the Company in the same amount (the “Restricted Cash”) and (y) $1,351,780 principal of Notes (the “Unrestricted Notes”), (ii) 4,200 shares of Series A Convertible Preferred Stock issued by us to the Investor (the “Series A Preferred Shares”) and (iii) 2,006 shares of Series B Convertible Preferred Stock issued by us to the Investor (the “Series B Preferred Shares”). All terms used and not defined herein are used as defined in the Securities Purchase Agreement.Stock.

Pursuant to the Agreement, (a) on the date thereof wethe Company and the Investor took the following actions (the “Initial Restructuring”): (i) the Investor released restrictions on $1,650,000 of Restricted Cash (the “Initial Release”), (ii) the Investor consented to the use of additional Restricted Cash to effect redemptions of the Series A Preferred Shares and the Series B Preferred Shares, (iii) the Investor cancelled $1,200,000 aggregate principal of the Notes (such portion of the Notes, the “Cancellation Note”), (iv) wethe Company redeemed all the Series A Preferred Shares outstanding for a cash payment to the Investor of $4.20 (the “Series A Redemption Price”) and (v) wethe Company redeemed the Series B Preferred Shares for a cash payment to the Investor of $2,006,000 (the “Series B Redemption Price”) and (b) upon the consummation of a reverse stock split of our Common Stock of at least twenty to one (the “Reverse Stock Split Event”, and such date, the “Reverse Stock Split Date”), we by September 15, 2017, the Company and the Investor shall takehave taken the following actions (the “Additional Restructuring”, and together with the Initial Restructuring, the “Restructuring”): (i) the Investor shall consent to the use of Restricted Cash to effect redemptions of $4,000,000 aggregate Restricted Principal of the Restricted Notes (such portion of the Restricted Notes, the “Redemption Notes”), (ii) wethe Company shall redeem the Redemption Notes for a redemption price of $6,436,852.80$6.4 million (the “Redemption Price”) and (iii) the Company shall exchange (the “Exchange”), pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, $2,436,852.80 aggregate Restricted Principal of the Restricted Notes (such portion of the Restricted Notes, the “Exchange Notes”, and together with the Redemption Notes, the “Restructured Notes”) for new warrants to purchase 40,000,000164 shares of ourits Common Stock (the “New Warrants”, as exercised, the “New Warrant Shares”). The New Warrants expire on the 42 month anniversary of the date of issuance and bear an exercise price of $0.35$85,750 per share (which shall be adjusted to the new lower purchase price per share if there is a subsequent “down round” financing). The Investor, in lieu of an exercise of the New Warrants pursuant to a cash payment of the aggregate exercise price of the number of New Warrants being exercised, may exercise the New Warrants, in whole or in part, by electing instead to receive upon such exercise two shares and one hundred and twenty-five thousandths of a share of ourthe Company’s Common Stock for each Warrant Share exercised pursuant to this provision.]. As a result of the fact that a reverse stock split did not occur by September 15, 2017 (as required by the Restructuring Agreement), the second part of the contemplated restructuring will not take place without the consent of the Investor.

The transactions set forth herein were being made in reliance upon the exemption from registration provided by Rule 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”) and Rule 144(d)(3)(ii) of the 1933 Act.

Series C Preferred Stock

On September 12, 2017, our Board authorized the establishment As a result of a new series of preferred stock designated as Series C Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock (the “Series C Certificate of Designations”) which was filed with the State of Delaware on September 20, 2017 (together with any preferred shares issued in replacement thereof in accordance with the terms thereof, the “Series C Preferred Stock”). On September 21, 2017, we entered into a securities purchase agreement (the “SPA”) with two of our investors which had purchased certain senior secured convertible notes (the “Notes”), convertible into shares of our common stock pursuant to a certain June 6, 2016 securities purchase agreement, of $0.5 million aggregate purchase price for 590 shares of Series C Preferred Stock (the “Series C Preferred Shares”). The purchase of the Series C Preferred Stock is being made in reliance upon the exemption from registration provided by Rule 4(a)(2) of the Securities Act of 1933, as amended. The Series C Preferred Shares shall be entitled to 519,421,250 votes and may only vote on approval of a reverse split of our outstanding common stock. The Series C Preferred Stock has no dividend, liquidation or other preferential rights to our common stock, and each share of Series C Preferred Stock shall be redeemable for the amount of $1,000.00, payable in cash, per share at our written election, and must be redeemed by us no later than December 21, 2017.

Our Board of Directors has determined that it is advisable and in our and our stockholders’ best interests that the Board of Directors be granted the authority to implement, in its sole discretion,not having effected a reverse stock split ofby September 15, 2017, the outstanding and treasury shares of our common stock at a specific exchange ratio set by the Board of Directors, at a range of ratios 1:50, 1:100 or 1:350, in the discretion of the Board of Directors and to be announced by press release, and to grant authorization to the Board of Directors to determine, in its sole discretion, whether to implement the reverse stock split, as well as its specific timing (butAdditional Restructuring did not later than September 19, 2018).

Accordingly, on September 21, 2017, shareholders holding a majority of votes of our capital stock approved an amendment to our amended and restated certificate of incorporation to effect a reverse stock split consistent with such terms and to grant authorization to the Board of Directors to determine, in its sole discretion, whether to implement the reverse stock split, as well as its specific timing and ratio (within the set of ratios listed above).

The Board of Directors strongly believes that the reverse stock split is necessary for the following reasons:

1.To provide us with resources and flexibility with respect to our capital sufficient to execute our business plans and strategy –we do not have sufficient capital with which to run our business and meet our obligations and will need to raise further capital through sale of our equity securities.

2.To enable repayment of certain senior secured convertible notes (the “Notes”) in shares of Common Stock –we are permitted to repay amounts due under the Notes in shares of our Common Stock based upon certain formulae set forth in the Notes, and we do not have sufficient authorized and unissued shares available with which to repay those obligations with shares of our common stock.

This Action is substantially the same as Proposal 5 contained in our Definitive Proxy Statement for our Annual Meeting of Stockholders originally scheduled for June 5, 2017 and held on June 16, 2017 and the Proposal in our Definitive Proxy Statement for our Consent Solicitation, which expired on September 7, 2017. Although a majority of the shares of our outstanding common stock that were actually cast on such Action voted for such Action, the number of votes cast in favor of the Action was less than the majority of total outstanding shares of common stock as of the record date for that meeting, which is required for approval under Delaware law. As of the record date for our Annual Meeting of Stockholders, we had 167,883,213 shares of our common stock issued and outstanding. As of July 11, 2017, we had 490,022,209 shares issued and outstanding, which represents a 191.9% increase since the previous record date. As the Board of Directors continues to believe that the reverse stock split is necessary and appropriate and as a result of the significant recent changes to our stockholder base, the Board of Directors worked with our shareholders to purchase our Series C preferred stock which has 880,375 votes for share in order to effect the necessary reverse split of our common stock.

Accordingly, the Board of Directors has unanimously approved a resolution proposing an amendment to our amended and restated certificate of incorporation to allow for the reverse stock split and directed that it be approved by our shareholders which occurred by a written consent in lieu of a special meeting of shareholders on September 21, 2017.occur.

Amendment

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13.

Other Expenses of Issuance and Distribution.

The following table sets forth the costs and expenses, other than underwriter fees to Restructuring Agreement

As a resultbe paid by us in connection with the sale of the lack of requisite approval by our stockholders for our proposed reverse stock split, the parties and the two investors in the 2016 convertible note placement entered into an amendment to the August restructuring agreement on October 10, 2017 as follows: (i) on the date that we do effect a reverse splitshares of our common stock (x)being registered hereby. All amounts are estimates except for the SEC registration fee, the FINRA filing fee and the NASDAQ listing fee. All such expenses will be borne by the Company.

SEC registration fee

  $6,568 

FINRA filing fee

   8,090 

NASDAQ listing fee

   50,000 

Legal fees and expenses

   100,000 

Accounting fees and expenses

   75,000 

Printing and engraving expenses

   5,000 

Transfer agent and registrar fees and expenses

   10,000 

Warrant agent fees and expenses

   5,000 

Other expenses

   15,342 
  

 

 

 

Total

  $275,000 
  

 

 

 

Item 14.

Indemnification of Directors and Officers.

Section 102(b)(7) of Delaware’s General Corporation Law (“DGCL”) allows a corporation to provide in its certificate of incorporation that a director of the corporation will not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except where the director breached the duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our amended and restated certificate of incorporation provides for this limitation of liability.

Section 145 of the DGCL, or Section 145, provides that a Delaware corporation may indemnify any person who was, is or is threatened to be made, party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person is or was an officer, director, employee or agent of such corporation or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who are, were or are a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person is or was a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit, provided such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporation’s best interests, provided that no indemnification is permitted without judicial approval if the officer, director, employee or agent is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him against the expenses which such officer or director has actually and reasonably incurred.

Section 145 further authorizes a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise, against any liability asserted against him and incurred by him in any such capacity, or arising out of his or her status as such, whether or not the corporation would otherwise have the power to indemnify him under Section 145.

Our amended and restated bylaws provides that we willmust indemnify our directors and officers to the fullest extent permitted by the DGCL and must also pay expenses incurred in defending any such proceeding in advance of its final disposition upon delivery of an undertaking, by or on behalf of an indemnified person, to repay all amounts so advanced if it should be determined ultimately that such person is not entitled to be indemnified.

II-1


We have entered into indemnification agreements with certain of our executive officers and directors pursuant to which have agreed to indemnify such persons against all expenses and liabilities incurred or paid by such person in connection with any proceeding arising from the fact that such person is or was an officer or director of our company, and to advance expenses as incurred by or on behalf of such person in connection therewith.

The indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter acquire under any statute, provision of our certificate of incorporation, our bylaws, agreement, vote of stockholders or disinterested directors or otherwise.

We maintain standard policies of insurance that provide coverage (1) to our directors and officers against loss rising from claims made by reason of breach of duty or other wrongful act and (2) to us with respect to indemnification payments that we may make to such directors and officers.

Item 15.

Recent Sales of Unregistered Securities

In connection with each of the following unregistered sales and issuances of securities, except as otherwise provided below, the Company relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated thereunder for transactions not involving a public offering.

On June 6, 2016, the Company completed a private placement, exempt for registration purposes under Section 4(a)(2) of the Securities Act, of $35 million aggregate principal amount of senior secured convertible notes (the “Notes”) pursuant to a Securities Purchase Agreement dated June 6, 2016 (the “SPA”) between the Company and certain institutional investors as set forth in the Schedule of Buyers attached to the SPA, as described in the Company’s Form8-K filed with the Securities and Exchange Commission on June 7, 2016.

The Notes were issued at an 8 percent original issue discount to the principal amount of Notes (a purchase price of $920 for each $1,000 principal amount of Notes and related warrants) for aggregate proceeds of $32.2 million. The Notes did not bear any ordinary interest and provided that the Company repay the principal amount of the Notes in equal monthly installments beginning seven months after the original date of issuance.

The Company also issued warrants to purchase one additional share of common stock to such institutional investors concurrently with the issuance of the Notes. The Company repurchased all of such warrants for cash, effective as of March 31, 2017.

On June 29, 2017, our Board authorized the establishment of a new series of preferred stock designated as Series A Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock (the “Series A Certificate of Designations”) which were filed with the State of Delaware on June 30, 2017 (together with any preferred shares issued in replacement thereof in accordance with the terms thereof, the “Series A Preferred Stock”). On July 2, 2017, we entered into an exchange agreement (the “Exchange”) with one of our investors which had purchased certain senior secured convertible notes (the “Notes”), convertible into shares of our common stock pursuant to a certain June 6, 2016 securities purchase agreement, of $4.2 million aggregate principal amount of such Notes for 4,200 shares of Series A Preferred Stock (the “Series A Preferred Shares”). The Exchange was made in reliance upon the exemption from registration provided by Rule 3(a)(9) of the Securities Act of 1933, as amended. The Series A Preferred Shares were entitled to the whole number of votes equal to $4.2 million divided by $901,600 (the closing bid price on June 13, 2016, the date of issuance of the Notes as adjusted for the reverse stock split effected in July 2016,) or 5 votes. The Series A Preferred Stock had no dividend, liquidation or other preferential rights to our common stock, and each share of Series A Preferred Stock was redeemed for the amount of $0.01 on August 28, 2017.

On July 11, 2017, we entered into an Amended and Restated Securities Purchase Agreement (the “Amended Purchase Agreement”) with certain institutional investors for the sale by the Company of 2,360 shares of Series B Preferred Stock (the “Series B Preferred Stock”) at a purchase price of $1,000 per share, in a private placement. The aggregate gross proceeds for the sale of the Series B Preferred Stock was $2.0 million. The Company used the proceeds from the transaction for general corporate purposes. The restricted shares of Series B Preferred Stock had no registration rights and were not be eligible for legend removal for a period of at least six months from the date of closing. This Amended Purchase Agreement amends the July 5, 2017 Securities Purchase Agreement (the “Purchase Agreement”) into which we entered with certain institutional investors (the “Investors”) for the sale by the Company of 2,360 shares of Series B Preferred Stock in a registered direct offering. The Series B Preferred Stock was entitled to the whole number of votes equal to $2.0 million divided by $45,745 (the closing bid price on July 5, 2017, the date of sale of the Series B Preferred Stock), or 44 votes. The Series B Preferred Stock had no liquidation or other rights which are preferential to our common stock. The Series B Preferred Stock was redeemed for $2,360,000 in August 2017.

II-2


On August 28, 2017, the Company entered into a Restructuring Agreement (the “Agreement”) with one of the institutional investors (the “Investor”) who was a party to the SPA. As of the date the Agreement was entered into, the Investor held $11,444,637 aggregate principal amount of Notes of which there was $10,092,857 aggregate Restricted Principal, (as defined in the Notes) of Notes (the “Restricted Notes”), secured by such aggregate cash amount held in a collateral account of the Company in the same amount (the “Restricted Cash”) and (y) $1,351,780 principal of Notes (the “Unrestricted Notes”), (ii) 4,200 shares of Series A Preferred Stock and (iii) 2,006 shares of Series B Convertible Preferred Stock.

Pursuant to the Agreement, (a) on the date thereof the Company and the Investor took the following actions (the “Initial Restructuring”): (i) the Investor released restrictions on $1,650,000 of Restricted Cash (the “Initial Release”), (ii) the Investor consented to the use of additional Restricted Cash to effect redemptions of the Series A Preferred Shares and the Series B Preferred Shares, (iii) the Investor cancelled $1,200,000 aggregate principal of the Notes (such portion of the Notes, the “Cancellation Note”), (iv) the Company redeemed all the Series A Preferred Shares outstanding for a cash payment to the Investor of $4.20 and (v) the Company redeemed the Series B Preferred Shares for a cash payment to the Investor of $2,006,000 and (b) upon the consummation of a reverse stock split of our Common Stock of at least twenty to one (the “Reverse Stock Split Event”, and such date, the “Reverse Stock Split Date”) by September 15, 2017, the Company and the Investor shall have taken the following actions (the “Additional Restructuring”, and together with the Initial Restructuring, the “Restructuring”): (i) the Investor shall consent to the use of Restricted Cash to effect redemptions of $4,000,000 aggregate Restricted Principal of the Restricted Notes (such portion of the Restricted Notes, the “Redemption Notes”), (ii) the Company shall redeem the Redemption Notes for a redemption price of $6.4 million (the “Redemption Price”) and (iii) the Company shall exchange (the “Exchange”), pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, an$2,436,852.80 aggregate principal amountRestricted Principal of those notes equal to $279,015.90the Restricted Notes (such portion of the Restricted Notes, the “Exchange Notes”, and together with the Redemption Notes, the “Restructured Notes”) for new warrants to purchase an aggregate of 44,642,544164 shares of ourits Common Stock and we shall redeem all(the “New Warrants”, as exercised, the Series C Preferred Shares then outstanding for a cash payment of $590,000 and (ii) upon“New Warrant Shares”). The New Warrants expire on the initial consummation, on or prior to December 15, 2017, by the Company of the offering contemplated by this registration statement on Form S-1 the following shall occur: (i) pursuant to Section 3(b) of the Restricted Notes, we shall be deemed (as adjusted downward by the Black-Scholes value of the warrants being issued in this offering) to have automatically, and irrevocably, adjusted the conversion price to 200% of the purchase price of a share of our common stock in the offering contemplated by this registration statement, (ii) the maturity date (as defined in the notes) shall automatically be extended to the earlier to occur of (x) the first42 month anniversary of the date of consummationissuance and bear an exercise price of $85,750 per share (which shall be adjusted to the new lower purchase price per share if there is a subsequent “down round” financing). The Investor, in lieu of an exercise of the offering contemplated by this registration statement and (y) December 30, 2018, (iii) until the earlier of (x) this maturity date and (y) the 75th calendar day after the date of consummationNew Warrants pursuant to a cash payment of the offering contemplated by this registration statement on Form S-1, all installments to be made under the notes shall be deemed automatically deferred with no conversions during that 75 day period, (iv) we agree to redeem any portion of the outstanding notes at any time requested by either investor thereto with $7.3 million in cash to be reduced by $0.6 million to redeem the Series C Preferred Stock remaining in the restricted accounts with respect to the 2016 convertible notes and (v) the conversion floor price on the notes is $0.05 and not subject to adjustments.

Theaggregate exercise price for the warrants issued in conjunction with the amended restructuring agreement is $0.35. The warrants contain a cashless exercise provision pursuant to which the warrants may be exercised for 133,927,632 shares of our common stock on or after the 75th day subsequent to the date of consummation of offering hereunder. On the 136th day subsequent to the date of consummation of the offering hereunder, there shall be a “true up” with regard to the issuance of shares upon exercise such that the difference between 133,927,632 shares and the number of shares that would be issuable ifNew Warrants being exercised, may exercise the exercise price were lowered to the average price per share of the variable weighted average price of our common stock for the five trading days commencing on the date which is 76 days after the date of consummation of the offering hereunder, but not lower than 33% of the variable weighted average price of a share of our common stock on the 81st date following the date of consummation of the offering hereunder. In lieu of the “true up”, on or before the 135th date following the date of consummation of the offering hereunder, we may buy out that provision for $6,138,349.80.

DESCRIPTION OF SECURITIES WE ARE OFFERING

We are offering (i) 422,535,211 units, each unit consisting of one share of our common stock and one Series C common warrant to purchase one share of our common stock, one Series D common warrant to purchase one share of our common stock and one Series E common warrant to purchase one share of our common stock common warrant to purchase one share of our common stock, or (ii) up to 422,535,211pre-funded units, eachpre-funded unit consisting of onepre-funded warrant to purchase one share of our common stock and one common Series C common warrant to purchase one share of our common stock, one Series D common warrant to purchase one share of our common stock and one Series E common warrant to purchase one share of our common stock warrant to purchase one share of our common stock. For eachpre-funded unit we sell, the number of units we are offering will be decreased on aone-for-one basis. The share of common stock and accompanying common warrant included in each unit will be issued separately, and thepre-funded warrant to purchase one share of common stock and the accompanying common warrants included in eachpre-funded unit will be issued separately. Units will not be issued or certificated. We are also registering the shares of common stock included in the units and the shares of common stock issuable from time to time upon exercise of thepre-funded warrants included inpre-funded units and common warrants included in the units and thepre-funded units offered hereby.

Common Stock

The material terms and provisions of our common stock and each other class of our securities which qualifies or limits our common stock are described under the caption “Description of Capital Stock” in this prospectus.

Pre-FundedNew Warrants,

“Pre-funded” warrants provide any purchaser in this offering with the ability purchase more than 4.99% of our issued and outstanding common stock. This is accomplished through purchasing“pre-funded” warrants at a price equal to the purchase price for units, less $.01, which $.01 is the exercise price for the“pre-funded” warrants. Each“pre-funded” unit is exercisable into a unit as offered hereunder. Thus, the purchaser is paying essentially the purchase price for a unit at closing of the offering but is not deemed to beneficially own the shares of common stock included in the units until the purchaser exercises the“pre-funded” warrant. Once purchased, the purchase price of the“pre-funded” warrants is not refundable. While the warrant permits waiver of provisions by us and the holder of the warrant, this would not affect the“pre-funding” as that is the purchase price of the instrument which is paid at the time of closing and becomes part of our proceeds received from the offering. In addition, thepre-funded warrants are perpetual and do not have expiration date.

Duration and Exercise Price

Eachpre-funded warrant will have an initial exercise price per share equal to $0.01. Thepre-funded warrants will be immediately exercisable and may be exercised at any time until thepre-funded warrants are exercised in full. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. Thepre-funded warrants will be issued separately from the accompanying common warrants included in thepre-funded units, and may be transferred separately immediately thereafter.

Exercisability

Thepre-funded warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of thepre-funded warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’spre-funded warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of thepre-funded warrants. Purchasers ofpre-funded units in this offering may also elect prior to the issuance of thepre-funded warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock.

Cashless Exercise

If, at the time a holder exercises itspre-funded warrants, a registration statement registering the issuance of the shares of common stock underlying thepre-funded warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may electelecting instead to receive upon such exercise (either in whole or in part) the net numbertwo shares and one hundred and twenty-five thousandths of shares of common stock determined according to a formula set forth in thepre-funded warrants.

Transferability

Subject to applicable laws, apre-funded warrant may be transferred at the optionshare of the holder upon surrender of thepre-funded warrant to us together with the appropriate instruments of transfer.

Fractional Shares

No fractional shares of common stock will be issued upon the exercise of thepre-funded warrants. Rather, the number of shares of common stock to be issued will, at our election, either be rounded up to the nearest whole number or we will pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the exercise price.

Trading Market

There is no trading market available for thepre-funded warrants on any securities exchange or nationally recognized trading system.

Right as a Stockholder

Except as otherwise provided in thepre-funded warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of thepre-funded warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise theirpre-funded warrants.

Warrants

The following is a summary of all material terms and provisions of the warrants that are being offered hereby, the form of which has been filed as an exhibit to the registration statement of which this prospectus is a part. We are offering Series C warrants, Series D warrants and Series E warrants. Where all three series of warrants contain identical terms, we have described below as pertaining to the warrants in general, and where the terms differ among the series of warrants, we have described those terms specifically with regard to each series of warrants. Prospective investors should carefully review the terms and provisions of the form of Series C warrant, Series D warrant and Series E warrant for a complete description of the terms and conditions of the warrants.

Duration and Exercise Price

Each warrant offered hereby will have an exercise price equal to (i) $             for the Series C warrants, (ii) $             for the Series D warrants and $             for the Series E warrants. The warrants will be immediately exercisable, and (i) the Series C warrants will expire on the fifth anniversary of the original issuance date, and (ii) the Series D warrants and Series E warrants will expire on the first anniversary of the original issuance date. The warrants will be issued separately from the common stock, and may be transferred separately immediately thereafter. Warrants will be issued in certificated form only.

Exercisability

The warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the warrant to the extent that the holder would own more than 4.99% of the outstanding common stock after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the warrants.

Antidilution Protection

The Series C warrants and the Series D warrants shall contain a provision which generally (subject to exclusion of certain types of excluded securities as set forth in the warrants) provides for a reduction in the exercise price of those warrants to the sales price of any securities sold by the Company at a price less than the exercise price of the warrants in effect at the time of issuance of the lower priced securities. The anti-dilution protection is in effect during the entire term of the Series D warrants and ceases after the two year anniversary of the issuance date of the Series C warrants.

Cashless Exercise

If, at the time a holder exercises its warrant, there is no effective registration statement registering, or the prospectus contained therein is not available for an issuance of the shares underlying the warrant to the holder, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the warrant.

Fundamental Transactions

In the event of any fundamental transaction, as described in the warrants and generally including any merger with or into another entity, sale of all or substantially all of our assets, tender offer or exchange offer, or reclassification of our common stock, then upon any subsequent exercise of a warrant, the holder will have the right to receive as alternative consideration,Company’s Common Stock for each share of our common stock that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of common stock of the successor or acquiring corporation or of our company, if it is the surviving corporation, and any additional consideration receivable upon or as a result of such transaction by a holder of the number of shares of our common stock for which the warrant is exercisable immediately prior to such event. The Series C warrants and Series D warrants also contain an alternate consideration provision in the case of a fundamental transaction resulting in a change in the control which provides that the holder can request cash payment in an amount equal to the Black Scholes value of the remaining warrant at the time of the change in control.

Transferability

Subject to applicable laws and a standard legend with regard to restriction on transfer only in compliance with a public offering or an available exemption therefrom, the warrant may be transferred at the option of the holder upon surrender of the warrant to us together with the appropriate instruments of transfer.

No Listing

There is no established trading market for the warrants, and we do not expect an active trading market to develop. We do not intend to list the warrants on any securities exchange or other trading market. Without a trading market, the liquidity of the warrants will be extremely limited.

Right as a Shareholder

Except as otherwise provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their warrants.

Waivers and Amendments

Subject to certain exceptions, any term of the warrants may be amended or waived with our written consent and the written consent of the holders of at least a majority of the then-outstanding warrants

CERTAIN U.S. FEDERAL INCOME TAX CONSIDERATIONS

The following is a general discussion of certain of the material U.S. federal income tax considerations with respect to the acquisition, ownership and disposition of the securities being sold in this offering applicable tonon-U.S. holders (as defined below) who purchase our common stock or warrantsWarrant Share exercised pursuant to this offering. This discussion is based on current provisions of the Internal Revenue Code of 1986, as amended (referred to as the “Code”), existing and proposed U.S. Treasury regulations promulgated thereunder, and administrative rulings and court decisions in effect as of the date hereof, all of which are subject to change at any time, possibly with retroactive effect. No ruling has been or will be sought from the Internal Revenue Service, or IRS, with respect to the matters discussed below, and there can be no assurance the IRS will not take a contrary position regarding the tax consequences of the acquisition, ownership or disposition of our common stock or warrants, or that any such contrary position would not be sustained by a court.

provision. The discussion below of certain of the U.S. federal income tax consequences with respect to actual holders of common stock and warrants should also apply to holders of Units (as the deemed owners of the underlying common stock and warrants that comprise the Units).

For purposes of this discussion, a“non-U.S. holder” means a beneficial owner of our securities that, for U.S. federal income tax purposes, is not any of the following:

an individual who is a citizen or resident of the United States;

a corporation created or organized (or deemed to be created or organized) in or under the laws of the United States, any state thereof or the District of Columbia;

an estate the income of which is subject to U.S. federal income taxation regardless of its source;

a trust if it either (1) is subject to the primary supervision of a court within the United States and one or more U.S. persons have the authority to control all substantial decisions of the trust or (2) has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a U.S. person for U.S. federal income tax purposes; or

an entity treated as a partnership or other pass-through entity for U.S. federal income tax purposes.

If an entity or arrangement treated as a partnership for U.S. federal income tax purposes holds shares of our common stock or warrants, the tax treatment of a partner generally will depend on the status of the partner and the activities of the partnership.Partnerships holding our common stock or warrants and partners in such partnerships are urged to consult their tax advisors as to the particular U.S. federal income tax consequences of acquiring, holding and disposing of our common stock and warrants.

It is assumed in this discussion that anon-U.S. holder holds shares of our common stock and warrants as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all aspects of U.S. federal income taxation that may be important to anon-U.S. holder in light of such holder’s particular circumstances or that may be applicable to holders subject to special treatment under U.S. federal income tax laws (including, for example, financial institutions, dealers in securities, traders in securities that electmark-to-market treatment, insurance companies,tax-exempt entities, holders who acquired our common stock pursuant to the exercise of employee stock options or otherwise as compensation, controlled foreign corporations, passive foreign investment companies, entities or arrangements treated as partnerships for U.S. federal income tax purposes, holders subject to the alternative minimum tax, certain former citizens or former long-term residents of the United States, holders deemed to sell our common stock or warrants under the constructive sale provisions of the Code and holders who hold our common stock or warrants as part of a straddle, hedge, synthetic security or conversion transaction), nor does it address any aspects of the unearned income Medicare contribution tax enacted pursuant to the Health Care and Education Reconciliation Act of 2010. In addition, except to the extent provided below, this discussion does not address U.S. federal tax laws other than those pertaining to the U.S. federal income tax, nor does it address any aspects of U.S. state, local ornon-U.S. taxes. Accordingly, prospective investors are encouraged to consult with their own tax advisors regarding the U.S. federalnon-income, state, local,non-U.S. income and other tax considerations of acquiring, holding and disposing of shares of our common stock and warrants.

THIS SUMMARY IS NOT INTENDED TO CONSTITUTE A COMPLETE DESCRIPTION OF ALL TAX CONSEQUENCES RELATING TO THE ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK AND WARRANTS. HOLDERS OF OUR COMMON STOCK AND WARRANTS ARE ENCOURAGED TO CONSULT WITH THEIR TAX ADVISORS REGARDING THE TAX CONSEQUENCES TO THEM (INCLUDING THE APPLICATION AND EFFECT OF ANY STATE, LOCAL,NON-U.S. INCOME AND OTHER TAX LAWS) OF THE ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK.

Allocation of Purchase Price and Characterization of a Unit

There is no authority addressing the treatment, for U.S. federal income tax purposes, of securities with terms substantially the same as the units being offered in this offering, and, therefore, that treatment is not entirely clear. Each unit may be treated for U.S. federal income tax purposes as an investment unit consisting of one share of our common stock and three warrants (to purchase three shares of our common stock). If this is the case, then for U.S. federal income tax purposes, each holder of a unit may be required to allocate the purchase price of a unit among the shares of common stock and the warrants that comprise the unit based on the relative fair market value of each at the time of issuance. The price allocated to each such share or warrant generally will be the holder’s tax basis in such share or warrant, as the case may be.

Neither the foregoing description of the treatment of our common stock and warrants nor a holder’s purchase price allocation is binding on the IRS or the courts. Because there are no authorities that directly address instruments that are similar to the units, no assurance can be given that the IRS or the courts will agree with the characterization described above or the discussion below. Accordingly, each holder is advised to consult its own tax advisor regarding the risks associated with an investment in a unit (including alternative characterizations of a unit) and regarding an allocation of the purchase price among the common stock and the warrant that comprise a unit. The balance of this discussion generally assumes that the characterization of the units described above is respected for U.S. federal income tax purposes.

Dividends

As discussed above under “Price Range of Common Stock and Dividend Policy,” we currently have no plans to make distributions of cash or other property on our common stock. In the event that we do make distributions of cash or other property on our common stock, generally such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current and accumulated earnings and profits, as determined for U.S. federal income tax purposes. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return of capital and will first reduce anon-U.S. holder’s adjusted basis in our common stock, but not below zero. Any excess will be treated as capital gain from the sale of our common stock in the manner described under “—Gain on Sale or Other Disposition of Our Common Stock” below. In general, dividends, if any, paid by us to anon-U.S. holder will be subject to U.S. withholding tax at a rate of 30% of the gross amount (or a reduced rate prescribed by an applicable income tax treaty) unless the dividends are effectively connected with a trade or business carried on by thenon-U.S. holder within the United States and, if required by an applicable income tax treaty, are attributable to a permanent establishment of thenon-U.S. holder within the United States. Dividends effectively connected with this U.S. trade or business, and, if required by an applicable income tax treaty, attributable to such a permanent establishment of thenon-U.S. holder, generally will not be subject to U.S. withholding tax if thenon-U.S. holder provides the applicable withholding agent with certain forms, including IRS FormW-8ECI (or any successor form), and generally will be subject to U.S. federal income tax on a net income basis, in the same manner as if thenon-U.S. holder were a U.S. person. Anon-U.S. holder that is a corporation and receives effectively connected dividends may also be subject to an additional “branch profits tax” imposed at a 30% rate (or lower treaty rate), subject to certain adjustments.

Anon-U.S. holder of shares of our common stock who wishes to claim the benefit of an applicable treaty rate (and avoid backup withholding, as discussed below) for dividends generally will be required (a) to complete IRS FormW-8BEN (or other applicable form) and certify under penalty of perjury that such holder is not a “United States person” as defined under the Code and is eligible for treaty benefits, or (b) if shares of our common stock are held through certain foreign intermediaries (including certain foreign partnerships), satisfy the relevant certification requirements of applicable U.S. Treasury Regulations. This certification must be provided to us or our paying agent prior to the payment to thenon-U.S. holder of any dividends, and may be required to be updated periodically.

Gain on Disposition of our Securities

Subject to the discussions below of backup withholding and the Foreign Account Tax Compliance Act (“FATCA”) legislation, any gain realized by anon-U.S. holder on the sale or other disposition of our securities generally will not be subject to United States federal income tax, unless:

the gain is effectively connected with a trade or business carried on by thenon-U.S. holder within the United States (in which case the branch profits tax discussed above may also apply if thenon-U.S. holder is a corporation) and, if required by an applicable income tax treaty, the gain is attributable to a permanent establishment of thenon-U.S. holder maintained in the United States;

thenon-U.S. holder is an individual and is present in the United States for 183 days or more in the taxable year of disposition and certain other conditions are satisfied; or

we are or have been a U.S. real property holding corporation (a “USRPHC”) for U.S. federal income tax purposes at any time during the shorter of the five-year period ending on the date of the disposition or the period that thenon-U.S. holder held such securities.

Gain described in the first bullet point above will be subject to U.S. federal income tax on a net income basis at the regular graduated U.S. federal income tax rates in much the same manner as if such holder were a resident of the United States. Anon-U.S. holder that is a corporation may also be subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of its effectively connected earnings and profits for the taxable year, as adjusted for certain items.Non-U.S. holders should consult any applicable income tax treaties that may provide for different rules.

Gain recognized by an individual described in the second bullet point above will be subject to U.S. federal income tax at a flat 30% rate (or such lower rate specified by an applicable income tax treaty), but may be offset by U.S.-source capital losses (even though the individual is not considered a resident of the United States), provided that thenon-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses.

With respect to the third bullet point above, we believe that we currently are not, and do not anticipate becoming, a USRPHC. Because the determination of whether we are a USRPHC depends on the fair market value of our interests in real property located within the United States relative to the fair market value of our interests in real property located outside the United States and our other business assets, however, there can be no assurance that we will not become a USRPHC in the future. Even if we were or were to become a USRPHC at any time during this period, generally gains realized upon a disposition of shares of our common stock (but not our warrants) by anon-U.S. holder that did not directly or indirectly own more than 5% of our common stock during this period would not be subject to U.S. federal income tax, provided that our common stock is “regularly traded on an established securities market” (within the meaning of Section 897(c)(3) of the Code). We expect our common stock to be “regularly traded” on an established securities market, although we cannot guarantee it will be so traded.

Acquisition of Common Stock Warrants Pursuant to the Exercise of a Warrant

Anon-U.S. holder generally will not recognize gain or loss upon the acquisition of common stock pursuant to the exercise of a warrant for cash. Common stock acquired pursuant to the exercise of a warrant for cash generally will have a tax basis equal to thenon-U.S. holder’s tax basis in the warrant, increased by the amount paid to exercise the warrant. The holding period of such common stock generally would begin on the day after the date of receipt of such common stock upon exercise of the warrant and will not include the period during which thenon-U.S. holder held the warrant. If a warrant is allowed to lapse unexercised, anon-U.S. holder generally will recognize a capital loss equal to such holder’s tax basis in the warrant.

The tax consequences of a cashless exercise of a warrant are not clear under current tax law. A cashless exercise may betax-free, either because the exercise is not a gain realization event or because the exercise is treated as a recapitalization for U.S. federal income tax purposes. In eithertax-free situation, anon-U.S. holder’s basis in the common stock or warrant received would equal the holder’s basis in the warrant. If the cashless exercise were treated as not being a gain realization event, anon-U.S. holder’s holding period in the common stock or warrant would be treated as commencing on the date following the date of exercise of the warrant. If the cashless exercise were treated as a recapitalization, the holding period of the common stock or warrant would include the holding period of the warrant being exercised. It is also possible that a cashless exercise could be treated as a taxable exchange in which gain or loss would be recognized. In such event, anon-U.S. holder could be deemed to have surrendered warrants equal to the number of shares of common stock and warrants having a value equal to the exercise price for the total number of warrants to be exercised. Thenon-U.S. holder would recognize capital gain or loss in an amount equal to the difference between the fair market value of the common stock or warrants represented by the warrants deemed surrendered and thenon-U.S. holder’s tax basis in the warrants deemed surrendered. In this case, anon-U.S. holder’s tax basis in the common stock received or warrants would equal the sum of the fair market

value of the common stock or warrants represented by the warrants deemed surrendered and thenon-U.S. holder’s tax basis in the warrants exercised. Anon-U.S. holder’s holding period for the common stock would commence on the date following the date of exercise of the warrant. Due to the absence of authority on the U.S. federal income tax treatment of a cashless exercise, there can be no assurance which, if any, of the alternative tax consequences and holding periods described above would be adopted by the IRS or a court of law. Accordingly,non-U.S. holders should consult their tax advisors regarding the U.S. federal income tax consequences of a cashless exercise.

If the cashless exercise of a warrant results in taxable gain to anon-U.S. holder, then the consequences to such holder will be as described above under “—Gain on Disposition of our Securities.”

Under Section 305 of the Code, an adjustment to the number of shares of common stock or warrants that will be issued on the exercise of the warrants, or an adjustment to the exercise price of the warrants, may be treated as a constructive distribution to anon-U.S. holder of the warrants if, and to the extent that, such adjustment has the effect of increasing suchnon-U.S. holder’s proportionate interest in the “earnings and profits” or assets of our company, depending on the circumstances of such adjustment (for example, if such adjustment is to compensate for a distribution of cash or other property to stockholders of our company). Adjustments to the exercise price of warrants made pursuant to a bona fide reasonable adjustment formula that has the effect of preventing dilution of the interest of the holders of the warrants should generally not be considered to result in a constructive distribution. Any such constructive distribution would be taxable whether or not there is an actual distribution of cash or other property. See “Dividends”.

Information Reporting and Backup Withholding

As discussed above under “Price Range of Common Stock and Dividend Policy,” we currently have no plans to pay regular dividends on our common stock. In the event that we do pay dividends, generally we or certain financial middlemen must report annually to the IRS and to eachnon-U.S. holder the amount of dividends paid to, and the tax withheld with respect to, eachnon-U.S. holder. These reporting requirements apply regardless of whether withholding was reduced or eliminated. Copies of this information also may be made available under the provisions of a specific treaty or agreement with the tax authorities in the country in which thenon-U.S. holder resides or is established.

U.S. backup withholding (currently at a rate of 28%) is imposed on certain payments to persons that fail to furnish the information required under the U.S. information reporting requirements. Dividends paid to anon-U.S. holder of our common stock generally will be exempt from backup withholding if thenon-U.S. holder provides to the applicable withholding agent a properly executed IRS FormW-8BEN,W-8BEN-E orW-8ECI (as applicable) or otherwise establishes an exemption.

Under U.S. Treasury regulations, the payment of proceeds from the disposition of our common stock or warrants by anon-U.S. holder effected at a U.S. office of a broker generally will be subject to information reporting and backup withholding, unless the beneficial owner, under penalties of perjury, certifies, among other things, its status as anon-U.S. holder or otherwise establishes an exemption. The certification procedures described in the above paragraph will satisfy these certification requirements as well. The payment of proceeds from the disposition of our common stock or warrants by anon-U.S. holder effected at anon-U.S. office of a broker generally will not be subject to backup withholding and information reporting, except that information reporting (but generally not backup withholding) may apply to payments if the broker is:

a U.S. person;

a “controlled foreign corporation” for U.S. federal income tax purposes;

a foreign person, 50% or more of whose gross income from certain periods is effectively connected with a U.S. trade or business; or

a foreign partnership if at any time during its tax year (a) one or more of its partners are U.S. persons who, in the aggregate, hold more than 50% of the income or capital interests of the partnership or (b) the foreign partnership is engaged in a U.S. trade or business.

Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules from a payment to anon-U.S. holder can be credited against thenon-U.S. holder’s U.S. federal income tax liability, if any, and any excess refunded, provided that the required information is furnished to the IRS in a timely manner.

Legislation Affecting Taxation of Securities Held by or Through Foreign Entities

Withholding taxes may be imposed under FATCA on certain types of payments made tonon-U.S. financial institutions and certain othernon-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends paid on, or gross proceeds from the sale or other disposition of, our common stock or warrants paid to a “foreign financial institution” or a“non-financial foreign entity” (each as defined in the Code), unless (1) the foreign financial institution undertakes certain diligence and reporting obligations, (2) thenon-financial foreign entity either certifies it does not have any “substantial United States owners” (as defined in the Code) or furnishes identifying information regarding each substantial United States owner, or (3) the foreign financial institution ornon-financial foreign entity otherwise qualifies for an exemption from these rules. If the payee is a foreign financial institution and is subject to the diligence and reporting requirements in (1) above, it must enter into an agreement with the U.S. Department of the Treasury requiring, among other things, that it undertake to identify accounts held by certain “specified United States persons” or “United States-owned foreign entities” (each as defined in the Code), annually report certain information about such accounts, and withhold 30% on certain payments tonon-compliant foreign financial institutions and certain other account holders. Foreign financial institutions located in jurisdictions that have an intergovernmental agreement with the United States governing FATCA may be subject to different rules. Under the applicable Treasury Regulations and IRS guidance, withholding under FATCA generally will apply to payments of dividends on our common stock, as well as to payments of gross proceeds from the sale or other disposition of such stock or warrants on or after January 1, 2019. Prospective investors should consult their tax advisors regarding the potential application of withholding under FATCA to their investment in our common stock.

UNDERWRITING

We have entered into an underwriting agreement with the underwriter named below. Oppenheimer & Co. Inc. is acting as the sole underwriter in this offering. The underwriting agreement provides for the purchase of a specific number of units by the underwriter. Subject to the terms and conditions of the underwriting agreement, Oppenheimer & Co. Inc. has agreed to purchase the number of unitstransactions set forth opposite its name below.

Underwriter

Number of
Units
Number of
Pre-Funded
Units

Oppenheimer & Co. Inc.

Total

The underwriter has agreed to purchase all of the securities offered by this prospectus (other than those covered by the over-allotment option described below) if any are purchased.

The securities comprising the units and pre-funded units should be ready for delivery on or about                     , 2017 against payment in immediately available funds.                     , 2017 is the 2nd trading day following the date of this prospectus. The underwriter is offering the units and pre-funded units subject to various conditions and may reject all or part of any order. The underwriter proposes to offer the units and pre-funded units directly to the public at the public offering price that appears on the cover page of this prospectus. In addition, the underwriter may offer some of the units to other securities dealers at such price less a concession not in excess of $             per unit. After the securities are released for sale to the public, the underwriter may change the offering price and other selling terms at various times. The underwriter has advised us that it does not intend to confirm sales to any account over which it exercises discretionary authority.

Discounts, Commissions and Expenses

We estimate that the total fees and expenses payable by us, excluding underwriting discounts and commissions, will be approximately $            . The following table shows the underwriting discounts to be paid to the underwriter by us in connection with this offering:

Per UnitPer
Pre-Funded
Unit
Total
Without
Exercise
of Over
Allotment
Option
Total With Full
Exercise of
Over-Allotment
Option

Public Offering Price per Unit (1)(2)

Underwriting Discount

$

Proceeds to us

(1)The public offering price and underwriting discount per unit corresponds to (i) a public offering price per share of common stock of $             and (ii) a public offering price per Series C common warrant of $            , Series D common warrant of $             and Series E common warrant of $            .
(2)The public offering price and underwriting discount per pre-funded unit corresponds to (i) a public offering price per pre-funded warrant of $             and (ii) a public offering price per Series C common warrant of $             , Series D common warrant of $             and Series E common warrant of $            .

We estimate the total expenses payable by us for this offering to be approximately $             which amount includes (i) the underwriting discount of $                     ($                     if the over-allotment option is exercised in full), (ii) the reimbursement of expenses of the underwriter, including its legal fees and expenses, in connection with this offering equal to $125,000, and (iii) other estimated company expenses of approximately $                which includes legal, accounting and printing costs and various fees associated with the registration and listing of our shares.

Over-allotment Option

We have granted to the underwriter an over-allotment option exercisable not later than 45 days after the date of this prospectus to purchase up to 63,380,281 additional shares of common stock and/or Series C warrants, Series D warrants and Series E warrants equal to 15% of the number of shares of common stock sold in the primary offering and/or 15% of the Series C common warrants, the Series D common warrants and Series E common warrants sold in the primary offering, in any combination thereof, at the public offering price per share of common stock and the public offering price per Series C common warrant, Series D common warrant and Series E common warrant set forth on the cover page hereto less the underwriting discounts and commissions. The underwriter may exercise the option solely to cover overallotments, if any,herein were being made in connection with this offering. If any additional shares of common stock and/or Series C warrants, Series D warrants and/or Series E warrants are purchased, the underwriter will offer these shares of common stock and/or warrants on the same terms as those on which the other securities are being offered. If this option is exercised in full, the total price to the public will be $             and the total gross proceeds to us will be $            .

Indemnification

Pursuant to the underwriting agreement, we have agreed to indemnify the underwriter against certain liabilities, including liabilities under the Securities Act, or to contribute to payments that the underwriter or such other indemnified parties may be required to make in respect of those liabilities.

Lock-Up Agreements

We have agreed not to (i) offer, pledge, issue, sell, contract to sell, purchase, contract to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any shares of our common stock or any securities convertible into or exercisable or exchangeable for our common stock; (ii) enter into any swap or other arrangement that transfers, in whole or in part, any of the economic consequences of ownership of shares of common stock; or (iii) file any registration statement with the SEC relating to the offering of any shares of our common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock, without the prior written consent of the underwriter for a period of 90 days following the date of this prospectus, subject to an18-day extension under certain circumstances (the“Lock-up Period”), for a price less than the public offering price per unit. This consent may be given at any time without public notice. These restrictions on future issuances do not apply to the securities to be sold in this offering.

In addition, each of our directors and executive officers has entered into alock-up agreement with the underwriter. Under thelock-up agreements, the directors and executive officers may not, directly or indirectly, (i) offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of, or announce the intention to otherwise dispose of, any shares of our common stock (including, without limitation, common stock which may be deemed to be beneficially owned by the undersigned in accordance with the rules and regulations promulgated under the Securities Act or securities convertible into or exercisable or exchangeable for our common stock, (ii) enter into any swap, hedge or similar agreement or arrangement that transfers in whole or in part, the economic risk of ownership of the beneficially owned shares or securities convertible into or exercisable or exchangeable for common stock, whether now owned or hereafter acquired by the undersigned or with respect to which the undersigned has or hereafter acquires the power of disposition, or (iii) engage in any short selling of the common stock or securities convertible into or exercisable or exchangeable for common stock for a period of 90 days following the date of closing of this offering. The restrictions on future dispositions by our directors and officers are subject to exceptions

for (i) one or more bona fide gift transfers of securities to immediate family members or to a trust, family partnership or family company the beneficiaries of which are exclusively members of immediate family, (ii) by will or intestate succession upon the death or (iii) as a bona fide gift. In addition, these restrictions shall not apply to sales of common stock by our directors and executive officers (i) pursuant to any trading plan established pursuant to Rule10b5-1 of the Exchange Act, (ii) constituting restricted stock outstanding prior to the date hereof that vests during theLock-Up Period, solely to the extent necessary to generate proceeds to fund any income taxes resulting from such vesting, and (iii) issued upon the exercise of stock options granted prior to the date hereof and scheduled to expire within six (6) months of the date hereof, solely to the extent necessary to generate proceeds to fund the exercise price thereof and any income taxes resulting from such exercise.

Price Stabilization, Short Positions and Penalty Bids

Rules of the Securities and Exchange Commission may limit the ability of the underwriter to bid for or purchase shares before the distribution of the shares is completed. However, the underwriter may engage in the following activities in accordance with the rules:

Stabilizing transactions – The underwriter may make bids or purchases for the purpose of pegging, fixing or maintaining the price of the shares, so long as stabilizing bids do not exceed a specified maximum.

Over-allotments and syndicate covering transactions – The underwriter may sell more shares of our common stock in connection with this offering than the number of shares than they have committed to purchase. This overallotment creates a short position for the underwriter. This short sales position may involve either “covered” short sales or “naked” short sales. Covered short sales are short sales made in an amount not greater than the underwriter’s over-allotment option to purchase additional shares in this offering described above. The underwriter may close out any covered short position either by exercising their over-allotment option or by purchasing shares in the open market. To determine how they will close the covered short position, the underwriter will consider, among other things, the price of shares available for purchase in the open market, as compared to the price at which they may purchase shares through the over-allotment option. Naked short sales are short sales in excess of the over-allotment option. The underwriter must close out any naked short position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriter is concerned that, in the open market after pricing, there may be downward pressure on the price of the shares that could adversely affect investors who purchase shares in this offering.

Syndicate covering transactions involve purchases of the common stock in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriter will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares through the over-allotment option. A naked short position occurs if the underwriter sells more shares than could be covered by the over-allotment option. This position can only be closed out by buying shares in the open market. A naked short position is more likely to be created if the underwriter is concerned that there could be downward pressure on the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.

Penalty bids. If the underwriter purchases shares in the open market in a stabilizing transaction or syndicate covering transactions, it may reclaim a selling concession from selling group members who sold those shares as part of this offering.

Similar to other purchase transactions, the underwriter’s purchases to cover the syndicate short sales or to stabilize the market price of our common stock may have the effect of raising or maintaining the market price of our common stock or preventing or mitigating a decline in the market price of our common stock. As a result, the price of the shares of our common stock may be higher than the price that might otherwise exist in the open market. The imposition of a penalty bid might also have an effect on the price of the shares if it discourages resales of the shares.

Neither we nor any underwriter make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our common stock. In addition, neither we nor any underwriter make any representation that the underwriter will engage in these transactions or that these transactions, once commenced, will not be discontinued without notice.

Other Relationships

Upon completion of this offering, we have granted the underwriter a right of first refusal to act as sole underwriter or exclusive placement agent in connection with any subsequent public or private offering of equity securities or other capital markets financing by us. This right of first refusal extends for 12 months from the closing date of this offering. The terms of any such engagement of the underwriter will be determined by separate agreement.

Conflicts of Interest

The underwriter is a full-service financial institution engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment management, principal investment, hedging, financing and brokerage activities. The underwriter and its respective affiliates may, from time to time, engage in transactions with and perform services for us in the ordinary course of their business for which they may receive customary fees and reimbursement of expenses. In the ordinary course of its various business activities, the underwriter and its respective affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (which may include bank loans and/or credit default swaps) for their own account and for the accounts of their customers and may at any time hold long and short positions in such securities and instruments. Such investments and securities activities may involve securities and/or instruments of ours or our affiliates. The underwriter and its affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or financial instruments and may hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.

Electronic Delivery of Preliminary Prospectus

A prospectus in electronic format may be delivered to potential investors by the underwriter participating in this offering. The prospectus in electronic format will be identical to the paper version of such preliminary prospectus. Other than the prospectus in electronic format, the information on any underwriter’s web site and any information contained in any other web site maintained by an underwriter is not part of the prospectus or the registration statement of which this prospectus forms a part.

Selling Restrictions

BELGIUM

The offering is exclusively conducted under applicable private placement exemptions and therefore it has not been and will not be notified to, and this document or any other offering material relating to the securities has not been and will not be approved by, the Belgian Banking, Finance and Insurance Commission (“Commission bancaire, financière et des assurances/Commissie voor het Bank-, Financie- en Assurantiewezen”). Any representation to the contrary is unlawful.

The underwriter has undertaken not to offer sell, resell, transfer or deliver directly or indirectly, any securities, or to take any steps relating/ancillary thereto, and not to distribute or publish this document or any other material relating to the securities or to the offering in a manner which would be construed as: (a) a public offering under the Belgian Royal Decree of 7 July 1999 on the public character of financial transactions; or (b) an offering of securities to the public under Directive 2003/71/EC which triggers an obligation to publish a prospectus in Belgium. Any action contrary to these restrictions will cause the recipient and the issuer to be in violation of the Belgian securities laws.

FRANCE

Neither this prospectus nor any other offering material relating to the securities has been submitted to the clearance procedures of theAutorité des marchés financiersin France. The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in France. Neither this prospectus nor any other offering material relating to the securities has been or will be: (a) released, issued, distributed or caused to be released, issued or distributed to the public in France; or (b) used in connection with any offer for subscription or sale of the securities to the public in France. Such offers, sales and distributions will be made in France only: (i) to qualified investors (investisseurs qualifiés) and/or to a restricted circle of investors (cercle restreint d’investisseurs), in each case investing for their own account, all as defined in and in accordance with ArticlesL.411-2,D.411-1,D.411-2,D.734-1,D.744-1,D.754-1 andD.764-1 of the FrenchCode monétaire et financier; (ii) to investment services providers authorised to engage in portfolio management on behalf of third parties; or (iii) in a transaction that, in accordance with articleL.411-2-II-1°-or-2°-or 3° of the FrenchCode monétaire et financierand article211-2 of the General Regulations (Règlement Général) of theAutorité des marchés financiers, does not constitute a public offer (appel public à l’épargne). Such securities may be resold only in compliance with ArticlesL.411-1,L.411-2,L.412-1 andL.621-8 throughL.621-8-3 of the FrenchCode monétaire et financier.

UNITED KINGDOM/GERMANY/NORWAY/THE NETHERLANDS

In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive (each, a “Relevant Member State”) an offer to the public of any securities which are the subject of the offering contemplated by this prospectus may not be made in that Relevant Member State other than the offers contemplated in this prospectus in name(s) of Member State(s) where prospectus will be approved or passported for the purposes of anon-exempt offer once this prospectus has been approved by the competent authority in such Member State and published and passported in accordance with the Prospectus Directive as implemented in name(s) of relevant Member State(s) only required where specific regulatory approvals being sought except that an offer to the public in that Relevant Member State of any securities may be made at any time under the following exemptions under the Prospectus Directive, if they have been implemented in that Relevant Member State:

(a)to legal entities which are authorised or regulated to operate in the financial markets or, if not so authorised or regulated, whose corporate purpose is solely to invest in securities;

(b)to any legal entity which has two or more of (1) an average of at least 250 employees during the last financial year; (2) a total balance sheet of more than €43,000,000 and (3) an annual net turnover of more than €50,000,000, as shown in its last annual or consolidated accounts;

(c)by the underwriter to fewer than 100 natural or legal persons (other than qualified investors as defined in the Prospectus Directive); or

(d)in any other circumstances falling within Article 3(2) of the Prospectus Directive,

provided that no such offer of securities shall result in a requirement for the publication by issuer or any underwriter of a prospectus pursuant to Article 3 of the Prospectus Directive.

For the purposes of this provision, the expression an “offer to the public” in relation to any securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase any securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State and the expression “Prospectus Directive” means Directive 2003/71/EC and includes any relevant implementing measure in each Relevant Member State.

The underwriter has represented, warranted and agreed that:

(a)it has only communicated or caused to be communicated and will only communicate or cause to be communicated any invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000 (theFSMA)) received by it in connection with the issue or sale of any securities in circumstances in which section 21(1) of the FSMA does not apply to the issuer; and

(b)it has complied with and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to the securities in, from or otherwise involving the United Kingdom.

ISRAEL

In the State of Israel, the securities offered hereby may not be offered to any person or entity other than the following:

(c)a fund for joint investments in trust (i.e., mutual fund), as such term is defined in the Law for Joint Investments in Trust, 5754-1994, or a management company of such a fund;

(d)a provident fund as defined in Section 47(a)(2) of the Income Tax Ordinance of the State of Israel, or a management company of such a fund;

(e)an insurer, as defined in the Law for Oversight of Insurance Transactions, 5741-1981, (d) a banking entity or satellite entity, as such terms are defined in the Banking Law (Licensing), 5741-1981, other than a joint services company, acting for their own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968;

(f)a company that is licensed as a portfolio manager, as such term is defined in Section 8(b) of the Law for the Regulation of Investment Advisors and Portfolio Managers, 5755-1995, acting on its own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968;

(g)a company that is licensed as an investment advisor, as such term is defined in Section 7(c) of the Law for the Regulation of Investment Advisors and Portfolio Managers, 5755-1995, acting on its own account;

(h)a company that is a member of the Tel Aviv Stock Exchange, acting on its own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968;

(i)an underwriter fulfilling the conditions of Section 56(c) of the Securities Law, 5728-1968;

(j)a venture capital fund (defined as an entity primarily involved in investments in companies which, at the time of investment, (i) are primarily engaged in research and development or manufacture of new technological products or processes and (ii) involve above-average risk);

(k)an entity primarily engaged in capital markets activities in which all of the equity owners meet one or more of the above criteria; and

(l)an entity, other than an entity formed for the purpose of purchasing securities in this offering, in which the shareholders equity (including pursuant to foreign accounting rules, international accounting regulations and U.S. generally accepted accounting rules, as defined in the Securities Law Regulations (Preparation of Annual Financial Statements), 1993) is in excess of NIS 250 million.

Any offeree of the securities offered hereby in the State of Israel shall be required to submit written confirmation that it falls within the scope of one of the above criteria. This prospectus will not be distributed or directed to investors in the State of Israel who do not fall within one of the above criteria.

ITALY

The offering of the securities offered hereby in Italy has not been registered with the Commissione Nazionale per la Società e la Borsa (“CONSOB”) pursuant to Italian securities legislation and, accordingly, the securities offered hereby cannot be offered, sold or delivered in the Republic of Italy (“Italy”) nor may any copy of this prospectus or any other document relating to the securities offered hereby be distributed in Italy other than to professional investors (operatori qualificati) as defined in Article 31, second paragraph, of CONSOB Regulation No. 11522 of 1 July, 1998 as subsequently amended. Any offer, sale or delivery of the securities offered hereby or distribution of copies of this document or any other document relating to the securities offered hereby in Italy must be made:

(a)by an investment firm, bank or intermediary permitted to conduct such activities in Italy in accordance with Legislative Decree No. 58 of 24 February 1998 and Legislative Decree No. 385 of 1 September 1993 (the “Banking Act”);

(b)in compliance with Article 129 of the Banking Act and the implementing guidelines of the Bank of Italy; and

(c)in compliance with any other applicable laws and regulations and other possible requirements or limitations which may be imposed by Italian authorities.

SWEDEN

This prospectus has not been nor will it be registered with or approved by Finansinspektionen (the Swedish Financial Supervisory Authority). Accordingly, this prospectus may not be made available, nor may the securities offered hereunder be marketed and offered for sale in Sweden, other than under circumstances which are deemed not to require a prospectus under the Financial Instruments Trading Act (1991: 980). This offering will only be made to qualified investors in Sweden. This offering will be made to no more than 100 persons or entities in Sweden.

SWITZERLAND

The securities offered pursuant to this prospectus will not be offered, directly or indirectly, to the public in Switzerland and this prospectus does not constitute a public offering prospectus as that term is understood pursuant to art. 652a or art. 1156 of the Swiss Federal Code of Obligations. The issuer has not applied for a listing of the securities being offered pursuant to this prospectus on the SWX Swiss Exchange or on any other regulated securities market, and consequently, the information presented in this prospectus does not necessarily comply with the information standards set out in the relevant listing rules. The securities being offered pursuant to this prospectus have not been registered with the Swiss Federal Banking Commission as foreign investment funds, and the investor protection afforded to acquirers of investment fund certificates does not extend to acquirers of securities.

Investors are advised to contact their legal, financial or tax advisers to obtain an independent assessment of the financial and tax consequences of an investment in securities.

LEGAL MATTERS

Certain legal matters will be passed upon for us by Wexler, Burkhart, Hirschberg & Unger, LLP, Garden City, New York, including the validity of the common stock offered hereby.

EXPERTS

The audited consolidated financial statements of Delcath Systems, Inc. as and for the year ended December 31, 2016, incorporated by reference in this prospectus and elsewhere in this registration statement have been so incorporated by reference in reliance upon the report of Grant Thornton, LLP, independent registered public accountants, upon the authority of said firm as experts in accounting and auditing.

WHERE YOU CAN FIND MORE INFORMATION

We file reports, proxy statements and other information with the SEC. You may read and copy any reports, proxy statements or other information filedexemption from registration provided by us at the SEC’s Public Reference Room at 100 F Street NE, Washington, D.C. 20549. You may obtain information on the operationRule 4(a)(2) of the Public Reference Room by calling the SEC at(800) SEC-0330. The SEC maintains a website that contains reports, proxy statementsSecurities Act of 1933, as amended (the “1933 Act”) and other information regarding issuers that file electronically with the SEC, including Delcath Systems, Inc. The addressRule 144(d)(3)(ii) of the SEC website is http://www.sec.gov.

INFORMATION INCORPORATED BY REFERENCE

The SEC’s rules allow us to “incorporate1933 Act. As a result of not having effected a reverse stock split by reference” information into this prospectus. This means that we can disclose important information to you by referring you to another document. The information incorporated by reference is considered to be a part of this prospectus. This prospectus incorporates by reference the documents listed below:

our Annual Report on Form10-K for the fiscal year ended December 31, 2016, as amended by our Form10-K/A for the fiscal year ended December 31, 2016;

our Quarterly Report on Form10-Q for the quarter ended March 31, 2017 and our Quarterly Report on Form10-Q for the quarter ended June 30, 2017;

our Definitive Proxy Statement on Schedule 14A, filed on April 29, 2017, our Definitive Proxy Statement on Schedule 14A, filed on July 26, 2017, and our Definitive Information Statement on Schedule 14C, filed on October 4, 2017;

our Current Reports on Form8-K, filed on January 26, 2017, January 30, 2017, FebruarySeptember 15, 2017, February 15, 2017, February 22, 2017, February 23, 2017, March 9, 2017, April 3, 2017 April 27, 2017, June 5, 2017, June 16, 2017, July 3, 2017, July 6, 2017, July 12, 2017, July 26, 2017, August 2 , 2017, August 8, 2017, August 21, 2017, August 28, 2017, September 5, 2017, September 13, 2017, September 21, 2017, September 21, 2017 and October 11, 2017; and

the description of our common stock contained in our Registration Statement on Form8-A filed on September 22, 2000, including all amendments and reports filed for the purpose of updating such description.

Any statement made in this prospectus or in a document incorporated by reference into this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus modifies or supersedes that statement. Any statement so modified or superseded willAdditional Restructuring did not be deemed, except as so modified or superseded, to constitute a part of this prospectus.

We will provide to each person, including any beneficial owner, to whom a prospectus is delivered, without charge upon written or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus, other than exhibits which are specifically incorporated by reference into such documents. Requests should be directed our Secretary at Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019 or by calling us at212-489-2100.occur.

FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2016 AND DECEMBER 31, 2015 AND THE THREE AND SIX MONTHS ENDED JUNE 30, 2017 AND JUNE 30, 2016

Incorporated by reference from our Annual Report on Form10-K for the year ended December 31, 2016 filed with the SEC on March 29, 2017 and our Quarterly Report on Form10-Q for the quarter ended June 30, 2017, filed with the SEC on August 8, 2017.

MANAGEMENT’S DISCUSSION AND ANALYSIS FOR THE YEARS ENDED DECEMBER 31, 2016 AND DECEMBER 31, 2016 AND THE THREE AND SIX MONTHS ENDED JUNE 30, 2017 AND JUNE 30, 2016

Incorporated by reference from our Annual Report on Form10-K for the year ended December 31, 2016 filed with the SEC on March 29, 2017 and our Quarterly Report on Form10-Q for the quarter ended June 30, 2017, filed with the SEC on August 8, 2017.

422,535,211 Units

Each Unit Consisting of One Share of Common Stock

and

One Series C Warrant to Purchase one Share of Common Stock

and

One Series D Warrant to Purchase one Share of Common Stock

and

One Series E Warrant to Purchase one Share of Common Stock

LOGO

Delcath Systems, Inc.

PRELIMINARY PROSPECTUS

Oppenheimer & Co.

, 2017


PART II

Item 13. Other expenses of issuance and distributionINFORMATION NOT REQUIRED IN PROSPECTUS

Item 13.

Other Expenses of Issuance and Distribution.

The following table sets forth the costs and expenses, other than underwriting discounts and commissionsunderwriter fees to be paid by us in connection with the sale of the units, warrants andshares of our common sharesstock being registered hereby. All amounts are estimates except for the SEC registration fee, and the FINRA filing fee and the NASDAQ listing fee. All such expenses will be borne by the Company.

 

SEC registration fee

  $12,357   $6,568 
  

 

 

FINRA filing fee

   10,175    8,090 

NASDAQ listing fee

   50,000 

Legal fees and expenses

   150,000    100,000 

Accounting fees and expenses

   40,000    75,000 

Printing and engraving expenses

   30,000    5,000 

Transfer agent and registrar fees and expenses

   10,000    10,000 

Warrant agent fees and expenses

   5,000 

Other expenses

   15,000    15,342 
  

 

   

 

 

Total

  $267,532   $275,000 
  

 

   

 

 

Item 14. Indemnification of directors and officers

Item 14.

Indemnification of Directors and Officers.

Section 102(b)(7) of the DGCLDelaware’s General Corporation Law (“DGCL”) allows a corporation to provide in its certificate of incorporation that a director of the corporation will not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except where the director breached the duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our amended and restated certificate of incorporation provides for this limitation of liability.

Section 145 of the DGCL, or Section 145, provides that a Delaware corporation may indemnify any person who was, is or is threatened to be made, party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person is or was an officer, director, employee or agent of such corporation or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who are, were or are a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person is or was a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit, provided such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the corporation’s best interests, provided that no indemnification is permitted without judicial approval if the officer, director, employee or agent is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him against the expenses which such officer or director has actually and reasonably incurred.

II-1


Section 145 further authorizes a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise, against any liability asserted against him and incurred by him in any such capacity, or arising out of his or her status as such, whether or not the corporation would otherwise have the power to indemnify him under Section 145.

Our amended and restated bylaws provides that we must indemnify our directors and officers to the fullest extent permitted by the DGCL and must also pay expenses incurred in defending any such proceeding in advance of its final disposition upon delivery of an undertaking, by or on behalf of an indemnified person, to repay all amounts so advanced if it should be determined ultimately that such person is not entitled to be indemnified.

II-1


We have entered into indemnification agreements with certain of our executive officers and directors pursuant to which have agreed to indemnify such persons against all expenses and liabilities incurred or paid by such person in connection with any proceeding arising from the fact that such person is or was an officer or director of our company, and to advance expenses as incurred by or on behalf of such person in connection therewith.

The indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter acquire under any statute, provision of our certificate of incorporation, our bylaws, agreement, vote of stockholders or disinterested directors or otherwise.

We maintain standard policies of insurance that provide coverage (1) to our directors and officers against loss rising from claims made by reason of breach of duty or other wrongful act and (2) to us with respect to indemnification payments that we may make to such directors and officers.

The proposed form of Underwriting Agreement to be filed as Exhibit 1.1 to this Registration Statement will provide for indemnification of our directors and officers by the underwriter party thereto against certain liabilities. See “Item 17. Undertakings” for a description

Item 15.

Recent Sales of Unregistered Securities

In connection with each of the SEC’s position regarding such indemnification provisions.

Item 15. Recentfollowing unregistered sales and issuances of unregistered securities, except as otherwise provided below, the Company relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated thereunder for transactions not involving a public offering.

On June 6, 2016, the Company completed a private placement, exempt for registration purposes under Section 4(a)(2) of the Securities Act, of $35 million aggregate principal amount of senior secured convertible notes (the “Notes”) pursuant to a Securities Purchase Agreement dated June 6, 2016 (the “SPA”) between the Company and certain institutional investors as set forth in the Schedule of Buyers attached to the SPA, as described in the Company’s Form8-K filed with the Securities and Exchange Commission on June 7, 2016.

The Notes were issued at an 8 percent original issue discount to the principal amount of Notes (a purchase price of $920 for each $1,000 principal amount of Notes and related warrants) for aggregate proceeds of $32.2 million. The Notes dodid not bear any ordinary interest and provideprovided that the Company will repay the principal amount of the Notes in equal monthly installments beginning seven months after the original date of issuance.

The Company also issued warrants to purchase 6.8 millionone additional sharesshare of common stock to such institutional investors concurrently with the issuance of the Notes. The Company repurchased all of such warrants for cash, effective as of March 31, 2017.

Series A Preferred Stock

On June 29, 2017, our Board authorized the establishment of a new series of preferred stock designated as Series A Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock (the “Series A Certificate of Designations”) which waswere filed with the State of Delaware on June 30, 2017 (together with any preferred shares issued in replacement thereof in accordance with the terms thereof, the “Series A Preferred Stock”). On July 2, 2017, we entered into an exchange agreement (the “Exchange”) with one of our investors which had purchased certain senior secured convertible notes (the “Notes”), convertible into shares of our common stock pursuant to a certain June 6, 2016 securities purchase agreement, of $4.2 million aggregate principal amount of such Notes for 4,200 shares of Series A Preferred Stock (the “Series A Preferred Shares”). The Exchange was made in reliance upon the exemption from registration provided by Rule 3(a)(9) of the Securities Act of 1933, as amended. The Series A Preferred Shares were entitled to the whole number of votes equal to $4.2 million divided by $3.68$901,600 (the closing bid price on June 13, 2016, the date of issuance of the Notes as adjusted for the reverse stock split effected in July 2016,) or 1,141,3045 votes. The Series A Preferred Stock had no dividend, liquidation or other preferential rights to our common stock, and each share of Series A Preferred Stock was redeemed for the amount of $0.001, paid in cash pursuant to the Restructuring Agreement signed$0.01 on August 28, 2017 and discussed in further detail below.2017.

Series B Preferred Stock

On June 29, 2017, our Board authorized the establishment of a new series of preferred stock designated as Series B Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock (the “Series B Certificate of Designations”) which was filed with the State of Delaware on June 30, 2017 (together with any preferred shares issued in replacement thereof in accordance with the terms thereof, the “Series B Preferred Stock”). On July 11, 2017, we entered into a securities purchase agreementan Amended and Restated Securities Purchase Agreement (the “Amended Purchase Agreement”) with existing holderscertain institutional investors for the sale by the Company of Notes pursuant to which the investors purchased $2,360,0002,360 shares of Series B Preferred Stock for(the “Series B Preferred Stock”) at a cash purchase price of $2,000,000$1,000 per share, in a private placement. The aggregate gross proceeds for the sale of the Series B Preferred Stock was $2.0 million. The Company used the proceeds from the transaction for general corporate purposes. The restricted shares of Series B Preferred Stock had no registration rights and were not be eligible for legend removal for a period of at least six months from the date of closing. This Amended Purchase Agreement amends the July 5, 2017 Securities Purchase Agreement (the “Purchase Agreement”) into which we entered with certain institutional investors (the “Investors”) for the sale by the Company of 2,360 shares of Series B Preferred Stock in a registered direct offering. The Series B Preferred Stock was entitled to the whole number of votes equal to $2.0 million divided by $0.1867$45,745 (the closing bid price on July 5, 2017, the date of the original securities purchase agreement forsale of the Series B Preferred Stock), or 10,712,37244 votes. The Series B Preferred Stock had no dividend, liquidation or other preferential rights (but had the redemption rights described below)which are preferential to our common stock and could have been converted into shares of our common stock at a price equal to $0.153 per share upon the earlier of the date of closing to the extent that the holder thereof reallocated shares of our common stock reserved for issuance under its Notes to conversion of the Series B Preferred Shares and otherwise upon receipt of shareholder approval of the Reverse Stock Split.stock. The Series B Preferred Stock was redeemed for $2,360,000 pursuant to the Restructuring Agreement signed onin August 28, 2017 and discussed in further detail below.2017.

II-2


On August 28, 2017, wethe Company entered into a Restructuring Agreement (the “Agreement”) with one of the institutional investors (the “Investor”) who was a party to the Securities Purchase Agreement, dated June 6, 2016, by and among us, the Investor and certain other buyers signatory thereto (the “Securities Purchase Agreement”), pursuant to which the Investor and such other buyers acquired (i) certain senior secured convertible notes (the “Notes”), convertible into shares of our common stock, par value $0.01 per share (the “Common Stock”) and (ii) warrants to acquire shares of the Common Stock.SPA. As of the date the Agreement was entered into, the Investor held $11,444,637 aggregate principal amount of Notes of which there was $10,092,857 aggregate Restricted Principal, (as defined in the Notes) of Notes (the “Restricted Notes”), secured by such aggregate cash amount held in a collateral account of the Company in the same amount (the “Restricted Cash”) and (y) $1,351,780 principal of Notes (the “Unrestricted Notes”), (ii) 4,200 shares of Series A Convertible Preferred Stock issued by us to the Investor (the “Series A Preferred Shares”) and (iii) 2,006 shares of Series B Convertible Preferred Stock issued by us to the Investor (the “Series B Preferred Shares”). All terms used and not defined herein are used as defined in the Securities Purchase Agreement.Stock.

Pursuant to the Agreement, (a) on the date thereof wethe Company and the Investor took the following actions (the “Initial Restructuring”): (i) the Investor released restrictions on $1,650,000 of Restricted Cash (the “Initial Release”), (ii) the Investor consented to the use of additional Restricted Cash to effect redemptions of the Series A Preferred Shares and the Series B Preferred Shares, (iii) the Investor cancelled $1,200,000 aggregate principal of the Notes (such portion of the Notes, the “Cancellation Note”), (iv) wethe Company redeemed all the Series A Preferred Shares outstanding for a cash payment to the Investor of $4.20 (the “Series A Redemption Price”) and (v) wethe Company redeemed the Series B Preferred Shares for a cash payment to the Investor of $2,006,000 (the “Series B Redemption Price”) and (b) upon the consummation of a reverse stock split of our Common Stock of at least twenty to one (the “Reverse Stock Split Event”, and such date, the “Reverse Stock Split Date”), we by September 15, 2017, the Company and the Investor shall takehave taken the following actions (the “Additional Restructuring”, and together with the Initial Restructuring, the “Restructuring”): (i) the Investor shall consent to the use of Restricted Cash to effect redemptions of $4,000,000 aggregate Restricted Principal of the Restricted Notes (such portion of the Restricted Notes, the “Redemption Notes”), (ii) wethe Company shall redeem the Redemption Notes for a redemption price of $6,436,852.80$6.4 million (the “Redemption Price”) and (iii) the Company shall exchange (the “Exchange”), pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, $2,436,852.80 aggregate Restricted Principal of the Restricted Notes (such portion of the Restricted Notes, the “Exchange Notes”, and together with the Redemption Notes, the “Restructured Notes”) for new warrants to purchase 40,000,000164 shares of ourits Common Stock (the “New Warrants”, as exercised, the “New Warrant Shares”). The New Warrants expire on the 42 month anniversary of the date of issuance and bear an exercise price of $0.35$85,750 per share (which shall be adjusted to the new lower purchase price per share if there is a subsequent “down round” financing). The Investor, in lieu of an exercise of the New Warrants pursuant to a cash payment of the aggregate exercise price of the number of New Warrants being exercised, may exercise the New Warrants, in whole or in part, by electing instead to receive upon such exercise two shares and one hundred and twenty-five thousandths of a share of ourthe Company’s Common Stock for each Warrant Share exercised pursuant to this provision.]. As a result of the fact that a reverse stock split did not occur by September 15, 2017 (as required by the Restructuring Agreement), the second part of the contemplated restructuring will not take place without the consent of the Investor.

The transactions set forth herein were being made in reliance upon the exemption from registration provided by Rule 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”) and Rule 144(d)(3)(ii) of the 1933 Act. As a result of not having effected a reverse stock split by September 15, 2017, the Additional Restructuring did not occur.

Amendment to Restructuring Agreement

As a result of the lack of requisite approval by Delcath stockholders for the Company’s proposed reverse stock split, the parties and the two investors in the Notes entered into an amendment to the August restructuring agreement on October 10, 2017 as follows: (i) on the date that the Company effects a reverse split of its common stock, (x) the Company will exchange, pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, an aggregate principal amount of those notes equal to $279,015 for new warrants to purchase an aggregate of 183 shares of Common Stock, and the Company shall redeem all the Series C Preferred Shares then outstanding for a cash payment of $590,000 and (ii) upon the initial consummation, on or prior to December 15, 2017, by the Company of the offering contemplated by the registration statement on FormS-1 that was filed with the SEC on October 11, 2017 the following shall occur: (i) pursuant to Section 3(b) of the Restricted Notes, the Company shall be deemed (as adjusted downward by the Black-Scholes value of the warrants being issued in this offering) to have automatically, and irrevocably, adjusted the conversion price of the Notes to 200% of the purchase price of a share of our common stock in the offering contemplated by the registration statement, (ii) the maturity date (as defined in the notes) shall automatically be extended to the earlier to occur of (x) the first anniversary of the date of consummation of the offering contemplated by the registration statement and (y) December 30, 2018, (iii) until the earlier of (x) this maturity date and (y) the 75th calendar day after the date of consummation of the offering contemplated by the registration statement, all installments to be made under the notes shall be deemed automatically deferred with no conversions during that 75 day period, (iv) the Company agreed to redeem any portion of the outstanding notes at any time requested by either investor thereto with $7.3 million in cash to be reduced by $0.6 million to redeem the Series C Preferred Stock remaining in the restricted accounts with respect to the 2016 convertible notes and (v) the conversion floor price on the notes is $0.05 and not subject to adjustments.

On September 21, 2017, we entered into a securities purchase agreement (the “SPA”) with two of our investors which had purchased certain senior secured convertible notes (the “Notes”), convertible into shares of our common stock pursuant to a certain June 6, 2016 securities purchase agreement, of $0.5 million aggregate purchase price for 590 shares of Series C Preferred Stock (the “Series C Preferred Shares”). The purchase of the Series C Preferred Stock was made in reliance upon the exemption from registration provided by Rule 4(a)(2) of the Securities Act of 1933, as amended. The Series C Preferred Shares was entitled to 2,121 votes and could only vote on approval of a reverse split of our outstanding common stock. The Series C Preferred Stock had no dividend, liquidation or other preferential rights to our common stock, and each share of Series C Preferred Stock was redeemable for the amount of $1,000.00, payable in cash, per share at our written election, and had to be redeemed by us no later than December 21, 2017. The Series C Preferred Stock was redeemed for $590,000 in November 2017.

 

II-2II-3


Item 16. ExhibitsOn November 15, 2017, Delcath Systems, Inc. (the “Company”) entered into exchange agreements (“Exchange Agreements”) with each of the two investors from its June 2016 private placement of senior secured convertible notes as contemplated by that certain Securities Purchase Agreement, dated June 6, 2016, by and Financial Statement Schedulesamong the Company and such investors. As of November 15, 2017, those investors held $11,157,970 aggregate principal amount of investor notes (the “Investor Notes”), including (a) such aggregate principal amount of the Investor Notes as set forth on the signature page of the Investor hereto that does not include Restricted Principal as of the date hereof and all accrued and unpaid interest under the Investor Notes (such portion of the Investor Notes, the “Unrestricted Investor Notes”) and such aggregate principal amount of the Investor Notes as set forth on the signature page of the investors hereto that solely consists of Restricted Principal as of the date hereof (such portion of the Investor Notes, the “Restricted Investor Notes”).

On November 15, 2017, the Company authorized a new series of senior secured convertible notes of the Company, in the aggregate original principal amount as set forth above (the “Exchange Notes”), which Exchange Notes shall be convertible into shares of Common Stock in accordance with the terms of the Exchange Notes. Subject to the terms and conditions of the Exchange Agreements, the Company and the investors exchanged (the “Exchange”) the Unrestricted Investor Notes for (a) Exhibits$10,562,425 aggregate principal amount of the Exchange Notes (the “New Notes”, and the shares of Common Stock issuable pursuant to the terms of the New Notes, including, without limitation, upon conversion or otherwise, collectively, the “New Conversion Shares”) and (b) warrants to purchase an aggregate of 10,000 shares of Common Stock (the “New Warrants”, as exercised, the “New Warrant Shares”).

The exhibit index attached heretoNew Conversion Shares and the New Warrant Shares are collectively referred to herein as the “New Underlying Securities” and, together with the New Notes and the New Warrants, the “New Securities”.

The New Notes, which were satisfied in full on December 28, 2017, bore the following terms:

The New Notes did not bear interest except upon the occurrence of an event of default upon which the interest rate is incorporated herein by reference.15% per annum.

(b) Financial Statement Schedule

The initial conversion price was $1,050 per share for an optional conversion and at any time, an investor could have instead engaged in an alternate conversion for which the conversion price is 82% (75% if an event of default) of the lowest volume weighted average price for the Company’s common stock on the three trading days prior to and including the date of the conversion. All schedulesconversions attributable to the Restricted Notes could have been omitted becauseconverted at the information requiredlower of the optional conversion price and the alternate conversion price, then in effect.

The obligation to prepay the Notes was extended to March 31, 2018, except in the case of an event of default or change in control.

Assuming equity conditions as stated in the New Notes are met, the investors would consent to release cash to the Company from the existing controlled accounts upon conversion of the New Notes.

The New Notes contained provisions waiving Section 8 of the Restricted Investor Notes, including, without limitation, any requirements for the Company to effect installment conversions or redemptions.

The New Notes contained customary and usual terms including but not limited to, events of default upon failure to trade on an eligible market, failure to timely deliver shares upon conversion, failure to maintain converted share reserve, for conversions, failure to make payments thereunder when due, failure to remove legends, cross defaults to other indebtedness, bankruptcy and the like, and any material adverse effect in the Company’s financial condition, as well as remedies and negative covenants substantially similar to those in the Investor Notes.

The New Warrants bear the following terms:

The Warrants will be exercisable for five years from the date of issuance.

The initial exercise price of the warrants is 115% of the closing bid price of the Company’s common stock as of the trading day ended immediately prior to the time of execution of the Exchange Agreement.

The Warrants contain full anti-dilution ratchet protection from lowered price securities issuances subsequent to the date of issuance for six months from the date of issuance and most favored nations protection for a year from the date of issuance.

The Warrants are exercisable on a cashless basis to the extent at any time commencing on the one year anniversary of the date of issuance the issuance of underlying securities is not covered by an effective registration statement.

To the extent the investors elect to apply any amounts in their controlled accounts to the balances of the New Notes, the number of shares into which the applicable New Warrant is exercisable shall be reduced by a formula set forth in the schedules is either not applicable or is shownNew Warrants.

II-4


On December 28, 2017, we entered into exchange agreements (collectively, “Exchange Agreements”), each by and between us and an investor from its June 2016 private placement of senior secured convertible notes (as further exchanged, the “Notes”) originally issued pursuant to that certain Securities Purchase Agreement, dated June 6, 2016, by and among us and such investors. Pursuant to the Exchange Agreements, we (i) extinguished our remaining $3,027,408 in outstanding obligations under the Notes in full, (ii) obtained a release of restrictions on $2,046,897.66 in restricted cash held in our control accounts, (iii) issued to the investors shares (the “Shares”) of our common stock (or rights (“Rights”) to receive common stock to the extent such issuance of Shares would otherwise result in the financial statementsbeneficial ownership by any such investor of more than 4.9% or 9.9% of our issued and outstanding stock), as applicable, of an aggregate of 0.1 million shares of our common stock (in each case, subject to trading restrictions set forth in leak out agreements we separately entered into with each investor (collectively, the“Leak-Out Agreements”)) and (iv) a cash payment to the investors of $829,830.54 from the restricted cash held in our control accounts. The number of shares of our issued and outstanding common stock immediately following issuance of the Initial Shares to the investors is 0.2 million.

The Rights could be exercised in whole or in part by an investor, without payment of additional consideration, at any time an investor would not beneficially own more than 4.9% or 9.9% (as set forth in the applicable Exchange Agreement) of our common stock (along with any shares of our common stock owned by any Attribution Parties) outstanding immediately after giving effect to such exercise. The Shares and Rights were issued in transactions exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended, and the Shares and Rights were also issued in compliance with Section 3(a)(9) thereunder such that for Rule 144 purposes the holding period for the Shares and Rights and shares of our common stock underlying the Rights may be tacked onto the holding period of the Notes.

June 2018, July 2018 and August 2018 Notes

In June 2018, the Company entered into a Securities Purchase Agreement (the “June 2018 SPA”) with an institutional investor pursuant to which the Company issued $3.3 million in principal face amount of senior secured convertible notes thereto.of the Company (the “June 2018 Notes”) and related June 2018 Series D Warrant and June 2018Pre-Funded Series D Warrants (the “June 2018 Series D Warrants”) to purchase additional shares of the Company’s common stock. June 2018 Notes in the amount of $3.3 million and June 2018Pre-Funded Warrants in the amount of $0.2 million were issued for cash proceeds of $2.4 million with an original issue discount in the amount of $1.1 million. The June 2018 Notes bear 8% interest payable upon maturity. Of the $3.3 million in issued June 2018 Notes, $2.5 million matures in six months; the balance of $0.8 million is payable in twelve installments beginning seven months after the original issuance date. Each payment shall be paid in cash or, provided that the Market Price (as defined in the June 2018 SPA) is at least the conversion price of $2,100, at the option of the Company, upon ten Trading Days’ written notice to the Holder, in free trading common stock at the conversion price. The transaction was exempt from registration under Regulation S, as amended promulgated under the Securities Act of 1933.

Item 17. UndertakingsOn July 20, 2018, pursuant to another Securities Purchase Agreement between the Company and a domestic institutional investor, the Company sold two 8% Senior Secured Convertible Promissory Notes for a total face amount of $2,223,525 and a purchase price of $1,507,557 to this institutional investor upon the same terms and conditions as the transaction consummated under the Securities Purchase Agreement in a transaction exempt from registration under Section 4(a)(2) and Regulation D, as amended promulgated under the Securities Act of 1933.

(1) Effective August 31, 2018, the Company entered into an agreement to sell up to $6.0 million purchase price of its 8% Senior Secured Convertible Promissory Notes (“Notes”) and warrants and prepaid warrants (“Warrants”) pursuant to a Securities Purchase Agreement (“Agreement”) with one or more institutional investors in transactions exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), Regulation S and Rule 506(b) promulgated thereunder. The Agreement provided for an aggregate subscription amount for all securities to all purchasers of up to $6.0 million and has substantially the same terms as the July 20, 2018 Securities Purchase Agreement with Discover Growth Fund, LLC, except that the conversion price under the Notes and exercise price of the Warrants is $1,225, and interest on the Notes shall accrue and be payable at maturity. On August 31, 2018, the Company sold $3,336,617 face amount of Notes and 2,888 Warrants and 33,968Pre-funded Warrants to Discover Growth Fund, LLC with gross proceeds to the Company of $2,500,000.

In March 2019, the Company amended the June 2018, July 2018 and August 2018 Notes to make themnon-convertible.

On April 19, 2019, April 26, 2019, May 9, 2019 and May 23, 2019, the Company borrowed an aggregate $3.3 million from two institutional investors and issued promissory notes to the investors. The promissory notes have an aggregate principal amount of $3.3 million, bear interest at the rate of 8% per annum and are due six months from the issuance of each note. The promissory notes are nonconvertible. The notes contain standard events of default and remedies therefor. The Company’s obligations under the promissory notes to the institutional investor are secured by a lien on the Company’s assets.

On June 6, 2019, the Company entered into an agreement with two institutional investors, pursuant to which the investors agreed to transfer and surrender to the Company for cancellation of 39,234 Series D Warrants and 0.1 millionPre-Funded Series D Warrants.

II-5


Under the terms of the Purchase Agreement, the investors agreed to defer the payment of the purchase price for the Series D Warrants andPre-Funded Series D Warrants and, accordingly, the Company agreed to sell and issue to the investors 8% Senior Secured Promissory Notes in an aggregate principal amount of $2.0 million in full payment and satisfaction of the purchase price for the Series D Warrants andPre-Funded Series D Warrants.

July 2019 Private Placement

On July 11, 2019, the Company and certain accredited investors (each an “Investor” and, collectively, the “Investors”) entered into a securities purchase agreement (the “Securities Purchase Agreement”) pursuant to which the Company expects to sell and issue to the Investors an aggregate of 20,000 shares of Series E Convertible Preferred Stock, par value $0.01 per share, at a price of $1,000 per share (the “Private Placement”). Pursuant to the Securities Purchase Agreement, the Company will issue to each Investor a warrant (a “Warrant”) to purchase a number of shares of common stock of the Company, par value $0.01 per share (“Common Stock”), equal to the number of shares of Common Stock issuable upon conversion of the Series E Preferred Stock purchased by the Investor. Each Warrant will have an exercise price equal to $23.04, subject to adjustment in accordance with the terms of the Warrants (the “Exercise Price”), and be exercisable at any time beginning on the date that the Company effects a reverse stock split until 5:00 p.m. (NYC time) on the date that is five years following the date that the Company effects a reverse stock split. The Company expects to receive gross proceeds from the Private Placement of approximately $20.0 million, before deducting cash fees in the amount of $1.4 million payable to Roth Capital Partners, LLC (“Roth”) for serving as placement agent for the Private Placement and cash fees in the amount of $552,000 payable to Roth for serving as placement agent for certain prior securities offerings by the Company, and other transaction costs, fees and expenses payable by the Company.

Pursuant to certain Waiver Agreements, certain holders of Common Stock (the “MFN Common Stockholders”) were issued 923 shares of Series E Preferred Stock, in the aggregate, and Warrants to purchase up to 21,976 shares of Common Stock, in the aggregate, in exchange for the MFN Common Stockholders’ waiver of certain most favored nations rights granted to them pursuant to exchange agreements between the Company and the MFN Common Stockholders, which exchange agreements were previously reported by the Company.

Following the closing of the July 2019 Private Placement, the Company entered into agreements (the “Exchange Agreements”) with the holders of (i) its 8% Senior Secured Promissory Notes in an aggregate amount (principal plus accrued interest) of approximately $10.8 million (the “Bridge Notes”), and (ii) its 8% Senior Secured Promissory Notes in an aggregate principal amount of $2.0 million (“Surviving Notes”) pursuant to which the Bridge Notes were converted into shares of Series E Preferred Stock and Warrants at the same $1,000 price per Unit as applied to the Private Placement and the Surviving Notes became convertible into shares of Series E Preferred Stock and Warrants at the price of $1,500 per Unit.

The sale and issuance of the Series E Preferred Stock and Warrants to the Investors, MFN Common Stockholders and holders of Bridge Notes were exempt from registration under the United States Securities Act of 1933, as amended (the “Act”), in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D promulgated thereunder.

The transactions set forth herein were made in reliance upon the exemption from registration provided by Rule 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”). As of the date of this Prospectus, all of the Rights have been exercised, and neither investor owns more than 4.9% of the issued and outstanding shares of our common stock.

August 2019 Private Placement

On August 19, 2019, the Company closed on its securities purchase agreement, dated August 15, 2019 (the “Securities Purchase Agreement”), entered into with certain accredited investors (each an “Investor” and, collectively, the “Investors”) pursuant to which the Company issued to the Investors an aggregate of 9,510 shares ofSeries E-1 Convertible Preferred Stock, par value $0.01 per share (the“Series E-1 Preferred Stock”), at a price of $1,000 per share (the “Private Placement”). Pursuant to the Securities Purchase Agreement, the Company also issued to each Investor a warrant (a “Warrant”) to purchase a number of shares of common stock of the Company, par value $0.01 per share (“Common Stock”), equal to the number of shares of Common Stock issuable upon conversion of theSeries E-1 Preferred Stock purchased by the Investor. Each Warrant has an exercise price equal to $23.04, subject to adjustment in accordance with the terms of the Warrants (the “Exercise Price”), and are exercisable at any time beginning on the date that the Company effects a reverse stock split until 5:00 p.m. (NYC time) on the date that is five years following the date that the Company effects a reverse stock split. The Company received gross proceeds from the Private Placement of approximately $9.5 million, before deducting cash fees in the amount of $738,285 payable to Roth Capital Partners, LLC for serving as placement agent for the Private Placement, and other transaction costs, fees and expenses payable by the Company.

The sale and issuance of the SeriesE-1 Preferred Stock and Warrants to the Investors were exempt from registration under the United States Securities Act of 1933, as amended (the “Act”), in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D promulgated thereunder.

II-6


On February 26, 2020, we issued 2,717 shares of restricted common stock in relation to certain advisory services received by us. In connection with the foregoing, we relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, for transactions not involving a public offering.

Support and Conversion Agreement

In March 2020, we entered into a support and conversion agreement with Rosalind and our executive officers (which was amended in April 2020) pursuant to which, among other things: (i) upon the consummation of this offering, the executive officers have agreed to receive payment of their 2019 annual incentive bonuses aggregating $221,000 in shares of our common stock valued at the combined public offering price per share and related Series F warrant set forth on the cover page of the prospectus included in this registration statement, and (ii) the executive officers have agreed to receive payment of certain back pay and deferred bonus amounts aggregating $765,000 in shares of our common stock at a value equal to the greater of (x) the last reported sale price per share as of the trading day immediately preceding the Equity Infusion Date and (y) the volume-weighted average price of the common stock for the five trading days immediately preceding the Equity Infusion Date.

The sale and issuance of shares of our common stock to our executive investors pursuant to the support and conversion agreement were exempt from registration under the Act, in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D promulgated thereunder.

II-7


Item 16.

Exhibits and Financial Statement Schedules

Exhibit

Description

  1.1Form of Underwriting Agreement.
  3.1Amended and Restated Certificate of Incorporation of Company (incorporated by reference to Exhibit  3.1 to the Company’s Registration Statement on Form S-1/A filed September 25, 2019).
  3.2Amendment to the Amended and Restated Certificate of Incorporation of the Company dated October  17, 2019 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 23, 2019).
  3.3Certificate of Correction to Amendment to the Amended and Restated Certificate of Incorporation of the Company dated October  22, 2019 (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed on October 23, 2019).
  3.4Amendment to the Amended and Restated Certificate of Incorporation of the Company, effective December  24, 2019 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form8-K filed on December 30, 2019).
  3.5Amended and RestatedBy-Laws of the Company (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to Company’s Registration Statement on FormSB-2).
  4.1Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock of Company (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form8-K filed July 11, 2019).
  4.2Certificate of Designation of Preferences, Rights and Limitations of SeriesE-1 Convertible Preferred Stock of Company (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form8-K filed August 16, 2019).
  4.3Form of Series E Warrant to Purchase Shares of Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form8-K filed July 11, 2019).
  4.4Form of SeriesE-1 Warrant to Purchase Shares of Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form8-K filed August 16, 2019).
  4.5Form of Registration Rights Agreement between the Company and each other party a signatory thereto (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form8-K filed July 11, 2019).
  4.6Form of Registration Rights Agreement between the Company and each other party a signatory thereto (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form8-K filed August 16, 2019).
  4.7Form ofPre-Funded Warrant.*
  4.8Form of Warrant Agency Agreement to be entered into between the Company and American Stock Transfer & Trust Company, LLC, including the form of Series F warrant.
  5.1Opinion of Lowenstein Sandler LLP.
10.12009 Stock Incentive Plan (incorporated by reference to Appendix B to the Company’s definitive Proxy Statement dated April 30, 2009).
10.2Form of Indemnification Agreement dated April  8, 2009 between the Company and members of the Company’s Board of Directors (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed April 10, 2009).
10.3Lease between SLG 810 Seventh Lessee LLC and the Company dated as of February  5, 2010 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form10-Q for the quarter ended March 31, 2010).
10.4Amended and Restated Supply Agreement between B. Braun Medical Inc and the Company dated as of May  4, 2010 (incorporated by reference to Exhibit 10.7 to the Company’s Quarterly Report on Form10-Q for the quarter ended March 31, 2010).
10.5Lease Modification, Extension and Additional Space Agreement between SLG 810 Seventh Lessee LLC and the Company dated as of September  27, 2010 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed September 30, 2010).

II-8


Exhibit

Description

10.6†License, Supply and Contract Manufacturing Agreement between Synerx Pharma, LLC and Bioniche Teoranta and the Company dated as of October 13, 2010 (incorporated by reference to Exhibit 10.32 to the Company’s Annual Report on Form10-K for the year ended December 31, 2010).
10.7Form of Employee Confidentiality and Restrictive Covenant Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed September 26, 2011).
10.8Lease Agreement, dated August 2, 2011 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form10-Q for the quarter ended September 30, 2011).
10.9Sublease between Delcath Systems, Inc. and SLG 810 Seventh Lessee LLC, dated May  22, 2014. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed May 28, 2014).
10.10Sublease Agreement between Delcath Systems, Inc. and ICV Partners, LLC dated August  18, 2014 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed September 30, 2014).
10.11Form of Warrant Repurchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed April 3, 2017).
10.12Exchange Agreement dated July 2, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on July 2, 2017).
10.13Securities Purchase Agreement dated July  5, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on July 6, 2017).
10.14Form ofLeak-Out Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed on July 2, 2017).
10.15Amended and Restated Securities Purchase Agreement dated July  5, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K/A filed on July 12, 2017).
10.16Form of Restructuring Agreement and Warrant (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on August 28, 2017).
10.17Securities Purchase Agreement dated September  19, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on September 21, 2017).
10.18Exchange Agreement, dated November  15, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on November 16, 2017).
10.19Form of Exchange Note (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed on November 16, 2017).
10.20Form of Exchange Warrant (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form8-K filed on November 16, 2017).
10.21Exchange Agreement, dated December  28, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on December 29, 2017).
10.22Form ofLeak-Out Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed on December 29, 2017).
10.23Executive Agreement between the Company and Jennifer Simpson (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on March 26, 2018).
10.24Executive Agreement between the Company and Barbra Keck (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed on March 26, 2018).
10.25Executive Agreement between the Company and John Purpura (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form8-K filed on March 26, 2018).
10.26Securities Purchase Agreement dated as of June  4, 2018 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on June 8, 2018).
10.27First Amendment to Securities Purchase Agreement dated as of July  20, 2018 to Securities Purchase Agreement dated as of June 4, 2018 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on July 26, 2018).

II-9


Exhibit

Description

10.28First Amendment to Warrants to Purchase Common Stock dated July  20, 2018 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed on July 26, 2018).
10.29Form of Securities Purchase Agreement dated August  31, 2018 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.30Form of Backstop Commitment Purchase Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.31Form of 8% Senior Secured Convertible Promissory Note (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.32Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.33Form ofPre-Funded Warrant to Purchase Common Stock (incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form8-K filed on September 7, 2018)
10.34Form of First Amendment to 8% Senior Secured Convertible Promissory Notes issued June  4, 2018 (incorporated by reference to Exhibit 10.6 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.35Form of Second Amendment to Warrants to Purchase Common Stock issued June 4, 2018 and July  20, 2018 (incorporated by reference to Exhibit 10.7 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.36Form ofPre-Funded Warrant to Purchase Common Stock (incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.37Form of Second Amendment to Warrants to Purchase Common Stock issued June 4, 2018 and July  20, 2018 (incorporated by reference to Exhibit 10.7 to the Company’s Current Report on Form8-K filed on September 7, 2018).
10.38Form of Stock Purchase Agreement dated as of November 16, 2018 (incorporated by reference to Exhibit 10.1 to the Form8-K filed November 7, 2018).
10.39License, Supply and Marketing Agreement for CHEMOSAT® dated as of December 10, 2018 between the Company and medac Gesellschaft für klinische Spezialpräparate mbH (incorporated by reference to Exhibit 10.38 to the Company’s Form10-K filed on June 14, 2019).
10.40Form of Exchange Agreement dated December 2018 (incorporated by reference to Exhibit 10.39 to the Company’s Form10-K filed on June 14, 2019).
10.41Form ofLeak-Out Agreement dated December 2018 (incorporated by reference to Exhibit 10.40 to the Company’s Form10-K filed on June 14, 2019).
10.422019 Equity Incentive Plan (incorporated by reference to Exhibit 4.01 to the Company’s Current Report on Form8-K filed on February 7, 2019).
10.43Global Settlement Agreement dated as of April  18, 2019 by and among the Company, Iroquois Capital Investment Group, LLC, Iroquois Master Fund Ltd. and FirstFire Global Opportunities Fund LLC (incorporated by reference to Exhibit 10.42 to the Company’s Form10-K filed on June 14, 2019).
10.44Securities Purchase Agreement dated as of April  19, 2019 (incorporated by reference to Exhibit 10.43 to the Company’s Form10-K filed on June 14, 2019).
10.45Securities Purchase Agreement dated as of April 26, 2019 (incorporated by reference to Exhibit  10.44 to the Company’s Form10-K filed on June 14, 2019).
10.46Securities Purchase Agreement dated as of May 9, 2019 (incorporated by reference to Exhibit  10.45 to the Company’s Form10-K filed on June 14, 2019).
10.47Securities Purchase Agreement dated as of May  23, 2019 (incorporated by reference to Exhibit 10.46 to the Company’s Form10-K filed on June 14, 2019).
10.48Note Purchase Agreement dated as of June  6, 2019 by and among Delcath Systems, Inc., Rosalind Master Fund LP and Rosalind Opportunities Fund I (incorporated by reference to Exhibit 10.47 to the Company’s Form10-K filed on June  14, 2019).

II-10


  Exhibit  

Description

  10.49Form of 8% Secured Promissory Note Due June 6, 2021 (incorporated by reference to Exhibit 10.48 to the Company’s Form10-K filed on June 14, 2019).
  10.50Securities Purchase Agreement dated as of July  11, 2019 between the Company and Roth Capital Partners, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed July 11, 2019).
  10.51Engagement Letter dated as of May  20, 2019 between the Company and Roth Capital Partners, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed July 11, 2019).
  10.52Securities Purchase Agreement dated as of August  15, 2019 between the Company and Roth Capital Partners, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form8-K filed August 16, 2019).
  10.53Engagement Letter dated as of August  14, 2019 between the Company and Roth Capital Partners, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form8-K filed August 16, 2019).
  10.54Amendment dated as of August  15, 2019 between the Company and each purchaser a signatory thereto to Securities Purchase Agreement dated as of July  11, 2019 between the Company and the purchasers signatories thereto (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form8-K filed August 16, 2019).
  10.55Support and Conversion Agreement dated as of March 11, 2020 among the Company and the other parties thereto.**
  10.56

Amendment to the Support and Conversion Agreement, dated as of April 8, 2020, among the Company and the other parties thereto.

  10.57Board Appointment Agreement dated as of April 8, 2020 among the Company and the other parties thereto.
  23.1Consent of Marcum LLP.
  23.2Consent of Lowenstein Sandler LLP (included as part of Exhibit 5.1).
  24.1Power of Attorney (included on the signature page).*
101.INSXBRL Instance Document
101.SCHXBRL Taxonomy Extension Schema Document
101.CALXBRL Taxonomy Extension Calculation Linkbase Document
101.DEFXBRL Taxonomy Extension Definition Linkbase Document
101.LABXBRL Taxonomy Extension Label Linkbase Document
101.PREXBRL Taxonomy Extension Presentation Linkbase Document

*

Previously filed.

Portions of this exhibit have been omitted.

**

Certain identified information has been excluded from this exhibit because it contains personal information.

Item 17.

Undertakings

The undersigned registrant hereby undertakesundertakes:

1. To file, during any period in which offers or sales are being made, a post-effective amendment to providethis registration statement:

i.

To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;

ii.

To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.

iii.

To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement,provided, however, that paragraphs (1)(i), (1)(ii) and (1)(iii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or 15(d) of the Exchange Act that are incorporated by reference in the registration statement.

II-11


2. That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the underwritersecurities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

3. To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the closing specifiedtermination of the offering.

4. That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the Underwriting Agreement certificatesregistration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such denominationsfirst use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

5. That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the registrant will be a seller to the purchaser and registered inwill be considered to offer or sell such names as required by the underwritersecurities to permit prompt delivery to each purchaser.such purchaser:

(2)

(i)

any preliminary prospectus or prospectus of the registrant relating to the offering filed pursuant to Rule 424;

(ii)

any free writing prospectus relating to the offering prepared by or on behalf of the registrant or used or referred to by the registrant;

(iii)

the portion of any other free writing prospectus relating to the offering containing material information about the registrant or its securities provided by or on behalf of the registrant; and

(iv)

any other communication that is an offer in the offering made by the registrant to the purchaser.

6. Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

(3) The undersigned registrant hereby undertakes that:

(a) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.II-12

(b) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and this offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-3


EXHIBIT INDEX

Exhibit

Description

1.1Form of Underwriting Agreement**
1.2Form of Series C Warrant, Series D Warrant and Series E Warrant**
1.3Form of Pre-Funded Warrant**
3.1Amended and Restated Certificate of Incorporation of the Company, as amended to June  30, 2005 (incorporated by reference to Exhibit 3.1 to Company’s Current Report on Form8-K filed June 5, 2006 (Commission FileNo. 001-16133)
3.2Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company, effective as of April  8, 2014 (incorporated by reference to Exhibit 3.1 to Company’s Current Report on Form8-K filed April 8, 2014 (Commission FileNo. 001-16133)
3.3Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company, effective as of July  20, 2016 (incorporated by reference to Exhibit 3.1 to Company’s Current Report on Form8-K filed July 21, 2016 (Commission FileNo. 001-16133)
3.4Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company, effective as of July  20, 2016 (incorporated by reference to Exhibit 3.2 to Company’s Current Report on Form8-K filed July 21, 2016 (Commission FileNo. 001-16133)
3.5Amended and RestatedBy-Laws of the Company (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to Company’s Registration Statement on FormSB-2 (RegistrationNo. 333-39470))
3.6Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company, effective as of June  30, 2017 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed July 3, 2017 (Commission File No. 001-16133))
3.7Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company, effective as of July  5, 2017 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed July 6, 2017 (Commission File No. 001-16133))
3.8Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company, effective as of September  20, 2017 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed September 21, 2017 (Commission File No. 001-16133))
5.1Opinion of Wexler, Burkhart, Hirschberg & Unger LLP**
23.1Consent of Grant Thornton, LLP**
23.2Consent of Wexler, Burkhardt, Hirschberg & Unger (included as part of Exhibit 5.1)
24.1Powers of Attorney (included on signature page to this Registration Statement)**

**Filed herewith


SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, Delcath Systems, Inc., a Delaware corporation, has duly caused this Amendment to Registration Statement onFormS-1 to to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New York, State of New York, on November 2, 2017.April 20, 2020.

 

DELCATH SYSTEMS, INC.
By: 

/s/ Jennifer K. Simpson Ph.D.

 

Name: Jennifer K. Simpson, Ph.D.

Title: President and Chief Executive Officer

Each person whose signature appears below constitutes and appoints Jennifer K. Simpson and Barbra C. Keck and each of them singly, his or her true and lawfulattorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this registration statement and any and all additional registration statements pursuant to Rule 462(b) of the Securities Act and to file the same, with all exhibits thereto and all other documents in connection therewith, with the SEC, granting unto each saidattorney-in-fact and agents full power and authority to do and perform each and every act in person, hereby ratifying and confirming all that saidattorneys-in-fact and agents or either of them or their, his or her substitute or substitutes may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, this Amendment to Registration Statement onFormS-1 has has been signed by the following persons in the capacities indicated.

 

SIGNATURE

  

TITLE

 

DATE

/s/ Jennifer K. Simpson, Ph.D.

Jennifer K. Simpson, Ph.D.

  

President and Chief Executive Officer and Director

(Principal Executive Officer)

 November 2, 2017April 20, 2020

/s/ Barbra C. Keck, M.B.A.

Barbra C. Keck, M.B.A.

  

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

 November 2, 2017April 20, 2020

/s/ Roger G. Stoll, Ph.D.*

Roger G. Stoll, Ph.D.

  Chairman of the Board November 2, 2017April 20, 2020

/s/ William D. RueckertElizabeth Czerepak

Elizabeth Czerepak

DirectorApril 20, 2020

*

William D. Rueckert

  Director November 2, 2017April 20, 2020

/s/ Marco Taglietti, M.D.*

John R. Sylvester

DirectorApril 20, 2020

*

Marco Taglietti, M.D.

  Director November 2, 2017April 20, 2020

*By:

/s/ Jennifer K. Simpson, Ph.D.

Jennifer K. Simpson, Ph.D.
Attorney-in-fact