Delcath Systems (DCTH) 8-K Regulation FD Disclosure

Exhibit 99.1

Investor Presentation
(NASDAQ: DCTH)

January 2015

2DELCATH SYSTEMS, INC

Forward-looking Statements

This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future
events and future financial performance which include statements about our expectations, beliefs, plans, objectives,
intentions, goals, strategies, assumptions and other statements that are not historical facts.  Forward-looking statements
are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which
could cause actual results to differ materially from expected results, performance or achievements expressed or implied
by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements
for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials
including without limitation the OM, HCC, ICC, and mCRC trials in the Company’s Clinical Development Program, clinical
adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for
the CHEMOSAT system in various markets including without limitation Germany and the United Kingdom, our ability to
successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for
patients with primary and metastatic disease in the liver, the Company's ability to satisfy the requirements of the FDA's
Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the
Melphalan/HDS system by the US FDA, submission and acceptance of the phase 3 trial publication, approval of the
current or future Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for
various indications in the US and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, our ability
to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and
revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, and
uncertainties regarding our ability to obtain financial and other resources for any clinical trials, research, development,
and commercialization activities. These factors, and others, are discussed from time to time in our filings with the
Securities and Exchange Commission including the section entitled ‘‘Risk Factors’’ in our most recent Annual Report on
Form 10-K and our Reports on Form 10-Q and Form 8-K.

3DELCATH SYSTEMS, INC

Why Invest in Delcath?

•We are a late-stage clinical company with early commercial activity in
Europe focused on cancers of the liver

•Cancers of the liver are an unmet medical need representing a multi-
billion dollar global market

•Focused clinical development program

oMultiple clinical trials: OM, HCC, ICC

oPrior FDA experience provides roadmap for clinical programs

•Demonstrated efficacy

oClinical and commercial patients across multiple tumor types

oEfficacy and QoL benefit shown as reported by patients and physicians

oThree recent scientific presentations at ESSO meeting highlighted
efficacy and safety

•Safety improvements implemented

o>180 treatments with improved device and procedure in US and EU
provides confidence safety can be validated in controlled clinical setting

Large Market Opportunity, Demonstrated Efficacy, Near-term Value Drivers

4DELCATH SYSTEMS, INC

2015 Milestones to Create Value

2014 Accomplishments

oPhase 2 HCC trial open and first patient treated

o100th patient treated in Europe (commercial and clinical)

oPositive efficacy data from three institutions presented at ESSO 2014

Q1

oPrior phase 3 publication submitted

oEU Registry open for enrollment

oICC cohort open for enrollment

oNUB reimbursement decision in Germany by February 1, 2015

Mid-year

oInterim analysis on HCC patients

oGo/no-go decision on ICC program

oInitiation of phase 3 ocular melanoma program

Obtaining Data in Multiple Tumor Types

5DELCATH SYSTEMS, INC

The Liver:A Life Limiting Organ

•Cancers of the liver remain a major unmet medical need
globally

oLarge global patient population - approximately 1.2 million* patients
diagnosed annually with primary or metastatic liver cancer

oThe liver is often the life limiting organ for cancer patients and one of the
leading causes of cancer death

oPrognosis after liver involvement is poor - overall survival generally less
than 12 months

•CHEMOSAT/Melphalan/HDS is a proprietary product uniquely
positioned to potentially treat the entire liver as a standalone or
complementary therapy

* SOURCE - 2008 GLOBOCAN

6DELCATH SYSTEMS, INC

Potential Applications

Unresectable
Hepatocellular
Carcinoma (HCC)

(76,000 Cases
Diagnosed in US/EU
Annually)

Ocular Melanoma
(OM) Liver
Metastases

( ~4,000 Cases
Diagnosed in US/EU
Annually)

Intra-hepatic
Cholangiocarcinoma (ICC)

(~11,500 Cases Diagnosed
in US/EU Annually)

Colorectal Cancer Liver
Metastases (mCRC)

(~65,000 Cases Diagnosed
in US/EU Annually)

Liver Cancers: Multi-Billion Dollar Global Market

Sources: ACS, SEER, NIH, OMF, KOL Interviews, 3rd Party Analysis

7DELCATH SYSTEMS, INC

The Melphalan Hepatic Delivery System (HDS)

•Device designed to administer high dose chemotherapy to the liver while reducing
systemic exposure

•Marketed as Delcath Hepatic CHEMOSAT® Delivery System (device only) in EU

•Investigational drug/device combination product regulated as a drug in the US

Liver Isolated Via Double Balloon
Catheter In IVC

Melphalan Infused Directly Into Liver
Via Catheter In Hepatic Artery

Blood Exiting The Liver Filtered By
Proprietary Extra-corporeal Filters

>240 Patients Treated In Clinical Development and Initial Commercial Use

8DELCATH SYSTEMS, INC

Focused Clinical Development Program

•Initiating global phase 3 trial mid-year in Ocular Melanoma
(OM) Liver Mets

•Establish Proof of Concept in Hepatocellular Carcinoma (HCC)
and Intrahepatic Cholangiocarcinoma (ICC)

oCommenced Global Phase 2 Program in HCC in 2014

oExpanding Program to include ICC Cohort in EU Trial

•EU Registry to collect efficacy and safety data in the
commercial setting

•Supporting Investigator Initiated Trials (IITs) in HCC &
mCRC

9DELCATH SYSTEMS, INC

Clinical Development Program at a Glance

10DELCATH SYSTEMS, INC

Clinical Development Program - Timeline

Leiden University (mCRC n=~30)

JWG (HCC n =~10)

First Patient In

Last Patient In

Data Readout

Additional IITs as Opportunities Present

11DELCATH SYSTEMS, INC

OM Rationale

•OM has high incidence of liver metastases

oUp to 90% of patients with metastases will have liver involvement

oLife expectancy of approximately 6 months

o~7,500 cases of OM liver metastases diagnosed in US and EU annually

•Clear efficacy signal seen in prior P3 trial of Melphalan/HDS

•Currently no standard of care

•Believed to be fastest pathway to NDA approval in the US

•Melphalan/HDS granted orphan drug status by FDA for treatment of patients

     with OM

5,700-8,600

Cases of Ocular
Melanoma

~50-55%

Metastasize

~90%

Show Liver Mets

~2,600 - 4,300

Eligible Patients

Limited TX Options

US/EU Market Size

*Sources: ACS, SEER, NIH, OMF, KOL Interviews, 2014 3rd Party
Analysis

12DELCATH SYSTEMS, INC

Intent-to-Treat Analysis (June 2012)

§5.3 mos improvement in hPFS

§Hazard ratio = 0.50

§(95% CI 0.31-0.80)

§P=0.0029

Months

7.0

1.7

1.0

1.0

0.8

0.8

0.6

0.6

0.4

0.4

0.2

0.2

0.0

0.0

Proportion of patients surviving

5.3 mo

Chemosaturation (CS-PHP)

Previous Ocular Melanoma Phase 3 Results

0

0

5

5

10

10

15

15

20

20

25

25

30

30

Best alternative care (BAC)

Hepatic Progression Free Survival (hPFS)

Chemosaturation (CS-PHP)

§3.8 mos improvement in PFS

§Hazard ratio = 0.42

§(95% CI 0.27-0.64)

§P<0.0001

Overall Progression Free Survival (Investigator)

Proportion of patients surviving

Months

5.4

1.6

1.0

1.0

0.8

0.8

0.6

0.6

0.4

0.4

0.2

0.2

0.0

0.0

3.8 mo

Intent-to-Treat Analysis (June 2012)

Best alternative care (BAC)

0

0

5

5

10

10

15

15

20

20

25

25

30

30

35

35

40

40

45

45

50

50

55

55

13DELCATH SYSTEMS, INC

HCC Rationale

•Significant opportunity in US and EU

oHCC most common primary cancer of the liver

o~76,000* cases diagnosed annually

•Large unmet medical need in first line therapy

oOnly one currently approved systemic therapy in US, EU, and certain
Asian markets

o~90% of pts not candidates for surgical resection

o20-30% of pts candidates for focal interventions

•Melphalan/HDS granted orphan drug status by FDA for treatment of patients

with unresectable HCC

76,000

~90%

HCC

~80-90%

Unresectable

~20-30%

Child Pugh Class A

~7,600 - 14,700

Eligible Patients

~20-30%

Interventional
TX

US/EU Market Size

*Sources: WHO, KOL Interviews, 2014 3rd Party Analysis

14DELCATH SYSTEMS, INC

ICC Rationale

•Significant Market Opportunity in US and EU

o~15% of new HCC cases diagnosed annually

o~90% of patients are not suitable for surgical resection

o~20-30% candidates for focal interventions

oEfficacy signals from early commercial uses in EU

•Unmet medical need – Delcath will pursue a melphalan orphan

drug designation from the FDA for patients with ICC

76,000

HCC Diagnosis

~90%

Unresectable

~6,500

Eligible Patients

US/EU Market Size

~15%

OfHCC
Cases

*Sources: ACS, SEER, NIH, KOL Interviews, 2014 3rd Party Analysis

~20-30%

Focal
Interventions

15DELCATH SYSTEMS, INC

Prior FDA Experience Provides Roadmap for Clinical Programs

•New Drug Application (NDA) submitted August 2012 seeking
indication in OM liver metastases with prior filters and
procedure

•ODAC meeting in May 2013

oNegative Vote

oComplete FDA & Delcath ODAC briefing materials available at
www.delcath.com/clinical-research/clinical-bibliography/

•Complete Response Letter (CRL) Issued September 2013

•FDA requests include, but not limited to:

oWell-controlled randomized trial(s) to establish the safety and
efficacy using the to-be-marketed device configuration

oOverall survival as the primary efficacy outcome measure

oDemonstrate clinical benefits outweigh risks

•Provides roadmap for clinical studies in anytumor type

16DELCATH SYSTEMS, INC

Risks Observed in Previous Clinical Program

•Risks observed with prior product and procedure protocol

•Integrated safety population of patients showed risks associated with
Melphalan/HDS to include:

o4.1% incidence of deaths due to adverse reactions

o4% incidence of stroke

o2% reported incidence of myocardial infarction in the setting of an incomplete cardiac
risk assessment

oa ≥ 70% incidence of grade 4 bone marrow suppression with a median time of
recovery of greater than 1 week

o18% incidence of febrile neutropenia, along with the additive risk of hepatic injury,
severe hemorrhage, and gastrointestinal perforation

•Deaths due to certain adverse reactions did not occur again during the

clinical trials following the adoption of related protocol amendments

•Reports from treating physicians in US and EU indicate improved safety

profile with improved device and procedure refinements

17DELCATH SYSTEMS, INC

Safety Improvements Implemented

•New generation filter

oimproved filter efficiency and consistency

•Vasopressors and methylprednisolone

oreduce cardiovascular risk

•Prophylactic transfusions and growth factors

oreduce risk of myelosuppression

•Intra-arterial nitroglycerin

oto prevent hepatic arterial spasm

•Liver tumor burden not to exceed >50%

oto address risk of liver failure

18DELCATH SYSTEMS, INC

Positive Developments

•Improved device and procedure since prior trials

o>180 treatments with improved device and procedure in US and EU

oMany issues raised at ODAC have not been reported

•EU patients report improved QoL

•Current device/procedure permitting multiple treatment cycles

•Recent scientific presentations at ESSO for OM from 3 centers in
US and EU

oUniversity Southampton reported 63% positive response (47% had a
partial response and 16% had a complete response)

oMoffittreported 67% positive response (partial response and one
complete response)

oLeiden reported 80% positive response (partial response)

Patients Benefiting from Melphalan/HDS

19DELCATH SYSTEMS, INC

European Commercialization

CHEMOSAT®

Hepatic Delivery System

•   Approved as Class IIb Medical Device; kit supplied
     w/o melphalan

•   Broad indication for intra-hepatic administration of
     melphalan hydrochloride and subsequent filtration of
     the venous blood return

•   150 commercial procedures performed in 15 leading
     cancer centers in the EU

•   Reimbursement via Individual Funding Requests;
    NUB Value 4 Status in Germany

•   Growing Support for NUB Value 1 Status among
    German KOLs; 2015 NUB decision by February 1,
     2015

•   UK Block Grants pending & private pay insurance

20DELCATH SYSTEMS, INC

CHEMOSAT® Commercial Treatments in Europe

•Multiple Tumor Types Treated Since EU Launch

Treatments/Re-treatments Increasing

21DELCATH SYSTEMS, INC

Cash & Capital Resources

Cash & Cash Equivalents	$23.3 million at September 30, 2014
Debt	None
ATM Program1	$40 million available at September 30, 2014
Working Capital Line of Credit2	$20 million credit facility
Shares Outstanding	9.4 million (10.5 million fully diluted3) at September 30, 2014

1)Subject to market conditions and certain limitations

2)Subject to certain limitations

3)Fully diluted includes approximate 0.2 million options and 0.9 million warrants

	2014 Operating Cash Spend (Unaudited)
	Q1 A	Q2 A	Q3 A	Q4 Est.	FY Est.
Quarterly Guidance	$5-6M	$5-6M	$4-5M	$4-5M	$16.5-17.5M
Quarterly Act.	$4.5M	$4.0M	$4.0M

22DELCATH SYSTEMS, INC

Summary

•Cancers of the liver are an unmet
medical need representing a multi-billion
dollar global market

•Demonstrated efficacy

oPrior phase 3 trial

oRecent presentations at ESSO

•>180 treatments with improved device
and procedure in US and EU

•Current device/procedure permitting
multiple treatment cycles

•Phase 2 HCC trial open for enrollment

•Value driving milestones in 2015

oInitiate Phase 3 OM trial

oExpand HCC trial to include ICC cohort

oInterim data in HCC

•Experienced team to help achieve
milestones in a cost efficient manner

Melphalan Hydrochloride for Injection for use with the
Delcath Hepatic Delivery System (Melphalan/HDS)

*DELCATH SYSTEMS, INC

© 2014 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED

Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.

24DELCATH SYSTEMS, INC

APPENDIX

25DELCATH SYSTEMS, INC

Previous Clinical Program

Clinical Trials	Phase 1	Phase 2	Phase 3	Follow Up
Unresectable Hepatic Tumors
Unresectable Hepatic Tumors (Multi-Histology)*
Melanoma Liver Metastases
		Integrated Safety Population

N=35

N=56

N=93

(44PHP, 49 BAC)

•Previous Clinical Program demonstrated improvement in hepatic
progression free survival in patients with OM

•Positive efficacy signals also seen in HCC, mNET

•Protocol Amendments and Procedure Refinements introduced in
response to Adverse Events (AEs) seen on trial

•Reports from treating physicians in US and EU indicate improved
safety profile with improved device and procedure refinements

26DELCATH SYSTEMS, INC

Publications

§Alexander, R., et al. Current Status of Percutaneous Hepatic Perfusion as Regional Treatment for
Patients with Unresectable Hepatic Metastases: A Review, American Oncology and Hematology
Review 2014: 15-23

§Vogl, et al. Chemosaturation with Percutaneous Hepatic Perfusions of Melphalan for Hepatic
Metastases: Experience from Two European Centers, Fortschr Röntgestr 2014

•H. Schulze-Bergkamen et al.Unresectable Isolated Hepatic Metastases from Solid
Pseudopapillary Neoplasm of the Pancreas: A Case Report of Chemosaturation with High-Dose
Melphalan, Pancreatology 2014

§Forster M., et al. Chemosaturation with Percutaneous Hepatic Perfusion for Unresectable
Metastatic Melanoma or Sarcoma to the Liver: A Single Institution Experience.Journal of Surgical
Oncology. 2013

§Yamamoto M, Zager J. Isolated Hepatic Perfusion for Metastatic Melanoma.Journal of Surgical
Oncology. 2013

2014 ESSO CongressPresentations

§A Single Institution Experience with Percutaneous Hepatic Perfusion for Unresectable Ocular
Melanoma and Sarcoma in the Liver---Moffitt Cancer Center, U.S.; J. Zager

§Percutaneous Hepatic Perfusion with Melphalan in Treating Unresectable Liver Metastases from
Colorectal Cancer and Uveal (Ocular) Melanoma - Leiden University Medical Centre (LUMC), The
Netherlands; N. de Leede

§Initial United Kingdom Experience with Melphalan Percutaneous Hepatic Perfusion (PHP) For
Treatment of Inoperable Ocular Melanoma Metastases---University Hospital Southampton, U.K; B.
Stedman