Delcath Systems (DCTH) 8-K Regulation FD Disclosure

Exhibit 99.1

Investor Presentation
(NASDAQ: DCTH)

November 2014

2 DELCATH 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, 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.

3 DELCATH SYSTEMS, INC

Why Invest in Delcath?

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

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

•Broad and Informed clinical development program

oMultiple clinical trials: OM, HCC, ICC

oPrior FDA experience provides roadmap for clinical programs

•Demonstrated efficacy

o>225 clinical 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

•Demonstrated safety

oWe believe EU commercial experience provides confidence safety can be
validated in controlled clinical setting

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

4 DELCATH SYSTEMS, INC

Near-term Milestones to Create Value

Multiple milestones within next 12 months

•2014

oPhase 3 publication submitted by year-end

oICC cohort open for enrollment by year-end

oEU Registry open for enrollment by year-end

•2015

oInterim analysis - first 11 HCC patients by mid-year

oGo/no-go decision on ICC programby mid-year

oInitiation of Phase 3 ocular melanoma program by mid-year

oNUB reimbursement decision in Germany by February 1, 2015

•Experienced team to achieve milestones

Obtaining Data in Multiple Tumor Types

5 DELCATH 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 is a proprietary product uniquely positioned to
potentially treat the entire liver as a standalone or
complementary therapy

* SOURCE - 2008 GLOBOCAN

6 DELCATH 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

7 DELCATH 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

>225 Patients Treated In Clinical Development and Initial Commercial Use

8 DELCATH SYSTEMS, INC

Broad and Informed Clinical Development Program

Multiple Clinical Trials

•   Initiating plans for Global phase 3 trial in Ocular Melanoma
    (OM) Liver Mets in 2015 for trial start mid year

•   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

Clinical Development Program at a Glance

10 DELCATH SYSTEMS, INC

Clinical Development Program - Timeline

Interim Analysis

Leiden University (mCRC n=~30)

JWG (HCC n =~10)

First Patient In

Last Patient In

Data Readout

Additional IITs as Opportunities Present

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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

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

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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

13 DELCATH SYSTEMS, INC

HCC Rationale

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

•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

14 DELCATH 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

76,000

HCC Diagnosis

~90%

Focal Interventions

~6,500

Eligible Patients

US/EU Market Size

~15%

OfHCC
Cases

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

~20-30%

Unresectable

15 DELCATH SYSTEMS, INC

Prior FDA Experience Provides Roadmap for Clinical Programs

•New Drug Application (NDA) submitted August 2012 seeking
indication in OM liver metastases

•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

16 DELCATH SYSTEMS, INC

Risks Observed in Previous Clinical Trials

•Risks observed using product and procedure protocol from Previous Clinical
Program

•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

oDeaths due to certain adverse reactions did not occur again during the
clinical trials following the adoption of related protocol amendments

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

17 DELCATH SYSTEMS, INC

Why Do We Believe?

•Improved device and procedure since prior trials

o>130 EU treatments

o>20 treatments in US Expanded AccessProgram and
Compassionate Use cases

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 47% of patients had a partial
response and 16% had a complete response

oMoffittreported 67% of patients had a partial response. In addition,
one patient was reported to have a complete response

oLeiden reported 80% of patients had a partial response

Patients Benefiting from Melphalan/HDS

18 DELCATH 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

•  >130 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

19 DELCATH SYSTEMS, INC

CHEMOSAT® Commercial Treatments in Europe

•Multiple Tumor Types Treated Since EU Launch

Treatments/Re-treatments Increasing

20 DELCATH 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 certain limitations

2)Subject to market conditions and 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./Est.	$4.5M	$4.0M	$4.0M

21 DELCATH SYSTEMS, INC

Summary

•Cancers of the liver represent a multi-
Billion dollar global market and unmet
medical need

•Demonstrated efficacy

oPhase 3 trial

oRecent presentations at ESSO

•>150 treatments with improved device
and procedure in US and EU

•Current device/procedure permitting
multiple treatment cycles

•Intend to initiate Phase 3 OM trial 2015

•Phase 2 HCC trial open for enrollment

•ICC cohort to open for enrollment by end
2014

§Several milestones over next 12 months

§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.

23 DELCATH SYSTEMS, INC

APPENDIX

24 DELCATH SYSTEMS, INC

Historic Clinical Program

Clinical Trials	Phase 1	Phase 2	Phase 3	Follow Up	EU Commercial Experience
Unresectable Hepatic Tumors
Unresectable Hepatic Tumors (Multi- Histology)*
Melanoma Liver Metastases
		Integrated Safety Population
Product Procedure Refinements					N= >90

N=35

N=56

N=93

(44PHP, 49 BAC)

•Historic 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

25 DELCATH 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