Delcath Systems (DCTH) 8-K This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future

Investor Presentation

(NASDAQ: DCTH)

October 2015

Exhibit 99.1

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 and the impact on sales, if any, of reimbursement 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 U.S. FDA, acceptance of the Phase 3 trial

publication, the impact of presentations and abstracts at major medical meetings and congresses (SSO, ASCO, CIRSE,

ESMO,

EADO, RSNA) and future clinical results consistent with the data presented, approval of the current or future

Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in

the U.S. 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

About Delcath Systems

•

A specialty pharmaceutical and medical device oncology company with a

principal therapeutic focus on the treatment of primary liver cancer and other

cancers that have metastasized to the liver

•

Proprietary system isolates the liver from circulation, delivers a substantially

higher concentration of chemotherapy (melphalan) compared with systemic

doses, and filters most of the chemotherapy out of the blood prior to returning

it to the patient

•

In late-stage clinical development in the U.S. with initial commercial activities

underway in Europe

•

Initially pursuing orphan indications in metastatic ocular melanoma, 

hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC)

Seeking to Make a Clinically Meaningful Difference For Cancer Patients With Liver Dominant Disease

4

DELCATH SYSTEMS, INC

Whole Organ-Focus Disease Control

Our Solution

•

Our proprietary system isolates the liver circulation, delivers a high concentration of

chemotherapy (melphalan) and filters most of the chemotherapy out of the blood prior

to returning it to the patient

•

The procedure typically takes approximately 2-3 hours to complete and involves a team

including the interventional radiologist, oncologist, anesthesiologist and perfusionist

•

We believe more than 250 treatments with improved device and procedure provide

confidence safety can be validated in a controlled setting

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

5

DELCATH SYSTEMS, INC

Investment Highlights

Large, Compelling Market Opportunity

•

Late-stage

asset

–

clinically

meaningful

efficacy

demonstrated

in

>600

procedures and in multiple tumor types

•

Active

clinical

program

–

initiating

global

Phase

3

study

in

ocular

melanoma; HCC/ICC Phase 2 program ongoing 

•

Unique,

highly

differentiated

solution

–

multiple

orphan

designations

create barriers to entry

•

Early

stage

commercialization

in

EU

–

>250

procedures

performed

in

EU with 2nd Generation product and protocol

•

Imminent

valuation

milestones

–

2015

value

drivers

include

publications,

reimbursement and clinical data

•

Attractive

business

model

–

initial

orphan

focus

and

anticipated

high

gross margins form basis of profitable long-term model

•

Experienced

management

team

–

aligned

with

requirements

of

clinically

driven pharmaceutical industry

6

DELCATH SYSTEMS, INC

2015 Milestones

1H-2015

NUB reimbursement decision in Germany –

Value 4 awarded for 2015

Submit Phase 3 metastatic melanoma trial results for publication

EU registry open for enrollment

ICC cohort open for enrollment

2H-2015

ZE Reimbursement in Germany

•

EADO Abstracts released

•

RSNA Abstract released

•

Initiation of global Phase 3 metastatic ocular melanoma program

•

Interim evaluation on HCC/ICC program

Executing on Multiple Fronts to Create Value

7

DELCATH SYSTEMS, INC

The Liver:  A Life-Limiting Organ

•

Cancers of the liver remain a major unmet medical need

o

Large global patient population –

approximately 1.2 million* patients

diagnosed annually with primary or metastatic liver cancer

o

The liver is often the life-limiting organ for cancer patients and one of the

leading causes of cancer death

o

Prognosis after liver involvement is poor, with 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

Effective Liver Cancer Treatment Remains a Major Unmet Medical Need

8

DELCATH SYSTEMS, INC

Existing Liver Cancer Treatments Landscape

Existing Liver Cancer Treatments Have Limitations

Treatment

Advantages

Disadvantages

Systemic

–

Non-invasive

–

Repeatable

–

Systemic toxicities

–

Limited efficacy in liver

Regional

(e.g., Isolated Hepatic Perfusion)

–

Therapeutic effect

–

Targeted

–

Invasive/limited repeatability

–

Multiple treatments are

required but not possible

Focal

(e.g., surgery, radioembolization,

chemoembolization,

radiofrequency ablation)

–

Partial removal or

treatment of tumors

–

Only 10%-20% are resectable

–

Invasive and/or limited

repeatability

–

Treatment is limited by tumor

size, number of lesions and

location

–

Tumor revascularization

–

Cannot treat diffuse disease

9

DELCATH SYSTEMS, INC

Melphalan Dosing & Background

•

Well-understood, dose-dependent, tumor-preferential, alkylating cytotoxic agent

that demonstrates little to no hepatic toxicity

•

Dose administered directly to liver is substantially higher than that of systemic IV

chemotherapy

•

Melphalan, an established chemotherapy agent, is proven active at high doses

with broad antitumor activity

An Established Drug for Liver Cancer Therapy

Type

Dosing (mg/kg)

Multiple Myeloma (label)

0.25

Chemoembolization

0.62

Surgical Isolated Hepatic Perfusion (IHP)

1.50

Myeloablation

2.50-3.50

Melphalan/HDS (PHP)

3.00

10

DELCATH SYSTEMS, INC

Total Available EU & U.S. Market Opportunity

Cancers Of The Liver Remain a Multibillion-Dollar Unmet Medical Need

Cancer Type

Annual

Incidence

1

Eligible PTS

2

Annual Potential

Market

Opportunity

(Millions)

3,5

Annual Potential

Market

Opportunity

(Millions)

4,5

Ocular Melanoma

5,700-8,600

2,600-4,300

$104-$215

$208-$430

Intrahepatic

Cholangiocarcinoma

(ICC)

11,500

6,500

$260-$330

$520-$660

Hepatocellular Carcinoma

(HCC)

64,500

7,600-14,700

$304-$735

$608-$1,470

Colorectal (CRC)

411,000

40,000-55,000

$1,600-$2,750

$3,200-$5,500

Total EU & U.S.

492,700-495,600

56,700-80,500

$2,268-$4,030

$4,536-$8,060

Notes:

1)

Globocan, American Cancer Society

2)

LEK, Strategy&, Company Estimates

3)

Assumes average of 2TX/patient

4)

Assumes average of 4TX/patient

5)

Assumes $20,000-$25,000 USD/TX

11

DELCATH SYSTEMS, INC

European Commercial Activity

CHEMOSAT

Hepatic Delivery System

•

Approved as Class IIb Medical Device; kit

supplied without melphalan

•

Broad indication for intra-hepatic

administration of melphalan hydrochloride and

subsequent filtration of the venous blood

return

•

>250 commercial procedures performed in

leading cancer centers across the EU

•

ZE National Procedure Code Established for

2016; 2015 Reimbursement via Individual

Funding Requests

•

UK private pay insurance; block grants

pending

•

2015 YTD EU Sales exceed 2014 on local

currency basis

®

12

DELCATH SYSTEMS, INC

ZE Reimbursement

•

First National Reimbursement Coverage Mechanism for CHEMOSAT in Europe

•

Establishes DRG Code for CHEMOSAT procedures in Germany

•

Augments coverage under established codes until dedicated, comprehensive DRG

code can be established

•

Hospitals negotiate reimbursement level with insurers beginning Feb 2016

•

Replaces annual NUB process

•

ZE Coverage in response to applications submitted by German Radiology Society;

represents significant support for CHEMOSAT TX for cancers in the liver

13

DELCATH SYSTEMS, INC

Increasing & Expanding Clinical Utilization

Utilization Expanding Into Other Tumor Types Beyond Ocular Melanoma

All

other

includes:

cutaneous

melanoma,

HCC,

ICC,

CRC,

breast

mets,

neuroendocrine

mets,

pancreatic,

mucosal

melanoma,

sarcoma,

and

gastric

mets

14

DELCATH SYSTEMS, INC

Clinically Differentiated Results

•

Phase 1, 2 and 3 trials produced positive results in multiple histologies

•

Melanoma Liver Mets

o

Positive Phase 3 results in hepatic metastatic melanoma

o

n=93 (90% ocular melanoma, 10% cutaneous melanoma)

•

Neuroendocrine Tumor (NET) Liver Mets

o

mNET cohort in Phase 2 trial showed encouraging 42% objective response rate

(ORR) vs. ~10% for approved targeted therapy

o

Median overall survival of ~32 months on ITT basis

•

Hepatocellular Carcinoma (HCC)

o

Positive signal with high-dose melphalan in HCC cohort of Phase 2 trial (5/8 patients)

is encouraging when approved systemic therapies have modest efficacy and

challenges with tolerability

•

Colorectal Cancer (CRC) Liver Mets

o

Data from surgical Isolated Hepatic Perfusion (IHP) with melphalan indicates strong

potential in well-defined patient population with earlier stage CRC yielding ~50-60%

median response rate and median OS of 17.4-24.8 mos

Encouraging Initial Results on a Broad Range of Histologies

15

DELCATH SYSTEMS, INC

Clinical Development Program

Trials

Tumor

Objectives

Phase 3 Pivotal Trial

OM liver mets

Global

Phase

3

trial

to

start

2H-2015

~240 PTS, 30 mos accrual, 2017 Interim Analysis

Primary endpoint: Overall

Survival (OS)

Believed to be fastest pathway to NDA approval in the U.S.

Phase 2 Program

HCC

(unresectable

confined to the

liver)

Protocol 201 (U.S. only)

Evaluate ORR (mRECIST)

Assess safety, PFS

Characterize systemic exposure of melphalan

Assess patient QoL

Protocol 202 (EU only)

Evaluate ORR (mRECIST)

Assess safety, PFS

Characterize systemic exposure of melphalan

Assess patient QoL

ICC

(unresectable

confined to the

liver)

Added to 202 HCC trial protocol

ORR of Melphalan/HDS treatment in patients with intra-hepatic cholangiocarcinoma (ICC)

Other measures as specified in the 202 EU protocol

Signal-seeking go/no-go decision 2H-2015

Investigator Initiated

Trials

mCRC

University of

Leiden study; 10 patients

treated to date

HCC

Johannes Wolfgang Goethe University

Hospital (Frankfurt) study; different patient selection from

202 study; open for enrollment

EU Commercial Registry

EU Commercial

Cases

Open

for

enrollment;

data

collection

on

safety,

QoL

assessments

Potential efficacy signals in additional tumor types

Support reimbursement in key markets

Safety,

efficacy

of

Melphalan/HDS

treatment

followed

by

sorafenib

Safety,

efficacy

of

Melphalan/HDS

treatment

w/o

sorafenib

in

patients

with

unresectable

liver cancer

16

DELCATH SYSTEMS, INC

OM Metastases Rationale

•

OM has high incidence of liver metastases

o

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

o

Life expectancy of approximately 6 months

o

5,700 -

8,600 cases of OM liver metastases diagnosed in U.S. and EU

annually

•

Clear efficacy signal seen in prior Phase 3 trial of Melphalan/HDS

•

Currently no standard of care

•

Believed to be fastest pathway to NDA approval in the U.S.

•

FDA granted Melphalan/HDS orphan drug designation for treatment of OM

*Sources:

ACS,

SEER,

NIH,

OMF,

KOL

Interviews,

2014

3

rd

Party

Analysis

Proven Efficacy in Attractive Orphan Opportunity

17

DELCATH 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

0

.

8

0

.

6

0

.

4

0

.

2

0

.

0

Proportion of patients surviving

5.3 mo

Chemosaturation (CS-PHP)

Previous Ocular Melanoma Mets Phase 3 Results

0

5

10

15

20

25

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

0

.

8

0

.

6

0

.

4

0

.

2

0

.

0

3.8 mo

Intent-to-Treat Analysis (June 2012)

Best alternative care (BAC)

0

5

10

15

20

25

30

35

40

45

50

55

Clinically

Meaningful

Benefit

Previously

Demonstrated

for

Metastatic

OM

Patients

4 subjects remain

alive at 5-8 years

All were recipients

of CS-PHP

18

DELCATH SYSTEMS, INC

HCC & ICC Rationale

•

Significant opportunity in the U.S. and EU

o

HCC most common primary cancer of the liver

o

~76,000* cases diagnosed annually

o

ICC represents ~15% of new HCC cases diagnosed annually

o

~90% HCC/ICC PTS not candidates for surgical resection

o

20-30% PTS candidates for focal interventions

•

Large unmet medical need in first-line therapy

o

Only one approved systemic therapy for HCC in the U.S., EU and certain

Asian markets

•

FDA granted Melphalan/HDS orphan drug designations for treatment of

unresectable HCC & ICC

•

Efficacy signals from early commercial uses in EU

*Sources:

WHO,

KOL

Interviews,

2014

3

rd

Party

Analysis

Large, Deadly Disease in Need of Better Treatments

19

DELCATH SYSTEMS, INC

Prior FDA Experience

•

New Drug Application (NDA) submitted August 2012 seeking

indication in OM liver metastases with first-generation filter and

procedure

•

ODAC meeting in May 2013

o

Efficacy shown with statistical significance

o

Negative vote due to benefit/risk analysis

o

Complete 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:

o

Well-controlled randomized trial(s) to establish the safety and

efficacy using the to-be-marketed device configuration

o

Overall survival as the primary efficacy outcome measure

o

Demonstrate clinical benefits outweigh risks

FDA Learnings Provide Beneficial Clinical Study Roadmap

20

DELCATH 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 included:

o

4.1% incidence of death due to adverse reactions

o

4% incidence of stroke

o

2% reported incidence of myocardial infarction in the setting of an incomplete cardiac

risk assessment

o

70% incidence of grade 4 bone marrow suppression with a median time of recovery

of greater than 1 week

o

18% 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

•

Safety improvements implemented

Treating Physicians in U.S. and EU Report Improved Safety Profile

21

DELCATH SYSTEMS, INC

Growing Body of Clinical Support for CHEMOSAT

EU KOL Forum affirms benefits to liver

cancer patients

o

4 TX being administered; shown to

be safe and well tolerated

o

Providing clinical benefit and good QoL

o

Reimbursement continues to be

covered through individual funding

requests

Abstracts Accepted at Major Medical

Meetings

o

ESSO 2014

o

SSO 2015

o

ASCO 2015

o

CIRSE 2015

o

EADO 2015

o

ESMO 2015

o

RSNA 2015

22

DELCATH SYSTEMS, INC

Recent Data Presentations –

ECCO

2015

Leiden University Medical Center, Erasmus Medical Center (the Netherlands)

Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous)

Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers

•

Investigators compared TX with IHP and PHP for ocular melanoma liver metastases

•

IHP cohort (n=30) treated between 1999 and 2009

o

PFS was 6 mos

o

Disease recurrence mainly in the liver

o

OS was 10 mos

(vs 6 mos historic avg for IHP)

•

PHP cohort ( n=9); PTS received 15 PHP TX since Feb 2014

o

Max follow up period was 14 mos

o

8 PTS still alive, 7 without disease progression

o

Decrease in red/white blood cell count observed following TX; 3 PTS received

blood transfusion

o

TX overall was well tolerated

•

Conclusion: PHP appears to be effective/safe procedure in select patients with

unresectable liver metastases from CRC or OM and can be repeated

23

DELCATH SYSTEMS, INC

Recent Data Presentations –

CIRSE 2015

Leiden University Medical Center (the Netherlands)

Safety

and

efficacy

of

Delcath

2

nd

Generation

filter

in

PHP

with

melphalan

for unresectable hepatic metastases of colorectal cancer and uveal melanoma

•

15 PHP procedures performed with CHEMOSAT on 10 pts; PK blood samples @ baseline, set

intervals

•

PHP performed with melphalan dose of 3mg/kg; 1st blood sample filtration efficiency = 93%

•

Grade 3 complications (mostly leukocytopenia, thrombocytopenia) in 7 pts; febrile neutropenia

(w/bacterial pharyngitis) in 1 pts (not seen following introduction of growth factors)

•

Conclusion:

2

nd

and acceptable morbidity

Southampton University (United Kingdom)

Lessons and Early Results from the Largest Single Center Experience in Europe of

Treating Ocular Melanoma Liver Metastases with Chemosaturation via Percutaneous

Hepatic Perfusion

•

Retrospective analysis of 22 pts; 20 received TX w/PHP

•

11 pts alive after median 280 days; one complete response > 1yr post TX

•

9 deaths from disease progress after median 264 days post TX

•

Complete response in liver in 2 pts (10%), 13 pts (65%) had partial liver response, 2 pts (10%)

had stable disease > 3mos

•

Conclusion: PHP effective palliative TX in bleak disease  with an acceptable side-effect 

profile

Generation filter efficiency very high; PHP associated with no mortality

24

DELCATH SYSTEMS, INC

Recent Data Presentations -

ASCO 2015

Southampton University Hospital (UK)

o

Analysis of 20 ocular melanoma patients who received 34 TX

o

Eleven patients remain alive after a median of 280 days with one complete

response ongoing at >1 year

o

From the diagnosis of liver metastases, 11 patients (55%) survived to one year and

3 (15%) for >2 years; no procedure related deaths were seen

o

ORR 85%: 2 patients (10%) demonstrated stable disease for >3 months, 13

patients (65%) had a partial response, 2 patients (10%) demonstrated complete

response

o

Nine deaths from disease progression occurred after a median of 264 days from

the first procedure

Adverse Events

o

Early AEs often expected with percutaneous hepatic perfusion (PHP) were

observed including coagulopathy, electrolyte disturbances and transient

transaminases (elevated liver enzymes).

Rare late AEs (1 patient each) included

hair loss, skin rash, myelosuppression and persistent transaminases (elevated liver

enzymes)

o

AEs seen were grade 1 (n=12), 2 (n=13), 3 (n=5) and 4 (n=1)

o

Grade 4 complication was pulmonary edema due to fluid overload

25

DELCATH SYSTEMS, INC

Recent Data Presentations -

SSO 2015

Moffitt Cancer Center (Tampa, FL)

Hepatic Progression Free and Overall Survival after Regional Therapy to the

Liver for Metastatic Melanoma

o

Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated

with Melphalan/HDS (n=10), chemoembolization (CE, n=12), and yttrium-90 (Y90,

n=6)

o

Study showed significant difference in hepatic progression free survival (HPFS) for

Melphalan/HDS (310 days), CE (80 days), Y90 (54 days)

o

Median overall survival (OS) longest for Melphalan/HDS (736 days) vs Y90 (285

days) CE (265 days), but did not reach statistical significance

o

Authors concluded that HPFS and progression free survival (PFS) were

significantly prolonged with Melphalan/HDS vs CE and Y90

26

DELCATH SYSTEMS, INC

Coming Soon

Leiden University Medical Center in the Netherlands

Treating Unresectable Liver Metastases Of Uveal Melanoma With

Percutaneous Hepatic Perfusion With Melphalan

Southampton University in the United Kingdom

Liver Directed Treatment Of Metastatic Uveal Melanoma By

Chemosaturation Via Percutaneous Hepatic Perfusion –

A Single Centre

Experience

Frankfurt University Hospital

Chemosaturation with Percutaneous Hepatic Perfusion of Melphalan

for Hepatic Metastases from Uveal Melanoma: Multiinstitutional

Evaluation

27

DELCATH SYSTEMS, INC

Cash & Capital Resources

Cash & Cash Equivalents

$19.1 million at July 31, 2015

Debt

None

ATM Program

1

$40 million available at July 31, 2015

Shares Outstanding

21.8

million

(40.7

million

fully

diluted

2

)

at

July

31,

2015

1)

Subject to market conditions and certain limitations

2)

Fully diluted includes approximately 0.8 million options and 18.1 million warrants

Focused Spending and Resources to Support Execution of Near-term Plan

In Summary

•

Attractive multi-billion dollar orphan

drug business model

•

Unique, highly differentiated solution

•

Late-stage asset in U.S. with active

clinical development program

•

Early commercial activity in EU with

increasing sales/procedure volumes

•

Compelling emerging data

•

Imminent valuation milestones

•

Experienced pharmaceutical

management team executing a

data-driven plan

28

DELCATH SYSTEMS, INC

30

DELCATH SYSTEMS, INC

© 2015 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED

Delcath

and CHEMOSAT are registered trademarks of Delcath

Systems, Inc.