Delcath Systems (DCTH) 8-K Regulation FD Disclosure

Investor Presentation

(NASDAQ: DCTH)

February 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

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.

3

DELCATH SYSTEMS, INC

Delcath at a Glance

•

A late-stage clinical company with early commercial activity in Europe

•

CHEMOSAT is approved as a medical device (CE Mark) in Europe;

investigational new combination product in U.S. for treating cancers of

the liver

•

Focused clinical development program initially pursuing orphan

indications in metastatic ocular melanoma and primary liver cancer

•

Based in New York with European operations in Galway, Ireland

•

Traded on NASDAQ under symbol DCTH

•

More than $23 million in cash at 9/30/2014

Seeking

to

Make

a

Clinically

Meaningful

Difference

For

Cancer

Patients

With

Liver

Dominant

Disease

4

DELCATH SYSTEMS, INC

Investment Highlights

We

Believe

We

are

Positioned

to

Capitalize

on

Large,

Compelling

Market

Opportunity

Large

market

opportunity

-

cancers

of

the

liver

remain

a

multi-billion

dollar

unmet

medical

need

Unique,

highly

differentiated

solution

–

orphan

designations

create

barriers

to

competitive

entry

Late-stage,

asset

-

demonstrated

clinically

meaningful

efficacy

in

over

550

procedures

and

multiple

tumor

types

Compelling

emerging

data

–

demonstrated

early

success

in

multiple

tumor

types

Imminent

valuation

milestones

-

2015

value

drivers

include

publications,

reimbursement

&

clinical

data

Attractive

business

model

-

initial

orphan

focus

and

anticipated

high

gross

margins

form

basis

of

profitable

long-term

model

Experienced

management

team

-

now

aligned

with

requirements

of

clinically

driven

pharmaceutical

industry

5

DELCATH SYSTEMS, INC

2014-2015 Milestones

Executing on Multiple Fronts to Create Value

2014 Accomplishments

o

Phase 2 HCC trial open and first patient treated

o

100

th

patient treated in Europe (commercial and clinical)

o

Positive efficacy data from three institutions presented at ESSO

2014

o

Q3 sales increased 201% Y/Y to $217K

o

Cash burn reduced by almost 60% Y/Y through September

1H-2015

o

Submit Phase 3 metastatic melanoma publication

o

EU Registry open for enrollment

o

ICC cohort open for enrollment

o

NUB reimbursement decision in Germany —

Value 4 awarded for 2015

2H-2015

o

Interim analysis on HCC patients

o

Initiation of phase 3 ocular melanoma program

6

DELCATH SYSTEMS, INC

The Liver:  A Life Limiting Organ

•

Cancers

of

the

liver

remain

a

major

unmet

medical

need

globally

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

–

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

7

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, radio

frequency ablation)

–

Partial removal or

treatment of tumors

–

Only 10% to 20% resectable

–

Invasive and/or limited

repeatability

–

Treatment is limited by tumor

size, number of lesions and

location

–

Tumor revascularization

–

Cannot treat diffuse disease

8

DELCATH SYSTEMS, INC

Concentrating the Power of Chemotherapy for Disease Control in the Liver

Our Solution –

Whole Organ-Focus Disease Control

•

Our proprietary system isolates the liver circulation, delivers a

substantially higher concentration of chemotherapy (melphalan)

to the liver 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 and perfusionist

•

We believe more than 180 treatments with improved device

and procedure in US and EU provides confidence safety can

be validated in a controlled setting

9

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

More Than 240 Patients Treated To Date

10

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

Type

Dosing (mg/kg)

Multiple Myeloma (label)

0.25

Chemoembolization

0.62

Surgical Isolated Hepatic Perfusion (IHP)

1.50

Myeloablation

2.50-3.50

Chemosaturation (PHP)

3.00

An Established Drug for Liver Cancer Therapy

11

DELCATH SYSTEMS, INC

The Evidence for Melphalan

•

Melphalan,

an

established

chemotherapy

agent,

is

proven

active

at

high

doses

with

broad

antitumor

activity

1.

Grover

AC,

et

al.

Surgery

2004;136:1176-82

2.

Noter

SL,

et

al.

Melanoma

Res

2004;14:67-72

3.

Alexander

HR

Jr,

et

al.

Clin

Cancer

Res

2000;6:3062-70

4.

Alexander

HR

Jr,

et

al.

Clin

Cancer

Res

2003;9:6343-9

5.

Alexander

HR

Jr,

et

al.

Ann

Surg

Oncol

2009;16:1852-9

6.

Van

Iersel

LB,

et

al.

Ann

Oncol

2008;19:1127-34

7.

Van

Iersel

LB,

et

al.

Ann

Oncol

2010;21:1662-7

8.

Verhoef

C,

et

al.

Ann

Surg

Oncol

15:1367-74

12

DELCATH SYSTEMS, INC

Potential Applications

Unresectable

Hepatocellular

Carcinoma (HCC)

Ocular Melanoma

(OM) Liver

Metastases

Intra-hepatic

Cholangiocarcinoma (ICC)

Colorectal Cancer Liver

Metastases (mCRC)

Multiple Opportunities Yields Potential Multi-Billion Dollar Global Market

13

DELCATH SYSTEMS, INC

Total Available EU & US Market Opportunity

Effective Liver Cancer Treatment Remains a Major Unmet Medical Need

Notes:

1)

Source:

Globocan,

American

Cancer

Society

2)

Source:

LEK,

Booz/PwC,

Company

estimates

3

)

Assumes

an

average

of

two

treatments

per

patient

Cancer Type

Annual 

Incidence

Eligible Pts 

Revenue per

Patient

Annual Potential

Market Opportunity

(millions)

Ocular Melanoma (OM)

5,700-8,600

2,600-4,300

$40,000-$50,000

$104-$215

Cholangio Carcinoma (ICC)

11,500

6,500

$40,000-$50,000

$260-$330

Hepatocellular Carcinoma (HCC)

64,500 

7,600-14,700

$40,000-$50,000

$304-$735

Colorectal (CRC)

411,000

40,000-55,000

$40,000-$50,000

$1,600-$2,750

Total EU and US

492,700-495,600

56,700-80,500

$2,268-$4,030

1

2

3

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 Overview

•

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)

o

Commenced Global Phase 2 Program in HCC in 2014

o

Expanding Program to include ICC Cohort in EU Trial

•

Initiating EU Registry to collect efficacy and safety data in

the commercial setting

•

Supporting Investigator Initiated Trials (IITs) in HCC &

mCRC

Focused on Liver Dominant, Orphan Diseases With High Unmet Need

Clinical Development Program at a Glance

17

DELCATH SYSTEMS, INC

Clinical Development Program –

Timeline

Legend

First Patient In

Last Patient In

Data Readout

Tumor Type

2014

2015

2016

2017

OM

(Phase 3 Pivotal Trial)

201 HCC

(US Phase 2)

202 HCC

(EU Phase 2)

Combined US, EU 31 patients

ICC Cohort

(to be added to 202 HCC;

n=11)

IITs

EU Commercial Registry

18

DELCATH SYSTEMS, INC

OM 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

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

*Sources:

ACS,

SEER,

NIH,

OMF,

KOL

Interviews,

2014

3

rd

Party

Analysis

Proven Efficacy in Attractive Orphan Opportunity

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

19

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

Proportion of patients surviving

Previous Ocular Melanoma Phase 3 Results

Hepatic Progression Free Survival (hPFS)

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

Intent-to-Treat Analysis (June 2012)

Clinically Meaningful Benefit Previously Demonstrated for Metastatic OM Patients

Chemosaturation (CS-PHP)

Best alternative care (BAC)

Chemosaturation (CS-PHP)

Best alternative care (BAC)

Months

20

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

o

Efficacy 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

*Sources:

ACS,

SEER,

NIH,

KOL

Interviews,

2014

3

rd

Party

Analysis

Encouraging Early Commercial Activity in Disease With Limited Treatment Options

76,000

HCC Diagnosis

~90%

Unresectable

~6,500

Eligible Patients

US/EU Market Size

~15%

Of  HCC

Cases

~20-30%

Focal

Interventions

21

DELCATH SYSTEMS, INC

HCC Rationale

•

Significant

opportunity

in

US

and

EU

o

HCC

most

common

primary

cancer

of

the

liver

o

~76,000*

cases

diagnosed

annually

•

Large

unmet

medical

need

in

first

line

therapy

o

Only

one

currently

approved

systemic

therapy

in

US,

EU,

and

certain

Asian

markets

o

~90%

of

pts

not

candidates

for

surgical

resection

o

20-30%

of

pts

candidates

for

focal

interventions

•

Melphalan/HDS

granted

orphan

drug

status

by

FDA

for

treatment

of

patients

with

unresectable

HCC

*Sources:

WHO,

KOL

Interviews,

2014

3

rd

Party

Analysis

Large, Deadly Disease in Need of Better Treatments

76,000

Cases of Primary Liver

Cancer

~80-90%

Unresectable

~20-30%

Child Pugh Class A

~7,600 –

14,700

Eligible Patients

~20-30%

Interventional

TX

US/EU Market Size

~90%

HCC

22

DELCATH SYSTEMS, INC

Prior FDA Experience

•

New Drug Application (NDA) submitted August 2012 seeking

indication in OM liver metastases with prior filters and

procedure

•

ODAC meeting in May 2013

o

Negative Vote

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

23

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 to include:

o

4.1% incidence of deaths 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

a

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

Treating Physicians in US and EU Report Improved Safety Profile

24

DELCATH SYSTEMS, INC

Safety Improvements Implemented

•

New generation filter

o

improved filter efficiency and consistency

•

Vasopressors and methylprednisolone

o

reduce cardiovascular risk

•

Prophylactic transfusions and growth factors

o

reduce risk of myelosuppression

•

Intra-arterial nitroglycerin

o

to prevent hepatic arterial spasm

•

Liver tumor burden not to exceed >50%

o

to address risk of liver failure

Decisive Measures to Seek to Improve Safety Implemented

25

DELCATH SYSTEMS, INC

Positive Developments

•

Improved device and procedure since prior trials

o

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

o

Many issues raised at ODAC have not been reported

•

Current device/procedure permitting multiple treatment cycles

•

Recent scientific presentations at ESSO for OM from 3 centers in

US and EU

o

University Southampton reported 63% positive response (47% had a

partial response and 16% had a complete response)

o

Moffitt  reported 67% positive response (partial response and one

complete response)

o

Leiden reported 80% positive response (partial response)

Patients Report Improved Quality of Life

26

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

•

150

commercial

procedures

performed

in

15

leading

cancer

centers

in

the

EU

•

Reimbursement

via

Individual

Funding

Requests;

NUB

Value

4

Status

in

Germany

•

UK

Block

Grants

pending

&

private

pay

insurance

27

DELCATH SYSTEMS, INC

CHEMOSAT

®

Commercial Treatments in Europe

•

Multiple Tumor Types Treated Since EU Launch

Treatments/Re-treatments Increasing

28

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

Congress

Presentations

Clinical Evidence and Awareness Continue to Build

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

29

DELCATH SYSTEMS, INC

Cash & Capital Resources

Cash & Cash Equivalents

$23.3 million at September 30, 2014

Debt

None

ATM Program

1

$40 million available at September 30, 2014

Shares Outstanding

9.4 million (10.5 million fully diluted

3

) at

September 30, 2014

1)

Subject to market conditions and certain limitations

2)

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

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

30

DELCATH SYSTEMS, INC

Summary

Melphalan

Hydrochloride

for

Injection

for

use

with

the

Delcath

Hepatic

Delivery

System

(Melphalan/HDS)

•

Cancers of the liver remain a large,

multi-billion dollar unmet medical

need

•

Unique, highly differentiated solution

•

Late-stage asset

•

Compelling emerging data

•

Imminent Valuation milestones

•

Attractive orphan drug business

model

•

Experienced pharmaceutical

management team executing a

data-driven plan

31

DELCATH SYSTEMS, INC

©

2014

DELCATH

SYSTEMS,

INC.

ALL

RIGHTS

RESERVED

Delcath

and

CHEMOSAT

are

registered

trademarks

of

Delcath

Systems,

Inc.