Delcath Systems (DCTH) 8-K Regulation FD Disclosure

Exhibit 99.1

2

DELCATH SYSTEMS, INC

Forward-looking Statements

Private

Securities

Litigation

Reform

Act

of

1995

provides

a

safe

harbor

for

forward-looking

statements

made

by

the

Company

or

on

its

behalf.

This

presentation

contains

forward-looking

statements,

which

are

subject

to

certain

risks

and

uncertainties

that

can

cause

actual

results

to

differ

materially

from

those

described.

Factors

that

may

cause

such

differences

include,

but

are

not

limited

to,

uncertainties

relating

to:

timing

of

completion

of

the

FDA’s

review

of

our

NDA,

the

extent

to

which

the

FDA

may

request

additional

information

or

data

and

our

ability

to

provide

the

same

in

a

timely

manner,

acceptability

of

the

Phase

1,

2

and

3

clinical

trial

data

by

the

FDA,

FDA

approval

of

the

Company's

NDA

for

the

treatment

of

metastatic

ocular

melanoma

to

the

liver,

adoption,

use

and

resulting

sales,

if

any,

for

the

chemosaturation

system

in

the

United

States,

adoption,

use

and

resulting

sales,

if

any,

for

the

Hepatic

CHEMOSAT

delivery

system

in

the

EEA,

our

ability

to

successfully

commercialize

the

chemosaturation

system

in

various

markets

and

the

potential

of

the

chemosaturation

system

as

a

treatment

for

patients

with

cancers

in

the

liver,

the

timing

and

our

ability

to

successfully

enter

into

strategic

partnership

and

distribution

arrangements

in

foreign

markets

including

Australia

and

key

Asian

markets

and

resulting

sales,

if

any,

from

the

same,

patient

outcomes

using

the

Generation

2

system,

approval

of

the

current

or

future

chemosaturation

system

for

other

indications

and/or

for

use

with

various

chemotherapeutic

agents,

actions

by

the

FDA

or

other

foreign

regulatory

agencies,

our

ability

to

obtain

reimbursement

for

the

CHEMOSAT

system

in

various

markets,

the

number

of

cancer

centers

in

Germany

able

to

successfully

negotiate

and

receive

reimbursement

for

the

CHEMOSAT

procedure

and

the

amount

of

reimbursement

to

be

provided,

submission

and

publication

of

the

Phase

II

and

III

clinical

trial

data,

the

timing

and

results

of

research

and

development

projects,

the

timing

and

results

of

future

clinical

trials

including

the

initiation

of

clinical

trials

in

key

Asian

markets

with

the

Hepatic

CHEMOSAT

Delivery

System

device

for

intra-hepatic

arterial

delivery

and

extracorporeal

filtration

of

doxorubicin,

approval

of

the

Hepatic

CHEMOSAT

Delivery

System

to

delver

and

filter

doxorubicin

in

key

Asian

markets

and

adoption,

sales,

if

any,

and

patient

outcomes

using

the

same,

the

timing,

price

and

use,

if

any,

of

the

committee

equity

financing

facility

with

Terrapin,

the

timing

and

use,

if

any,

of

the

line

of

credit

from

SVB

and

our

ability

to

access

this

facility

and

uncertainties

regarding

our

ability

to

obtain

financial

and

other

resources

for

any

research,

development

and

commercialization

activities.

These

factors,

and

others,

are

discussed

from

time

to

time

in

our

filings

with

the

Securities

and

Exchange

Commission.

You

should

not

place

undue

reliance

on

these

forward-looking

statements,

which

speak

only

as

of

the

date

they

are

made.

We

undertake

no

obligation

to

publicly

update

or

revise

these

forward-looking

statements

to

reflect

events

or

circumstances

after

the

date

they

are

made.

3

DELCATH SYSTEMS, INC

Investment Considerations

Concentrating the Power of Chemotherapy

•

Commercial stage company focused on oncology

•

Proprietary CHEMOSAT delivery system allows unique whole organ

therapy for the liver

•

CHEMOSAT system has demonstrated extension of progression free

survival

•

Addressing large unmet market need for cancer patients who usually die

of liver failure

•

2013 estimated addressable market opportunity of ~$2.3 billion

•

Expanding clinical data expected to broaden clinical use and indications

•

On the cusp of realizing the potential:

o

EU commercial launch underway

o

Reimbursement in additional key EU markets expected in Q1

o

U.S. NDA under review –

PDUFA date June 15, 2013

•

Attractive

financial

model,

multiple

capital

resources

available

and

experienced

management

team

to

execute

plan

4

DELCATH SYSTEMS, INC

1.

ISOLATE

2.

SATURATE

3.

FILTRATE

The Delcath CHEMOSAT System

Minimally Invasive, Repeatable Liver Procedure That Could Complement Systemic Therapy

Chemosaturation

•

Improves disease

control in the liver

•

Treats entire liver

(macro and micro)

•

Controls systemic

toxicities

•

Allows for over

100x effective dose

escalation at tumor

site

5

DELCATH SYSTEMS, INC

Melanoma Liver Metastases

A Great Demonstration of CHEMOSAT’s Potential

•

A challenging histology

•

Notoriously insensitive to

systemic chemotherapy and

focal interventions

•

CHEMOSAT has

demonstrated ability to extend

progression free survival

Our Opportunity

•

Ability to achieve ultra-high concentrations of chemotherapy that are

effective on a wide variety of cancers in the liver

•

Physicians are recognizing the broad applicability of CHEMOSAT, based

on early EU experience

6

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

•

Safety profiles consistent with pivotal US Phase 3 melanoma trial

Encouraging Initial Results on a Broad Range of Histologies

7

DELCATH SYSTEMS, INC

INDEPENDENT

REVIEW

COMMITTEE

(IRC)

ASSESSMENT

-

UPDATED

ANALYSIS

(4

June

2012)

Hepatic progression-free survival (IRC)

Hazard ratio = 0.50

(95% CI 0.31–0.80)

P=0.0029

0               

5                       10                     15

20

25                      30              

Months

7.0

1.7

1.0

0.8

0.6

0.4

0.2

0.0

Proportion of patients surviving

5.3 mo

Intent-to-treat population

Chemosaturation (CS-PHP)

Best alternative care (BAC)

Positive Phase 3 Results –

Primary Endpoint hPFS

CS-PHP Demonstrated 4x or 5.3 months Improvement in Primary Endpoint of hPFS

8

DELCATH SYSTEMS, INC

INVESTIGATOR

ASSESSMENT

-

UPDATED

ANALYSIS

(4

June

2012)

Overall progression-free survival (investigator)

Months

5.4

1.6

1.0

0.8

0.6

0.4

0.2

0.0

Proportion of patients surviving

Hazard ratio = 0.42

(95% CI 0.27–0.64)

P<0.0001

0             5            10            15

20

25           30            35           40         

45           50           55

3.8 mo

Intent-to-treat population

Chemosaturation (CS-PHP)

Best alternative care (BAC)

Positive Phase 3 Results –

Overall PFS

CS-PHP also Demonstrated a Highly Statistically Significant Improvement in Overall PFS

9

DELCATH SYSTEMS, INC

TOTAL CS-PHP vs BAC ONLY

Overall Survival –

Exploratory Subset Analysis

Overall Survival Tail For  CS-PHP Treated Patients

Proportion of subjects surviving

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

12

36

0

24

48

60

11.4

Total CS-PHP incl. crossover

BAC only

Months

4.1

Intent-to-treat population

7.3 mo

10

DELCATH SYSTEMS, INC

Phase 2 Multi-Histology NCI Trial –

Summary

•

Strong efficacy signals in mNET

o

42% objective Response Rate (ORR) vs ~10%

for approved targeted therapy

o

66% patients had hepatic tumor shrinkage and

durable disease stabilization

•

Positive Signal in primary hepatic malignancies

(HCC and Cholangiocarcinoma) in 5 of 8 patients

•

Similar safety profiles across tumor types

Positive Efficacy Signals In Additional Types of Cancer

11

DELCATH SYSTEMS, INC

Phase 2 NCI Trial –

Metastatic Neuroendocrine Cohort

Pre-CS

(Baseline)

Post-CS #2

(+4 Months)

Post-CS #1

(+6 Weeks)

Compelling Clinical Data in Attractive mNET Market

Phase 2 mNET Tumor Cohort  (n=24)*

Number (n)

Tumor Types

Pancreatic NET

13

Carcinoid tumor

3

Other NET

8

Response

Partial Response (PR)

10

Stable disease (SD)

6

Progressive disease

3

Not assessed or evaluable

5

Objective Response Rate

42%

Median Duration of Hepatic Response

Partial Response (n-10)

23.5 months

Partial Response/Stable Disease (n=16)

16.8 months

Hepatic Progression Free Survival (IIT n=24)

Median Hepatic PFS

16.8

Min/Max

2.1, 64.1

Overall Survival After CS

Median

31.9 months

Min/Max

2.4, 81.1

66%

disease

control

12

DELCATH SYSTEMS, INC

Phase 2 NCI Trial –

Hepatobiliary Carcinoma Cohort

•

Best hepatic tumor response by modified RECIST assessed by investigators

o

Partial response (PR)

1 patient

o

Stable disease (SD)

4 patients

o

Progressive disease

1 patient

o

Not assessed or evaluable

2 patients 

•

Median duration of response

o

hPR (N=1)

6.42 months

o

hPR/SD (N=5) 

8.12 months

•

Hepatic progression free survival (ITT N=8)

o

Median 

5.60 months

o

Minimum, Maximum 

2.7, 12.2 months

•

Overall survival (ITT N=8)

o

Median 

9.12 months

o

Minimum, Maximum 

3.4, 20.5 months

•

HCC is the most common primary cancer of the liver, with approximately 750,000* new

cases diagnosed worldwide annually

•

Intend to initiate new HCC trials with  CHEMOSAT

Encouraging Positive Signal for Primary Liver Cancer

*Source: GLOBOCAN

13

DELCATH SYSTEMS, INC

•

Substantial clinical evidence of benefit of using ultra-high dose

melphalan to treat mCRC via isolated hepatic perfusion (IHP)

procedure

o

Over 800 patients treated in 15 studies since 1998

o

Patients treated only once

o

Median response rate of ~50-60% and median OS of 17.4 –

24.8 mos

1,2

•

Delcath

Phase

2

NCI

Chemosaturation

Trial

–

mCRC

Cohort

o

Challenges enrolling at NCI due to competing FOLFOX & FOLFIRI trials

o

17

patients treated since 2004

o

Safety profile –

expected and consistent with pivotal FDA Phase III

melanoma trial

•

Intend to invest in new mCRC trials with CHEMOSAT Melphalan

Strong Rationale for Using CHEMOSAT with Melphalan to Treat mCRC

1)

van Iersel LB, Gelderblom H, et al. Ann Oncol. 2008;19:1127-34

2)

Alexander, HR, Barlett DL, et al. Ann Surg Oncol, 16:1852-9, 2009

Phase 2 NCI Trial –

mCRC Cohort

14

DELCATH SYSTEMS, INC

Additional Clinical Data Generation

•

Goals:

Expand US (CS-PHP: MEL) label indications beyond the

initial indication we are seeking

Generate robust clinical data to support commercialization

•

FDA has accepted IND Amendment to include Gen 2 device in

Expanded Access Program (EAP), compassionate use (CU),

and all future clinical trials

•

Initiated EAP to treat first patient in January, 2013

•

Activate EU Registry to systematically collect data from

commercial experience

Establish CHEMOSAT as the Standard of Care (SOC) for Disease Control in the Liver

15

DELCATH SYSTEMS, INC

2013 Clinical Development Plan

•

Planned company sponsored trials, pending discussion with the FDA

Metastatic Neuroendocrine tumor (NET) with liver dominant disease

o

Global Phase 3 Randomized CHEMOSAT Melphalan vs. Best

Alternative Care (BAC)

-

Primary endpoint: Hepatic PFS

Hepatocellular carcinoma (HCC)

o

Global Phase 3 Randomized CHEMOSAT Melphalan vs. best supportive

care (BSC) for patients where Sorafenib is inappropriate

-

Primary endpoint: Overall Survival

Advanced colorectal cancer (CRC) with liver dominant metastasis

o

Global Phase 3 Randomized CHEMOSAT Melphalan vs. best alternative

care (BAC)

-

Primary endpoint: Overall Survival

•

Planned phase 2 studies including global Investigator-initiated trials (IITs) in

multiple indications: HCC, NET, CRC, melanoma

Establish CHEMOSAT as the Standard of Care (SOC) for Disease Control in the Liver

16

DELCATH SYSTEMS, INC

8,708

6,563

4,085

8,212

7,202

33,966

19,861

33,953

52,143

5,585

7,671

99,749

0

25,000

50,000

75,000

100,000

125,000

150,000

175,000

200,000

USA

EU

APAC

$2.3 Billion Market Opportunity in 2013 with Pharmaceutical-Like Gross Margins

Sources: LEK Consulting, GLOBOCAN, Company estimates.

EU: Initial target countries of Germany, UK, Italy, France, Spain, Netherlands, Ireland.

APAC: Initial target countries of China, Japan, S. Korea, Taiwan, Australia.

Assumes 2.5 treatments per patient.

Assumes EU ASP of $15K; US ASP of $25K; APAC ASP of $5K.

55,389

$2.2 B

42,367

$2.6 B

189,943

$2.2 B

HCC

CRC

Melanoma

NET

$2.3B Initial Opportunity

•$100M Initial on-label

opportunity in Ocular

Melanoma in US*

•$2.2B multi-histology

opportunity in EU

* Assumes FDA approval for ocular

melanoma metastatic to the liver

CHEMOSAT -

Potential Multi-Billion Dollar Global Market

17

DELCATH SYSTEMS, INC

Approved  (CE Mark Device)

NDA Filing Accepted by the FDA with PDUFA goal date of June 15, 2013

Mutual Recognition of European CE Mark –

Applications Planned or

Submitted

Global Commercialization Status

Addressing A Multi-Billion Dollar Global Market

18

DELCATH SYSTEMS, INC

CHEMOSAT: EU Launch Underway

•

Marketing in target EU countries -

Italy, Germany, France,

UK, Ireland, NL, Spain

•

Training completed in key centers

o

Eight EU Clinical Sites activated in 2012

•

EU clinicians using CHEMOSAT for a broad range of liver

metastases

o

Use includes: cutaneous melanoma, ocular melanoma, colorectal

cancer (CRC), gastric cancer, breast cancer, neuroendocrine tumor

(NET), hepatocellular carcinoma (HCC) and Cholangiocarcinoma

•

EU reimbursement gaining momentum

o

Italy –

Reimbursement pathway established

o

Germany –

Value 4 NUB interim reimbursement granted February

2013

o

UK –

Reimbursement anticipated Q1 2013

Rapid

Expansion

of

EU

Clinical

and

Commercial

Footprint

Expected

in

2013

19

DELCATH SYSTEMS, INC

Multiple Tumor Types Treated in Europe

•

Countries: Germany, Italy, UK, France, Ireland

•

EU Registry To Be Initiated Q2

20

DELCATH SYSTEMS, INC

U.S. NDA Under Review

•

PDUFA date: June 15, 2013

•

Initial indication: unresectable metastatic ocular melanoma

in the liver

o

Provides lowest risk pathway to FDA approval and fastest access

•

NDA filing included:

o

Comprehensive set of additional data in a new FDA compliant

CDISC database

o

Gen 2 filter as part of the Chemistry, Manufacturing and Control

(CMC) module

•

Oncology Drug Advisory Committee (ODAC) panel

expected May 2013

•

Three meetings scheduled with FDA to discuss clinical

programs for planned label expansions in each of NET,

HCC,CRC

FDA Decision Expected in June

21

DELCATH SYSTEMS, INC

U.S. Commercialization Strategy

•

Launch in Q4 2013 assuming approval on PDUFA date of June

15, 2013

•

Initial commercial focus on centers that are active in the EAP or

participated in the Phase 3 clinical trial

•

Utilize active EAP hospitals as Centers of Excellence for training

and support of new centers

•

Intend to seek chemosaturation specific CPT reimbursement

code, based upon value proposition relative to other cancer

therapies

•

Educate Medical Oncologists via Medical Science Liaison (MSL)

•

Direct strategy to sell to hospital based Interventional

Radiologists and Surgeons

Participating EAP Centers Provide Immediate Commercial Footprint

22

DELCATH SYSTEMS, INC

Barriers to Entry

•

Patent Protection

o

6 U.S. patents in force and 6 U.S. patent applications pending

o

9 foreign patents in force (with patent validity in 25 countries) and 14 foreign patent

applications pending

o

Primary US device patent set to expire August 2016

o

Up to 5 years of patent extension post FDA approval

•

Trade Secret Protection

o

Developed improved filter media via proprietary manufacturing processes

•

FDA Protection

o

Orphan Drug Designation granted for melphalan in the treatment of ocular

melanoma, cutaneous melanoma and metastatic neuroendocrine tumors, as well as

for doxorubicin in the treatment of HCC

Provides 7 years of marketing exclusivity post FDA approval

o

Additional Orphan Drug applications to be filed for other drugs and indications,

including melphalan for HCC and CRC

Multiple Levels of Protection

23

DELCATH SYSTEMS, INC

Financial Summary

1) Fully diluted includes an additional 4.8 million options and 5.6 million warrants

Multiple Capital Resources Available  to Execute Plan

Cash & Cash Equivalents:

$23.7 million at December 31, 2012 (unaudited)

ATM Program

$21.5 million remaining as of December 31, 2012

Committed Equity Financing

Facility (CEFF)

Up to $32.8 million as of December 31, 2012

Working Capital Line of Credit:

$20 million credit facility

Debt:

None

Cash Spend:

Approx. $10 million in 4Q 2012 (unaudited)

Projected 2013 quarterly cash spend $9-$12 million

Shares Outstanding:

76.8 million (87.2 million fully diluted

1

) as of

December 31, 2012

24

DELCATH SYSTEMS, INC

Management: A Track Record of Success

Executive

Title

Prior Affiliation(s)

Years of

Experience

Eamonn Hobbs

President and CEO

AngioDynamics, E-Z-EM

32

Graham Miao, Ph.D.

EVP & CFO

D&B, Pagoda Pharma, Schering-Plough,

Pharmacia, JP Morgan

23

Krishna Kandarpa, M.D.,

Ph.D.

CSO and EVP, R&D

Harvard, MIT(HST), Cornell, UMass

33

Agustin Gago

EVP, Global Sales

AngioDynamics, E-Z-EM

31

Jennifer Simpson, Ph.D.

EVP, Global Marketing

Eli Lilly (ImClone), Johnson & Johnson

(Ortho Biotech)

23

Peter Graham, J.D.

EVP, General Counsel &

Global Human Resources

Bracco, E-Z-EM

18

David McDonald

EVP, Business Development

AngioDynamics, RBC Capital Markets

30

John Purpura

EVP, Regulatory Affairs & Quality

Assurance

E-Z-EM, Sanofi-Aventis

29

Harold Mapes

EVP, Global Operations

AngioDynamics, Mallinckrodt

27

Gloria Lee, M.D., PH.D.

EVP, Clinical  & Medical Affairs

Hoffmann-La Roche, Syndax

Pharmaceuticals, Inc.

21

Bill Appling

SVP Medical Device R&D

AngioDynamics

27

Dan Johnston, Ph.D.

VP, Pharmaceutical R&D

Pfizer, Wyeth

12

25

DELCATH SYSTEMS, INC

2012 Accomplishments

•

First patients treated with CHEMOSAT Melphalan in Europe in

January

•

Obtained CE Mark for Gen 2 CHEMOSAT Melphalan filter in

April

•

Executed contract for MSL services in EU in 1Q 2012 (Quintiles

was selected to support EU launch of CHEMOSAT)

•

Secured agreements with 14 leading cancer centers in EU

•

8 EU Clinical Sites Activated for commercial use

•

US NDA submitted in August 2012

•

US NDA accepted with PDUFA date of June 15, 2013

•

Obtained CE Mark for CHEMOSAT Doxorubicin in October

•

Interim reimbursement established in Italy in December

Considerable Achievements Built the Foundation For Commercial Success

26

DELCATH SYSTEMS, INC

2013 Anticipated Milestones                                 

First patient enrolled in EAP -

Q1 2013

•

Secure interim reimbursement in Germany and UK -

Q1 2013

•

Submission for publications of Phase 3 data and mNET arm of Phase 2 data in

Q1 2013

•

Initiate EU Registry -

Q1 2013

•

First commercial sale in APLA –

Q2 2013

•

ODAC Panel Meeting May 2013

•

Receive NDA approval of Delcath’s chemosaturation system by PDUFA date of

June 15, 2013

•

Commence Company’s first investigator initiated trial (IIT) –

Q2 2013

•

First patient enrolled in Company sponsored trial (CST) to expand indications –

Q4 2013

•

US commercial launch of Delcath’s chemosaturation system –

Q4 2013

•

First patient enrolled in Taiwan HCC pivotal trial –

Q4 2013

•

Execute strategic partnership for China

A Busy Year Focused on Increased Commercial Adoption and Clinical Data

27

DELCATH SYSTEMS, INC

A Compelling Investment Opportunity

•

Commercial stage company focused on oncology

•

CHEMOSAT provides a unique whole organ therapy for the liver

•

CHEMOSAT system has demonstrated extension of progression

free survival (PFS)

•

Addressing large unmet market need for cancer patients who

usually die of liver failure

•

EU commercial launch underway

•

2013 estimated addressable market opportunity of $2.3 billion

•

Reimbursement in additional key EU markets expected in Q1

•

U.S. NDA under review

•

Expanding clinical data expected to broaden clinical use and US

labeling

•

Attractive financial model, multiple capital resources available

and experienced management team to execute plan

.

On the Cusp of Realizing the Potential for Patients and Shareholders

28

DELCATH SYSTEMS, INC

©

2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED

29

DELCATH SYSTEMS, INC

Appendices

30

DELCATH SYSTEMS, INC

LIVER CANCER TREATMENT

OPTIONS

Appendix 1

31

DELCATH SYSTEMS, INC

Existing Liver Cancer Treatments Have Significant Limitations

The Problem

•

Metastatic disease to the liver, brain or lungs is often the life-

limiting location of solid tumors

o

Often life-limiting or leads to withdrawal of systemic treatments in

favor of palliative care

•

Effective treatment for patients with liver-limited or dominant

cancers remains a clinical challenge

o

Can be diffuse

o

Often not responsive to chemotherapy and radiation therapy

•

Whole organ therapy creates a new option for patients in the

management of liver dominant disease

32

DELCATH SYSTEMS, INC

Existing Liver Cancer Treatments Have Limitations

Unmet Medical Need Exists for More Effective Liver Cancer Treatments

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

33

DELCATH SYSTEMS, INC

Diffuse Hepatic Metastases from Melanoma

•

Diffuse disease in the liver is prevalent

•

Effective treatment for patients with liver-limited or dominant cancers

remains a clinical challenge

•

Whole organ therapy creates a new option for patients in the management

of liver dominant disease

34

DELCATH SYSTEMS, INC

Concentrating the Power of Chemotherapy for Disease Control in the Liver

Our Solution –

Whole Organ-Focus Disease Control

•

Our proprietary CHEMOSAT system isolates the liver

circulation, delivers an ultra-high 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 two hours to

complete and involves a team including the interventional

radiologist and perfusionist

•

CHEMOSAT (Gen 2) has demonstrated minimal systemic

toxicities and impact to blood components in initial commercial

use and may complement systemic therapy

•

CHEMOSAT has been used on approximately 200

patients to

date through clinical development and early commercial launch

35

DELCATH SYSTEMS, INC

CHEMOSAT MARKET OPPORTUNITY

BY DISEASE & TARGET COUNTRIES

Appendix 2

36

DELCATH SYSTEMS, INC

•

Europe –

Largest near-term opportunity

•

CRC –

Largest opportunity worldwide

•

Melanoma –

Largest opportunity is in the US

•

China –

Largest opportunity for HCC

Market Opportunity by Disease (patients)

Market Opportunity defined as Total Potential

Market (TPM) for CHEMOSAT

®

1.Primary cancer incidence

2.Adjusted for predominant disease in the liver (primary or      

metastatic cancer)

3.Adjusted

for

addressable

patients

via

Delcath

CHEMOSAT

®

37

DELCATH SYSTEMS, INC

Europe Market by Disease –

Device Only

Germany

(Direct)

UK

(Direct)

France

(Indirect)

Italy

(Indirect)

Spain

(Indirect)

Netherlands

(Direct)

Ireland

(Direct)

Total 

Potential

(patients)

Potential

Market

($ MM)

1,2,3

Total Potential Market #Patients

Ocular

Melanoma

404

297

295

285

197

79

19

1,576

$ 62

Cutaneous

Melanoma

1,625

994

753

801

360

379

73

4,987

$ 206

CRC

9,902

5,300

5,475

7,281

4,016

1,644

335

33,953

$1,339

HCC

(Primary)

1,637

720

1,514

2,597

1,087

82

35

7,671

$277

NET

1,783

1,336

1,353

1,299

974

360

98

7,202

$ 281

TOTAL

15,351

8,647

9,389

12,263

6,634

2,545

560

55,389

$ 2,166

Europe Presents Significant Potential Market Opportunity

Sources: LEK Consulting, GLOBOCAN, Company estimates.

1) Assumes 2.5 treatments per patient.

2) Assumes ASP of  ~$15K USD.

3) Assumes mix of direct sales and distributors.

38

DELCATH SYSTEMS, INC

US Market by Disease –

Device and Drug Combination

Liver Metastasis

Potential Market

# Patients

Potential Market

# Procedures

Potential Market

($MM)

1,2

Ocular

Melanoma

1,685

4,213

$ 105

Cutaneous

Melanoma

7,023

17,557

$ 439

CRC

19,861

49,653

$ 1,241

HCC (Primary)

5,586

13,964

$ 349

NET

8,212

20,530

$ 513

TOTAL

42,367

105,917

$ 2,648

Sources: LEK Consulting, GLOBOCAN, Company estimates.

1) Assume 2.5 treatments per patient.

2) Estimated ASP of $25K.

39

DELCATH SYSTEMS, INC

APAC Market by Disease

China

(Device)

S. Korea

(Device)

Japan

(Device)

Taiwan

(Device)

Australia

(Device)

Total 

Potential

(patients)

Potential

Market

($MM)

1,2

Total Potential Market  #Patients

HCC

(Primary)

85,780

3,258

8,296

2,152

263

99,749

$ 1,156

Other

CRC

31,127

3,245

14,298

1,441

2,031

52,143

$ 642

NET

29,197

1,048

2,759

500

462

33,966

$ 393

Ocular 

Melanoma

1,765

66

175

31

96

2,134

$ 25

Cutaneous

Melanoma

382

43

136

246

1,144

1,951

$ 23

OTHER

TOTAL

62,472

4,403

17,368

2,218

3,733

90,194

$ 1,083

TOTAL

148,104

7,661

25,665

4,370

3,996

189,943

$ 2,239

APAC Target Markets Represent Over $2 Billion Potential Market Opportunity 

Sources: LEK Consulting, GLOBOCAN, Company estimates.

1) Assume 2.5 treatments per patient.

2) Estimated ASP of ~$5K.

40

DELCATH SYSTEMS, INC

HIGH-DOSE MELPHALAN

HISTORY AND RATIONALE

Appendix 3

41

DELCATH SYSTEMS, INC

The Evidence for Melphalan

Melphalan, an established chemotherapy agent, is proven active at

high doses with broad antitumor activity

42

DELCATH SYSTEMS, INC

Melphalan Dosing & Background

•

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

that demonstrates little to no hepatic toxicity

•

Manageable systemic toxicities associated with Neutropenia and

Thrombocytopenia

•

Drug dosing 12x higher than FDA-approved dose via systemic IV chemotherapy

•

Dose delivered to tumor is over 100x 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

43

DELCATH SYSTEMS, INC

Melphalan Sensitivity: In Vitro Tumor Cell Lines Study

We Believe CHEMOSAT Will Be Effective On a Wide Range of Solid Tumors

44

DELCATH SYSTEMS, INC

PHASE 3 TRIAL

Appendix 4

45

DELCATH SYSTEMS, INC

Phase III Clinical Trial Design

Randomized to CS

93 patients: ocular

or cutaneous melanoma

Best Alternative Care (BAC)

Investigator and patient decision

(any and all treatments)

CS/Melphalan

Treat every 4 weeks x 4 rounds

(responders

can receive up to 6 rounds)

Cross-over

Primary Trial Endpoint

•

Statistically significant difference in Hepatic Progression

Free Survival (“hPFS”): p < 0.05 (IRC)

•

Over 80% of Oncologic drugs approved by FDA between

2005 –

2007 on endpoints other than overall survival

Modeled hPFS for Trial Success:

7.73 months (CS) 

vs.

4 months (BAC)

Secondary Trial Endpoints

•

Investigator hPFS

•

Hepatic objective response rate

•

Overall objective response rate

•

Overall

Survival

–

Diluted

by

Cross

Over

•

SAP calls for analysis of various patient subsets

Pre-CS (Baseline)

Post-CS (22+ Months)

Hepatic Response –

Metastatic Melanoma

Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study

CS = Chemosaturation (CHEMOSAT)

46

DELCATH SYSTEMS, INC

Positive Phase 3 Results

•

Primary endpoint (hPFS by IRC) exceeded, p value = 0.0029, hazard ratio of 0.50

as of June, 2012

o

CS/PHP median hepatic progression free survival (hPFS) was 4-fold

of control, or 5.3 months improvement

o

CS/PHP achieved a median hPFS of 7.0

months  vs 1.7 months for BAC control

o

75% overall clinical benefit (CR + PR + SD)

•

Secondary endpoints consistent with primary endpoints

o

CS/PHP achieved a median overall PFS of 5.4 months vs. 1.6 months for BAC

o

OS –

No difference demonstrated due to heavy crossover from BAC to CS/PHP

o

Median OS 10.6 months vs. 10.0 months for CS/PHP and BAC respectively

•

OS exploratory analyses supportive of key observations

o

Median overall survival of 11.4 months for all patients treated with melphalan, including crossover

o

BAC patients did not cross-over to CS/PHP had a median survival of 4.1 months

o

7 CS/PHP-treated and 3 BAC-only patients still alive as of 6/2012

•

Gen 1 Safety profile –

consistent with currently approved labeling for melphalan

o

30-day deaths on PHP: 3/44 patients (6.8%)

1 Neutropenic Sepsis (2.3%); 1 Hepatic Failure 2.5% (95% tumor burden); 1 gastric perforation

o

30-day deaths on BAC: 3/49 patients (6.1%)

Trial Outcomes Favorable and Consistent with Special Protocol Assessment

47

DELCATH SYSTEMS, INC

PUBLISHED PHASE 1 / 2 STUDIES OF

DOXORUBICIN WITH CS-PHP

Appendix 5

48

DELCATH SYSTEMS, INC

Phase 1 & 2 Studies of PHP-Doxorubicin For HCC

Delivered Safely in Multiple Studies with Promising Response Rates 

1) Ku Y et al. Chir Gastroenterol 2003;19:370–376.

2) Curley SA et al. Ann Surg Oncol 1994;1:389–99.

3) Ravikumar TS et al. J Clin Oncol 1994;12:2723–36.

4) Hwu WJ et al. Oncol Res 1999;11:529–37.

49

DELCATH SYSTEMS, INC

PRODUCT DEVELOPMENT PIPELINE

Appendix 6

50

DELCATH SYSTEMS, INC

Product Development Pipeline

•

Orphan Drug -

Ocular

Melanoma liver mets

•

Proprietary drug-melphalan &

CHEMOSAT System

•

All liver cancers –

melphalan

•

Classified as Medical Device

•

3

party

melphalan

•

Gen 2 melphalan CE Mark

•

Doxorubicin system CE Mark

•

CHEMOSAT for additional drugs

•

CHEMOSAT for other organs (lung

and brain)

•

mNET, mCRC and HCC

indications

Initial Opportunity

Near Term (< 5 years)

Intermediate Term (> 5 years)

•

mCRC and HCC clinical trials

•

CHEMOSAT for additional drugs

•

CHEMOSAT for other organs (lung

and brain)

•

CHEMOSAT Melphalan in

Taiwan and Japan 

•

CHEMOSAT Doxorubicin in

China and South Korea

•

3

party

doxorubicin

•

CHEMOSAT for additional drugs

•

CHEMOSAT for other organs (lung

and brain)

•

CHEMOSAT Melphalan in

Australia, New Zealand, and

Hong Kong

•

3

party

melphalan

Development Aligned to Address Significant Market Opportunity

rd

rd

rd

51

DELCATH SYSTEMS, INC

CHEMOSAT System for Doxorubicin –

CE Mark

•

Satisfied all of the requirements to affix the CE Mark to Hepatic

CHEMOSAT Delivery System device for intra-hepatic arterial delivery

and extracorporeal filtration of doxorubicin in October, 2012

o

Provides a pathway for regulatory approval in China and S. Korea

•

Provides basis for partnership opportunities in China and S. Korea

where doxorubicin has a broad label for multiple tumor types

•

Multiple published Phase I/II studies from MD Anderson Cancer Center

and Yale with percutaneous hepatic perfusion (PHP) and Kobe

University using doxorubicin show promising response rates for HCC*

•

Plan to use CHEMOSAT Doxorubicin in Asia Phase III 2L

HCC trials

Addressing the Large HCC Market Opportunity in China

52

DELCATH SYSTEMS, INC

NON US/EU

REGULATORY UPDATE

Appendix 7

53

DELCATH SYSTEMS, INC

International Strategy beyond EU and US

•

Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT

System in other international markets

o

Obtained approval for Gen 2 CHEMOSAT System with melphalan in Australia

•

International regulatory submissions status:

Application submitted and expected approvals in

Hong Kong

-

2013

Singapore

-

2013

Argentina

-

2013

Brazil

-

2014

Intend to submit applications

S. Korea

(CHEMOSAT Doxorubicin)

Mexico

China

(CHEMOSAT Doxorubicin)

Taiwan

Russia

India

Japan

Israel

•

Utilize 3   party melphalan and doxorubicin available to physicians

Combination of Strategic Partnerships and Specialty Distributors

rd

54

DELCATH SYSTEMS, INC

CHEMOSAT CENTERS

Appendix 8

55

DELCATH SYSTEMS, INC

CHEMOSAT Centers in Europe

•

Entered training and marketing agreements with leading cancer centers in Europe

o

Milan, Italy –

European Institute of Oncology (IEO)

o

Frankfurt, Germany –

Johann Wolfgang Goethe-Universität (JWG)

o

Kiel, Germany –

Universitätsklinikum Schleswig-Holstein

o

Villejuif, France –

Cancer Institute Gustave Roussy (IGR)

o

Barcelona, Spain –

El Hospital Quiron

o

Naples, Italy –

Instituto Nazionale Tumori Fondazione "G. Pascale"

o

Amsterdam, The Netherlands –

Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital

o

Erlangen, Germany –

University Hospital of Erlangen

o

Pamplona, Spain –

Clinica Universidad de Navarra

o

Bordeaux, France –

Hôpital Saint-André

(St Andre)

o

Galway, Ireland –

University Hospital Galway (UHG)

o

Leiden, The Netherlands –

Leiden University Medical Center

o

Southampton, United Kingdom –

Southampton University Hospital (SUH)

o

Göttingen, Germany -

University Medical Center Göttingen (UMG)

o

Varese, Italy –

Varese University Hospital (VUH)

•

Training completed and patients treated at IEO, JWG, IGR, St Andre, UHG, SUH, UMG, VUH

•

Liver metastases from cutaneous melanoma, ocular melanoma, gastric cancer, breast cancer,

neuroendocrine tumor (NET), hepatocellular carcinoma (HCC) and Cholangiocarcinoma