Delcath Systems (DCTH) 8-K This presentation contains forward-looking statements within the meaning of the Safe Harbor Provisions of the U.S. Private

Investor Presentation

(NASDAQ: DCTH)

May 2012

Exhibit 99.1

2

DELCATH SYSTEMS, INC

Forward-looking Statements

This presentation contains forward-looking statements within the meaning of the Safe Harbor Provisions of the U.S. Private

Securities Litigation Reform Act of 1995. These statement 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: the benefits of the Gen 2 CHEMOSAT system and market acceptance of the same, patient outcomes using the Gen 2

CHEMOSAT system, agreements with additional early launch centers in Europe, our ability to manufacture CHEMOSAT systems

and the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for

the CHEMOSAT system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the

chemosaturation system as a treatment for patients with cancers in the liver, acceptability of the Phase III clinical trial data by the

FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of

our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of

metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the CHEMOSAT system

in foreign markets, approval of the current or future chemosaturation system for other indications and/or with other chemotherapeutic

agents, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our

ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue

associated with such foreign markets, uncertainties relating to the timing and results of research and development projects and future

clinical trials, acceptance of our IND amendment, submission and publication of the Phase II and III clinical trial data, 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 raise

additional capital and 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 including our annual

report on Form 10-K and our reports on Forms 10-Q and 8-K. 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

Our Mission

Concentrating the Power of Chemotherapy for Disease Control in the Liver

•

We are a cancer therapy company

•

Our technology offers the opportunity to gain control of tumors

in the liver

•

The liver is a site where uncontrolled disease is often life-limiting

or leads to withdrawal of systemic treatments in favor of

palliative care

•

We plan on being a fully-integrated company and are building

the infrastructure to develop and commercialize our products in

Europe and North America

o

In Europe our first product is approved and we have begun selling it

•

We believe that our first product, CHEMOSAT, may extend the

lives of a large number of cancer patients

4

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

In contrast to the brain and lungs, where systemic chemotherapy

and radiation can exert some degree of local control, tumors in the

liver are not particularly responsive to chemotherapy and radiation

therapy

•

Existing treatments to control tumors in the liver include:

Surgical resection

Radioembolization (SIRT)

Chemoembolization (TACE)

Radiofrequency ablation (RFA), Microwave, Cryoablation

Hepatic arterial infusion (HAI)

Systemic chemotherapy

5

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

–

“See a tumor, treat a tumor”

6

DELCATH SYSTEMS, INC

Concentrating the Power of Chemotherapy for Disease Control in the Liver

Our Solution

•

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

7

DELCATH SYSTEMS, INC

Chemosaturation

1.

ISOLATE

2.

SATURATE

3.

FILTRATE

The Delcath CHEMOSAT System

Improved disease control in the liver

Treats entire liver (macro and micro)

Controls systemic toxicities

Allows for over 100x effective dose

escalation at tumor site

Repeatable & minimally invasive,

Complements systemic therapy

Minimally Invasive, Repeatable Liver Procedure That Could Complement Systemic Therapy

Note:  Image not to scale.

8

DELCATH SYSTEMS, INC

Concentrating the Power of Chemotherapy for Disease Control in the Liver

The Data

•

We conducted a randomized Phase 3 study under a Special

Protocol Assessment (“SPA”) using Generation 1 of our

chemosaturation system in patients with melanoma (ocular and

cutaneous) metastatic to the liver

•

Melanoma liver metastases are relatively homogeneous

regardless of origin

•

Liver metastases are typically the life-limiting aspect of the

disease

•

Melanoma is notoriously insensitive to systemic chemotherapy

and our study was a great demonstration of our technology’s

potential in a challenging histology

9

DELCATH SYSTEMS, INC

Phase III Clinical Trial Design

Randomized to CS

92 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

•

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

•

Hepatic

response

and

duration

of

hepatic

response

•

Overall

response

and

duration

of

overall

response

•

Overall

Survival

–

Diluted

by

Cross

Over

•

SAP calls for analysis of various patient cohorts

Pre-CS (Baseline)

Post-CS (22+ Months)

Hepatic Response –

Metastatic Melanoma

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

CS = ChemoSaturation (CHEMOSAT)

10

DELCATH SYSTEMS, INC

Phase 3 Hepatic Progression-free Survival (ITT)

Hazard Ratio: 0.35    

(CI: 0.23-0.54)

0            5            10          15

20

25   

30           35

Months

CS-PHP

BAC

8.0

1.6

p<0.0001

1.0

Survival probability

0.8

0.6

0.4

0.2

0.0

CS-PHP Demonstrated a 5x Improvement in Primary Endpoint of hPFS

11

DELCATH SYSTEMS, INC

Phase 3 Overall Progression-free Survival (ITT)

Hazard Ratio: 0.36    

(CI: 0.23-0.57)

0            5            10          15

20

25   

30           35

Months

CS-PHP

BAC

6.7

1.6

p<0.0001

1.0

Survival probability

0.8

0.6

0.4

0.2

0.0

CS also Demonstrated a Highly Statistically Significant Improvement in Overall PFS

12

DELCATH SYSTEMS, INC

Overall survival (ITT population)

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

Time (months)

60

p-value = 0.4170

BAC

PHP

Censored observations

BAC vs PHP

55% Cross-over

HR=1.20 (CI: 0.78-1.85)

Overall Survival Confounded By Crossover Study Design

9.8

10.0

13

DELCATH SYSTEMS, INC

Overall survival (ITT population)

Time (months)

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

4.1

PHP randomized

BAC crossover*

BAC only*

Censored observations

PHP randomized vs PHP crossover vs BAC only

9.8

13.1

Overall Survival Tail PHP Treated Patients

* Similar patient characteristics and demographics between BAC crossover and BAC only 

14

DELCATH SYSTEMS, INC

Overall survival (ITT population)

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 PHP incl. crossover

BAC only

Censored observations

Time (months)

Total PHP vs BAC only

4.1

Overall Survival Tail For Treated Patients

15

DELCATH SYSTEMS, INC

Positive Phase III Results*

•

Primary endpoint exceeded, p value = 0.0001, hazard ratio of .35

o

Treatment arm shows 5x median hepatic progression free (hPFS) survival compared to control arm

o

CS/PHP median hPFS of 8.0 months compared to 1.6 months for BAC

o

86% overall clinical benefit (CR + PR + SD)

•

Secondary endpoints support results

o

OS Secondary endpoint –

No difference in Kaplan-Meier curves due to cross over treatment response (9.8

months compared to 10.0 months)

o

CS/PHP median overall PFS of 6.7 months vs. 1.6 months for BAC

•

OS exploratory cohort analysis favorable

o

Median survival of 9.8 months for treatment arm compared to 4.1 months non-crossover BAC patients

o

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

o

8 CS/PHP-treated patients and 2 BAC-treated patients still alive as of 4/2012

•

Gen 1 Safety profile –

expected and 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

* Updated Investigator results presented at 2011 ECCO/ESMO Annual Meeting.

16

DELCATH SYSTEMS, INC

Melphalan Sensitivity: In Vitro Tumor Cell Lines Study

Cancer Origin

(Cell lines)

Apoptosis

Induction

(uM)

Thyroid

2.54

Ovarian

4.31

Melanoma

4.53

CNS

6.40

Sarcoma

6.68

Head and Neck

6.78

Bladder

9.50

Colon

15.12

Cervix

15.16

Prostate

17.55

Liver

23.23

Pancreas

25.00

Lung

28.60

Breast

31.82

Kidney

35.30

Uterus

44.60

We Believe CHEMOSAT Will Be Effective On a Wide Variety of Histologies

Melphalan Sensitivity-

Apoptosis Induction

Melphalan

Conc.

achieved

during

CHEMOSAT

=

~

192

uM

Tissue of Origin for Cell Line

17

DELCATH SYSTEMS, INC

Our Opportunity

•

At the concentrations of melphalan we are achieving in the

liver, we believe CHEMOSAT will be effective on a wide variety

of histologies

•

We believe that physicians are recognizing the broad

applicability of CHEMOSAT, based on early experience and

their interest in testing our technology with melphalan in a

variety of tumor histologies

•

CE Mark approved broad indication

•

Large global market opportunity with pharmaceutical-like gross

margin

Concentrating the Power of Chemotherapy for Disease Control in the Liver

18

DELCATH SYSTEMS, INC

CHEMOSAT -

Potential Multi-Billion Dollar Market

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

$7 Billion Annual Global Opportunity with Pharmaceutical-Like Gross Margins

Sources: LEK Consulting, GLOBOCAN, Company estimates.

*TPM for initial U.S. labeled indication only.

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

8,708*

$2.6 B

189,943

$2.2 B

HCC

CRC

Melanoma

NET

19

DELCATH SYSTEMS, INC

Approved  (CE Mark Device)

Regulatory Filing (NDA) Planned in August, 2012

Application

Submitted/

Planned

–

Mutual

Recognition

of

European

CE Mark in 2012-2013

Global Commercialization Status

On The Cusp of Addressing A Multi-Billion Dollar Global Market in Next Two Years

20

DELCATH SYSTEMS, INC

European Commercialization Strategy

Strategy:

•

Focus efforts in 7 Target Countries (EU 5 + Netherlands & Ireland)

•

8-10 leading EU cancer centers as initial training centers

•

Validate business model and demonstrate scalability

•

Push and Pull marketing and selling strategy

Tactics & Execution:

•

Educate medical oncologists via contract organization

•

Sell to hospital-based interventional radiologists, surgeons and C-suite decision makers with

combination of direct sales and distributors

•

Hospitals procure melphalan from third parties and physicians use at their discretion

•

Establish European patient education & awareness programs (PR, website)

•

Leverage existing new technology reimbursement channels, while pursuing permanent procedure

reimbursement via Health Technology Assessment (HTA)

•

Clinical trials to generate additional data for CRC and HCC to support revenue ramp up

Currently In Initial Training and Marketing Phase

21

DELCATH SYSTEMS, INC

Patient Referral Path

Interventional

Radiologist

Offers chemosaturation

procedure

Patient

Primary

Care

Medical

Oncologist

Offers systemic therapy

Surgical

Oncologist

Offers resection or

other focal therapy

Chemosaturation

Diagnosis

of Cancer

Identification

of

liver

involvement

with no

improvement from systemic

therapy

When liver disease is

controlled

patients return to the Medical

Oncologist for additional systemic therapy

22

DELCATH SYSTEMS, INC

CHEMOSAT Training and Marketing Commenced in Europe

Continue Training and Marketing Centers Roll-Out

•

Entered training and marketing agreements with leading cancer centers in Europe

o

Institute of European Oncology (IEO), Milan, Italy

o

Johann Wolfgang Goethe (JWG) University Hospital, Frankfurt, Germany

o

University Medical Center Schleswig-Holstein, Kiel Campus, Germany

o

Institut Gustave Roussy ("IGR"), Villejuif, France

o

Instituto Oncologico Baselga (IOB), Grupo Quiron, Barcelona, Spain

o

Istituto Nazionale Tumori Fondazione G. Pascale in Naples, Italy

o

Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital

o

Universidad de Navarra Pamplona, Spain

•

Training completed and first patients treated at IEO and JWG University Hospital,

Frankfurt, Germany

o

Cutaneous melanoma, ocular melanoma, gastric cancer, and breast cancer liver metastases

•

Agreements with additional leading cancer centers expected in Target Countries in 2012

•

Selected Quintiles to support EU launch

•

We are establishing direct sales force in UK, Germany and Netherlands and seeking

exclusive distributors in Italy, France and Spain

23

DELCATH SYSTEMS, INC

European Reimbursement Considerations

•

No centralized pan-European medical device reimbursement body –

regional and national systems

•

Devices typically reimbursed under Diagnosis Related Groups (DRG) as

part of a procedure

•

Working

with

reimbursement

specialists

to

develop

a

plan

in

each

of

our

key markets

•

Immediate reimbursement plans:

o

Utilize existing codes where permitted until permanent reimbursement

established (e.g. Italy)

o

Apply

for

funding

under

existing

New

Technology

Payment

programs

(e.g.

NUB in Germany and HAS in France)

o

Other oncology therapies currently reimbursed, despite lacking randomized

data

Reimbursement Mechanisms in Place to Support Commercial Launch

24

DELCATH SYSTEMS, INC

International Strategy beyond EU and US

•

Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT

System in other international markets

•

International regulatory submissions status:

Application

submitted

and

expected

approvals

in

Australia

-

2012 (approved)

Hong Kong

-

2012

S. Korea

-

2013

Singapore

-

2013

Brazil

-

2013

Intend

to

submit

applications

Israel

Canada

Mexico/Argentina

Russia

India

Japan

China and Taiwan

•

Utilize

3

rd

party

melphalan

and

doxorubicin

available

to

physicians

Combination of Strategic Partnerships and Specialty Distributors

25

DELCATH SYSTEMS, INC

U.S. FDA Regulatory Status

•

Pre-NDA submission meeting with FDA conducted in January 2012

o

Satisfied with FDA response

o

Addressed RTF related issues

Manufacturing plant inspection timing

Product and sterilization validation

Additional statistical analysis clarification

Additional safety data

•

Completed data entry and monitoring

o

Completed data migration to new FDA compliant CDISC database

o

Created new Case Report Form (CRF)

•

We will lock database on May 25, 2012

•

Plan to file NDA submission in Mid-August 2012

•

Initiated

dialogue

with

FDA

to

discuss

optimal

approval

path

for

Gen 2

Progress on Track to Submit NDA

26

DELCATH SYSTEMS, INC

U.S. Commercialization Strategy

•

Initial focus on leading cancer centers and referring community hospitals

•

Educate Medical Oncologists via Medical Science Liaison (MSL)

•

Direct strategy to sell to Interventional Radiologists and Surgeons: 12

sales territories ultimately expanding to as many as 60 territories as

revenues ramp

•

5 Clinical Specialists initially to support site initiation and training

•

Utilize top centers from Phase III trial as Centers of Excellence for

training and support

•

Intend to seek chemosaturation specific codes based upon value

proposition relative to other cancer therapies

Direct Sales Channels Supplemented with Contract MSLs

27

DELCATH SYSTEMS, INC

Clinical Development Program

•

Goal:

o

Expand indications for HCC and mCRC with US registration trials

o

Generate robust clinical data to support commercialization

•

Submitted IND Amendment to include Gen 2 in Expanded Access

Program (EAP), compassionate use and all future clinical trials

o

Assuming IND Amendment accepted, initiate EAP for metastatic melanoma in September 2012

•

Planned Clinical Trials (first patient enrolled in 2013)

o

HCC

Global Phase 2 randomized 1L CHEMOSAT Melphalan vs. Sorafenib

US

registration

–

Global

Phase

3

Randomized

2L

CHEMOSAT

Melphalan

vs.

BSC

for

Sorafenib Failure

Asia Phase 3 Randomized 2L CHEMOSAT Doxorubicin vs. BSC for Sorafenib Failure

o

mCRC

Global Phase 2 Signal Seeking/Safety 2L CHEMOSAT Melphalan

US

Registration

–

Global

Phase

3

Randomized

2L

CHEMOSAT

Melphalan

vs.

Approved

Alternatives

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

28

DELCATH SYSTEMS, INC

2012 Milestones

•

First patients have been treated with CHEMOSAT Melphalan in Europe -

Done

•

Execute contract for MSL services in EU –

1Q 2012 (Quintiles was selected to

support EU launch of CHEMOSAT) -

Done

•

Secure agreements with 6-8 leading cancer centers in EU -

Done

•

Obtain CE Mark for Gen 2 CHEMOSAT Melphalan -

Done

•

US NDA submission in August 2012

•

Submission for publications of Phase III data and mNET arm of Phase II data –

2H 2012

•

First

patients

enrolled

in

EAP

–

September

2012

•

Submit and seek approval of CE Mark for CHEMOSAT Doxorubicin –

2H 2012

•

Potential Asia strategic partnership –

dedicated BD with China a top priority

29

DELCATH SYSTEMS, INC

Financial Update

Cash & Cash Equivalents:

$20.8 million at March 31, 2012

Financing Program

$4.8 million raised via At-The-Market (ATM)

equity offering program in Q1 2012

Working Capital Line of Credit

$20.0 million credit facility

Cash Spend:

$14.7 million in Q1 2012

Debt:

None

Shares Outstanding:

49.8

million

(57.5

million

fully

diluted

1

)

Institutional Ownership

22%

Market Capitalization

$155 million as of March 31, 2012

Avg. Daily Volume (3 mo.)

400,000

1) As of March 31, 2012 fully diluted includes an additional 5.0 million options at $4.96 and 2.7 million warrants at $3.03

30

DELCATH SYSTEMS, INC

Team

Executive

Title

Prior Affiliation(s)

Years of

Experience

Eamonn Hobbs

President and CEO

AngioDynamics, E-Z-EM

31

Graham Miao, Ph.D.

EVP & CFO

D&B, Pagoda Pharma, Schering-

Plough, Pharmacia, JP Morgan

22

Krishna Kandarpa,

M.D., Ph.D.

CMO and EVP, R&D

Harvard, MIT(HST), Cornell,

UMass

32

Agustin Gago

EVP, Global Sales

AngioDynamics, E-Z-EM

30

Jennifer Simpson,

Ph.D.

EVP, Global Marketing

Eli Lilly (ImClone), Johnson &

Johnson (Ortho Biotech)

22

Peter Graham, J.D.

EVP, General Counsel &

Global Human Resources

Bracco, E-Z-EM

17

David McDonald

EVP, Business Development

AngioDynamics, RBC Capital

Markets

29

John Purpura

EVP, Regulatory Affairs &

Quality Assurance

E-Z-EM, Sanofi-Aventis

28

Harold Mapes

EVP, Global Operations

AngioDynamics, Mallinkrodt

26

J. Chris Houchins

SVP, Clinical and Medical

Affairs

Arno, Schering-Plough, Pfizer,

Pharmacia, GD Searle

21

Bill Appling

SVP Medical Device R&D

AngioDynamics

26

Dan Johnston, Ph.D.

VP, Pharmaceutical R&D

Pfizer, Wyeth

11

31

DELCATH SYSTEMS, INC

Appendices

32

DELCATH SYSTEMS, INC

Appendix I

Intellectual Property

33

DELCATH SYSTEMS, INC

Intellectual Property

•

Patent Protection

o

7 issued U.S. patents, 10 foreign patents issued and 4 pending

o

Primary 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 new 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

34

DELCATH SYSTEMS, INC

Appendix II

CHEMOSAT Market Opportunity

by Disease and Target Counties

35

DELCATH SYSTEMS, INC

•

Europe

–

Largest

near-term

opportunity

•

CRC –

Largest opportunity worldwide

•

Melanoma

–

Largest

opportunity

is

in

US

•

China-

Largest opportunity for HCC

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

®

Market Opportunity by Disease (patients)

36

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.

37

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

TOTAL MELANOMA

(Initial Expected Label)

8,708

21,770

$ 544

CRC

19,861

49,653

$ 1,241

HCC (Primary)

5,586

13,964

$ 349

NET

8,212

20,530

$ 513

OTHER TOTAL

(Potential Label Expansion)

33,659

84,147

$ 2,104

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.

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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.

39

DELCATH SYSTEMS, INC

Appendix III

CHEMOSAT Melphalan Phase I and II

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DELCATH SYSTEMS, INC

Melphalan Dosing & Background

•

Well understood, dose dependant, 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

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DELCATH SYSTEMS, INC

Phase II 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 II mNET Tumor Cohort  (n=24)*

Number (n)

Primary Tumor Histology

Carcinoid

4

Pancreatic Islet Cell

20

Response

Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver

Transplantation)

4

Progressive Disease

2

Minor Response / Stable Disease

4

Partial

Response

(30.0%

-

99.0%

Tumor

Reduction)

13

Complete Response (No Evidence of Disease)

1

Objective Tumor Response

14

Objective Tumor Response Rate

70%

Duration (months)

Median Hepatic PFS

15.5

Overall Survival After CS

30.4

*Presentation at ECCO/ESMO 2011 annual meeting.

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DELCATH SYSTEMS, INC

Phase II NCI Trial –

HCC Cohort

•

Hepatocellular

carcinoma

(HCC)

is

the

most

common

primary

cancer

of

the liver, with approximately 749,000* new cases diagnosed worldwide

annually

•

Nine patients with tumors of hepatobiliary origin: five HCC patients and

four cholangiocarcinoma patients

•

Both groups received CHEMOSAT procedures and had positive efficacy

signals

•

The responses were especially encouraging in the HCC group and

consisted of confirmed partial response or durable stable disease

•

Safety profile –

expected and consistent with pivotal US Phase III

melanoma trial

•

Intend to invest in new HCC trials with CHEMOSAT

Encouraging Initial Positive Signal for Primary Liver Cancer

*Source: GLOBOCAN

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DELCATH SYSTEMS, INC

•

Substantial clinical evidence of benefit of using 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

47%

(range

29%-76%)

1

•

Delcath

Phase

II

NCI

Chemosaturation

Trial

–

mCRC

Cohort

o

Challenges enrolling at NCI

o

16 patients treated since 2004

o

Inconclusive

efficacy

due

to

advanced

disease

status

(generally

5

th

or

6

th

line)

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, Koopman M, Van D, V, et al. Ann Oncol. 2010;21:1662-7.

Phase II NCI Trial –

mCRC Cohort

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DELCATH SYSTEMS, INC

Appendix IV

Published Phase I/II Studies of

Doxorubicin with PHP (percutaneous hepatic

perfusion) for HCC

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DELCATH SYSTEMS, INC

CHEMOSAT Doxorubicin Development

•

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*

•

Status:

o

First pass removal efficiency 95% in initial in vitro studies

o

Utilize new trade secret manufacturing process

o

Intend to file and seek CE Mark approval in 2H 2012

o

Plan to use CHEMOSAT Doxorubicin in Asia Phase III 2L

HCC trials

•

Expected Benefits:

o

Multiple treatments

o

Reduced systemic toxicity for improved safety profile

o

Concomitant therapy (complements systemic therapies)

Addressing the Large HCC Market Opportunity in China

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DELCATH SYSTEMS, INC

Phase I/II 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.

No. of

pts

No. of

PHP/

pt

Disease stage

(tumor diameter)

Treatment

Median  survival

(mo)

Response

Rates

Reference

HCC

(n=79)

CHM

(n=23)

1–4

1–2

IV A: n=66

IV B: n=13

All multiple

bilobar

Extrahepatic disease in 52%

Doxorubicin 60

–150 mg/m

2

Cisplatin

50–150 mg/m

2

Mitomycin C 50–200 mg/m

2

16

13

HCC pts

RR 64.5%

5-year

survival 20.3%

Kobe

1

Phase I/II

HCC

(n=11)

1–3

Mean

9.5 cm

Doxorubicin 60

–120 mg/m

2

6.5

13 (responders)

2 (non-responders)

RR 20%

MDACC

2

Phase I

HCC

(n=5)

CHM

(n=8)

Other

(n=8)

2–4

Extrahepatic disease in 17%

Doxorubicin 50

–120 mg/m

2

5-FU 1000–5000 mg/m

2

NR

RR 22%

Yale

3

Phase I

HCC

(n=7)

Other

(n=11)

1–10

NR

Doxorubicin 90

–120 mg/m

2

23 (responders)

8 (non-responders)

RR 58%

Yale

4

Phase I

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DELCATH SYSTEMS, INC

Appendix V

Product Development Pipeline

Product Development Pipeline

•

Melanoma liver mets

•

Proprietary drug-melphalan &

CHEMOSAT

•

All liver cancers –

melphalan

•

Class III medical device

•

3

rd

party melphalan

•

Gen 2 melphalan CE Mark

•

CHEMOSAT for additional drugs

•

CHEMOSAT for other organs (lung

and brain)

•

mCRC and HCC indications

Initial Opportunity

Near Term (< 5 years)

Intermediate Term (> 5 years)

•

Doxorubicin system CE Mark

•

mCRC and HCC clinical trials

•

CHEMOSAT for additional drugs

•

CHEMOSAT for other organs (lung

and brain)

•

CHEMOSAT Melphalan in South

Korea, Japan 

•

CHEMOSAT Doxorubicin in

China and Taiwan

•

3

rd

party doxorubicin

•

CHEMOSAT for additional drugs

•

CHEMOSAT for other organs (lung

and brain)

•

CHEMOSAT Melphalan in

Australia and Hong Kong

•

3

rd

party melphalan

Development Aligned to Address Significant Market Opportunity

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DELCATH SYSTEMS, INC

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U

A

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I

A

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DELCATH SYSTEMS, INC

©

2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED