DELCATH SYSTEMS, INC. - FORM 8-K - EX-99.1 - DELCATH SYSTEMS, INC. INVESTOR PRESENTATION SLIDES

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Investor Presentation

(NASDAQ: DCTH)

November 2012

Exhibit 99.1

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: our ability to address the contents of the 74 Day letter, 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 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, 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 device for intra-hepatic arterial delivery

and extracorporeal filtration of doxorubicin in key Asian markets and adoption and patient outcomes using the same, 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.

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, while pursuing opportunities in other

regions

o

In Europe, CHEMOSAT with Melphalan is approved and is currently being sold

•

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

lives of a large number of cancer patients

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

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

DELCATH SYSTEMS, INC

Diffuse Hepatic

Metastases

from

Ocular

and

Cutaneous

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

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

approximately

200

patients

date through clinical development and early commercial launch

DELCATH SYSTEMS, INC

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

ISOLATE

SATURATE

FILTRATE

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 with melphalan 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

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

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

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)

Primary Trial Endpoint

•

Statistically

significant

difference

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

DELCATH SYSTEMS, INC

Hepatic progression-free survival (IRC)

Positive Phase III Results –

Primary Endpoint hPFS

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

Hazard ratio = 0.50

(95%

0.31–0.80)

P=0.0029

5 10 15

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)

INDEPENDENT REVIEW COMMITTEE (IRC) ASSESSMENT

UPDATED ANALYSIS (4 June 2012)

DELCATH SYSTEMS, INC

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

25 30 35 40

45 50 55

3.8 mo

Intent-to-treat population

Chemosaturation (CS-PHP)

Best alternative care (BAC)

Positive Phase III Results –

Overall PFS

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

INVESTIGATOR ASSESSMENT

UPDATED ANALYSIS (4 June 2012)

DELCATH SYSTEMS, INC

TOTOL CS-PHP vs BAC ONLY

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

11.4

Total

CS-PHP

incl.

crossover

BAC only

Months

4.1

Intent-to-treat population

7.3 mo

Overall Survival –

Exploratory Subset Analysis

Overall

Survival

Tail

For

CS-PHP

Treated

Patients

DELCATH SYSTEMS, INC

Positive Phase III 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

control,

5.3

months

improvement

o

CS/PHP

achieved

median

hPFS

7.0

months

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

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

4. Alexander HR Jr, et al. Clin Cancer Res 2003;9:6343-9

7. Van Iersel LB, et al. Ann Oncol 2010;21:1662-7

2. Noter SL, et al. Melanoma Res 2004;14:67-72

5. Alexander HR Jr, et al. Ann Surg Oncol 2009;16:1852-9

8. Verhoef C, et al. Ann Surg Oncol 15:1367-74

3. Alexander HR Jr, et al. Clin Cancer Res 2000;6:3062-70

6. Van Iersel LB, et al. Ann Oncol 2008;19:1127-34

DELCATH SYSTEMS, INC

Melphalan Sensitivity: In Vitro Tumor Cell Lines Study

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

192 uM

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 ~ 80%

Concentrating the Power of Chemotherapy for Disease Control in the Liver

DELCATH SYSTEMS, INC

CHEMOSAT -

Potential Multi-Billion Dollar Market

$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

8,708

6,563

4,085

8,212

7,202

33,966

19,861

33,953

52,143

5,585

7,671

99,749

25,000

50,000

75,000

100,000

125,000

150,000

175,000

200,000

USA

APAC

DELCATH SYSTEMS, INC

Approved (CE Mark Device)

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

Application Submitted/ Planned –

Mutual Recognition of European CE Mark

Global Commercialization Status

Addressing A Multi-Billion Dollar Global Market

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 and surgical oncologists via contract organization

•

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

with combination of direct sales and distributors

•

Focus on medical and surgical oncologists at referral centers

•

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

•

Establish

European

patient

education

and

awareness

programs

(PR,

website)

•

Leverage interim reimbursement channels, while pursuing permanent procedure reimbursement

•

Focused clinical trial program to generate additional data and build clinical experience across multiple

centers for various tumor types (e.g. HCC, NET and CRC)

Currently In Initial Training and Marketing Phase

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

liver

involvement

with no

improvement from systemic

therapy

When liver disease is

Oncologist for additional systemic therapy

patients

return

the

Medical

controlled,

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

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

o

Galway, Ireland –

University Hospital Galway

o

Leiden, The Netherlands –

Leiden University Medical Center

o

Southampton, United Kingdom –

Southampton University Hospital

•

Training completed and patients treated at IEO, Italy; JWG University Hospital, Frankfurt,

Germany; IGR, France; UHG, Ireland; Southampton, UK, St Andre, France

o

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

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

•

Selected Quintiles to support EU launch with medical science liaisons (MSL)

DELCATH SYSTEMS, INC

European Reimbursement Considerations

•

No centralized

pan-European

medical

device

reimbursement

body

–

reimbursement

mechanisms vary greatly at national and regional levels across our target markets

•

Working with reimbursement specialists to execute plan in each of our key markets

for both interim and long term reimbursement

•

Interim reimbursement plans expected to begin coming online during fourth quarter

•

Italy –

Secured

pathway

for

reimbursement

using

existing

Diagnosis

Group

code (DRG)

for

use

with

CHEMOSAT.

will

continue

seek

additional

supplemental

new technology payments, and potentially pursue a new higher reimbursing DRG for

CHEMOSAT

o

A limited number of procedures are currently being covered by private payment and research funding

o

Apply for funding under existing New Technology Payment programs

o

Italy –

First Regional Application submitted for supplemental (in addition to DRG) new technology

payments.

o

Germany -

Interim reimbursement process is being actively sponsored and driven by the German

Radiology

Society

–

NUB

applications

filed

o

United

Kingdom

–

Our

lead

centers

are

seeking

gain

PCT

(Primary

Care

Trust)

approval.

This

would

allow

perform

CHEMOSAT

procedures

key

centers

the

Reimbursement Program Now In Execution Phase

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 Austrailia

•

International regulatory submissions status:

Application

submitted

and

expected

approvals

Hong Kong

2012 (Gen 2 expected in Dec.)

Canada

2012 (Gen 2 expected in Dec.)

Singapore

2013

Argentina

2013

Brazil

2014

Intend

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

DELCATH SYSTEMS, INC

U.S. FDA Regulatory Status

•

NDA accepted and under active FDA review since submission in mid

August, 2012

•

We are working closely with the FDA during the review process

•

PDUFA goal date of June 15, 2013 assigned by the FDA

•

FDA advised Oncology Drug Advisory Committee (ODAC) panel to be

expected

•

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

•

We have also amended IND and Expanded Access Program (EAP)

and Gen 2 has been accepted by the FDA for use in EAP,

compassionate use and prospective clinical trials in the US

DELCATH SYSTEMS, INC

U.S. Commercialization Strategy

•

Initial focus on centers that participated in the phase III clinical trial

•

Educate Medical Oncologists via Medical Science Liaison (MSL)

•

Direct strategy to sell to Interventional Radiologists and Oncologists

o

Approximately 12 sales territories ultimately expanding to as many as 60

territories as revenues ramp

•

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

training and support

•

Intend to seek chemosaturation specific CPT reimbursement code,

based upon value proposition relative to other cancer therapies

Direct Sales Channels with MSL Clinical Support

DELCATH SYSTEMS, INC

Clinical Development Program

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

•

Goal:

o

Expand US (CS-PHP: MEL) label indications to include HCC and mCRC

o

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

o

Intend to initiate EAP for metastatic melanoma by Q412

•

Initiate EU Registry to systematically collect relevant data from commercial experience

•

New Clinical Trials (first patient enrolled in 2013)

o

mCRC

Global

Phase

Randomized

CHEMOSAT

Melphalan

vs.

Approved

Alternatives

o

HCC

Global Phase

Randomized

CHEMOSAT

Melphalan

vs.

BSC

for

Sorafenib

Failure

Asia Regional

Phase

Randomized

CHEMOSAT

Doxorubicin

vs.

BSC

for

Sorafenib

Failure

•

Multiple Phase 2 studies under evaluation: HCC, NET, mBreast, Pancreatic

•

Support investigator-initiated trials (IITs)

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

•

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

•

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

use

CHEMOSAT

Doxorubicin

Asia

Phase

III

HCC trials

Addressing the Large HCC Market Opportunity in China

DELCATH SYSTEMS, INC

2012 Milestones

•

First patients have been treated with CHEMOSAT Melphalan in Europe -

Done

•

Execute contract for MSL services in EU in 1Q 2012 (Quintiles was selected to

support EU launch of CHEMOSAT) -

Done

•

Secure agreements with 8-10 leading cancer centers in EU -

Done

•

Obtain CE Mark for Gen 2 CHEMOSAT Melphalan -

Done

•

US NDA submission in August 2012 -

Done

•

US NDA acceptance with standard review in October 2012 -

Done

•

Obtain CE Mark for CHEMOSAT Doxorubicin in 2H 2012 -

Done

•

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

Q4 2012

•

First patients enrolled in EAP in Q4 2012

•

Initiate EU Registry in Q4 2012

•

Potential Asia strategic partnership –

dedicated BD with China a top priority

DELCATH SYSTEMS, INC

Financial Update

Cash & Cash Equivalents:

$28.3 million at September 30, 2012

Financing:

$21.1 million (net) raised in a follow-on equity

offering in May 2012

ATM Program

$24.5 million remaining as of September 30,

2012

Working Capital Line of Credit:

$20.0 million credit facility

Debt:

None

Cash Spend:

$14.6 million in 3Q2012

Shares Outstanding:

73.4

million

(83.8

million

fully

diluted

)

Institutional Ownership:

13%

Market Capitalization:

$120 million as of September 30, 2012

Avg. Daily Volume (3 mo.):

1,000,000

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

DELCATH SYSTEMS, INC

Team

Executive

Title

Prior Affiliation(s)

Years of

Experience

Eamonn Hobbs

President and CEO

AngioDynamics, E-Z-EM

Graham Miao, Ph.D.

EVP & CFO

D&B, Pagoda Pharma, Schering-Plough,

Pharmacia, JP Morgan

Krishna Kandarpa, M.D.,

Ph.D.

CSO and EVP, R&D

Harvard, MIT(HST), Cornell, UMass

Agustin Gago

EVP, Global Sales

AngioDynamics, E-Z-EM

Jennifer Simpson, Ph.D.

EVP, Global Marketing

Eli Lilly (ImClone), Johnson & Johnson

(Ortho Biotech)

Peter Graham, J.D.

EVP, General Counsel &

Global Human Resources

Bracco, E-Z-EM

David McDonald

EVP, Business Development

AngioDynamics, RBC Capital Markets

John Purpura

EVP, Regulatory Affairs & Quality

Assurance

E-Z-EM, Sanofi-Aventis

Harold Mapes

EVP, Global Operations

AngioDynamics, Mallinkrodt

J. Chris Houchins

SVP, Clinical Affairs

Arno, Schering-Plough, Pfizer,

Pharmacia, GD Searle

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

SVP, Global Clinical Development

Hoffmann-La Roche, Syndax

Pharmaceuticals, Inc.

Bill Appling

SVP Medical Device R&D

AngioDynamics

Dan Johnston, Ph.D.

VP, Pharmaceutical R&D

Pfizer, Wyeth

DELCATH SYSTEMS, INC

Appendices

DELCATH SYSTEMS, INC

Appendix I

Intellectual Property

DELCATH SYSTEMS, INC

Intellectual Property

•

Patent Protection

o

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

o

6 foreign patents in force (with patent validity in 22 countries) and 15 foreign patent

applications 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

DELCATH SYSTEMS, INC

Appendix II

CHEMOSAT Market Opportunity

by Disease and Target Counties

DELCATH SYSTEMS, INC

Market Opportunity by Disease (patients)

Market

Opportunity

defined

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

•

Europe

–

Largest

near-term

opportunity

•

CRC

–

Largest

opportunity

worldwide

•

Melanoma

–

Largest

opportunity

•

China -

Largest

opportunity

for

HCC

DELCATH SYSTEMS, INC

Europe Market by Disease –

Device Only

Germany

(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

1,576

$ 62

Cutaneous

Melanoma

1,625

994

753

801

360

379

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

7,671

$277

NET

1,783

1,336

1,353

1,299

974

360

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.

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.

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

175

2,134

$ 25

Cutaneous

Melanoma

382

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.

DELCATH SYSTEMS, INC

Appendix III

CHEMOSAT Melphalan Phase I and II

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

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

Chemosaturation (PHP)

3.00

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

Pancreatic Islet Cell

Response

Not Evaluable (Toxicity, Incomplete Treatment, Orthotopic Liver

Transplantation)

Progressive Disease

Minor Response / Stable Disease

Partial

Response

(30.0%

99.0%

Tumor

Reduction)

Complete Response (No Evidence of Disease)

Objective Tumor Response

Objective Tumor Response Rate

58%

Duration (months)

Median Hepatic PFS

15.5

Overall Survival After CS

30.4

*Presentation at ECCO/ESMO 2011 annual meeting.

DELCATH SYSTEMS, INC

Phase II NCI Trial –

Hepatobilliary carcinoma

•

11 patients with tumors of hepatobiliary origin: 5 HCC, 2 intrahepatic and

3 extrahepatic cholangiocarcinoma,1 mixed histology

•

CHEMOSAT treatment showed encouraging anti-tumor activities in

hepatocellular carcinoma (HCC)

o

1 Confirmed partial response lasting 7 months

o

2 stable disease lasting 8 months, 6 months respectively

•

Safety profile –

consistent with pivotal US Phase III melanoma trial

•

HCC is the most common primary cancer of the liver, with approximately

750,000* new cases diagnosed worldwide annually

•

Intend to invest in new HCC trials with CHEMOSAT

Encouraging Initial Positive Signal for Primary Liver Cancer

*Source: GLOBOCAN

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%)

•

Delcath

Phase

NCI

Chemosaturation

Trial

–

mCRC

Cohort

o

Challenges enrolling at NCI

o

16 patients treated since 2004

o

Inconclusive

efficacy

due

advanced

disease

status

(generally

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

DELCATH SYSTEMS, INC

Appendix IV

Published Phase I/II Studies of

Doxorubicin with PHP (percutaneous hepatic

perfusion) for HCC

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/

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

Cisplatin

50–150 mg/m

Mitomycin C 50–200 mg/m

HCC pts

RR 64.5%

5-year

survival 20.3%

Kobe

Phase I/II

HCC

(n=11)

1–3

Mean

9.5 cm

Doxorubicin 60

–120 mg/m

6.5

13 (responders)

2 (non-responders)

RR 20%

MDACC

Phase I

HCC

(n=5)

CHM

(n=8)

Other

(n=8)

2–4

Extrahepatic disease in 17%

Doxorubicin 50–120 mg/m

5-FU 1000–5000 mg/m

RR 22%

Yale

Phase I

HCC

(n=7)

Other

(n=11)

1–10

Doxorubicin

90–120

mg/m

23 (responders)

8 (non-responders)

RR 58%

Yale

Phase I

DELCATH SYSTEMS, INC

Appendix V

Product Development Pipeline

DELCATH SYSTEMS, INC

Product Development Pipeline

•

Melanoma liver mets

•

Proprietary drug-melphalan &

CHEMOSAT

•

All liver

cancers

–

melphalan

•

Classified as Medical Device

•

3 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

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 and Hong Kong

•

3 party melphalan

Development Aligned to Address Significant Market Opportunity

DELCATH SYSTEMS, INC

Appendix VI

European Regulatory Update

DELCATH SYSTEMS, INC

European Regulatory Update

•

Retained new Notified Body

•

Device reclassified from class III to class IIB, permitting self-certification in

accordance with the same established quality management system

o

The primary difference between Class III and Class IIb is that for Class IIb medical

devices the Notified Body is not required to carry out an examination of the product’s

design dossier as part of its conformity assessment

o

The Company must continue to comply with the essential requirements of the EU

Medical

Devices

Directive

(Directive

93/42

EC)

and

subject

conformity

assessment procedure requiring the intervention of a Notified Body

o

The conformity assessment procedure for Class IIb medical devices requires the

manufacturer to lodge an application for the assessment of its quality system for the

design, manufacture and inspection of its medical devices by a Notified Body

o

The Notified Body will audit the system to determine whether it conforms to the

provisions of the Medical Devices Directive. If the Notified Body’s assessment is

favorable it will issue a Full Quality Assurance Certificate, which enables the

manufacturer to draw a Declaration of Conformity and affix the CE mark to the medical

devices covered by the assessment

o

Thereafter, the Notified Body will carry out periodic audits to ensure that the approved

quality system is applied by the manufacturer.

DELCATH SYSTEMS, INC

Concentrating the Power of Chemotherapy™

DELCATH SYSTEMS, INC. - FORM 8-K - EX-99.1 - DELCATH SYSTEMS, INC. INVESTOR PRESENTATION SLIDES - November 9, 2012

Attached files

DELCATH SYSTEMS, INC. Reports