Full Press Release Details
Investor Presentation
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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 news release 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: the impact of the negative advisory vote by the ODAC panel on the FDA's decision regarding the
Company's new drug application (NDA), timing of completion of the FDA's review of our NDA, the extent to which the FDA may
request additional information, data, or new clinical trials and our ability to provide the same in a timely manner, additional extensions
to the PDUFA date by the FDA, 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 ocular metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States,
clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe, our ability to
successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients
with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets,
the timing and results of future clinical trials including without limitation the HCC trials, approval of the current or future
chemosaturation system for delivery and filtration of melphalan, doxorubicin or other chemotherapeutic agents for various indications
in the US and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, our ability to successfully enter into
strategic partnership and distribution arrangements in foreign markets including Australia and key Asian markets and timing and
revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects,, and uncertainties
regarding our ability to obtain financial and other resources for any research, development, clinical trials 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
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Investment Rationale
Clinically proven therapeutic concept for liver cancers
Positive efficacy signal in multiple tumor types
Initiating Clinical Development Plan in first line treatment for
Hepatocellular Carcinoma (HCC)
o Yuman Fong, MD (Memorial Sloan-Kettering), world renown
expert in primary liver cancer, to act as Study Chair
Intend to seek strategic partner for Phase 3 HCC trial
Developing Compelling Reimbursement in Key EU Markets
Manageable Cash Spend
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Pursuit of new clinical trials to support regulatory applications in
hepatocellular carcinoma (HCC)
EU Commercialization of the Hepatic CHEMOSAT Delivery
System, with near term focus on:
o Expanding clinical usage
o Obtaining compelling reimbursement in key markets
U.S. Food & Drug Administration (FDA) approval of New Drug
Application (NDA) for MelblezTM Kit (Melblez (melphalan) for
Injection for use with the Delcath Hepatic Delivery System)
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Multiple Capital Resources Available to Execute Plan
| Cash & Cash Equivalents: | $32.3 million at June 30, 2013 |
| ATM Program | up to $48.2 million available as of July 31, 2013 |
| Committed Equity Financing Facility (CEFF) | Up to $23.9 million as of July 31, 2013 |
| Working Capital Line of Credit: | $20 million credit facility |
| Strategic Partner(s) | Intend to Seek Partner to Finance Phase 3 HCC Trial |
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| Debt: | None |
| Cash Utilization: | $11.3 million in Q1 2013 $10.5 million in Q2 2013 Projected quarterly cash spend: $9-$10 million for Q3 2013 $6-$8 million for Q4 2013 |
| Shares Outstanding: | 101.6 million (112.0 million fully diluted 1 ) as of July 31, 2013 |
1) Fully diluted includes an additional 5.0 million options and 5.4 million warrants
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How the Combination Product Works
returned to systemic
2. Blood and melphalan
collected in IVC as they exit
liver via hepatic veins
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Melblez KitTM (Melblez (melphalan) for
Injection for use with the Delcath
Hepatic Delivery System)
Proprietary Drug/Device Combination
Product Regulated as a drug 505(b)(2)
Proposed initial indication for the
treatment of patients with unresectable
ocular melanoma metastatic to the liver
Melblez Kit comprised of MelblezTM
(melphalan hydrochloride for injection)
and the Delcath Hepatic Delivery System
PDUFA Date: September 13, 2013
CHEMOSAT Hepatic Delivery
Regulated as a Class IIb Medical
Indicated for the intra-hepatic of
administration of melphalan
hydrochloride and subsequent
filtration of the venous blood return.
CHEMOSAT Kit supplied without
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New Drug Application Pending
o Oncology Drug Advisory Committee (ODAC) negative vote based
on procedural safety concerns that Company believes were
corrected via protocol amendments and related procedure
o Investigator reported deaths seen on trial did not occur again
following protocol amendments (in the opinion of the treating
o Gen 2 filter contained in the Chemistry, Manufacturing and Control
(CMC) module as a technical change - Company believes use of
Gen 2 coupled with procedure refinements offer improved patient
experience via shorter hospital stays and reduced impact to blood
components as observed in EU, EAP and Compassionate Use
o Actively collecting Gen 2 clinical data
U.S. Expanded Access Program (melanoma)
EU retrospective & prospective registries (mixed histologies)
FDA Action Expected in September
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Risks associated with the CHEMOSAT/Melbez Kit Procedure
In clinical trials, the integrated safety population of patients showed risks
associated with the CHEMOSAT/MELBLEZ Kit procedure to include:
o a 4.1% incidence of deaths due to adverse reactions;
o 4% incidence of stroke;
o 2% reported incidence of myocardial infarction in the setting of an incomplete
cardiac risk assessment;