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 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: the outcome of the ODAC meeting, and the impact, if any, of the advisory panel's recommendation on the
FDA's decision regarding the Company's new drug application (NDA), 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 Delcath Hepatic Delivery
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 Delivery System in various markets and the potential of the 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 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 and Italy 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 CHEMOSAT Hepatic Delivery System device for
intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin, approval of the CHEMOSAT Hepatic 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.
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Investment Considerations
Concentrating the Power of Chemotherapy
Commercial stage company focused on oncology
Proprietary CHEMOSAT Hepatic Delivery System allows unique whole
organ therapy for the liver
CHEMOSAT system has demonstrated extension of progression free
Addressing large unmet market need for cancer patients who usually die
Estimated initial market opportunity of ~$2.3 billion in U.S. & EU
Expanding clinical data expected to broaden clinical use and indications
On the cusp of realizing the potential:
o EU - early commercial launch underway; reimbursement in key EU markets expected
o U.S. - NDA under review ; ODAC May 2, PDUFA date June 15, 2013
Attractive financial model, multiple capital resources available and
experienced management team to execute plan
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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 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
Marketed under the trade name
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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The Delcath Hepatic Delivery System
Minimally Invasive, Repeatable Procedure That Could Complement Systemic Therapy
control in the liver
Treats macro and micro
Allows for over 100x
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Melanoma Liver Metastases
A Great Demonstration of CHEMOSAT's Potential
A challenging histology
Notoriously insensitive to
systemic chemotherapy and
demonstrated ability to extend
progression free survival
Ability to achieve ultra-high concentrations of chemotherapy provides
potential treatment options for a wide variety of cancers in the liver
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Clinically Differentiated Results
Phase 1, 2 and 3 trials with percutaneous hepatic perfusion (PHP) produced positive
results in multiple histologies
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
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
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