Full Press Release Details
Annual Shareholder Meeting
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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 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 PDUFA
goal date extensions 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 metastatic ocular melanoma to the liver, adoption, use and resulting sales, if any, for the MelblezTM Kit 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 Melblez/CHEMOSAT 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, the timing and use, if any, of the At-the-Market financing program, 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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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
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
CHEMOSAT Kit supplied without
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How the Combination Product Works
2. Blood and melphalan
collected in IVC as they
exit liver via hepatic
4. Filtered Blood returned
to systemic circulation via
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Unresectable hepatic tumors
EU Propsective Registry
Hepatocellular Carcinoma
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ODAC - U.S. NDA Still Under Review
Oncology Drug Advisory Committee (ODAC) negative vote based on
NDA filing included:
o Gen 2 filter contained in the Chemistry, Manufacturing and Control
(CMC) module as a technical change
Waiting for FDA Clarification of what additional Gen 2 clinical data is
o Actively collecting Gen 2 Clinical Data
EU Retrospective & Prospective Registries (mixed
PDUFA Goal Date: September 13, 2013
Initial indication: seeking unresectable metastatic ocular melanoma in
FDA Decision Expected in September
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ODAC Briefing Materials Available on Website
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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 Phase 3 trial in HCC in 2013
o Met with FDA and obtained feedback on trial design
Encouraging Positive Signal for Primary Liver Cancer
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Large U.S. & Global Market
Liver centric disease, liver centric treatment
Unmet need in 2L therapies