Full Press Release Details
Investor Presentation
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Forward-looking Statements
This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future
events and future financial performance which include statements about our expectations, beliefs, plans, objectives,
intentions, goals, strategies, assumptions and other statements that are not historical facts. Forward-looking statements
are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which
could cause actual results to differ materially from expected results, performance or achievements expressed or implied
by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements
for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials
including without limitation the OM, HCC, ICC, and mCRC trials in the Company's Clinical Development Program, clinical
adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for
the CHEMOSAT system in various markets including without limitation Germany and the United Kingdom, our ability to
successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for
patients with primary and metastatic disease in the liver, the Company's ability to satisfy the requirements of the FDA's
Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the
Melphalan/HDS system by the US FDA, approval of the current or future Melphalan/HDS system for delivery and filtration
of melphalan 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 and the 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 clinical trials, 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 the section entitled
Risk Factors'' in our most recent Annual Report on Form 10-K and our Reports on Form 10-Q and Form 8-K.
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Why Invest in Delcath?
We are a clinical company with early commercial activity in Europe
focused on cancers of the liver
Cancers of the liver represent a multi-billion dollar global market and
an unmet medical need
Broad and Informed clinical development program
o Multiple clinical trials: OM, HCC, ICC
o Prior FDA experience provides roadmap for clinical programs
Demonstrated efficacy
o >225 clinical and commercial patients across multiple tumor types
o Efficacy and QoL benefit shown as reported by patients and physicians
o Three recent scientific presentations at ESSO meeting highlighted
o We believe EU commercial experience provides confidence safety can be
validated in controlled clinical setting
Large Market Opportunity, Demonstrated Efficacy, Near-term Value Drivers
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Near-term Milestones to Create Value
Multiple milestones within next 12 months
o Phase 3 publication submitted by year-end
o ICC cohort open for enrollment by year-end
o EU Registry open for enrollment by year-end
o Interim analysis - first 11 HCC patients by mid-year
o Go/no-go decision on ICC program by mid-year
o Initiation of Phase 3 ocular melanoma program by mid-year
o NUB reimbursement decision in Germany by February 1, 2015
Experienced team to achieve milestones
Obtaining Data in Multiple Tumor Types
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The Liver: A Life Limiting Organ
Cancers of the liver remain a major unmet medical need
o Large global patient population - approximately 1.2 million* patients
diagnosed annually with primary or metastatic liver cancer
o The liver is often the life limiting organ for cancer patients and one of the
leading causes of cancer death
o Prognosis after liver involvement is poor - overall survival generally less
CHEMOSAT is a proprietary product uniquely positioned to
potentially treat the entire liver as a standalone or
complementary therapy
* SOURCE - 2008 GLOBOCAN
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Potential Applications
Cholangiocarcinoma (ICC)
(~11,500 Cases Diagnosed
Colorectal Cancer Liver
(~65,000 Cases Diagnosed
Liver Cancers: Multi-Billion Dollar Global Market
Sources: ACS, SEER, NIH, OMF, KOL Interviews, 3rd Party Analysis
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The Melphalan Hepatic Delivery System (HDS)
Device designed to administer high dose chemotherapy to the liver while reducing
Marketed as Delcath Hepatic CHEMOSAT Delivery System (device only) in EU
Investigational drug/device combination product regulated as a drug in the US
Liver Isolated Via Double Balloon
Melphalan Infused Directly Into Liver
Via Catheter In Hepatic Artery
Blood Exiting The Liver Filtered By
Proprietary Extra-corporeal Filters
>225 Patients Treated In Clinical Development and Initial Commercial Use
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Broad and Informed Clinical Development Program
Multiple Clinical Trials
Initiating plans for Global phase 3 trial in Ocular Melanoma
(OM) Liver Mets in 2015 for trial start mid year
Establish Proof of Concept in Hepatocellular Carcinoma (HCC)
and Intrahepatic Cholangiocarcinoma (ICC)
o Commenced Global Phase 2 Program in HCC in 2014
o Expanding Program to include ICC Cohort in EU Trial
EU Registry to collect efficacy and safety data in the
Supporting Investigator Initiated Trials (IITs) in HCC &
Clinical Development Program at a Glance
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Clinical Development Program - Timeline
Leiden University (mCRC n=~30)
Additional IITs as Opportunities Present
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