Full Press Release Details
Investor Presentation
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Forward-looking Statements
This presentation contains forward-looking statements, within the meaning of 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 time
required to build inventory and establish commercial operations in Europe, CE Marking for the
Generation Two High Efficiency filter, the timing of our commercial launch in Europe, adoption, use and
resulting sales, if any, for the CHEMOSAT system in the EEA, our ability to successfully commercialize
the chemosaturation system and the potential of the system as a treatment for patients with cancer in
the liver, availability of melphalan in the EEA, acceptability of the Phase III clinical trial data by the FDA,
our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing
of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA,
approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and
resulting sales, if any, in the United States, approval of the current or future chemosaturation system for
other indications or the same indication in other foreign markets, actions by the FDA or other foreign
regulatory agencies, our ability to successfully enter into distribution and strategic partnership
agreements in foreign markets and the corresponding revenue associated with such foreign markets,
our ability to secure reimbursement for the chemosaturation system, progress of our research and
development programs and results of future clinical trials, uncertainties regarding our ability to obtain
financial and other resources for any research, development and commercialization activities, overall
economic conditions and other factors described 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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Our goal is making established chemotherapeutic drugs work better in target organs
Initial focus is high dose chemotherapy for improved disease control in the liver
Successful and highly statistically significant Phase 3 trial results reported
Encouraging Phase 2 data in additional tumor types
On verge of commercial launch in Europe
Filed for CE Marking for Gen Two High Efficiency Filter
Positioned to address potential $3.0 billion long term European labeled market
Filing applications seeking regulatory approval in multiple foreign markets
Intend to re-file NDA as soon as possible following January meeting with FDA
Potential $675 million US labeled market opportunity
Issued patents and orphan drug designations create competitive barriers
Deep and experienced management team
Concentrating the Power of Chemotherapy for Disease Control in the Liver
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Potential Multi-Billion Dollar Market Opportunity*
Additional Indications
CE Mark in EU for delivery of melphalan to
the liver permits physician use on a broad
range of liver cancers
Potential $3 Billion long term EU Market
Leverage CE Mark to gain regulatory
approvals in Asia, America's (EX US), MEA,
Potential $8 Billion Asia/Australia Market
Seeking initial indication for metastatic
melanoma in U.S., a potential $670 million **
Significant potential label expansion is
possible in U.S. in the future with additional
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Spectrum of Liver Cancer Treatments
Existing Treatments Involve Significant Limitations
| Type of Treatment | Advantages | Disadvantages |
| Systemic | o Non-invasive o Repeatable | - Systemic toxicities - Limited efficacy in liver |
| Regional (e.g., IHP) | o Therapeutic effect o Targeted | - Invasive/limited repeatability - Multiple treatments are required |
| Focal | o Isolated removal of tumor | - 90% unresectable - Invasive and/or limited repeatability |
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Open Surgical IHP - Where It All Began
Isolated Hepatic Perfusion: Proof of Concept, but High Morbidity and Non-Repeatable
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The Delcath Chemosaturation System
Three Steps of Chemosaturation
Advantages of Chemosaturation
Improved disease control in the
Allows for ~ 100x effective dose
escalation of drug agents at
Controls systemic toxicities
Complements systemic therapy
Minimally Invasive, Repeatable Liver Procedure That Could Complement Systemic Therapy
Note: Image not to scale.
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Melphalan Dosing & Background
Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that
demonstrates no hepatic toxicity
Manageable systemic toxicities associated with Neutropenia and Cytopenia
Drug dosing over 10x higher than FDA-approved dose via systemic IV chemotherapy
Dose delivered to tumor is approximately 100x higher than that of systemic IV
| 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 |
An established Drug For Liver Cancer Therapy
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What Chemosaturation Offers
o Significant improvement in disease control in the liver compared to
standard of care in patients with unresectable hepatic melanoma mets
o Manageable systemic toxicities
o Time, so that primary cancers can continue to be treated
o Novel, targeted liver directed treatment to complement other
o Repeatable, percutaneous procedure
o Ability to treat the entire liver, including both visible and micro tumors
o Ability to continue treating patients for extra-hepatic disease
Attractive Clinical and Economic Proposition For Patient and Providers
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Offers systemic therapy to
Offers resection or other focal therapy
to treat cancer in Liver
Identification of liver