Full Press Release Details
Investor Presentation
2 DELCATH SYSTEMS, INC
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: stockholder approval of the proposed reverse
stock split and the Board of Directors implementation of the same, the impact of the reverse stock split on the Company's
stock price and the desired effect of a reverse stock split to regain compliance with the NASDAQ Marketplace Rules, the
Company's ability to regain compliance with the NASDAQ Marketplace Rules and maintain its listing on the NASDAQ
Capital market, the timing and results of future clinical trials including without limitation the Phase 2 and Phase 3 HCC
trials, 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, 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, the Company's ability to satisfy the
requirements of the FDA's Complete Response Letter 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 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 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.
3 DELCATH SYSTEMS, INC
Innovative therapy addresses an underserved liver cancer
Commercially available in Europe; under clinical development
in the United States
Positive efficacy signal in multiple tumor types
Plan for 2014 initiation of Phase 2 clinical development
program in patients with unresectable Hepatocellular
Seeking reimbursement in key EU markets
Resources to support core objectives throughout 2014
4 DELCATH SYSTEMS, INC
The Delcath Hepatic Delivery System
2. Blood and melphalan
collected in IVC as they
exit liver via hepatic
4. Filtered blood returned
to systemic circulation via
5 DELCATH SYSTEMS, INC
Melphalan for Injection with
Delcath Hepatic Delivery System
Clinical development stage - proprietary
Drug/Device Combination Product Regulated
as a drug by the FDA
Intend to conduct global HCC clinical
Evaluating best path forward in ocular
melanoma liver metastases following FDA
Complete Response Letter (CRL) in
Hepatic Delivery System
Regulated as a Class IIb Medical Device
Indicated for the intra-hepatic
administration of melphalan hydrochloride
and subsequent filtration of the venous
CHEMOSAT Kit supplied without
In EU, the product at market access and
clinical adoption stage
Seeking reimbursements: NUB-1 in
Germany, block grant in UK
6 DELCATH SYSTEMS, INC
Positive Efficacy Signals in Multiple Liver Tumor Types
Unresectable hepatic tumors
EU Prospective Registry
Hepatocellular Carcinoma
7 DELCATH SYSTEMS, INC
Clinically Differentiated Results
Phase 1, 2 and 3 trials produced positive results in multiple tumor types
Positive Phase 3 results in hepatic metastatic melanoma
n=93 (90% ocular melanoma, 10% cutaneous melanoma)
Neuroendocrine Tumor (NET) Liver Mets
mNET cohort in Phase 2 trial showed encouraging 42% objective response rate
(ORR) vs ~10% for approved targeted therapy
Median overall survival of ~32 months on Intent to Treat (ITT) basis
Hepatocellular Carcinoma (HCC)
Encouraging signal in HCC cohort of Phase 2 trial
Colorectal Cancer (CRC) Liver Mets
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 months
8 DELCATH SYSTEMS, INC
INDEPENDENT REVIEW COMMITTEE (IRC) ASSESSMENT - UPDATED ANALYSIS (4 June 2012)
Hepatic progression-free survival (IRC)
Proportion of patients surviving
Intent-to-treat population
Chemosaturation (CS-PHP)
Best alternative care (BAC)
Phase 3 Results - Primary Endpoint hPFS
CS-PHP Demonstrated 4x or 5.3 months Improvement in Primary Endpoint of hPFS
9 DELCATH SYSTEMS, INC
INVESTIGATOR ASSESSMENT - UPDATED ANALYSIS (4 June 2012)
Overall progression-free survival (investigator)
Proportion of patients surviving
0 5 10 15 20 25 30 35 40 45 50 55
Intent-to-treat population
Chemosaturation (CS-PHP)
Best alternative care (BAC)