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Forward-looking Statements
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 U.S. FDA, acceptance of the Phase 3 trial publication, the impact of the presentations at ESSO and SSO and future clinical results consistent with the data
presented, approval of the current or future Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. 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.
2DELCATH SYSTEMS, INC
About Delcath Systems
A specialty pharmaceutical
and medical device oncology company with a principal therapeutic focus on the treatment of primary liver cancer and other cancers that have metastasized to the liver
Proprietary system isolates the liver from circulation, delivers a substantially higher concentration of chemotherapy (melphalan) compared with systemic doses, and filters most of the
chemotherapy out of the blood prior to returning it to the patient
In late-stage clinical development in the
U.S. with initial commercial activities underway in Europe
Initially pursuing orphan indications in metastatic
ocular melanoma, hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC)
Clinically Meaningful Difference For Cancer Patients With Liver Dominant Disease
3DELCATH SYSTEMS, INC
Investment Highlights
approved and initial commercial activities underway in EU; demonstrated clinically meaningful efficacy in more than 600 procedures and multiple tumor types
Active clinical program initiating global Phase 3 study in ocular melanoma; HCC/ICC Phase 2 program ongoing
Unique, highly differentiated solution orphan designations create
Large market opportunity
cancers of the liver remain a multibillion-dollar unmet medical need; early commercial activity EU
valuation milestones 2015 value drivers include publications, reimbursement and clinical data
Attractive business model initial orphan focus and anticipated high gross margins form basis of profitable
Experienced management team aligned with requirements of clinically driven
pharmaceutical industry Believe We are Positioned to Capitalize on Large, Compelling Market Opportunity
4DELCATH SYSTEMS, INC
2014-2015 Milestones
2014 Accomplishments
Phase 2 HCC trial open and first patient treated
100th patient treated in Europe (commercial and clinical)
Positive efficacy data from three institutions presented at ESSO 2014 Product revenue increased 118% Y/Y to $1.1 million
Cash burn reduced by 50% Y/Y
NUB reimbursement decision in Germany Value 4 awarded for 2015 Submit Phase 3 metastatic melanoma trial results for publication EU registry open for enrollment o ICC cohort open for
o Initiation of global Phase 3 metastatic ocular melanoma program o Interim evaluation on HCC/ICC program
Executing on Multiple Fronts to Create Value
5DELCATH SYSTEMS, INC
The Liver: A Life-Limiting Organ
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, with overall survival generally less than 12 months
CHEMOSAT Melphalan/HDS is a proprietary product
uniquely positioned to potentially treat the entire liver as a standalone or complementary therapy
Liver Cancer Treatment Remains a Major Unmet Medical Need
* SOURCE 2008 GLOBOCAN
6DELCATH SYSTEMS, INC
Existing Liver Cancer Treatments Landscape
Treatment Advantages Disadvantages
Systemic Non-invasive Systemic toxicities
Repeatable Limited efficacy in liver
Invasive/limited repeatability Regional Therapeutic effect
Multiple treatments are
(e.g., Isolated Hepatic Perfusion) Targeted required but not possible
Only 10%-20% are resectable
Invasive and/or limited
(e.g., surgery, radioembolization, Partial removal or Treatment is limited by tumor chemoembolization,
treatment of tumors size, number of lesions and radiofrequency ablation) location
Cannot treat diffuse disease
Existing Liver Cancer Treatments Have Limitations
7DELCATH SYSTEMS, INC
Our Solution: Whole Organ-Focus Disease Control
Our proprietary system isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan) and
filters most of the chemotherapy out of the blood prior to returning it to the patient
The procedure typically
takes approximately 2-3 hours to complete and involves a team including the interventional radiologist and perfusionist
We believe more than 200 treatments with improved device and procedure in the U.S. and EU provide confidence safety can be validated in a controlled setting
Concentrating the Power of Chemotherapy for Disease Control in the Liver
8DELCATH SYSTEMS, INC
The Melphalan Hepatic Delivery System (HDS)
Isolated Via Double Balloon Melphalan Infused Directly Into Liver Blood Exiting The Liver Filtered By
In IVC Via Catheter In Hepatic Artery Proprietary Extra-corporeal Filters
Device designed to administer
high-dose chemotherapy to the liver while reducing systemic exposure Marketed as Delcath Hepatic CHEMOSAT Delivery System (device only) in EU Investigational drug/device combination product regulated as a drug in the U.S.
More Than 300 Patients Treated To Date
9DELCATH SYSTEMS, INC
Melphalan Dosing & Background
Multiple Myeloma (label) 0.25
Chemoembolization 0.62
Surgical Isolated Hepatic Perfusion (IHP) 1.50
Myeloablation 2.50-3.50
Chemosaturation (PHP) 3.00
dose-dependent, tumor-preferential, alkylating cytotoxic agent that demonstrates little to no hepatic toxicity
Dose administered directly to liver is substantially higher than that of systemic IV chemotherapy Melphalan, an
established chemotherapy agent, is proven active at high doses with broad antitumor activity
Drug for Liver Cancer Therapy
10DELCATH SYSTEMS, INC
Total Available EU & U.S. Market Opportunity