Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) October 2015
Slide 2: Forward-looking Statements
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, a
Slide 3: About Delcath Systems
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
Slide 4: Our Solution
Our Solution Liver Isolated Via Double Balloon Melphalan Infused Directly Into Liver Blood Exiting The Liver Filtered By Catheter In IVC Via Catheter In Hepatic Artery Proprietary Extra-corporeal Filters • Our proprietary system isolates the liver circulation, delivers a high concentration of chemot
Slide 5: Investment Highlights
Investment Highlights • Late-stage asset – clinically meaningful efficacy demonstrated in >600 procedures and in multiple tumor types • Active clinical program – initiating global Phase 3 study in ocular melanoma; HCC/ICC Phase 2 program ongoing • Unique, highly differentiated solution – multiple or
Slide 6: 2015 Milestones
2015 Milestones 1H-2015 NUB reimbursement decision in Germany – Value 4 awarded for 2015 Submit Phase 3 metastatic melanoma trial results for publication EU registry open for enrollment ICC cohort open for enrollment 2H-2015 ZE Reimbursement in Germany • EADO Abstracts released • RSNA Abstract relea
Slide 7: The Liver: A Life-Limiting Organ
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
Slide 8: Existing Liver Cancer Treatments Landscape
Existing Liver Cancer Treatments Landscape Treatment Advantages Disadvantages – Non-invasive – Systemic toxicities Systemic – Repeatable – Limited efficacy in liver – Invasive/limited repeatability Regional – Therapeutic effect – Multiple treatments are (e.g., Isolated Hepatic Perfusion) – Targeted
Slide 9: Melphalan Dosing & Background
Melphalan Dosing & Background Type Dosing (mg/kg) Multiple Myeloma (label) 0.25 Chemoembolization 0.62 Surgical Isolated Hepatic Perfusion (IHP) 1.50 Myeloablation 2.50-3.50 Melphalan/HDS (PHP) 3.00 • Well-understood, dose-dependent, tumor-preferential, alkylating cytotoxic agent that demonstrates l
Slide 10: Total Available EU & U.S. Market Opportunity
Total Available EU & U.S. Market Opportunity Annual Potential Annual Potential Annual 2 Market Market Cancer Type 1 Eligible PTS Incidence Opportunity Opportunity (Millions) 3,5 (Millions) 4,5 Ocular Melanoma 5,700-8,600 2,600-4,300 $104-$215 $208-$430 Intrahepatic 11,500 6,500 $260-$330 $520-$660 C
Slide 11: European Commercial Activity
European Commercial Activity ® CHEMOSAT Hepatic Delivery System • Approved as Class IIb Medical Device; kit supplied without melphalan • Broad indication for intra-hepatic administration of melphalan hydrochloride and subsequent filtration of the venous blood return • >250 commercial procedures perf
Slide 12: ZE Reimbursement
ZE Reimbursement • First National Reimbursement Coverage Mechanism for CHEMOSAT in Europe • Establishes DRG Code for CHEMOSAT procedures in Germany • Augments coverage under established codes until dedicated, comprehensive DRG code can be established • Hospitals negotiate reimbursement level with in
Slide 13: Increasing & Expanding Clinical Utilization
Increasing & Expanding Clinical Utilization All other includes: cutaneous melanoma, HCC, ICC, CRC, breast mets, neuroendocrine mets, pancreatic, mucosal melanoma, sarcoma, and gastric mets Utilization Expanding Into Other Tumor Types Beyond Ocular Melanoma 13 DELCATH SYSTEMS, INC
Slide 14: Clinically Differentiated Results
Clinically Differentiated Results • Phase 1, 2 and 3 trials produced positive results in multiple histologies • Melanoma Liver Mets o Positive Phase 3 results in hepatic metastatic melanoma o n=93 (90% ocular melanoma, 10% cutaneous melanoma) • Neuroendocrine Tumor (NET) Liver Mets o mNET cohort in
Slide 15: Clinical Development Program
Clinical Development Program Trials Tumor Objectives Global Phase3 trial to start 2H-2015 ~240 PTS, 30 mos accrual, 2017 Interim Analysis Phase 3 Pivotal Trial OM liver mets Primary endpoint: OverallSurvival (OS) Believed to be fastest pathway to NDA approval in the U.S. Protocol 201 (U.S. only) Saf
Slide 16: OM Metastases Rationale
OM Metastases Rationale • OM has high incidence of liver metastases o Up to 90% of patients with metastases will have liver involvement o Life expectancy of approximately 6 months o 5,700 - 8,600 cases of OM liver metastases diagnosed in U.S. and EU annually • Clear efficacy signal seen in prior Pha
Slide 17: Previous Ocular Melanoma Mets Phase 3 Results
Previous Ocular Melanoma Mets Phase 3 Results Hepatic Progression Free Survival (hPFS) Overall Progression Free Survival (Investigator) Proportion of patients surviving Proportion of patients surviving 1 1 5.3 mo . 3.8 mo Chemosaturation (CS-PHP) Chemosaturation (CS-PHP) . 0 0 00 Best alternative ca
Slide 18: HCC & ICC Rationale
HCC & ICC Rationale • Significant opportunity in the U.S. and EU o HCC most common primary cancer of the liver o ~76,000* cases diagnosed annually o ICC represents ~15% of new HCC cases diagnosed annually o ~90% HCC/ICC PTS not candidates for surgical resection o 20-30% PTS candidates for focal inte
Slide 19: Prior FDA Experience
Prior FDA Experience • New Drug Application (NDA) submitted August 2012 seeking indication in OM liver metastases with first-generation filter and procedure • ODAC meeting in May 2013 o Efficacy shown with statistical significance o Negative vote due to benefit/risk analysis o Complete FDA & Delcath
Slide 20: Risks Observed in Previous Clinical Program
Risks Observed in Previous Clinical Program • Risks observed with prior product and procedure protocol • Integrated safety population of patients showed risks associated with melphalan/HDS included: o 4.1% incidence of death due to adverse reactions o 4% incidence of stroke o 2% reported incidence o
Slide 21: Growing Body of Clinical Support for CHEMOSAT
Growing Body of Clinical Support for CHEMOSAT EU KOL Forum affirms benefits to liver cancer patients o 4 TX being administered; shown to be safe and well tolerated o Providing clinical benefit and good QoL o Reimbursement continues to be covered through individual funding requests Abstracts Accepted
Slide 22: Recent Data Presentations – ECCO 2015
Recent Data Presentations – ECCO 2015 Leiden University Medical Center, Erasmus Medical Center (the Netherlands) Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers • Investigators compared TX wi
Slide 23: Recent Data Presentations – CIRSE 2015
Recent Data Presentations – CIRSE 2015 Leiden University Medical Center (the Netherlands) nd Safety and efficacy of Delcath 2 Generation filter in PHP with melphalan for unresectable hepatic metastases of colorectal cancer and uveal melanoma • 15 PHP procedures performed with CHEMOSAT on 10 pts; PK
Slide 24: Recent Data Presentations - ASCO 2015
Recent Data Presentations - ASCO 2015 Southampton University Hospital (UK) o Analysis of 20 ocular melanoma patients who received 34 TX o Eleven patients remain alive after a median of 280 days with one complete response ongoing at >1 year o From the diagnosis of liver metastases, 11 patients (55%)
Slide 25: Recent Data Presentations - SSO 2015
Recent Data Presentations - SSO 2015 Moffitt Cancer Center (Tampa, FL) Hepatic Progression Free and Overall Survival after Regional Therapy to the Liver for Metastatic Melanoma o Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated with Melphalan/HDS (n=10), chemoembolizat
Slide 26: Coming Soon
Coming Soon Leiden University Medical Center in the Netherlands Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan Southampton University in the United Kingdom Liver Directed Treatment Of Metastatic Uveal Melanoma By Chemosaturation Via Percut
Slide 27: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $19.1 million at July 31, 2015 Debt None 1 ATM Program $40 million available at July 31, 2015 Shares Outstanding 2 21.8 million (40.7 million fully diluted ) at July 31, 2015 1) Subject to market conditions and certain limitations 2) Fully diluted inc
Slide 28: In Summary
In Summary • Attractive multi-billion dollar orphan drug business model • Unique, highly differentiated solution • Late-stage asset in U.S. with active clinical development program • Early commercial activity in EU with increasing sales/procedure volumes • Compelling emerging data • Imminent valuati
Slide 29: DELCATH SYSTEMS, DELCATH
© 302015 DELCATH DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.