Slide 1: Annual Shareholder Meeting
Annual Shareholder Meeting (NASDAQ: DCTH) May 16, 2013
Slide 2: Forward-looking Statements
Forward-looking Statements Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual re
Slide 3: Product Status
Product Status US Market • Proposed Trade Name Melblez Kit TM (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) • Proprietary Drug/Device Combination Product Regulated as a drug 505(b)(2) NDA by U.S. FDA • Proposed initial indication for the treatment of patients w
Slide 4: How the Combination Product Works
How the Combination Product Works Filters Veno-veno Bypass Pump 3. Filters 2. Blood and melphalan collected in IVC as they exit liver via hepatic veins 1. Melphalan Administration directly into Hepatic Artery blood flow 4. Filtered Blood returned to systemic circulation via jugular vein
Slide 5: Clinical Program Timeline 2001-2016
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Clinical Program Phase I Unresectable hepatic tumors N=34 PHP Phase II Unresectable hepatic tumors N=56 PHP Phase III Melanoma N=93 44 PHP, 49 BAC OS Follow-up EAP Program Melanoma EU Retro- Registry EU Propsective Regis
Slide 6: ODAC – U.S. NDA Still Under Review
ODAC – U.S. NDA Still Under Review • Oncology Drug Advisory Committee (ODAC) negative vote based on Gen 1 Data • NDA filing included: o Gen 2 filter contained in the Chemistry, Manufacturing and Control (CMC) module as a technical change • Waiting for FDA Clarification of what additional Gen 2 clini
Slide 7: Patient letter to ODAC
Desa ral Ofer Onsopc Drage Adve Camis From Dee otheger Sbjct ODAC Apticaion #201888 ago with carmela 201 age 9. hal prec ena of my He fay soy of melanoma pre sn and no aon Be cose aha asus ah ote cp emo ae wc wel tong i ‘Sedma animate ay nd Ao 8 Ne iat cy and my non wasting woe. net ack omy CP an ep
Slide 8: ODAC Briefing Materials Available on Website
ODAC Briefing Materials Available on Website
Slide 9: Phase NCI Trial – Hepatobiliary Carcinoma Cohort
Phase 2 NCI Trial – Hepatobiliary Carcinoma Cohort • Best hepatic tumor response by modified RECIST assessed by investigators o Partial response (PR) 1 patient o Stable disease (SD) 4 patients o Progressive disease 1 patient o Not assessed or evaluable 2 patients • Median duration of response o hPR
Slide 10: HCC Opportunity
HCC Opportunity • Large U.S. & Global Market • Liver centric disease, liver centric treatment • Unmet need in 2L therapies • Clinical Trial Design: o Gen 2 Filter o OS primary endpoint o No Crossover – clear OS data o QoL data collection • Expect Improved Safety over P2 & P3 trials: o P2 & P3 Protoc
Slide 11: HCC – Global Market Opportunity Estimate
HCC – Global Market Opportunity Estimate Market # Patients Potential # Procedures Potential Market ($MM) 1,2,3 United States 5,586 13,964 $ 1,047 Europe 7,671 19,177 $277 APAC 99,749 249,373 $ 1,156 TOTAL 113,006 282,514 $2,480 Sources: LEK Consulting, GLOBOCAN, Company estimates. 1) Assume 2.5 trea
Slide 12: US Market by Disease – Device and Drug Combination
US Market by Disease – Device and Drug Combination Liver Metastasis Potential Market # Patients Potential Market # Procedures Potential Market ($MM) 1,2,3 Ocular Melanoma 1,685 4,213 $ 300 HCC (Primary) 5,586 13,964 $ 1,047 CRC 19,861 49,653 $ 1,241 NET 8,212 20,530 $ 513 Cutaneous Melanoma 7,023 17
Slide 13: Europe Market by Disease – Device Only
Europe Market by Disease – Device Only Germany (Direct) UK (Direct) France (Indirect) Italy (Indirect) Spain (Indirect) Netherlands (Direct) Ireland (Direct) Total Potential (patients) Potential Market ($ MM) 1,2,3 Total Potential Market #Patients Ocular Melanoma 404 297 295 285 197 79 19 1,576 $ 62
Slide 14: APAC Market by Disease
APAC Market by Disease China (Device) S. Korea (Device) Japan (Device) Taiwan (Device) Australia (Device) Total Potential (patients) Potential Market ($MM) 1,2 Total Potential Market #Patients HCC (Primary) 85,780 3,258 8,296 2,152 263 99,749 $ 1,156 Other CRC 31,127 3,245 14,298 1,441 2,031 52,143
Slide 15: 2013 Clinical Development Plan
2013 Clinical Development Plan Hepatocellular carcinoma (HCC) Trial Design: Global Phase 3 Randomized (1:1) CHEMOSAT/MELBLEZ Melphalan vs. best supportive care (BSC) for patients who have failed Sorafenib (or are intolerant due to unacceptable toxicity) – Primary endpoint: Overall Survival w/no cros
Slide 16: Additional Clinical Data Generation
Additional Clinical Data Generation • Goals: § Expand US (PHP: MEL) label indications beyond the initial indication we are seeking § Generate robust clinical data to support commercialization • FDA has accepted IND Amendment that includes Gen 2 device in US Expanded Access Program (EAP), compassiona
Slide 17: Publications: Abstracts Accepted in 2012
Publications: Abstracts Accepted in 2012 • Over 20 Abstracts Accepted and Presented in 2012 Ø Moeslein F. Chemosaturation therapy - evolution, clinical experience and applications. Ø Deneve JL. Percutaneous hepatic perfusion for unresectable metastatic sarcoma to the liver. Ø Wood B. Isolated liver
Slide 18: New Publications in 2012
New Publications in 2012 • Deneve, Jeremiah L., et al. "Chemosaturation with Percutaneous Hepatic Perfusion for Unresectable Isolated Hepatic Metastases from Sarcoma." Cardiovasc Intervent Radiol (2012) • Leong, Stanley PL, et al. "Progression of Cutaneous Melanoma: Implications for Treatment." Clin
Slide 19: A Glimpse of 2013 Publications Thus Far
A Glimpse of 2013 Publications Thus Far • Publications o Uzgare RP, et al. Evaluation of melphalan, oxaliplatin, and paclitaxel in colon, liver, and gastric cancer cell lines in a short-term exposure model of chemosaturation therapy by percutaneous hepatic perfusion. Anticancer Research. 2013;33:198
Slide 20: 2013 Abstracts
2013 Abstracts • Abstracts presented in Q1 2013 • Other accepted abstracts to be presented o Forster M. Percutaneous hepatic perfusion for unresectable melanoma or sarcoma to the liver: a single institution experience. o Testori A. Chemosaturation therapy with percutaneous hepatic perfusion for unre
Slide 21: 2013 Planned Publications
2013 Planned Publications • Agarwala, et al. “ Treatment of Melanoma Liver Metastases: Impact on Overall Survival” Under Review • Ferrucci, et al. “ Experience with Generation 1 Filters vs Generation 2 Filters” Under Review. • Alexander, et al. “ Review of Percutaneous Hepatic Perfusion for Ocular M
Slide 22: CHEMOSAT: EU Commercial Launch Underway
CHEMOSAT: EU Commercial Launch Underway • Marketing in target EU countries – Italy, Germany, France, UK, Ireland, NL, Spain • Training completed in key centers o Nine EU Clinical Sites activated as of March, 2013 • EU clinicians using CHEMOSAT for a broad range of liver metastases o Use includes: cu
Slide 23: Active CHEMOSAT Centers in Europe
Active CHEMOSAT Centers in Europe • Milan, Italy – European Institute of Oncology (IEO) • Frankfurt, Germany – Johann Wolfgang Goethe-Universität (JWG) • Villejuif, France – Cancer Institute Gustave Roussy (IGR) • Bordeaux, France – Hôpital Saint-André (St Andre) • Galway, Ireland – University Hospi
Slide 24: CHEMOSAT: Multiple Tumor Types Treated in Europe
CHEMOSAT: Multiple Tumor Types Treated in Europe • Physicians are recognizing the potential of CHEMOSAT in various tumor types • CHEMOSAT utilized in Germany, Italy, UK, France, Ireland, and the Netherlands • EU Retrospective Data Collection to be initiated in Q2 • EU Prospective Registry To Be Init
Slide 25: European media coverage
Germany The Netherlands The Netherlands kanker-actueel.nl Italy 25 DELCATH SYSTEMS, INC Fondazione Melanoma
Slide 26: Media coverage: liver cancer chemo-bath
Mail Oniine Breakthrough cancer treatment could prolong life by bathing just one organ in chemotherapy + First time patients in UK h 1d chemotherapy ‘treatment on just one organ + U.S study found patients who had new ‘PHP’ treatment survived five times longer before the disease spread ‘compared to t
Slide 27: Financial Update
Financial Update Cash & Cash Equivalents: $42.8 million at March 31, 2013 ATM Program up to $50.0 million available Committed Equity Financing Facility (CEFF) Up to $23.9 million as of March 31, 2013 Working Capital Line of Credit: $20 million credit facility Debt: None Cash Utilization: $11.3 milli
Slide 28: All Rights Reserved
© 2011 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED * DELCATH SYSTEMS, INC