Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2014)
30 slides from Delcath Systems's investor presentation, Jan 13, 2014
Slide 1: Investor Presentation
Investor Presentation (NASDAQ: DCTH) January 2014
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: Investment Thesis
Investment Thesis § Innovative therapy addresses an underserved liver cancer market § 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 wi
Slide 4: The Delcath Hepatic Delivery System
The Delcath Hepatic Delivery System 4. Filtered blood returned to systemic circulation via 3. Filters jugular vein Veno-veno 1. Melphalan Bypass Pump administration 2. Blood and melphalan directly into collected in IVC as they Hepatic Artery exit liver via hepatic blood flow 4 DELCATH SYSTEMS, INC v
Slide 5: Product Status
Product Status EU Markets U.S. Market CHEMOSAT® Melphalan for Injection with Hepatic Delivery System Delcath Hepatic Delivery System § Regulated as a Class IIb Medical § Clinical development stage - proprietary Device Drug/Device Combination Product § Indicated for the intra-hepatic Regulated admini
Slide 6: Positive Efficacy Signals in Multiple Liver Tumor Types
Positive Efficacy Signals in Multiple Liver Tumor Types 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Phase 1 Unresectable hepatic tumors N=34 PHP Phase 2 Unresectable hepatic tumors N=56 PHP Phase III Melanoma Liver Mets OS Follow-up N=93 44 PHP, 49 BAC EU Retro- E
Slide 7: Clinically Differentiated Results
Clinically Differentiated Results § Phase 1, 2 and 3 trials produced positive results in multiple tumor types § Melanoma Liver Mets § Positive Phase 3 results in hepatic metastatic melanoma § n=93 (90% ocular melanoma, 10% cutaneous melanoma) § Neuroendocrine Tumor (NET) Liver Mets § mNET cohort in
Slide 8: Phase 3 Results - Primary Endpoint hPFS
Phase 3 Results - Primary Endpoint hPFS Hepatic progression-free survival (IRC) Proportion of patients surviving 1.0 5.3 mo Chemosaturation (CS-PHP) Best alternative care (BAC) 0.8 Hazard ratio = 0.50 0.6 (95% CI 0.31-0.80) P=0.0029 7.0 1.7 0.4 0.2 0.0 0 5 10 15 20 25 30 Intent-to-treat population M
Slide 9: Phase 3 Results - Overall PFS
Phase 3 Results - Overall PFS Overall progression-free survival (investigator) Proportion of patients surviving 1.0 3.8 mo Chemosaturation (CS-PHP) 0.8 Best alternative care (BAC) 0.6 Hazard ratio = 0.42 5.4 (95% CI 0.27-0.64) 1.6 P<0.0001 0.4 0.2 0.0 0 5 10 15 20 25 30 35 40 45 50 55 Intent-to-trea
Slide 10: Risks associated with Melphalan HDS
Risks associated with Melphalan HDS § In clinical trials using early versions of the device, the integrated safety population of patients showed risks associated with Melphalan HDS to include: § 4.1% incidence of deaths due to adverse reactions § 4% incidence of stroke § 2% reported incidence of myo
Slide 11: FDA Complete Response Letter (CRL) on Melanoma NDA
FDA Complete Response Letter (CRL) on Melanoma NDA § Issued in September 2013 § FDA requests include, but not limited to: § Well-controlled randomized trial(s) to establish the safety and efficacy using the to-be-marketed device configuration § Overall survival as the primary efficacy outcome measur
Slide 12: HCC Rationale - U.S. & Global
HCC Rationale - U.S. & Global § Large Global Market § HCC most common primary cancer of the liver § ~750,000* new cases diagnosed worldwide annually § ~100,000 potentially suitable for treatment with CHEMOSAT/Melphalan HDS § Liver centric disease, liver centric treatment § Large unmet need in first
Slide 13: Encouraging Signal in Previous P2 HCC Study with Mel/HDS
Encouraging Signal in Previous P2 HCC Study with Mel/HDS Subject Age Sex Race Baseline Number Hepatic hPFS Overall OS ID (yr) (M/F) tumor of PHP response/ (month) PFS (Month) burden (% received overall (month) of hepatic response involveme nt) 008 57 F white 5 3 SD/SD 4.37 4.37 19.88 010 63 M white
Slide 14: Global Hepatocellular Carcinoma (HCC) Clinical Plan
Global Hepatocellular Carcinoma (HCC) Clinical Plan § Global Phase 2 1L - Mel/HDS - sorafenib sequential treatment of HCC confined to the liver § Multi-center, open label trial § Staged trial design with early opportunity for interim analysis/proof of concept in 2014 § Objective Response Rate (CR +
Slide 15: CHEMOSAT: Expanding Clinical Use in the EU
CHEMOSAT: Expanding Clinical Use in the EU § Continued commercial market access and clinical adoption activities in key EU countries § Current focus on Germany and UK § 15 Clinical Sites treated patients in EU § Clinicians using CHEMOSAT for a broad range of liver metastases § Including: cutaneous m
Slide 16: CHEMOSAT: Commercial Treatments in Europe
CHEMOSAT: Commercial Treatments in Europe Multiple Tumor Types Treated Patients/Treatments Year 2012 2013 Total PTS 27 28 55 TX 33 40 73 2nd TX 4 11 15 3rd TX 2 1 3 16 DELCATH SYSTEMS, INC
Slide 17: CHEMOSAT Treatment Sites in Europe
CHEMOSAT Treatment Sites in Europe § University of Heidelberg Hospital § Berlin Charité Hospital § University Medical Center Göttingen § Johann Wolfgang Goethe- Universität § University of Bonn § Asklepios Clinic Bambek § Southampton University Hospital § SPIRE Southampton Hospital § European Instit
Slide 18: EU Reimbursement Status
EU Reimbursement Status 2012 2013 2014 2015 ZE Denied NUB Value 4 Granted NUB NUB Decision DRG Code ZE Application NUB 2/2013 Resubmission 1 Feb 2014 ~2 years data collection (German Radiology Society) Submission ZE Resubmission October 2013 from 1st introduction 10/2012 March 2013 Block funding Alt
Slide 19: Multiple Capital Resources Available to Execute Plan
Multiple Capital Resources Available to Execute Plan Cash & Cash Equivalents $31.2 million at December 31, 2013 Debt None ATM Program $44 million available at December 31, 2013 Committed Equity Financing $24 million available at December 31, 2013 Facility (CEFF) Working Capital Line of Credit $20 mi
Slide 20: Investment Thesis
Investment Thesis § Innovative therapy addresses an underserved liver cancer market § 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 wi
Slide 21: 2013 DELCATH SYSTEMS, * DELCATH
© 2013 DELCATH * DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED
Slide 22: Appendix
APPENDIX 22 DELCATH SYSTEMS, INC
Slide 23: Leadership Team
LEADERSHIP TEAM Jennifer Simpson, PhD., M.S.N., Graham G. Miao, Ph.D., M.S., MBA Peter J. Graham C.R.N.P. Interim Co-President and Co-CEO, Executive Vice President, Interim Co-President and Co-CEO EVP, Chief Financial Officer General Counsel, Chief EVP, Global Head of Business Compliance Officer and
Slide 24: Publications
Publications • Published in 2013 o Metastatic melanoma to the liver: A contemporary and comprehensive review of surgical, systemic, and regional therapeutic options. Agarwala SS, Eggermont AM, O'Day S, Zager JS. Cancer. 2013 Dec 2. o Chemosaturation with percutaneous hepatic perfusion for unresectab
Slide 25: Abstracts Presented (2012-2013)
Abstracts Presented (2012-2013) Ø Moeslein F. Chemosaturation therapy - evolution, clinical Ø Moeslein F. Chemosaturation using percutaneous hepatic perfusion: pre- experience and applications. embolization of GI branches in a phase 3 clinical trial. Ø Deneve JL. Percutaneous hepatic perfusion for u
Slide 26: Delcath ODAC Presentation - Summary
Delcath ODAC Presentation - Summary Full Delcath and FDA ODAC Briefing Materials Available at http://www.delcath.com/clinical-research/clinical-bibliography/ Procedure-related deaths § Five deaths (4.1%) in the Phase 2 and Phase 3 clinical trials were considered treatment-related and resulted from a
Slide 27: Delcath ODAC Presentation - Summary
Delcath ODAC Presentation - Summary Full Delcath and FDA ODAC Briefing Materials Available at http://www.delcath.com/clinical-research/clinical-bibliography/ § One death due to hepatic failure: § A death due to hepatic failure occurred in male patient in the Phase 3 trial during the first cycle of m
Slide 28: Delcath ODAC Presentation - Summary
Delcath ODAC Presentation - Summary Full Delcath and FDA ODAC Briefing Materials Available at http://www.delcath.com/clinical-research/clinical-bibliography/ § Prophylactic growth factor support, which is used to treat neutropenia, was not protocol specified and rarely used during P2 and P3 melanoma
Slide 29: FDA ODAC Presentation - Summary
FDA ODAC Presentation - Summary Full Delcath and FDA ODAC Briefing Materials Available at http://www.delcath.com/clinical-research/clinical-bibliography/ FDA disagreed with Delcath assessment and added three additional deaths, for a total of a 7% percent death rate, in the Phase 2 and Phase 3 progra
Slide 30: EU Reimbursement - Acronym Definition
EU REIMBURSEMENT - Acronym Definition Germany ZE - (Zusatzentgeld) form of additional compensation for approved treatments which are not sufficiently compensated by the existing DRG codes in place. NUB - (Neue Untersuchungs- und Behandlungsmethoden) provides reimbursement between the gap of availabi
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