Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) August, 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 news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual re
Slide 3: Investment Rationale
Investment Rationale • Clinically proven therapeutic concept for liver cancers • Positive efficacy signal in multiple tumor types • Initiating Clinical Development Plan in first line treatment for Hepatocellular Carcinoma (HCC) o Yuman Fong, MD (Memorial Sloan-Kettering), world renown expert in prim
Slide 4: Pursuit of new clinical trials to support regulatory applications in HCC
• Pursuit of new clinical trials to support regulatory applications in hepatocellular carcinoma (HCC) • EU Commercialization of the Hepatic CHEMOSAT® Delivery System, with near term focus on: o Expanding clinical usage o Obtaining compelling reimbursement in key markets • U.S. Food & Drug Administra
Slide 5: Multiple Capital Resources Available to Execute Plan
Multiple Capital Resources Available to Execute Plan Cash & Cash Equivalents: $32.3 million at June 30, 2013 ATM Program up to $48.2 million available as of July 31, 2013 Committed Equity Financing Up to $23.9 million as of July 31, 2013 Facility (CEFF) Working Capital Line of Credit: $20 million cr
Slide 6: Financial Update
Financial Update Debt: None $11.3 million in Q1 2013 $10.5 million in Q2 2013 Cash Utilization: Projected quarterly cash spend: $9-$10 million for Q3 2013 $6-$8 million for Q4 2013 101.6 million (112.0 million fully diluted1) as of Shares Outstanding: July 31, 2013 1) Fully diluted includes an addit
Slide 7: How the Combination Product Works
How the Combination Product Works 4. Filtered Blood returned to systemic 3. Filters circulation via jugular vein Filters Veno-veno 1. Melphalan Bypass Pump Administration directly into 2. Blood and melphalan Hepatic Artery collected in IVC as they exit blood flow 7 DELCATH SYSTEMS, INC liver via hep
Slide 8: Product Status
Product Status U.S. Market Ex U.S. Markets Melblez KitTM (Melblez (melphalan) for CHEMOSAT® Hepatic Delivery Injection for use with the Delcath System Hepatic Delivery System) • Regulated as a Class IIb Medical • Proprietary Drug/Device Combination Device Product Regulated as a drug 505(b)(2) • Indi
Slide 9: U.S. Status
U.S. Status • New Drug Application Pending o Oncology Drug Advisory Committee (ODAC) negative vote based on procedural safety concerns that Company believes were corrected via protocol amendments and related procedure refinements o Investigator reported deaths seen on trial did not occur again follo
Slide 10: Risks associated with the CHEMOSAT/Melbez Kit Procedure
Risks associated with the CHEMOSAT/Melbez Kit Procedure • In clinical trials, the integrated safety population of patients showed risks associated with the CHEMOSAT/MELBLEZ Kit procedure to include: o a 4.1% incidence of deaths due to adverse reactions; o 4% incidence of stroke; o 2% reported incide
Slide 11: Clinical Development Positive Efficacy Signals in Multiple Liver Tumor Types
Clinical Development 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 OS Follow-up N=93 44 PHP, 49 BAC E
Slide 12: HCC Rationale - US & Global
HCC Rationale - US & Global • Large Global Market o HCC most common primary cancer of the liver o ~750,000* new cases diagnosed worldwide annually o ~100,00 potentially suitable for treatment with Melblez/CHEMOSAT • Liver centric disease, liver centric treatment • Large unmet need in first line ther
Slide 13: Phase 2 NCI Trial - HCC Cohort
Phase 2 NCI Trial - HCC Cohort • Best hepatic tumor response by RECIST assessed by investigators o Partial response (PR) 1 patient (12.2 mos, survived 20.47 mos) o Stable disease (SD) 3 patients (PFS 3.45-815 mos, survival 5.26-19.88 mos) o Not assessed or evaluable 1 patients • No evidence of extra
Slide 14: Staged Hepatocellular Carcinoma (HCC) Trial Plan
Staged Hepatocellular Carcinoma (HCC) Trial Plan • Global Phase 2 - first line treatment for unresectable, advanced HCC confined to the liver § Yuman Fong, MD, (Memorial Sloan-Kettering) - Study Chairman § Multi-center, open label trial § Early opportunity for interim analysis/proof of concept in 20
Slide 15: Clinical and Regulatory HCC Phase 2 - Anticipated Milestones
Clinical and Regulatory HCC Phase 2 - Anticipated Milestones US IND Filing US IND clearance 1st IRB/contract approval 1st pt in Interim analysis 11 pts, 4 OR= PR+CR: go/no-go decision Last pt in Last pt out Database lock data readout Topline 15 DELCATH SYSTEMS, INC
Slide 16: Additional Clinical Data Generation
Additional Clinical Data Generation • FDA has accepted IND Amendment that includes Gen 2 device in US Expanded Access Program (EAP), compassionate use (CU), and all future clinical trials • US EAP with Gen 2 initiated in January 2013; two patients received a total of 5 treatments • Activating EU Reg
Slide 17: CHEMOSAT: Expanding Clinical Use in the EU
CHEMOSAT: Expanding Clinical Use in the EU • Continued pre-commercial activities in key EU countries - o Current focus on Germany, UK, Italy o Secondary focus on Netherlands, Spain, Ireland, France • 12 EU Clinical Sites as of August 2013 • EU clinicians using CHEMOSAT for a broad range of liver met
Slide 18: CHEMOSAT: Multiple Tumor Types Treated in Europe
CHEMOSAT: Multiple Tumor Types Treated in Europe 18 DELCATH SYSTEMS, INC
Slide 19: CHEMOSAT Centers in Europe
CHEMOSAT Centers in Europe • Milan, Italy - European Institute of Oncology • Frankfurt, Germany - Johann Wolfgang Goethe-Universität • Villejuif, France - Cancer Institute Gustave Roussy • Bordeaux, France - Hôpital Saint-André • Galway, Ireland - University Hospital Galway • Southampton, United Kin
Slide 20: Driving Compelling Reimbursement
Driving Compelling Reimbursement 20 DELCATH SYSTEMS, INC
Slide 21: 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-year data collection (German Radiology Society) Submission ZE Resubmission September 2013 from 1st introduction 10/2012 March 2013 Alternative Inter
Slide 22: EU Reimbursement Status
EU REIMBURSEMENT STATUS 2012 2013 2014 2015 Existing DRG Codes Phase 3 Data · Possibility exists to apply existing Published Referred DRG Code (2016) Chemotherapeutic codes to partly cover to BOM phase 3 data required costs for all stages CVZ Assment (consultation with BOM) • Health Ministry Decisio
Slide 23: 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 Ø Moeslein F. Chemosaturation using percutaneous hepatic perfusion: pre- experience and applications. embolization of GI branches in a phase 3 clini
Slide 24: 2013 Abstracts
2013 Abstracts • Abstracts presented in Q1 2013 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 unresectable liver metastases: the European Ins
Slide 25: 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 Melan
Slide 26: Conclusion
Conclusion • Clinically proven therapeutic concept for liver cancers • Positive efficacy signal in multiple tumor types • Initiating Clinical Development Plan in first line treatment for Hepatocellular Carcinoma (HCC) • Developing compelling reimbursement in Key EU Markets • Multiple Capital Resourc
Slide 27: 2013 DELCATH SYSTEMS, * DELCATH
© 2013 DELCATH * DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED
Slide 28: Appendix
APPENDIX 28 DELCATH SYSTEMS, INC
Slide 29: ODAC Summary
ODAC Summary Procedure-related deaths • Five deaths (4.1%) in the Phase 2 and Phase 3 clinical trials were considered treatment-related and resulted from adverse events o Four deaths in Phase 3 trial; one in Phase 2 trial o Treatment-related deaths in the pooled percutaneous hepatic perfusion (PHP)
Slide 30: ODAC Summary
ODAC Summary • One death due to hepatic failure: o A death due to hepatic failure occurred in male patient in the Phase 3 trial during the first cycle of melphalan/PHP treatment. Following melphalan/PHP treatment, this patient experienced fluid overload, myelosuppression, and hepatorenal syndrome. §
Slide 31: ODAC Summary
ODAC Summary Two deaths were attributable to complications of neutropenia, beyond the first cycle of treatment • One patient died of streptococcal sepsis and another died of neutropenic complications. o Prophylactic growth factor support, which is used to treat neutropenia, was not protocol specifie
Slide 32: ODAC Summary
ODAC Summary In FDA’s presentation at ODAC, FDA disagreed with this adjudication and added three additional deaths, for a total of a 7% percent death rate, in the Phase 2 and Phase 3 programs. • Two deaths related to hepatic failure and one death related to myelosuppression, were described. o Upon b
Slide 33: Reimbursement Plan - Acronym Definition
REIMBURSEMENT PLAN - 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 availa