Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2015)
26 slides from Delcath Systems's investor presentation, Jan 12, 2015
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) January 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: Why Invest in Delcath?
Why Invest in Delcath? • We are a late-stage clinical company with early commercial activity in Europe focused on cancers of the liver • Cancers of the liver are an unmet medical need representing a multi- billion dollar global market • Focused clinical development program o Multiple clinical trials
Slide 4: 2015 Milestones to Create Value
2015 Milestones to Create Value 2014 Accomplishments o Phase 2 HCC trial open and first patient treated o 100th patient treated in Europe (commercial and clinical) o Positive efficacy data from three institutions presented at ESSO 2014 Q1 o Prior phase 3 publication submitted o EU Registry open for
Slide 5: The Liver: A Life Limiting Organ
The Liver: A Life Limiting Organ • Cancers of the liver remain a major unmet medical need globally 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 o
Slide 6: Potential Applications
Potential Applications Unresectable Hepatocellular Carcinoma (HCC) (76,000 Cases Intra-hepatic Diagnosed in US/EU Cholangiocarcinoma (ICC) Annually) (~11,500 Cases Diagnosed in US/EU Annually) Ocular Melanoma Colorectal Cancer Liver (OM) Liver Metastases (mCRC) Metastases (~65,000 Cases Diagnosed (
Slide 7: The Melphalan Hepatic Delivery System (HDS)
The Melphalan Hepatic Delivery System (HDS) 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 • Device designed to administer high dose chemotherapy to the liv
Slide 8: Focused Clinical Development Program
Focused Clinical Development Program • Initiating global phase 3 trial mid-year in Ocular Melanoma (OM) Liver Mets • Establish Proof of Concept in Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC) o Commenced Global Phase 2 Program in HCC in 2014 o Expanding Program to include
Slide 9: Clinical Development Program at a Glance
Clinical Development Program at a Glance 9 DELCATH SYSTEMS, INC
Slide 10: Clinical Development Program - Timeline
Clinical Development Program - Timeline Leiden University (mCRC n=~30) JWG (HCC n =~10) Additional IITs as Opportunities Present First Patient In Last Patient In Data Readout 10 DELCATH SYSTEMS, INC
Slide 11: OM Rationale
OM 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 ~7,500 cases of OM liver metastases diagnosed in US and EU annually • Clear efficacy signal seen in prior P3 trial of Melphalan/H
Slide 12: Previous Ocular Melanoma Phase 3 Results
Previous Ocular Melanoma Phase 3 Results Hepatic Progression Free Survival (hPFS) Overall Progression Free Survival (Investigator) Proportion of patients surviving Proportion of patients surviving 1.0 1.0 3.8 mo Chemosaturation (CS-PHP) 5.3 mo Chemosaturation (CS-PHP) 0.8 0.8 Best alternative care B
Slide 13: HCC Rationale
HCC Rationale • Significant opportunity in US and EU o HCC most common primary cancer of the liver o ~76,000* cases diagnosed annually • Large unmet medical need in first line therapy o Only one currently approved systemic therapy in US, EU, and certain Asian markets o ~90% of pts not candidates for
Slide 14: ICC Rationale
ICC Rationale • Significant Market Opportunity in US and EU o ~15% of new HCC cases diagnosed annually o ~90% of patients are not suitable for surgical resection o ~20-30% candidates for focal interventions o Efficacy signals from early commercial uses in EU • Unmet medical need – Delcath will pursu
Slide 15: Prior FDA Experience Provides Roadmap for Clinical Programs
Prior FDA Experience Provides Roadmap for Clinical Programs • New Drug Application (NDA) submitted August 2012 seeking indication in OM liver metastases with prior filters and procedure • ODAC meeting in May 2013 o Negative Vote o Complete FDA & Delcath ODAC briefing materials available at www.delca
Slide 16: 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 to include: o 4.1% incidence of deaths due to adverse reactions o 4% incidence of stroke o 2% reported incidenc
Slide 17: Safety Improvements Implemented
Safety Improvements Implemented • New generation filter o improved filter efficiency and consistency • Vasopressors and methylprednisolone o reduce cardiovascular risk • Prophylactic transfusions and growth factors o reduce risk of myelosuppression • Intra-arterial nitroglycerin o to prevent hepatic
Slide 18: Positive Developments
Positive Developments • Improved device and procedure since prior trials o >180 treatments with improved device and procedure in US and EU o Many issues raised at ODAC have not been reported • EU patients report improved QoL • Current device/procedure permitting multiple treatment cycles • Recent sc
Slide 19: European Commercialization
European Commercialization CHEMOSAT® Hepatic Delivery System • Approved as Class IIb Medical Device; kit supplied w/o melphalan • Broad indication for intra-hepatic administration of melphalan hydrochloride and subsequent filtration of the venous blood return • 150 commercial procedures performed in
Slide 20: CHEMOSAT Commercial Treatments in Europe
CHEMOSAT® Commercial Treatments in Europe • Multiple Tumor Types Treated Since EU Launch Treatments/Re-treatments Increasing 20 DELCATH SYSTEMS, INC
Slide 21: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $23.3 million at September 30, 2014 Debt None ATM Program1 $40 million available at September 30, 2014 Working Capital Line of Credit2 $20 million credit facility 9.4 million (10.5 million fully diluted3) at Shares Outstanding September 30, 2014 1) Su
Slide 22: Summary
Summary • Cancers of the liver are an unmet Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) medical need representing a multi-billion dollar global market • Demonstrated efficacy o Prior phase 3 trial o Recent presentations at ESSO • >180 treatm
Slide 23: 2014 DELCATH SYSTEMS, * DELCATH
© 2014 DELCATH * DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.
Slide 24: APPENDIX
APPENDIX 24 DELCATH SYSTEMS, INC
Slide 25: Previous Clinical Program
Previous Clinical Program Clinical Trials Phase 1 Phase 2 Phase 3 Follow Up Unresectable Hepatic Tumors N=35 Unresectable Hepatic Tumors (Multi-Histology)* N=56 Melanoma Liver Metastases N=93 (44PHP, 49 BAC) Integrated Safety Population • Previous Clinical Program demonstrated improvement in hepatic
Slide 26: Publications
Publications § Alexander, R., et al. Current Status of Percutaneous Hepatic Perfusion as Regional Treatment for Patients with Unresectable Hepatic Metastases: A Review, American Oncology and Hematology Review 2014: 15-23 § Vogl, et al. Chemosaturation with Percutaneous Hepatic Perfusions of Melphala
Delcath Systems — Investor Presentation (January 2015) on 6ix