Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (November 2014)
25 slides from Delcath Systems's investor presentation, Nov 18, 2014
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) November 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: Why Invest in Delcath?
Why Invest in Delcath? • We are a clinical company with early commercial activity in Europe focused on cancers of the liver • Cancers of the liver represent a multi-billion dollar global market and an unmet medical need • Broad and Informed clinical development program o Multiple clinical trials: OM
Slide 4: Near-term Milestones to Create Value
Near-term Milestones to Create Value Multiple milestones within next 12 months •2014 o Phase 3 publication submitted by year-end o ICC cohort open for enrollment by year-end o EU Registry open for enrollment by year-end •2015 o Interim analysis - first 11 HCC patients by mid-year o Go/no-go decision
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: Broad and Informed Clinical Development Program
Broad and Informed Clinical Development Program Multiple Clinical Trials • Initiating plans for Global phase 3 trial in Ocular Melanoma (OM) Liver • Establish Mets Proof in 2015 for of Concept trial start midCarcinoma in Hepatocellular year (HCC) and Intrahepatic Cholangiocarcinoma (ICC) o Commenced
Slide 9: Clinical Development Program at a Glance
Clinical Development Program at a Glance
Slide 10: Clinical Development Program - Timeline
Clinical Development Program - Timeline Interim Analysis 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 US/EU Market Size 76,000 ~15% ~90% ~20-30
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 • ODAC meeting in May 2013 o Negative Vote o Complete FDA & Delcath ODAC briefing materials available at www.delcath.com/clinical-research/clinical
Slide 16: Risks Observed in Previous Clinical Trials
Risks Observed in Previous Clinical Trials • Risks observed using product and procedure protocol from Previous Clinical Program • 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 str
Slide 17: Why Do We Believe?
Why Do We Believe? • Improved device and procedure since prior trials o >130 EU treatments o >20 treatments in US Expanded Access Program and Compassionate Use cases o Many issues raised at ODAC have not been reported • EU patients report improved QoL • Current device/procedure permitting multiple t
Slide 18: 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 • >130 commercial procedures performed i
Slide 19: CHEMOSAT Commercial Treatments in Europe
CHEMOSAT® Commercial Treatments in Europe • Multiple Tumor Types Treated Since EU Launch Treatments/Re-treatments Increasing 19 DELCATH SYSTEMS, INC
Slide 20: 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 21: Summary
Summary • Cancers of the liver represent a multi- Melphalan Hydrochloride for Injection for use with the Billion dollar global market and unmet Delcath Hepatic Delivery System (Melphalan/HDS) medical need • Demonstrated efficacy o Phase 3 trial o Recent presentations at ESSO • >150 treatments with i
Slide 22: 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 23: Appendix
APPENDIX 23 DELCATH SYSTEMS, INC
Slide 24: Historic Clinical Program
Historic Clinical Program Clinical Trials Phase 1 Phase 2 Phase 3 Follow EU Commercial Up Experience Unresectable Hepatic N=35 Tumors Unresectable Hepatic Tumors (Multi- N=56 Histology)* Melanoma Liver N=93 Metastases (44PHP, 49 BAC) Integrated Safety Population Product Procedure N= >90 Refinements
Slide 25: 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
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