Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (February 2015)
31 slides from Delcath Systems's investor presentation, Feb 2, 2015
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation (NASDAQ: DCTH) February 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: Delcath at a Glance
Delcath at a Glance • A late-stage clinical company with early commercial activity in Europe • CHEMOSAT is approved as a medical device (CE Mark) in Europe; investigational new combination product in U.S. for treating cancers of the liver • Focused clinical development program initially pursuing orp
Slide 4: Investment Highlights
Investment Highlights Large market opportunity - cancers of the liver remain a multi-billion dollar unmet medical need Unique, highly differentiated solution – orphan designations create barriers to competitive entry Late-stage, asset - demonstrated clinically meaningful efficacy in over 550 procedu
Slide 5: 2014-2015 Milestones
2014-2015 Milestones 2014 Accomplishments o Phase 2 HCC trial open and first patient treated o 100 th patient treated in Europe (commercial and clinical) o Positive efficacy data from three institutions presented at ESSO 2014 o Q3 sales increased 201% Y/Y to $217K o Cash burn reduced by almost 60% Y
Slide 6: 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 7: Existing Liver Cancer Treatments Landscape
Existing Liver Cancer Treatments Landscape Treatment Advantages Disadvantages – Non-invasive – Systemic toxicities Systemic – Repeatable – Limited efficacy in liver – Invasive/limited repeatability Regional – Therapeutic effect – Multiple treatments are (e.g., Isolated Hepatic Perfusion) – Targeted
Slide 8: Our Solution – Whole Organ-Focus Disease Control
Our Solution – Whole Organ-Focus Disease Control • Our proprietary system isolates the liver circulation, delivers a substantially higher concentration of chemotherapy (melphalan) to the liver and filters most of the chemotherapy out of the blood prior to returning it to the patient • The procedure
Slide 9: 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 10: Melphalan Dosing & Background
Melphalan Dosing & Background Type Dosing (mg/kg) Multiple Myeloma (label) 0.25 Chemoembolization 0.62 Surgical Isolated Hepatic Perfusion (IHP) 1.50 Myeloablation 2.50-3.50 Chemosaturation (PHP) 3.00 • Well understood, dose dependent, tumor preferential, alkylating cytotoxic agent that demonstrates
Slide 11: The Evidence for Melphalan
The Evidence for Melphalan • Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity 1. GroverAC,et al. Surgery2004;136:1176-82 4. AlexanderHRJr,et al. ClinCancerRes2003;9:6343-9 7. VanIerselLB,et al. Ann Oncol2010;21:1662-7 2. Noter SL,et al. Melan
Slide 12: Potential Applications
Potential Applications Unresectable Hepatocellular Carcinoma (HCC) Intra-hepatic Cholangiocarcinoma (ICC) Ocular Melanoma Colorectal Cancer Liver (OM) Liver Metastases (mCRC) Metastases Multiple Opportunities Yields Potential Multi-Billion Dollar Global Market 12 DELCATH SYSTEMS, INC
Slide 13: Total Available EU & US Market Opportunity
Total Available EU & US Market Opportunity Annual Potential Annual 2 Revenue per Cancer Type Incidence 1 Eligible Pts Patient 3 Market Opportunity (millions) Ocular Melanoma (OM) 5,700-8,600 2,600-4,300 $40,000-$50,000 $104-$215 Cholangio Carcinoma (ICC) 11,500 6,500 $40,000-$50,000 $260-$330 Hepato
Slide 14: Clinically Differentiated Results
Clinically Differentiated Results • Phase 1, 2 and 3 trials produced positive results in multiple histologies • Melanoma Liver Mets o Positive Phase 3 results in hepatic metastatic melanoma o n=93 (90% ocular melanoma, 10% cutaneous melanoma) • Neuroendocrine Tumor (NET) Liver Mets o mNET cohort in
Slide 15: Clinical Development Program Overview
Clinical Development Program Overview • 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 includ
Slide 16: Clinical Development Program at a Glance
Clinical Development Program at a Glance
Slide 17: Clinical Development Program – Timeline
Clinical Development Program –Timeline Tumor Type 2014 2015 2016 2017 OM (Phase 3 Pivotal Trial) 201 HCC (US Phase 2) 202 HCC (EU Phase 2) Combined US, EU 31 patients ICC Cohort (to be added to 202 HCC; n=11) IITs EU Commercial Registry Legend First Patient In Last Patient In Data Readout 17 DELCATH
Slide 18: 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 5,700 - 8,600 cases of OM liver metastases diagnosed in US and EU annually • Clear efficacy signal seen in prior P3 trial of Melp
Slide 19: 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 Chemosaturation (CS-PHP) Chemosaturation (CS-PHP) Best alternative care (BAC) Best alternative care (BA
Slide 20: 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 21: 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 22: Prior FDA Experience
Prior FDA Experience • 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.delcath.com/clinical-research/clinical-bibli
Slide 23: 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 24: 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 25: 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 • Current device/procedure permitting multiple treatment cycles • Recent scientific presentations at ESSO for
Slide 26: 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 i
Slide 27: CHEMOSAT Commercial Treatments in Europe
CHEMOSAT ® Commercial Treatments in Europe • Multiple Tumor Types Treated Since EU Launch Treatments/Re-treatments Increasing 27 DELCATH SYSTEMS, INC
Slide 28: 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. Chemosaturationwith Percutaneous Hepatic Perfusions of Melphalan for
Slide 29: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $23.3 million at September 30, 2014 Debt None ATM Program 1 $40 million available at September 30, 2014 Shares Outstanding 9.4 million (10.5 million fully diluted 3) at September 30, 2014 1) Subject to market conditions and certain limitations 2) Full
Slide 30: Summary
Summary MelphalanHydrochloridefor Injectionfor usewiththe DelcathHepaticDeliverySystem(Melphalan/HDS) • Cancers of the liver remain a large, multi-billion dollar unmet medical need • Unique, highly differentiated solution • Late-stage asset • Compelling emerging data • Imminent Valuation milestones
Slide 31: DELCATH SYSTEMS, DELCATH
© 312014 DELCATH DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.
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