Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2017)
34 slides from Delcath Systems's investor presentation, Jan 30, 2017
Slide 1: Delcath Investor Presentation
Delcath Investor Presentation (NASDAQ: DCTH) January 2017 Exhibit 99.1
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: Jennifer Simpson, CEO & President
Jennifer Simpson, PhD., MSN, CRNP Named CEO & President of Delcath in May of 2015. Prior Pharmaceutical Roles at ImClone/Lilly/Johnson & Johnson Experience: Product development and commercialization of late stage asset across 5 indications. Field Research and clinical trial experience Led Co-Promoti
Slide 4: Delcath Systems
Delcath Systems Interventional oncology Company focused on treatment of primary/metastatic liver cancers Proprietary system delivers high-dose chemotherapy (melphalan) directly to the liver with extra-corporeal filtration to limit systemic toxicity Commercial Stage in the EU Late-stage clinical deve
Slide 5: Cancers of the Liver - A Major Unmet Medical Need
Cancers of the Liver - A Major Unmet Medical Need Large global patient population of ~1.2 million* patients diagnosed annually with primary or metastatic liver cancer Liver a common site of metastases and often the life-limiting organ for cancer patients Prognosis is poor, OS generally <12 months Cu
Slide 6: Limitations of Current Liver Cancer Treatments
Limitations of Current Liver Cancer Treatments Systemic Chemotherapy Regional Therapy Surgical Resection Focal Interventions Emerging Therapy Temozolomide, carboplatin/ Paclitaxel Isolated Hepatic Perfusion Y-90, Chemo/ Radiofrequency Ablation Checkpoint Inhibitors, Immunotherapy Systemic Toxicities
Slide 7: Our Solution – Liver Focused Disease Control
Our Solution – Liver Focused Disease Control CHEMOSAT® Melphalan/HDS product uniquely positioned to treat the entire liver as a standalone or as complementary therapy System isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), filters most chemotherapy out of th
Slide 8: Benefits Demonstrated in Prior Phase 3 Trial
Months Benefits Demonstrated in Prior Phase 3 Trial Percutaneous Hepatic Perfusion (PHP) Overall Progression Free Survival (INV Assessment) Months 1.0 0.8 0.6 0.4 0.2 0.0 Proportion of patients surviving 5.4 1.6 3.8 mo Best alternative care (BAC) 0 5 10 15 20 25 30 35 40 45 50 55 4 PTS alive as of D
Slide 9: Global Phase III Clinical Trial
Global Phase III Clinical Trial Clinical Trial For Patients with Hepatic-Dominant Ocular Melanoma Melphalan/HDS TX every 6-8 weeks ≤ 6 cycles BAC Dacarbazine,TACE, ipilimumab, or pembrolizumab determined by institution SOC Primary Endpoint (Overall Survival) Secondary Endpoints (Progression Free Sur
Slide 10: Clinical Development Program
Clinical Development Program Program Tumor Type P2 P3 Upcoming Milestones 201 HCC Trial (US Only) u 202 HCC/ICC Trial (EU Only) u Open for enrollment FOCUS Trial P3 Pivotal Study in Hepatic Dominant OM u Interim Safety Analysis FDA 2019 Ocular Melanoma (OM) Hepatocellular Carcinoma (HCC) Intrahepati
Slide 11: ICC Development Path
ICC Development Path Phase 2 ICC Cohort initiated to determine if efficacy signal present ICC Cohort: Patient treatment and data collection continuing; interim data to be released upon maturity Concurrently, a multi-center retrospective data collection by EU investigators was conducted in 2015 and d
Slide 12: Initial Commercialization
Initial Commercialization CE Marked as Class IIb Medical Device with broad indication Presence established in several major markets (~22 cancer centers) National reimbursement established in Germany for 2016 after <3 years of commercial activity European centers producing data to support reimburseme
Slide 13: Clinical Utilization
Clinical Utilization ~350 commercial procedures performed EU Physicians opting to retreat patients as familiarity/confidence grows UK Patient received record 7th TX in Jan 2017 Established in treating centers as preferred TX for OM liver mets where reimbursement is available Broad range of tumor typ
Slide 14: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1 CR ongoing >1yr LUMC -
Slide 15: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1 CR ongoing >1yr LUMC -
Slide 16: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1 CR ongoing >1yr LUMC -
Slide 17: Recent Data Presentations
Recent Data Presentations Abstract N= Efficacy Toxicity/AEs Notes OS CR PR SD HPFS Zager – SSO 30 (CM, OM) 736 days 310 days OS results provide confidence for new P3 Trial Southampton - ASCO 20 2 13 2 GR1 (n=12), GR2 (n=13), GR3 (n=5) GR4 (n=1) 11 pts alive median 280 days, 1 CR ongoing >1yr LUMC -
Slide 18: Peer Reviewed Publications
Peer Reviewed Publications Hepatic Progression-free and Overall Survival After Regional Therapy to the Liver for Metastatic Melanoma – American Journal of Clinical Oncology – Accepted for Publication Chemosaturation with Percutaneous Hepatic Perfusion in Patients with Unresectable Hepatic Metastases
Slide 19: 2017 International Symposium on Regional Cancer Therapies
2017 International Symposium on Regional Cancer Therapies Percutaneous Hepatic Perfusion (PHP) for unresectable metastatic ocular melanoma to the liver: A Multi-institutional report of outcomes New Data accepted for oral presentation Retrospective analysis conducted by Moffitt Cancer Center/Universi
Slide 20: CIRSE 2016 Secondary Resectability of Ocular Melanoma Liver Metastases
CIRSE 2016 Secondary Resectability of Ocular Melanoma Liver Metastases (OMLM) Following Percutaneous Hepatic Perfusion (PFP) by M. Zeile, et al. Asklepios Barmbek Clinic (Hamburg, Germany) evaluated 7 patients with unresectable ocular melanoma liver metastases treated with CHEMOSAT ORR after 1-2 tre
Slide 21: 6th European Post-Chicago 2016 Chemosaturation Update
6th European Post-Chicago 2016 Chemosaturation Via Percutaneous Hepatic Perfusion – An Update on A Single Centre Experience of Treating Metastatic Uveal Melanoma Southampton University (United Kingdom) Methods – A retrospective evaluation of 27 patients treated with CHEMOSAT over 4 years; analysis o
Slide 22: Multi-Billion Dollar Opportunity in Orphan Diseases
Multi-Billion Dollar Opportunity in Orphan Diseases EU & US TAM Cancer Type Annual Incidence1 Eligible PTS2 Annual Potential Market Opportunity (Millions)3,4 Ocular Melanoma ~4,700 ~2,000 ~$80-$200 Intrahepatic Cholangiocarcinoma (ICC) ~14,000 ~9,300 ~$372-$930 Hepatocellular Carcinoma (HCC) 64,500
Slide 23: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $3.7 million at September 30, 2016 Debt $35.0 million at September 30, 2016 Restricted Cash $30.3 million at September 30, 2016 Shares Outstanding 18.1 million (25.4 million fully diluted1)2 at January 25, 2017 Fully diluted includes approximately 41,
Slide 24: Convertible Note
Convertible Note $35.0 million senior secured convertible notes issued June 2016 subject to certain equity conditions $32.2 million aggregate proceeds to fund clinical development programs, commercial activities & ongoing operations $6.0 million released; $26.2 million restricted cash remaining Repa
Slide 25: 2017 Value Drivers
2017 Value Drivers 2H 2016 German ZE Reimbursement Defined 1H 2017 ICC Development Path Finalized 2H 2017 Phase2/Retrospective Data Collection Informed ICC Development Path EU Health Authority Submissions FOCUS P3 Interim Safety Analysis
Slide 26: Investment Highlights
Investment Highlights Attractive multi-billion dollar orphan drug business model Unique, highly differentiated solution Late-stage asset in US with active clinical development program Commercial activity in EU supports increasing procedure volumes & reimbursement appeals Imminent valuation drivers F
Slide 27: Concentrating the Power of Chemotherapy
Concentrating the Power of Chemotherapy™ INC. ALL
Slide 28: Appendix
Appendix 28 DELCATH SYSTEMS, INC
Slide 29: SSO 2015 Hepatic Progression Free and Overall Survival
SSO 2015 Hepatic Progression Free and Overall Survival after Regional Therapy to the Liver for Metastatic Melanoma - Moffitt Cancer Center (Tampa, FL) Methods – Retrospective analysis of 30 patients with ocular or cutaneous melanoma treated with Melphalan/HDS (n=10), chemoembolization (CE, n=12), an
Slide 30: ASCO 2015 Single Centre Experience of Chemosaturation PHP
ASCO 2015 Single Centre Experience of Chemosaturation Percutaneous Hepatic Perfusion in the Treatment of Metastatic Uveal Melanoma - Southampton University Hospital (UK) Methods - Analysis of 20 ocular melanoma patients who received 34 TX Results - Eleven patients remain alive after a median of 280
Slide 31: CIRSE 2015 Safety and Efficacy of 2nd Generation Filter
CIRSE 2015 Safety and efficacy of Delcath 2nd Generation filter in PHP with melphalan for unresectable hepatic metastases of colorectal cancer and uveal melanoma - Leiden University Medical Center (the Netherlands) 15 PHP procedures performed with CHEMOSAT on 10 pts; PK blood samples @ baseline, set
Slide 32: ECCO 2015 Treating Unresectable Liver Metastases of Uveal Melanoma
ECCO 2015 Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers - Leiden University Medical Center, Erasmus Medical Center (the Netherlands) Methods - Investigators compared TX with IHP and PHP for
Slide 33: EADO 2015 Treating Unresectable Liver Metastases of Uveal Melanoma
EADO 2015 Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, Leiden University Medical Center, Erasmus Cancer Institute (the Netherlands) presented by Dr. Mark Burgmans (Leiden) Methods - two-center Phase 2 study aims to evaluate 20 patients
Slide 34: EADO 2015 Chemosaturation for Hepatic Metastases from Uveal Melanoma
EADO 2015 Chemosaturation with Percutaneous Hepatic Perfusion of Melphalan for Hepatic Metastases from Uveal Melanoma: Multi-institutional Evaluation, poster presented by lead author Prof. Thomas Vogl, Frankfurt University Hospital Methods - retrospective evaluation of non-resectable hepatic metasta
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