Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (March 2018)
23 slides from Delcath Systems's investor presentation, Mar 13, 2018
Slide 1: Delcath Investor Presentation March 2018
Delcath Systems, Inc. Delcath Investor Presentation (OTCQB: DCTH) March 2018
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 Systems
Delcath Systems • Interventional oncology company focused on treatment of primary/metastatic liver cancers • Proprietary percutaneous hepatic perfusion (PHP) system delivers high-dose chemotherapy (melphalan) directly to the liver with extra-corporeal filtration to limit systemic toxicity • Commerci
Slide 4: Clinical / Commercial Pipeline
Clinical / Commercial Pipeline Program Phase 2 Phase 3 Registry Commercialization HCC ICC mOM Multi-Histology Market Approval Closed Enrollment Complete FDA SPA 2017 ~40 US/EU Centers EU (Safety, Efficacy QoL) EU CE Mark 4 DELCATH SYSTEMS, INC
Slide 5: 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 a complementary therapy • System isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), and filters most chemotherapy ou
Slide 6: 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, overall survival (OS)
Slide 7: Limitations of Current Liver Cancer Treatments
Limitations of Current Liver Cancer Treatments Systemic Regional Surgical Focal Emerging Chemotherapy Therapy Resection Interventions Therapy Temozolomide, Isolated Y-90, Chemo/ Checkpoint carboplatin/ Hepatic Radiofrequency Inhibitors, Paclitaxel Perfusion Ablation Immunotherapy Systemic Toxicities
Slide 8: Building Shareholder Value Through Clinical Development
Building Shareholder Value Through Clinical Development Tumor Type Program Notes Milestones Ocular Melanoma (OM) Intrahepatic Cholangiocarcinoma (ICC) Hepatocellular Carcinoma (HCC) FOCUS Trial P3 Pivotal Study in Hepatic Dominant OM Pivotal Trial in ICC 201 HCC Trial (US Only) 202 HCC/ICC Trial (EU
Slide 9: FOCUS Global Phase III Clinical Trial
Focus Global Phase III Clinical Trial Clinical Trial For Patients with Hepatic-Dominant Ocular Melanoma Multinational, Multicenter Randomized Phase 3 Trial in Patients with Hepatic Dominant Ocular Melanoma (N=240) Melphalan/HDS TX every 6-8 weeks £ 6 cycles R1:1 BAC Dacarbazine,TACE, ipilimumab, or
Slide 10: FOCUS Trial Status
FOCUS Trial Status Challenges Lack of cross over in the trial design combined with commercial availability of CHEMOSAT in EU inhibiting enrollment Inclusion/exclusion criteria focused on limited extra-hepatic metastases, narrowing available patient pool Path Forward Amended SPA with FDA (Jan 2018) e
Slide 11: ICC Development Path
ICC Development Path • Phase 2 ICC Cohort initiated to determine efficacy signal • 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 determined efficacy
Slide 12: Global Pivotal Trial in ICC
Global Pivotal Trial in ICC A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma Screening Pha
Slide 13: Focused On Fastest Path To U.S. Market
Focused On Fastest Path To U.S. Market Orphan Indications EU & US Total Addressable Market Annual Potential Cancer Type Annual Incidence1 Eligible PTS2 Market Opportunity (Millions)3,4 Ocular Melanoma ~4,700 ~2,000 ~$80-$200 Intrahepatic Cholangiocarcinoma ~14,000 ~9,300 ~$372-$930 (ICC) Colorectal
Slide 14: Recent Data Provides Confidence: PD-L1 Expression
Recent Data Provides Confidence PD-L1 Expression In Tumor Metastasis Is Different Between Uveal Melanoma And Cutaneous Melanoma – A. Javed, D. Arguello, et al (Thomas Jefferson University, Caris Life Sciences) Immunotherapy, Nov 2017 PD-L1 expression on melanoma cells is significantly lower in metas
Slide 15: Recent Data Provides Confidence: PHP Multi-institutional Report
Recent Data Provides Confidence Percutaneous Hepatic Perfusion (PHP) for unresectable metastatic ocular melanoma to the liver: A Multi-institutional report of outcomes – Moffitt Cancer Center, University Hospital Southampton (Journal Surgical Oncology – Jan 2018) 51 PTS treated between 2008 and 2016
Slide 16: Recent Data Provides Confidence: Regional Therapy Survival
Recent Data Provides Confidence Hepatic Progression-free and Overall Survival After Regional Therapy to the Liver for Metastatic Melanoma, Moffitt Cancer Center (AJCO) Analysis of 3 non-randomized approaches for treatment of 30 patients with liver metastases primarily resulting from ocular melanoma
Slide 17: European Commercialization
European Commercialization • Presence established in several major markets (~22 cancer centers) ~500 commercial procedures performed German national reimbursement established after <3 years of commercial activity Added to Medical Oncology National Treatment Guidelines for Ocular Melanoma liver metas
Slide 18: European Commercialization
European Commercialization • ~ 500 commercial procedures performed • EU physicians moving toward 2-3 initial TX as standard • UK patient received record 8th TX in March 2017 • SPIRE Southampton (UK) and Hannover Medical School (Germany) have each performed >100 TX • Established network of treating c
Slide 19: Recent Financing and Events
Recent Financing and events • $5.0 million registered offering closed on Feb 9, 2018 • 250.0 million units of one share of common stock (or pre-funded warrant) and one warrant to purchase two shares of common stock • Filed a definitive proxy statement on Feb 26, 2018 seeking approval for: • increase
Slide 20: Cash & Capital Resources
Cash & Capital Resources Cash & Cash Equivalents $2.5 million at September 30, 2017 Debt None Shares Outstanding 435.0 million (480.0 million fully diluted1) at Mar 1, 2018 2016 Convertible Note Extinguished December 2017 1) Fully diluted includes approximately 38.0 million pre-funded warrants issue
Slide 21: 2017 Highlights
2017 Highlights • FY 2017 (9 mos) revenue increased ~53% to $2.0 million over FY2016 total revenue • National reimbursement coverage in Germany under ZE system • Inclusion of CHEMOSAT in Medical Oncology National Treatment Guidelines for liver metastases in the Netherlands • 2017 SPA agreement with
Slide 22: 2018 Milestones
2018 Milestones • Dose first patient in Phase 3 ICC clinical trial • Data publication from ICC retrospective analysis • Data presentation from Phase 2 ICC Cohort • Phase 3 OM Trial Update • Presentations at major meetings (ECIO, SSO, CIRSE) 22 DELCATH SYSTEMS, INC
Slide 23: Concentrating the power of chemotherapy
Concentrating the power of chemotherapy TM © 2018 DELCATH SYSTEMS, INC. ALL RIGHTS RESERVED Delcath and CHEMOSAT are registered trademarks of Delcath Systems, Inc.