Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (December 2019)
19 slides from Delcath Systems's investor presentation, December 2019
Slide 1: Delcath Systems Corporate Presentation
Delcath Systems Corporate Presentation (OTCQB: DCTH) December 2019
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relat
Slide 3: Management Team
Management Team Jennifer Simpson, PhD., M.S.N., C.R.N.P. - President & Chief Executive Officer ♦ Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc/Eli Lilly ♦ Product Director, Oncology Therapeutics Marketing at Ortho Biotech ♦ Earlier in her career Dr. Simpson spent over
Slide 4: Delcath Systems
Delcath Systems ♦ Interventional oncology (IO) company with multiple near term catalysts ♦ 2H 2019 - FOCUS trial expected to complete enrollment; Publication from Prospective Phase 2 Study ♦ 1H 2020 - Topline data expected to be complete ♦ 2H 2020 - FDA NDA submission for indication expected ♦ “IO i
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 Need
Cancers of the Liver - A Major Unmet Need Need Large global patient population ~1.2 million* patients diagnosed annually with primary or metastatic liver cancer Liver a common site of metastases Often the life-limiting organ for cancer patients Prognosis is poor Overall survival (OS) generally
Slide 7: Focused On Fastest Path To U.S. Market
Focused On Fastest Path To U.S. Market EU & US Total Addressable Market Annual Potential Annual Market Cancer Type Eligible PTS2 Incidence1 Opportunity (Millions)3,4 Ocular Melanoma ~4,700 ~2,000 ~$200 Orphan Indications Intrahepatic ~14,000 ~11,000 ~$825 Cholangiocarcinoma (ICC) Colorectal (CRC) ~4
Slide 8: Metastatic Ocular Melanoma (mOM) Rationale
Metastatic Ocular Melanoma (mOM) Rationale ♦ OM has high incidence of liver metastases o ~4,700 cases of OM diagnosed in U.S. and EU annually o Up to 90% of patients with metastases will have liver involvement o Life expectancy of approximately 6 months ♦ Currently no standard of care; therapies uti
Slide 9: Global Registrational Clinical Trial
Global Registrational Clinical Trial Clinical Trial For Patients with Hepatic-Dominant Ocular Melanoma Primary Endpoint (Objective Response Rate) Multinational, Multicenter Secondary Non-Randomized Melphalan/HDS Endpoints Registration Trial in TX every 6-8 weeks ≤ 6 (Duration of Response, cycles Dis
Slide 10: Melphalan/HDS Response Comparison - Reasons for Confidence
Melphalan/HDS Response Comparison - Reasons for Confidence Publication CR PR ORR SD DCR mOS Safety (mos) Majority of adverse events were related to bone marrow Hughes 2015 suppression. Four deaths were attributed to PHP-Mel, (n=44) 0.0% 27.3% 27.3% 52.3% 79.6% 10.6 three in the primary PHP-Mel group
Slide 11: ORR trials in oncology
ORR trials in oncology Approval Endpoint Trial Design/Results Erivedge (vismodegib) Standard ORR 1 single-arm trial; ORR 43%, duration 7.6 months; (2012) metastatic ORR 30%, duration 7.6 months Istodax (romidepsin) Standard ORR 2 single-arm trials; ORR 34% duration 454 days, (2009) ORR 35% duration
Slide 12: Multi-Center ICC Outcomes Data Published in European Radiology
Multi-Center ICC Outcomes Data Published in European Radiology Percutaneous Hepatic Perfusion (Chemosaturation) with Melphalan in Patients with Intrahepatic Cholangiocarcinoma: European Multicentre Study on Safety, Short Term Effects and Survival, European Radiology 2018, Marquardt, et al ♦ Study ev
Slide 13: The ALIGN Trial - Global Pivotal Trial in ICC
The ALIGN Trial - 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 Cholangiocarci
Slide 14: Building Shareholder Value Through Clinical Development
Building Shareholder Value Through Clinical Development Tumor Type Program Tasks 2018 1H 2019 2H 2019 1H 2020 2H 2020 Amended Protocol Focus Trial Pivotal Registration FPI Amended Study in Trial Ocular Melanoma Hepatic Dominant Safety Analysis (OM) OM (DSMB) ** Fastest path to US LPI market approval
Slide 15: Broad Device Indication in Europe Demonstrates Potential
Broad Device Indication in Europe Demonstrates Potential Device label permits use in broad range of primary & Tumor Types Treated metastatic liver cancers 13 tumor types treated since CHEMOSAT launch Vast Majority: Presence established in several major markets (~22 OM Mets cancer centers) ~7
Slide 16: European Commercialization – medac Licensing
European Commercialization – medac Licensing Licensing agreement announced December 2018 Extensive network throughout Europe €6 million in upfront and milestone payments Allows Delcath to focus on Clinical Fixed transfer price and royalty payments Development Program Agreement includes E
Slide 17: 2019 Private Placements
2019 Private Placements $29.5 Million raised (July 2019 - August 2019) ♦ $12.0 million in debt equitized in addition to cash proceeds ♦ Cash runway beyond top line data ♦ Clean capitalization table ♦ Foundation for a possible path to National Exchange listing Positioned for success through multi
Slide 18: Capitalization
Capitalization Authorized Issued and Outstanding Preferred Shares 10,000,000 41,716 Common Shares 1,000,000,000 24,388,054 Shares reserved for conversion of Preferred Stock: 695,263,245 Warrants and Options: Feb 2015 Warrants ($0.01; exp 2/2020) 9 July 2015 Warrants ($0.01; exp 7/2020) 9 Oct 2016 Wa
Slide 19: Summary
Summary Ocular Melanoma (OM) Late-stage clinical development trial expected to complete accrual in 2H 2019 Topline data expected to complete in 1H 2020 FDA NDA submission for indication expected in 2H 2020 Focused on cancers of the liver with high unmet medical need & no established SOC
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