Delcath Systems, Inc
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Delcath Systems, Inc. Corporate Presentation (NASDAQ: DCTH) August 2020 Forward-looking Statements This presentation contains forward-looking statements, which are subject to certain risksand 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 relating to: the timing and results of the Company’s clinical trials including without limitation the OM and ICC clinical trial programs, timely enrollment and treatment of patients in the global Phase 3 OM and ICC Registration trials, IRB or ethics committee clearance of the Phase 3 OM and ICC Registration trial protocols from participating sites andthe timing of site activation and subject enrollment in each trial, the impact of the presentations at major medical conferences and future clinical results consistent with the data presented, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the impact of the Company’s exclusive licensing agreement with medac on commercial adoption in Europe and resulting revenue, if any, the Company’s ability to successfully enter into other strategic partnerships and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they aremade. 2 Delcath: Restructured, Recapitalized, Refocused Fully restructured in 2019, emerging with a clean balance sheet and capital table. Recapitalized with $51.5 million over the last 12 months, led by healthcare focused funds, to complete the Phase 3 FOCUS trial in metastatic ocular melanoma (top-line data end-2020/early-2021) and refile a New Drug Application (NDA) with FDA (mid-2021). Refocused on the approval and commercialization of Melphalan/HDS as a unique, high-value, interventional oncology platform, for the treatment of ultra-orphan and other orphan indications in areas of high unmet need. 3 Capital Structure and Share Information Share Listing Current DCTH (NASDAQ) Shares Outstanding1 6.53mm Cash and Cash Equivalents2 16.2mm Warrants Outstanding3 4.00mm 2019 Cash Burn4 23.6mm Debt $2.0mm 52 week Low – High5 $6.06 - $13.08 30d Average Daily Volume6 63,551 1 As of August 14, 2020, including Common, Preferred E & E1 & Pre-funded Warrants as converted 2 As of June 30, 2020 3 Warrants at a $10 exercise price 4 Net cash used in operating activities in 2019 5 Used NASDAQ price information starting on May 1st through August 14th 6 30-day average calculated between July 14th and August 14th 4 Management Team John Purpura - Interim Chief Executive Officer Previously Mr. Purpura was with Bracco Diagnostics/E-Z-EM as Vice President and then Executive Director of International Regulatory affairs from 2007 to 2008, and Head of Regulatory Affairs for North America and Latin America from 2008 to October 2009. Prior to E-Z-EM Mr. Purpura had an 11-year career with Sanofi-Aventis with progressively more senior Regulatory and CMC responsibilities, ultimately serving as Associate VP for Regulatory and CMC from 2005 to 2007. Prior To Sanofi, Mr. Purpura held various quality and regulatory management roles with Pharma companies from 1985 to 1995. Mr. Purpura earned a MS in Management & Policy and BS degrees in Chemistry and Biology at the State University of New York at Stony Brook. Christine Padula – Principal Accounting Officer Ms. Padula joined the Company as the Vice President of Finance in September 2019. Previously she was with medCPU, Inc. as the Vice President of Finance and Controller from 2015 to 2019. Ms. Padula had a 19- year career with Siemens of which 17 years were with Siemens Financial Services, Inc. ultimately serving as the Vice President and Controller of the US division. From 1987 to 1995, she had various senior and staff accountant roles. Ms. Padula earned her B.S. degree in Business Administration with a concentration in Accounting at Montclair State University in New Jersey. Ms. Padula holds an inactive CPA license from the State of New Jersey. Johnny John, MD – Vice President Medical Affairs Dr. John has worked in oncology drug development and clinical trials for over 15 years. Prior to joining Delcath he worked in Clinical Trial Operations at InVentivHealth.Amongtheclinicalprogramsheworkedon there were the trials that resulted in the FDA approval of Ipilimumab. Prior to InVentiv Health, Dr. John spent over 11 years in clinical practice. He received his medical degree from Mangalore University, India and post- graduate training at the University of Illinois. 5 Board of Directors Roger G. Stoll, Ph.D. Chairman (since December 2008) Appointed Chairman, September 2015. From 2002 to 2008, served as Chairman, CEO and President of Cortex Pharmaceuticals, Inc. (CORX). Dr. Stoll has served on eight corporate boards including; St. Jude Medical, The BOC Group (London), Questcor, Agensys, and Chelsea Therapeutics. John R. Sylvester, Director (since July 2019) From 2005-2019, John was at BTG PLC, an international specialist healthcare company that develops and commercializes products targeting critical care, cancer and other disorders, and served as Chief Commercial Officer from 2011 to 2019. He received his BSc (Honors) in Biochemistry and Applied Molecular Biology at the University of Manchester in England. Elizabeth Czerepak, Director (since February 2020) Ms. Czerepak recently served and CFO and CBO of Genevant Sciences, Inc. Experience includes CFO at other biotechnology companies, including Altimmune, Isarna Therapeutics, and Cancer Genetics where she played a key role in achieving Altimmune’s public listing through reverse merger and Cancer Genetics’ IPO and subsequent uplisting to Nasdaq. Steven Salamon, Director (since May 2020) Mr. Salamon holds a MBA from the Ivey Business School and an Engineering Physics degree from the University of Toronto. Prior to cofounding Rosalind Advisors, Mr. Salamon worked as an equity analyst at HSBC securities and RBC Capital Markets. Gil Aharon, Ph.D. Director (since May 2020) Dr. Aharon holds a Ph.D in Biophysics and Molecular Biology from the University of Toronto. Prior to co- founding Rosalind Advisors, Dr. Aharon worked as an equity analyst at Infinium Securities. 6 Delcath Systems, Inc. - Overview ◆ Interventional oncology (IO) company with multiple near-term catalysts ◆ Enrollment completed in a phase 3 registration trial in metastatic ocular melanoma ◆ End-2020/early-2021 - Topline data expected ◆ Mid-2021 - FDA NDA submission for indicationexpected ◆ Proprietary IO system (PHP) targets primary/metastatic liver cancers ◆ A differentiated, high-value IO platform targeting high unmet need indications with unsatisfactory standard-of-care. ◆ Delivers chemotherapy directly to the liver with subsequent filtration to improve safety ◆ Minimally invasive, repeatable, predictable, manageable systemic toxicity profile, can delay tumor progression and can potentially improve survival ◆ Commercial / Clinical Status ◆ Commercial stage in the EU under the CHEMOSAT® brand ◆ ~1,000 commercial procedures performed ◆ Late-stage (Phase 3) clinical development in the US (Melphalan/HDS) ◆ Pursuit of marketing approval for orphan indications in metastatic ocular ◆ melanoma (mOM), intrahepatic cholangiocarcinoma (ICC) or others presently under strategic assessment Our Mission is to Make a Clinically Meaningful Difference for Patients with Cancers of the Liver 7 Interventional Oncology Companies have become a Strategic Asset IO – the fourth pillar of oncology treatment. Interventional oncology has rapidly become an integrated specialty component of comprehensive oncology care. IO is fully accepted and demanded by knowledgeable oncologists where it has become an integral part of the treatment referral pattern. Notable Recent Transactions in the Interventional Oncology Space June 2018 - CDH investments acquires Sirtex August 2019 - Boston Scientific acquires BTG June 2019 - Varian Medical Systems acquires Endocare and Alicon August 2019 - Varian acquires Boston Scientific’s microsphere business February 2019 - Johnson & Johnson acquires Auris Health, Inc. 8 The PHP Solution – Liver Focused Disease Control Liver-focused disease control. CHEMOSAT® Melphalan/Hepatic Delivery System (HDS) product uniquely positioned to treat the entire liver as a standalone or a complementary therapy Limited systemic exposure = responses with better Quality of Life. System isolates the liver circulation, delivers a high concentration