Delcath Investor Presentation (NASDAQ
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Delcath Systems Corporate Presentation (OTCQB: DCTH) January 2020 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 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 and the 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 are made. 2 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 a decade as a hematology/oncology-nurse practitioner and educator ♦ Dr. Simpson earned a Ph.D. in Epidemiology from the University of Pittsburgh, an M.S. in Nursing from the University of Rochester, and a B.S. in Nursing from the State University of New York at Buffalo Barbra C. Keck, Chief Financial Officer ♦ Deloitte & Touche, LLP ♦ Earlier in her career, Ms. Keck spent several years in executive roles in the non-profit sector ♦ Ms. Keck earned her M.B.A. in Accountancy from Baruch College and Bachelor of Music in Music Education from the University of Dayton John Purpura, Executive Vice President - Global Head of Operations ♦ Vice President and then Executive Director of International Regulatory Affairs with Bracco/ E-Z-EM ♦ Associate Vice President for Regulatory and CMC with Sanofi- Aventis ♦ Prior to Sanofi, Mr. Purpura held various quality and regulatory management roles with Pharma companies from 1985 to 1995. He earned a MS in Management & Policy and BS degrees in Chemistry and Biology at the State University of New York at Stony Brook 3 Delcath Systems ♦ Interventional oncology (IO) company with multiple near term catalysts ♦ Enrollment completed ♦ Mid-2020 - Topline data expected ♦ Q1 2021 - FDA NDA submission for indication expected ♦ “IO is the Fourth pillar of Oncology treatment” - ASCO ♦ Competitors include Boston Scientific (BTG), Sirtex ♦ Proprietary IO system (PHP) designed to treat primary/metastatic liver cancers ♦ Delivers chemotherapy directly to the liver ♦ Minimally invasive, repeatable, predictable, manageable systemic toxicity profile, can delay tumor progression and could potentially improve survival ♦ Commercial / Clinical Status ♦ Commercial stage in the EU under the CHEMOSAT® brand ♦ ~750 commercial procedures performed ♦ Late-stage (Phase 3) clinical development in the US (Melphalan/HDS) ♦ Pursuit of orphan indications in metastatic ocular melanoma (mOM) and intrahepatic cholangiocarcinoma (ICC) 4 Our Mission is to Make a Clinically Meaningful Difference for Patients with Cancers of the Liver 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 out of the blood prior to returning it to the patient ♦ Repeatable procedure typically takes ~2-3 hours 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 5 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 < 12 months Currently available/emerging therapies Limited * SOURCE – 2008 GLOBOCAN 6 Focused On Fastest Path To U.S. Market EU & US Total Addressable Market Estimated Annual Annual Cancer Type Eligible PTS2 Incidence1 Addressable Market 3,4 Ocular Melanoma ~4,700 ~2,000 ~$200MM Orphan Indications Intrahepatic ~14,000 ~11,000 ~$825MM Cholangiocarcinoma (ICC) Total EU & U.S. ~18,700 ~13,000 ~$1.25B Notes: 1) Globocan, American Cancer Society 2) LEK, Strategy&, Company Estimates 3) Assumes 4 TX/patient for OM and 3TX/patient for ICC 4) Based on current reimbursed amount in Europe ~$25,000 USD/TX Cancers Of The Liver Remain a Multibillion-Dollar Unmet Medical Need 7 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 utilized include: o Immunotherapy o TACE o Y-90 ♦ DCTH believes this is fastest pathway to NDA approval in the U.S ♦ FDA granted Melphalan hydrochloride orphan drug designation for treatment of OM ♦ Efficacy signal seen in multiple publications with Melphalan/HDS 8 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 Disease Control Rate, Patients with Hepatic Overall Survival, Progression Dominant Ocular Free Survival) Melanoma Safety, (N=~80) Pharmacokinetics, QoL (Rigorous Analyses to Assess Risk/Benefit Profile) Trial Highlights ♦ Ability to collect and report Overall Survival data when survival data matures (all patients followed until death) ♦ Non-randomized, single-arm trial ♦ Prior enrollment counted to amended enrollment target ♦ PTS treated in prior randomized protocol continue to be treated/evaluated ♦ Enrollment complete 9 Melphalan/HDS Response Comparison - Reasons for Confidence Publication CR PR ORR SD DCR mOS Safety (mos) Hughes 2015 Majority of adverse events were related to bone marrow 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, and one post- (Gen 1 Filter) crossover to PHP-Mel from BAC. 37.5% had Grade 3 or 4 non-hematologic toxicity Karydis 2018 N=9 (17.6%) of PTS showed cardiovascular toxicity (n=51) 3.9% 43.1% 47.0% 37.2% 84.3% 15.3 31.3% PTS showed Grade 3 or 4 neutropenia vs 85.7% in (Gen 2 Filter) prior P3 trial. No TX related deaths. Burgmans Safety analysis showed 14 serious AEs, no deaths, no 2018* (n=35) 3.1% 71.0% 74.1% 12.5% 86.6% 20.3 severe bleeding complications, myocardial or cerebral (Gen 2 Filter) infarctions observed . Artzner 2019 Safety analysis showed Grade 3 SAEs observed in 14% of TX (anemia, leukopenia, thrombocytopenia). (n=15) 0.0% 60.0% 60.0% 33.3% 93.3% 27.4 Most SAEs were Grade 1/2, 5% of reported Grade 3/4 (Gen 2 Filter) SAEs required intervention. * Oral Presentation – ECIO, Not yet published Superior Results 10 FDA Has Approved a Number of Treatments for Oncology Indications Based on Single-Arm Trials Measuring ORR 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 336 days Libtayo (cemiplimab) Standard ORR 2 single-arm trials; ORR 47% from pooled results (2018) Darzalex (daratumumab) Accelerated ORR Single-arm trial; ORR 29% (2015) Kyprolis (carfilzomib) Accelerated ORR Single-arm trial; ORR 23% duration 7.8 months (2012) Velcade (bortezomib) Accelerated ORR 2 Single-arm trials; ORR 29.6% (2003) Darzalex