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Delcath Investor Presentation
Forward-looking Statements
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, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to
differ materially from expected results, performance or achievements expressed or implied by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including, but not
limited to, uncertainties relating to: our ability to repay and comply with the obligations under our senior secured convertible notes, the timing and results of future clinical trials including without limitation the OM, HCC, ICC, and mCRC trials
in the Company s Clinical Development Program, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for the CHEMOSAT system in various markets, including without limitation
Germany and the United Kingdom and the impact on sales, if any, of reimbursement in these markets including ZE reimbursement in the German market, our ability to successfully commercialize the Melphalan/HDS system and the potential of the
Melphalan/HDS system as a treatment for patients with primary and metastatic disease in the liver, the Company s ability to satisfy the remaining requirements of the FDA s Complete Response Letter relating to the ocular melanoma indication
and the timing of the same, approval of the Melphalan/HDS system by the U.S. FDA, the impact of presentations and abstracts at major medical meetings and congresses (SSO, ASCO, CIRSE, ESMO, EADO, RSNA) and future clinical results consistent with the
data presented, approval of the current or future Melphalan/HDS 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, our ability to successfully enter into strategic partnership 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 our ability to obtain financial and other resources for any clinical trials, research, development, and commercialization activities. These factors, and others, are discussed from time to time in our
filings with the Securities and Exchange Commission including the section entitled Risk Factors in our most recent Annual Report on Form 10-K for year ended December 31, 2016, and
our Reports on Form 10-Q for the quarters ended March 30, June 30, and September 30 2017, and all Form 8-K filings made in 2017.
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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
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Our Solution Liver Focused Disease Control
Liver Isolated Via Double Balloon Catheter In IVC
Melphalan Infused Directly Into Liver Via Catheter In Hepatic Artery
Blood Exiting The Liver
Filtered By Proprietary Extra-corporeal Filters
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Cancers of the Liver A Major Unmet Medical Need
* SOURCE 2008 GLOBOCAN
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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 Limited efficacy in liver Invasive Not
Repeatable Small % of PTS are candidates Limited Efficacy in Diffuse Disease
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 Only) Fastest Path to U.S. Market Approval Amended SPA Jan 2018 FDA SPA
2017 Strong Signal in Commercial Setting Value Driver ICC Cohort Fully Enrolled HCC Remains Closed to Enrollment Interim Safety Analysis end 2017 Rollout of expanded protocol Enrollment to open in 1H 2018 ICC Data Release By Investigators 8 DELCATH
Focus Global Phase III Clinical Trial
Trial For Patients with Hepatic-Dominant Ocular Melanoma
Multinational, Multicenter Randomized Phase 3 Trial in Patients with Hepatic Dominant Ocular Melanoma
Melphalan/HDS TX every 6-8 weeks 6 cycles R1:1
BAC Dacarbazine,TACE, ipilimumab, or pembrolizumab determined by institution SOC Primary Endpoint (Overall Survival) Secondary Endpoints (Progression Free Survival, Objective
Response Rate) Safety, Pharmacokinetics, QoL (Rigorous Analyses to Assess Risk/Benefit Profile) ~40 leading cancer centers in US & EU participating in Phase 3 OM Trial
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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
Amended SPA with FDA (Jan 2018) expands inclusion/exclusion criteria
Expanded number of sites in both EU & US
Rollout expanded inclusion/exclusion
protocol to participating centers
Updated enrollment projections 2H 2018
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ICC Development Path
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Global Pivotal Trial in ICC
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
Screening Phase (N=295) GEM/CIS Induction Phase (4 cycles) R 1:1 Melphalan/HDS TX every 6-8 weeks 6 cycles GEM/CIS Re-Induction Primary Endpoint (Overall Survival) Secondary Endpoints (Progression Free Survival, Objective Response Rate, Safety)
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Focused On Fastest Path To U.S. Market
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
Colorectal (CRC) 411,000 40,000-55,000 ~$1,600-$5,500 Total EU & U.S. 429,700 51,300-66,300 ~$2,052-$6,630
1) Globocan, American Cancer Society
2) LEK, Strategy&, Company Estimates
4) Assumes ~$20,000-$25,000 USD/TX
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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 metastatic uveal melanoma (MUM) as compared with metastatic
cutaneous melanoma (MCM)
Low PD-L1 expression in MUM likely explains its lack of response to treatment with PD-1 immune check-point inhibitors
MUM also seems to demonstrate lesser PD-1 expressing
tumor-infiltrating lymphocytes as compared with MCM
Tumor cells in melanoma liver metastasis (both MUM and MCM) tend to demonstrate low PD-1 expression. This observation should be further explored in prospective studies investigating immune check-point inhibitor therapy to assess the utility of such treatments in the setting of liver metastases
Studies of novel immunotherapeutic interventions in MUM should include a focus on developing modulators of the immune-suppressive environment of the liver
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Recent Data Provides Confidence
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; (largest data set outside of a clinical trial)
received a total of 134 PHP TX (median TX = 2)
Hepatic response to PHP was evaluable in 46 patients
25 (49%) showed partial (N=22, 43.1%) or complete (N=3, 5.9%) hepatic response
17 (33.0%) had stable disease 3 months
82.4% hepatic disease control rate
Median follow up (367 days), PFS = 8.1 months, HPFS = 9.1
months; OS was 15.3 months
37.5% had Grade 3 or 4 non-hematologic toxicity
N=9 (17.6%) of PTS showed cardiovascular toxicity
31.3% PTS showed Grade 3 or 4 neutropenia vs 85.7% in prior P3 trial
No TX related deaths
Conclusion results clearly demonstrate that PHP Therapy appears to be an effective means of obtaining rapid intrahepatic disease control, and is a sensible
option in patients with predominant liver disease
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Recent Data Provides Confidence
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 and skin melanoma.
10 PTS received PHP using melphalan
12 PTS received chemoembolization (CE)
6 PTS received radioembolization with yttrium-90 (Y90)