Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (March 2022)
42 slides from Delcath Systems's investor presentation, March 2022
Slide 1: Corporate Presentation
Corporate Presentation (NASDAQ: DCTH) March 2022
Slide 2: Forward-looking Statements
Forward-looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actua
Slide 3: Executive Summary
Executive Summary Delcath aims to be the leader in targeted, safe and highly-effective minimally-invasive treatments for patients with cancers of the liver. UNMET NEED PERCUTANEOUS HEPATIC COMPANY & LARGE MARKET LIVER CANCER PERFUSION (PHP) CLINICAL PROGRAM OPPORTUNITY Incidence US/EU PHP drug-devic
Slide 4: U.S. Incidence of Liver-Dominant Cancers
Liver-Dominant Cancers High incidence with poor prognosis US Incidence USIncidence Incidence of of Liver ofLiver Liver Dominant Dominant Dominant Cancers Cancers Cancers* (partial (partial (partial set setshown) set shown) shown) Up to Many patients with liver metastases are 80% 50,000 not amenable
Slide 5: Limitations of Current Liver-Directed Therapies
Limitations of Current Liver-Directed Therapies Trans Arterial Chemo Embolization (TACE)17 Y9016 » Beads obstruct blood flow to tumor and elute chemo » Radioactive beads delivered into the tumor » 50-60k treatments per year in US (and growing) » 10-15k treatments per year in US (and growing) Majorit
Slide 6: Isolated Hepatic Perfusion (IHP)
Isolated Hepatic Perfusion (IHP) The pathway to developing Percutaneous Hepatic Perfusion Benefits HISTORY OF IHP 15 Dr. Robert Ausman publishes 1st description » Temporarily isolates liver 1961 of IHP technique blood supply » Delivers substantially higher Stehlin demonstrates effects of Melphalan i
Slide 7: IHP Results in mOM Provided Rationale for PHP
IHP Results in mOM Provided Rationale for PHP in mOM and Provides Rationale for CRC and Other Tumor Types IHP/mOM ORR18-22 IHP/CRC ORR23-29 80% 80% 68% 70% 70% 61% 62% 62% 59% 60% 60% 60% 50% 47% 50% 50% 41% ORR % ORR % 40% 40% 29% 30% 20% 20% 10% 0% 0% n=34 n=17 n=27 1 n=22 n=29 n=99 n=120 n=105 n=
Slide 8: HEPZATO Kit: Percutaneous Hepatic Perfusion (PHP)
HEPZATO™ Kit: Percutaneous Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control Next-Generation, Minimally-Invasive Liver-Directed Treatment Percutaneous Hepatic Perfusion (PHP) with Melphalan Hydrochloride The only minimally invasive cancer treatment that isolates the
Slide 9: Three Steps. Targeted Treatment.
Three Steps. Targeted Treatment. Novel, whole-organ treatment that provides targeted, high-dose liver chemo while minimizing systemic exposure. ISOLATION SATUR ATION FILTR ATION Hepatic venous flow is isolated, Melphalan (chemo) treats micro Proprietary filters remove greater enabling 12x increased
Slide 10: History of HEPZATO Kit Development
History of HEPZATO Kit Development 2009 Randomized Phase III Study Completed 2013 FDA Issues a Complete Response Letter 2021 Enrollment for FOCUS Trial Completed Q1 2023 Commercial Launch HEPZATO Kit 2006 Randomized Phase III Study Begins 2012 Gen 2 Filter CHEMOSAT Granted CE Mark EU Commercializati
Slide 11: mOM: Beachhead Market Opportunity
mOM: Beachhead Market Opportunity No FDA-approved treatment, no current standard of care Unmet Need Low Risk Opportunity » ~6,000 cases of ocular melanoma per year in » FOCUS pivotal trial has met primary endpoints to the US/EU12,34 support approval in mOM37 » 50% metastasize, 90% to the liver2,35 »
Slide 12: Competitive Landscape for mOM
Competitive Landscape for mOM HEPZATO™ is the only highly-effective, targeted mOM treatment that enables repeat treatments while optimizing QoL Minimally Invasive – Liver Directed Infusion – Systemic Mono/Combo HEPZATO™ TACE17 Y90/SIRT16 Tebentafusp29* IO38 High Efficacy 31.4% <21% <17% 5.5% Up to 9
Slide 13: First Phase 3 RCT Results
First Phase 3 RCT Results * Hepatic Progression Free Survival Overall Progression Free Survival Response Rates (IRC Assessment) (INV Assessment) (ITT population) Proportion of patients surviving Proportion of patients surviving 1.0 1.0 3.8 PHP 5.4 mo PHP 0.8 mo PHP BAC P- 0.8 Best alternative care C
Slide 14: Safety Issues and Resulting Improvements
Safety Issues and Resulting Improvements Safety Issue Improvement Hematological toxicities led to 3 patient deaths Gen 2 Filter introduced in 2013 Gen 1 Gen 2 Adverse Event Hughes 201628 Adverse Event Karydis 201833 % Improvement G3/4 G3/4 Gen 1 2 % n % n Anemia 62.9% 44 Anemia 29.4% 15 53% ↓ Neut
Slide 15: FOCUS Trial Overview
OVERVIEW: FOCUS Trial • Multinational, multicenter, single-arm trial 2nd Registration Clinical • Endpoints: Trial for Patients with » Primary: Objective Response Rate compared to historic control » Secondary: Duration of response, disease control rate, overall survival, mOM progression free survival
Slide 16: FOCUS Trial Analysis: Prespecified Endpoint Met
FOCUS Trial Analysis: Prespecified Endpoint Met ORR Advantage Coupled With Meaningful Duration of Response Intent to Treat: PHP Primary Effectiveness Endpoint19 95% CI (N=91 treated + 11 untreated) Objective Response Rate 31.4% [22.55-41.31] Lower bound 22.55% far exceeds 14 Month Duration of Respon
Slide 17: Hematological Toxicities - Comparison with Previous Trials
Hematological Toxicities - Comparison with Previous Trials Focus Trial Hughes 201628 Grade 3 or higher Adverse Events (n=91) (n=70) Anemia 27 (29.7%) 44 (62.9%) Thrombocytopenia 24 (26.4%) 56 (80.0%) Neutropenia 18 (19.8%) 60 (85.7%) Hematological AE’s consistent with European experience 16
Slide 18: FOCUS Trial – Safety Comparison with Previous Trials
FOCUS Trial – Safety Comparison with Previous Trials FOCUS Trial Pooled Analysis of Category (N=91) Prior Studies (N=121) Patients who Withdrew due to an AE or 20 (22%) 46 (38%) SAE Patients who Required a Dose 12 (13.2%) 27 (22.3%) Reduction Average Number of Cycles 4.1 2.8 Improvement in tolerabil
Slide 19: 2020–'21 Initial Approvals Using ORR in Single-Arm Oncology Trials
2020 –’21 Initial Approvals Using ORR in Single-Arm Oncology Trials Two trials n=22 / 38 Single trial n=114 Single trial n=71 Single trial n=95 Single trial n=105 Single trial n=97 Single trial n=108 Danyelza (naxitamab- Gavreto (pralsetinib) Monjuvi (tafasitamab-cxix) Tazverik (tazemetostat) Zepzel
Slide 20: Supportive Evidence: Comparison Versus BAC
Supportive Evidence: Comparison Versus BAC Amended Study Enrolled Treated Best Alternative Care (BAC) Arm N=42 N=32 » FOCUS was initially a RCT against Best Alternative Care (BAC) Dacarbazine 1 0 » Due to enrollment challenges as a result of known limited Ipilimumab 7 1 efficacy of BAC control arm a
Slide 21: FOCUS Trial – Exploratory Analyses vs BAC
FOCUS Trial – Exploratory Analyses vs BAC Statistically Significant ORR and DCR Advantage vs. BAC Intent to Treat: PHP BAC Efficacy Endpoint P-Value* (N=102) (N=42) Objective Response Rate - Primary 32 (31.4%) 4 (9.5%) 0.0059 95% CI [22.55 - 41.31] [2.66 - 22.62] Disease Control Rate 67 (65.7%) 12 (
Slide 22: FOCUS Trial – Exploratory Analyses vs BAC
FOCUS Trial – Exploratory Analyses vs BAC ORR Advantage Coupled With Meaningful Duration of Response mITT Population PHP BAC (N=91) (N=32) Duration of Response 14.00 mos. NC (DOR, median) 95% CI [8.54 - NC] [6.93 - NC] Patients with Confirmed 32 4 CR or PR Patients with Subsequent PD 14 (43.7%) 1 (2
Slide 23: FOCUS Trial - Exploratory Analyses vs BAC
FOCUS Trial - Exploratory Analyses vs BAC PHP Progression-Free Survival ~3X that of BAC19 PHP BAC Secondary Endpoint P-Value* (N=91)* (N=32)* Median Progression-Free Survival 9.03 mos. 3.12 mos. 0.0007 95% CI [6.34 - 11.56] [2.89 - 5.65] PFS Status Events 64 (70.3%) 25 (78.1%) Censored 27 (29.7%) 7
Slide 24: Focus Trial Results – 12 Month Survival
Focus Trial Results – 12 Month Survival* Intent to Treat: PHP BAC Secondary Endpoint (N=102) (N=42) % Surviving at 12 months 68% 36% Hazard Ratio** 0.42 95% CI 0.20 - 0.88 p-value 0.0215 Modified Intent to Treat***: PHP BAC Secondary Endpoint (N=91) (N=32) % Surviving at 12 months 75% 47% Hazard Rat
Slide 25: Focus Trial Results – Overall Survival
Focus Trial Results – Overall Survival Data still maturing Last PHP treatment was Intent to Treat: in May 2021, BAC in 2018 PHP BAC OS will be analyzed 24 Secondary Endpoint P-Value* (N=102)* (N=42)* months post last patient last treatment Overall Survival (OS, Median) 19.25 mos. 14.06 mos. 0.2021 9
Slide 26: mOM Beachhead Market Strategy
mOM Beachhead Market Strategy BEACHHEAD MARKET | mOM LIVER DISEASE SIGNIFICANT REVENUE OPPORTUNITY: • Oncologists* believe ~80% of mOM patients would be HEPZATO candidates - ~800 patients US TAM • Considered a significant advancement over other therapies >$200M per year • Payer & hospital finance st
Slide 27: Experienced Interventional Oncology Leadership
Experienced Interventional Oncology Leadership • Kevin Muir-VP Commercial • Formerly Head of Sales for US Therasphere Y90 (BTG/Boston Scientific) • Led sales revenue growth from $60M to $220M • Built sales team to focus on all members of the MDT • Michael Ujhelyi - US Medical Director • Formerly Hea
Slide 28: Specialized, Targeted Sales Team
Specialized, Targeted Sales Team Leveraging EAP and Longitudinal Data EAP (FDA Approved) • Provide immediate access to patients • First Commercial Sites • Train new medical teams to use Hepzato after launch Regional Based Sales Team • Experienced, Oncology focused • Upon launch, placed in key geogra
Slide 29: PHP Is Likely Part of Current NCCN Guidelines for mOM
PHP Is Likely Part of Current NCCN Guidelines for mOM “Regional Isolation Perfusion of the Liver” PHP- Percutaneous Hepatic Perfusion 28
Slide 30: Reimbursement
Reimbursement HEPZATO will be billed as a drug with a J-Code • Medicare Patients • Majority of patients will be outpatient (2 midnight rule) with the drug directly covered by Medicare • For patients which become inpatient patients split billing (inpatient / outpatient) allows the drug to still be di
Slide 31: EU – Broad Reimbursement Pending Focus Trial Data
EU – Broad Reimbursement Pending Focus Trial Data, But Strong Interest Across Multiple Indications » CE Marked - available in ~23 centers in 4 countries » Delcath resumed direct sales on 3/1/22 CHEMOSAT Used In 13 Tumor Types ~70%: Metastatic Ocular Melanoma (mOM) » NICE (UK) upgraded status from Ot
Slide 32: Market Expansion: Liver Disease
Market Expansion: Liver Disease BEACHHEAD MARKET | mOM LIVER DISEASE Limited, but 50,000 Possible Areas for Further PHP High Unmet Need Development* IHP Efficacy Well 40,000 Documented28 Limited, but High Unmet Need US TAM >$1B 30,000 U.S. Incidence ~10 EU Cases27 20,000 Phase 2 Data Per Year Extens
Slide 33: Clinical Rationale for Broad Development Effort
Clinical Rationale for Broad Development Effort “Broad-spectrum” alkylating • Promising ORR and DCR signals seen across agent given at 12X normal multiple tumor types in Europe and in earlier systemic doses studies with IHP • When the liver is the life limiting organ, systemic Liver mets are often l
Slide 34: Near Term HEPZATO Development Plan
Near Term HEPZATO Development Plan Ongoing 2022 Goals 2023+ Pan Tumor I/O Combination LD Breast and/or Other LD Pancreatic NET Pancreatic ICC 2nd Line LD 2nd Line Additive Hepatic ctDNA Liver Stage II/III Post Resection CRC Stage IV Post Resection MRD Dx LD MRD ctDNA+ I/O Combination OM No Radiologi
Slide 35: FOCUS Study – Upcoming News Flow
FOCUS Study – Upcoming News Flow Mid-2022 4Q 2022 1Q 2023 Potential Approval Launch NDA Submission 6 Month PDUFA for Launch Multiple NDA Resubmission Trials in 2023 34
Slide 36: Capital Structure and Share Information – December 31, 2021
Capital Structure and Share Information – December 31, 2021 Share Listing - Current DCTH (NASDAQ) Shares Outstanding1 9.33M Does not include $27.0M $15M venture Cash and Cash Equivalents2 debt transaction closed on 8/6. Warrants Outstanding3 3.61M Stock Options Granted 1.73M 2021 Cash Burn (YTD)4 $2
Slide 37: Multi-Disciplinary, Experienced Leadership Team
Multi-Disciplinary, Experienced Leadership Team GERARD MICHEL JOHN PURPURA Chief Executive Officer Chief Operating Officer » 30+ yrs. pharma/medtech experience » Past VP and Exec Director roles of Reg. Affairs for Bracco Diagnostics » C-suite roles at Vericel Corp, Biodel, & NPS » Held senior roles
Slide 38: Delcath: A Unique Opportunity
Delcath: A Unique Opportunity Novel platform in interventional oncology Multiple near-term catalysts (Final data and NDA filing, new indications) Safety and efficacy supported by multiple trials and commercial usage Initial orphan indication allows for targeted marketing effort and rapid uptake Plat
Slide 39: Thank You
THANK YOU 38 38
Slide 40: References
References 1. Cancer.net Editorial Board (2020) Eye Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/eye-cancer/statistics. Accessed 22 Jun 2020. 2. Ocular Melanoma Foundation. Treatment of Metastatic Disease. In: OMF – Metastatic Treatment. http://www.ocularmelanoma.org/mets
Slide 41: References
References 14. Key Statistics About Liver Cancer. American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, Ga. 2021. Key Statistics About Liver Cancer. American Cancer Society. Facts and Figures 2021. American Cancer Society. Atlanta, GA 2021. 15. Isolated hepatic perfusion f
Slide 42: References
References 27. Vahrmeijer AL, van Dierendonck JH, Keizer HJ, et al. Increased local cytostatic drug exposure by isolated hepatic perfusion: a phase I clinical and pharmacologic evaluation of treatment with high dose melphalan in patients with colorectal cancer confined to the liver. Br J Cancer. 200