Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (June 2022)
40 slides from Delcath Systems's investor presentation, Jun 7, 2022
Slide 1: Corporate Presentation June 2022
Exhibit 99.1 Corporate Presentation (NASDAQ: DCTH) June 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 CLINICAL PROGRAM LIVER CANCER PERFUSION (PHP) OPPORTUNITY Incidence US/EU PHP drug-devic
Slide 4: Liver-Dominant Cancers: High incidence with poor prognosis
Liver-Dominant Cancers High incidence with poor prognosis US In In US cid cid Inc In enc enc ciden iden e e ce o oce f f o L L o f iv iv fL er er L iv iv er Do Do er Do m m Dom in in m ant ant inan in an Canc Canc t tCanc Can er ers s cer erss* (p (p(p a art rt a(p iirt a ailla a s s rt l e e s ia t
Slide 5: Limitations of Current Liver-Directed Therapies
Limitations of Current Liver-Directed Therapies 17 16 Trans Arterial Chemo Embolization (TACE) Y90 » 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) Effec
Slide 6: Isolated Hepatic Perfusion (IHP)
Isolated Hepatic Perfusion (IHP) The pathway to developing Percutaneous Hepatic Perfusion 15 HISTORY OF IHP Benefits st Dr. Robert Ausman publishes 1 description » Temporarily isolates liver 1961 of IHP technique blood supply » Delivers substantially higher Stehlin demonstrates effects of Melphalan
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 18-22 IHP/mOM ORR 23-29 IHP/CRC ORR 80% 80% 70% 68% 70% 61% 60% 62% 62% 59% 60% 60% 50% 50% 47% 50% 41% 40% 40% 29% 30% 20% 20% 10% 0% 0% n=105 n=71 n=29 n=99 n=120 n=24 n=30* n=34 n=17 n=27 n=2
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 SATURATION FILTRATION Hepatic venous flow is isolated, Melphalan (chemo) treats micro Proprietary filters remove greater 33 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/Q2 2023 Commercial Launch HEPZATO Kit 2006 Randomized Phase III Study Begins 2012 Gen 2 Filter CHEMOSAT Granted CE Mark 2016 EU Commerc
Slide 11: mOM: Beachhead Market Opportunity
mOM: Beachhead Market Opportunity No FDA-approved treatment, no current standard of care Unmet Need Low Risk Opportunity » FOCUS pivotal trial has met primary endpoints to » ~6,000 cases of ocular melanoma per year in 37 12,34 support approval in mOM the US/EU 2,35 » Significantly improved safety pr
Slide 12: Competitive Landscape for mOM
Competitive Landscape for mOM Minimally Invasive – Liver Directed Infusion – Systemic 17 16 38 29* HEPZATO™ TACE Y90/SIRT Mono/Combo IO Tebentafusp High Efficacy 25 36.3%** <21% <17% 5.5% Up to 9% ORR % OS at 12 months 77%*** - - - 73%**** (% surviving) Repeatable (>3x) X ü X /üüü Preserves QoL X üü
Slide 13: First Phase III RCT Results
* First Phase 3 RCT Results Response Rates Hepatic Progression Free Survival Overall Progression Free Survival (ITT population) (IRC Assessment) (INV Assessment) Proportion of patients surviving Proportion of patients surviving 1.0 3.8 1.0 PHP 5.4 mo PHP PHP BAC P- mo 0.8 Cohort Best alternative car
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 28 33 Adverse Event Adverse Event % Improvement Hughes 2016 Karydis 2018 Gen 1 à 2 G3/4 G3/4 % n % n Anemia 62.9% 44 Anemia 29.4% 15 53% ¯ Ne
Slide 15: FOCUS Trial design
• Multinational, multicenter, single-arm trial • Efficacy Endpoints: FOCUS Trial » Primary: Objective Response Rate (ORR) compared to meta-analysis of IO therapy » Secondary: Duration of Response (DOR), Disease Control Rate (DCR), Overall nd Survival (OS), Progression Free Survival (PFS) 2 Registrat
Slide 16: 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=71 Single trial n=95 Single trial n=105 Single trial n=108 Single trial n=114 Single trial n=97 Danyelza (naxitamab- Gavreto (pralsetinib) Monjuvi (tafasitamab-cxix) Tazverik (tazemetostat) Zepzel
Slide 17: FOCUS Trial Success Criteria
Focus Trial Success Criteria - Informed By FDA Interactions Critical Single Arm Efficacy End Points* Overall Risk Benefit Assessment • “Clinically Meaningful” ORR** • Positive trends in exploratory BAC comparisons (ORR, DOR, DCR, PFS and OS) » Trial powered to show an advantage over immuno- oncology
Slide 18: FOCUS Trial Analysis: Prespecified Endpoint Met
FOCUS Trial Analysis: Prespecified Endpoint Met* ORR Advantage Coupled With Meaningful Duration of Response DOR in the Treated Population ORR and DCR in the Treated Population Lower bound 22.55% far exceeds 8.3% upper bound prespecified threshold** 14 Month Duration of Response 26.44% >> 8.3% prespe
Slide 19: Progression Free Survival Exploratory Analyses
Progression Free Survival Pre-Specified Exploratory Analyses* Kaplan Meier Curves in Treated Populations* Exploratory comparison versus BAC supportive * 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 18
Slide 20: Overall Survival Exploratory Analyses
Overall Survival Pre-Specified Exploratory Analyses* Kaplan Meier Curves in Treated Populations* Exploratory comparison versus BAC supportive ** 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 19
Slide 21: Best Percent Change in Target Lesion Tumor Burden
Best Percent Change in Target Lesion Tumor Burden PHP Patients (n=91) BAC Patients (n=32) CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable. * Best Overall Response (BOR) is based on status of target, nontarget and new lesions, so a 30% or 10
Slide 22: Hematological Toxicities - Comparison with Previous Trials
Hematological Toxicities - Comparison with Previous Trials* 28 Focus Trial Hughes 2016 Grade 3 or higher Adverse Events (n=91) (n=70) 27 (29.7%) 44 (62.9%) Anemia 24 (26.4%) 56 (80.0%) Thrombocytopenia Neutropenia 18 (19.8%) 60 (85.7%) Hematological AE’s consistent with European experience * Data cu
Slide 23: 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 12 (13.2%) 27 (22.3%) Patients who Required a Dose Reduction 4.1 2.8 Average Number of Cycles Improvement in tolerabi
Slide 24: 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 >$200M • Payer & hospital finance stakeholders suggest pricing exp
Slide 25: 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 26: 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 27: 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 26
Slide 28: IO Combination Therapy Likely – Ongoing CHOPIN Trial
IO Combination Therapy Likely – Ongoing CHOPIN Trial Safety and efficacy of combined melphalan percutaneous hepatic perfusion (M-PHP) and ipilimumab plus nivolumab (IPI+NIVO) in metastasized uveal melanoma (mUM): First results of the phase Ib part of the CHOPIN trial. Abstract Number: 9560 (2022 ASC
Slide 29: 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 30: 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 31: Market Expansion: Liver Disease
Market Expansion: Liver Disease BEACHHEAD MARKET | mOM LIVER DISEASE Limited, but 50,000 High Unmet Possible Areas for Further PHP Need Development* IHP Efficacy Well 28 Documented 40,000 Limited, but High Unmet US TAM Need 30,000 ~10 EU 27 Cases >$1B 20,000 Phase 2 Data Per Year Extensive EU 26 Exp
Slide 32: 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 chemotherapy can be pa
Slide 33: FOCUS Study – Upcoming News Flow
FOCUS Study – Upcoming News Flow 3Q-2022 1Q 2023 1H 2023 Launch Potential Approval NDA Submission 6 Month PDUFA for Initiate Multiple NDA Resubmission Trials in 2023 32
Slide 34: Capital Structure and Share Information
Capital Structure and Share Information – May 31, 2022 DCTH (NASDAQ) Share Listing - Current 1 9.33M Shares Outstanding Does not include $15M venture 2 $20.5M Cash and Cash Equivalents debt transaction closed on 8/6. 3 3.61M Warrants Outstanding 2.2M Stock Options Granted 4 $6.4M 2022 Q1 Cash Burn (
Slide 35: Multi-Disciplinary, Experienced Leadership Team
Multi-Disciplinary, Experienced Leadership Team GERARD MICHEL JOHN PURPURA Chief Executive Officer Chief Operating Officer » Past VP and Exec Director roles of Reg. » 30+ yrs. pharma/medtech experience Affairs for Bracco Diagnostics » C-suite roles at Vericel Corp, Biodel, & NPS » Held senior roles
Slide 36: 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 37: Thank You
THANK YOU 3 36 6
Slide 38: 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 39: 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 40: 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