Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (March 2023)
42 slides from Delcath Systems's investor presentation, Mar 28, 2023
Slide 1: Corporate Presentation
Exhibit 99.1 Corporate Presentation (NASDAQ: DCTH) March 26, 2023
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 news release 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 HEPATIC DELIVERY COMPANY & LARGE MARKET CLINICAL PROGRAM LIVER CANCER SYSTEM (HDS) OPPORTUNITY Incidence US/EU HDS + Melphalan enabl
Slide 4: Liver-Dominant Cancers: High incidence with poor prognosis
Liver-Dominant Cancers High incidence with poor prognosis US Incidence Incid Incid US Incidence ence ence of of of Liv Liv of Liv er er Liv er Dom Dom er Dom Dom inan inan inan inan t t Cancers Cancers t t Cancers Cancers* (p (p(p a arti rti a(p rti a alla a s s rti l e e sa t t els s t s h h s e o
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: HEPZATO Kit: Enables Percutaneous Hepatic Perfusion (PHP)
HEPZATO™ Kit: Enables Percutaneous Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control ISOLATION Hepatic venous flow is isolated, Blood Return Catheter enabling 12x increased dose Chemo Chemo Isolation Filtration (Balloon) Catheter SATURATION Liver Melphalan (chemo) tr
Slide 7: mOM: Beachhead Market Opportunity
mOM: Beachhead Market Opportunity High Unmet Need, Favorable Reimbursement Environment Unmet Need Low Risk Opportunity » >5,000 cases of primary ocular melanoma per year » FOCUS pivotal trial has met primary endpoints to 12,34 2,35 37 in the US/EU , ~50% metastasize to the liver support approval in
Slide 8: 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 Q3/Q4 2023 Commercial Launch HEPZATO Kit 2006 Randomized Phase III Study Begins 2012 Gen 2 Filter CHEMOSAT Granted CE Mark 2016 EU Commerc
Slide 9: First Phase 3 RCT Results - Primary Efficacy Endpoint Met
* First Phase 3 RCT Results - Primary Efficacy Endpoint Met 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
Slide 10: Safety Issues from Phase 3 and Resulting Improvements
st Safety Issues from 1 Phase 3 and Resulting Improvements Safety Issues Primarily Due to Filter Improvement Hematological toxicities led to 3 patient deaths Gen 2 Filter introduced in 2013 Gen 1 Gen 2 28 33 % Improvement Adverse Event Adverse Event Hughes 2016 Karydis 2018 Gen 1 → 2 G3/4 G3/4 % n %
Slide 11: FOCUS Trial: Registration Clinical Trial for mOM
• 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 12: Initial Approvals Using ORR in Single-Arm Oncology Trials
2020 –’23 Initial Approvals Using ORR in Single-Arm Oncology Trials Product Indication N ORR Gavreto (pralsetinib) Metastatic RET NSCLC 114 naïve = 70%, exp. = 57% Monjuvi (tafasitamab-cxix) Relapsed or refractory large B-cell lymphoma 71 39% mutant = 69%, wild-type = Tazverik (tazemetostat) Lymphom
Slide 13: FOCUS Trial Success Criteria - Informed By FDA Interactions
Focus Trial Success Criteria - Informed By FDA Interactions Critical Single Arm Efficacy End Points* Overall Risk Benefit Assessment • “Clinically Meaningful” ORR** • Significantly improved safety relative to first pivotal trial » Trial powered to show an advantage over immuno- oncology (IO) agents
Slide 14: FOCUS Trial Analysis: Prespecified Endpoint Met
FOCUS Trial Analysis: Prespecified Endpoint Met* ORR Advantage Coupled With Meaningful Duration of Response ORR and DCR in the Treated Population DOR in the Treated Population PHP (n=91) BAC (n=32) † Efficacy Endpoint PHP (n=91) BAC (n=32) p Value Median DOR, months 14 NC ORR, n (%) 33 (36.3) 4 (12.
Slide 15: Progression Free Survival Kaplan Meier Curves
Progression Free Survival Kaplan Meier Curves in Treated Populations* Pre-Specified Exploratory Analyses* Secondary Endpoint PHP (n=91) BAC (n=32) p Value Median PFS, months 9.03 3.12 † 0.0003 [95% CI] [6.34, 11.56] [2.89, 5.65] PFS status, n (%) Events 67 (73.6) 25 (78.1) Censored 24 (26.4) 7 (21.9
Slide 16: Overall Survival Kaplan Meier Curves
Overall Survival Kaplan Meier Curves in Treated Populations* Pre-Specified Exploratory Analyses* Secondary Endpoint PHP (n=91) BAC (n=32) p Value Median OS, months 20.53 14.49 † 0.1077 [95% CI] [16.79, 25.26] [11.10, 19.78] OS status, n (%) Events 67 (73.6) 25 (78.1) Censored 24 (26.4) 7 (21.9) Haza
Slide 17: Overall Survival Comparison by Best Overall Response
Overall Survival Comparison by Best Overall Response Kaplan Meier Curves in Treated Populations* Post Hoc Exploratory Analyses* CR PR SD PD/ND ( (N=7) (N=26) N=34) (N=24) Status of OS, N (%) Events 1 (14.3) 17 (65.4) 29 (85.3) 20 (83.3) 6 (85.7) 9 (34.6) 5 (14.7) 4 (16.7) Censored † NC 28.16 19.25 1
Slide 18: Adverse Events Are Predictable and Manageable
Adverse Events Are Predictable and Manageable Related Serious Adverse Events Occurring in >5% of PHP Patients Category, n (%) FOCUS Trial (n=95) Thrombocytopenia* 14 (14.7%) † Neutropenia 10 (10.5%) Febrile neutropenia 7 (7.4%) ‡ Leukopenia 5 (5.3%) *Thrombocytopenia includes thrombocytopenia (8, 8.
Slide 19: Hematological Toxicities - Comparison with Previous Trials
Hematological Toxicities - Comparison with Previous Trials* Grade 3 or higher Adverse Events, FOCUS Trial* Hughes 2016 Post-procedural (n=91) (n=70) 8 (8.8%) 44 (62.9%) Anemia Thrombocytopenia 27 (29.7%) 56 (80.0%) † Neutropenia 27 (29.7%) 60 (85.7%) Hematological AE’s consistent with European exper
Slide 20: FOCUS Trial – Safety Comparison with Previous Trials
FOCUS Trial – Safety Comparison with Previous Trials* FOCUS Trial Pooled Analysis of Category (N=95) Prior Studies (N=121) Patients who Withdrew due to an AE or 17 (17.9%) 46 (38%) SAE Patients who Received a Reduced Dose 12 (12.6%) 27 (22.3%) due to an AE or SAE 4.1 2.8 Average Number of Cycles Imp
Slide 21: FOCUS Trial Comparison to Other Published Studies
FOCUS Trial Comparison to Other Published Studies* Median OS Median PFS Clinical Study Type Treatment (months) (months) N Study/Publication (95% CI) (95% CI) AL 91 20.53 9.03 FOCUS Single-Arm Hepzato (16.79 to 25.26) (6.34 to 11.56) 13 Khoja et al 2019 systemic and liver-directed 10.2 3.3 Meta-Analy
Slide 22: Expanded Access Program (EAP)
Expanded Access Program (EAP) Institution City Principal Investigator Status Moffitt Cancer Center Tampa, Florida Dr. Jonathan Zager Open and Enrolling Duke University Durham, North Carolina Dr. Georgia Beasley Open and Enrolling University of Tennessee Memphis, Tennessee Dr. Evan Glazer Open and En
Slide 23: 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 >$450M • Payer & hospital finance stakeholders suggest pricing exp
Slide 24: Specialized, Targeted Sales Team Leveraging EAP and Longitudinal Data
Specialized, Targeted Sales Team Leveraging EAP and Longitudinal Data EAP (FDA Approved) – Up to 8 Sites • 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, plac
Slide 25: Reimbursement
Reimbursement HEPZATO will be billed as a drug with a J-Code • Medicare Patients • Initially a C-Code • Majority of patients will be outpatient (2 midnight rule) with the drug directly covered by Medicare • Private Payer Patients • Private Payers for rare disease generally follow Medicare guidelines
Slide 26: PHP Is Already Part of Current NCCN Guidelines for mOM
PHP Is ALREADY Part of Current NCCN Guidelines for mOM Regional Isolation Perfusion Methods include isolated hepatic infusion (IHP), percutaneous hepatic perfusion (PHP), HAI, and embolization techniques. PHP is a simpler, less invasive alternative to IHP that can be repeated. It uses a double-ballo
Slide 27: Components of Hospital Reimbursement
Components of Hospital Reimbursement Assuming Outpatient Pass Through Status with C Code CPT Code mapping underway – while Drug Healthcare Facility “Physician” payment important, it will not Fee have a meaningful • ASP+6% (CMS) • Actually goes to hospital impact on drug but still matters to MD • Hig
Slide 28: Hepzato vs. Kimmtrak Cost of Treatment Comparisons
Hepzato vs. Kimmtrak Cost of Treatment Comparisons At First Assessment (first time to discontinue treatment because of progression) Drug Dose Cost Treatments # Total cost Kimmtrak $20,261 24 $486,264 Hepzato t.b.d. 2 t.b.d. Mean Hepzato treatment vs. mean treatment duration of Kimmtrak Drug Dose Cos
Slide 29: Rapid Uptake for FDA Approved Treatment in mOM
Rapid Uptake for FDA Approved Treatment in mOM • Demonstrated demand for FDA approved treatments for mOM Kimmtrak US Quarterly Sales – Kimmtrak - $38 million in Q4 2022 US sales ($152M annualized revenue) (USD) – Only 45% of mOM patients are eligible for treatment with Kimmtrak (unique MOA) $40,000,
Slide 30: IO Combination Proof of Principle – Ongoing CHOPIN Trial
IO Combination Proof of Principal – Ongoing CHOPIN Trial • N=7 in Phase 1b portion of the trial (mOM patients) • 1CR, 6 PR and 1 PD (85.7% ORR, 100% DCR) – meta-analysis of prior IO trials has shown ORR<<10% • As of 11/15/22 the median follow-up was 29.1 months (range 8.9 – 30.2), the median PFS was
Slide 31: The Local Hepatic Myeloablative Effect May Improve IO Efficacy
The Local Hepatic Myeloablative Effect May Improve IO Efficacy 30
Slide 32: EU – Broad Reimbursement Pending FOCUS Trial Data
EU – Broad Reimbursement Pending Focus Trial Data; Demonstrated 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
Slide 33: IHP Results in mOM Provide Rationale for PHP in CRC and Other Tumors
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 34: 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 35: Market Expansion: Significant Investigator Interest
Market Expansion: Significant Investigator Interest Possible Areas for Further Hepzato Development* Combination Therapy – IO Agents Limited, but 50,000 High Unmet Need IHP Efficacy Well 28 Documented 40,000 Limited, but US TAM High Unmet Need 30,000 ~10 EU 27 >$1B Cases 20,000 Phase 2 Data Per Year
Slide 36: 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 37: Capital Structure and Share Information
Capital Structure and Share Information Material One Time Q1 Events 12/31/22 1, 2 Incremental (+/-) Changes 3 1 12.72 +7.58 Shares Outstanding 1 +$23.5M Cash and Cash $11.8M 2 Equivalents -$4M 4 1 3.61M +11.94M Warrants Outstanding 2.34M NA Stock Options Granted $25.0M NA 2022 Cash Burn 5 1 $16.9M -
Slide 38: Delcath: Investment Summary
Delcath: Investment Summary 3Q approval in mOM likely due to strong pivotal data and real-world experience Kimmtrak proving out significant commercial opportunity ($200M run rate) with 45% of the HEPZATO TAM Rapid uptake likely due to favorable reimbursement environment, NCCN guidelines including PH
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