Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2023)
42 slides from Delcath Systems's investor presentation, Jan 3, 2023
Slide 1: Corporate Presentation
Corporate Presentation (NASDAQ: DCTH) January 2023 Exhibit 99.1
Slide 2: Forward-looking statements safe harbor
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 actual results to differ materia
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. Incidence US/EU >200K primary and metastatic liver tumors per year1-14 Current local/regional treatments Cannot treat the whole liver Targeted
Slide 4: Liver-Dominant Cancers: High incidence with poor prognosis
Liver-Dominant Cancers High incidence with poor prognosis U.S. Incidence Incidence of Liver Dominant Cancers (partial set shown) Liver: Common Site of Metastases Limited Overall Survival – Unresectable Liver Cancer Often the life-limiting organ Many patients with liver metastases are not amenable to
Slide 5: Treatment Limitations of Current Liver-Directed Therapies
Majority of Treatment Limitations of Current Liver-Directed Therapies Beads obstruct blood flow to tumor and elute chemo 50-60k treatments per year in US (and growing) Radioactive beads delivered into the tumor 10-15k treatments per year in US (and growing) Trans Arterial Chemo Embolization (TACE)17
Slide 6: Isolated Hepatic Perfusion (IHP)
Isolated Hepatic Perfusion (IHP) The pathway to developing Percutaneous Hepatic Perfusion Temporarily isolates liver blood supply Delivers substantially higher concentrations of chemotherapy (Melphalan) with limited toxicity High treatment related mortality (>5%) Not repeatable and few patients are
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 ORR % ORR % IHP/mOM ORR18-22 IHP Studies in other disease states Primary HCC and ICC utilizing IHP (melphalan +/- TNF alpha). ORR = 67% (N=13) with a median actuarial survival of 16.3 months.30
Slide 8: HEPZATO Kit: Percutaneous Hepatic Perfusion (PHP)
HEPZATO™ Kit: Percutaneous Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control ISOLATION Hepatic venous flow is isolated, enabling 12x increased dose SATURATION Melphalan (chemo) treats micro and macro lesions simultaneously FILTRATION Proprietary filters remove greate
Slide 9: History of HEPZATO Kit Development
Randomized Phase III Study Begins 2006 Gen 2 Filter CHEMOSAT Granted CE Mark EU Commercialization 2012 Clinical Trial for Patients with Hepatic-Dominant Ocular Melanoma (FOCUS) 2016 Randomized Phase III Study Completed 2009 FDA Issues a Complete Response Letter 2013 Enrollment for FOCUS Trial Comple
Slide 10: mOM: Beachhead Market Opportunity
Unmet Need Low Risk Opportunity High Barrier to Entry Favorable Commercial Economics mOM: Beachhead Market Opportunity No FDA-approved treatment, no current standard of care ~6,000 cases of ocular melanoma per year in the US/EU12,34 50% metastasize, 90% to the liver2,35 Median survival up to 12 mont
Slide 11: Competitive Landscape for mOM
Competitive Landscape for mOM Minimally Invasive – Liver Directed Infusion – Systemic Minimally Invasive HEPZATO™ TACE17 Y90/SIRT16 Mono/Combo IO38 Tebentafusp29* High Efficacy 36.3%** <21% <17% 5.5% Up to 9%25 ORR % OS at 12 months (% surviving) 77%*** - - - 73%**** Repeatable (>3x) ü X / ü X ü ü P
Slide 12: First Phase III RCT Results
First Phase 3 RCT Results* Months Overall Progression Free Survival (INV Assessment) Crossover design confounded overall survival analysis – most subjects in BAC arm [57.1%] crossed over to PHP arm Proportion of patients surviving 7.0 1.6 5.4 mo PHP 0 5 10 15 20 25 30 Best alternative care Hepatic P
Slide 13: Safety Issues and Resulting Improvements
Safety Issues and Resulting Improvements Safety Issue Hematological toxicities led to 3 patient deaths Improvement Gen 2 Filter introduced in 2013 Adverse Event G3/4 Gen 1 Hughes 201628 % n Anemia 62.9% 44 Neutropenia 85.7% 60 Thrombocytopenia 80.0% 56 Adverse Event G3/4 Gen 2 Karydis 201833 % Impro
Slide 14: 2nd Registration Clinical Trial for Patients with mOM
2nd Registration Clinical Trial for Patients with mOM Multinational, multicenter, single-arm trial Efficacy Endpoints: Primary: Objective Response Rate (ORR) compared to meta-analysis of IO therapy Secondary: Duration of Response (DOR), Disease Control Rate (DCR), Overall Survival (OS), Progression
Slide 15: Initial Approvals Using ORR in Single-Arm Oncology Trials
2020 –’21 Initial Approvals Using ORR in Single-Arm Oncology Trials Danyelza (naxitamab-gqgk) Gavreto (pralsetinib) Monjuvi (tafasitamab-cxix) Tazverik (tazemetostat) Zepzelca (lurbinectedin) Tabrecta (capmatinib) Trodelvy (sacituzumab) Accelerated Accelerated Accelerated Accelerated Accelerated Acc
Slide 16: FOCUS Trial Success Criteria
Significantly improved safety relative to first pivotal trial Positive trends in exploratory BAC comparisons (ORR, DOR, DCR, PFS and OS) Focus Trial Success Criteria - Informed By FDA Interactions Best Alternative Care (BAC) Arm Enrolled N=42 Treated N=32 Dacarbazine 1 0 Ipilimumab 7 1 Pembrolizumab
Slide 17: FOCUS Trial Analysis: Prespecified Endpoint Met
FOCUS Trial Analysis: Prespecified Endpoint Met* ORR and DCR in the Treated Population Lower bound 22.55% far exceeds 8.3% upper bound prespecified threshold** PRELIMINARY DATA - SUBJECT TO CHANGE * 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 20
Slide 18: Progression Free Survival Kaplan Meier Curves
Progression Free Survival Kaplan Meier Curves in Treated Populations* * 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 Pre-Specified Exploratory Analyses* Exploratory comparison versus BAC supportive
Slide 19: Overall Survival Kaplan Meier Curves
Overall Survival Kaplan Meier Curves in Treated Populations* ** 29-Apr-2022 data cut, data continues to mature and patients will be followed at least through May, 2023 Pre-Specified Exploratory Analyses* Exploratory comparison versus BAC supportive
Slide 20: 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 21: Hematological Toxicities - Comparison with Previous Trials
Hematological Toxicities - Comparison with Previous Trials* Grade 3 or higher Adverse Events Focus Trial (n=91) Hughes 201628 (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 * Data cut
Slide 22: FOCUS Trial Safety Comparison with Previous Trials
FOCUS Trial – Safety Comparison with Previous Trials* Category FOCUS Trial (N=91) Pooled Analysis of Prior Studies (N=121) Patients who Withdrew due to an AE or SAE 20 (22%) 46 (38%) Patients who Required a Dose Reduction 12 (13.2%) 27 (22.3%) Average Number of Cycles 4.1 2.8 Improvement in tolerabi
Slide 23: Clinical Improvement Over Only Other FDA-Approved Therapy for mOM
Substantial Clinical Improvement for All Patients Over the Only Other FDA-Approved Therapy for mOM Treatment PT n CR PR ORR SD DCR PD PFS DOR mOS 1yr OS Hepzato Kit* TN,2L,3L 102 7.7 28.6 36.3 37.4 73.6 25.3 9.03 14 19.3 77% Kimmtrak3 TN 252 0 9 9 35 46 64 3.3 9.9 21.7 73% Hepzato Kit is available f
Slide 24: mOM Beachhead Market Strategy
mOM Beachhead Market Strategy LIVER DISEASE BEACHHEAD MARKET | mOM SIGNIFICANT REVENUE OPPORTUNITY: Oncologists* believe ~80% of mOM patients would be HEPZATO candidates - ~800 patients Considered a significant advancement Payer & hospital finance stakeholders suggest pricing expectations in the ran
Slide 25: Specialized, Targeted Sales Team
Specialized, Targeted Sales Team Regional Based Sales Team Experienced, Oncology focused Upon launch, placed in key geographies Supplement with Clinical Support Specialist Leverage Longitudinal Data Partnered with data provider to access patient level longitudinal data with 3-week refresh Accurately
Slide 26: 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 For patients which become inpatient patients split billing (inpatient / outpatient) allows the drug t
Slide 27: 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 28: Components of Hospital Reimbursement
Components of Hospital Reimbursement Assuming Outpatient Pass Through Status with C Code Drug ASP+6% (CMS) Likely similar for commercial payers “Physician” payment Actually goes to hospital but still matters to MD Highly variable based on coding – we do not “map” to any existing code Using existing
Slide 29: 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 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) Other Types Treated: Intrahepatic Chola
Slide 31: 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 32: The Local Hepatic Myeloablative Effect May Improve IO Efficacy
The Local Hepatic Myeloablative Effect May Improve IO Efficacy
Slide 33: Market Expansion: Significant Investigator Interest
Market Expansion: Significant Investigator Interest *Metastatic Ocular Melanoma (mOM)1,2, Cholangiocarcinoma (ICC)3,4, Liver-dominant Breast Cancer (mBC)7-10, Metastatic Neuroendocrine Tumors (mNET)6,7 Metastatic Pancreatic Cancer (mPC)7,13, Metastatic Colorectal Cancer (mCRC)11,12, Hepatocellular c
Slide 34: Clinical Rationale for Broad Development Effort
Clinical Rationale for Broad Development Effort “Broad-spectrum” alkylating agent given at 12X normal systemic doses Promising ORR and DCR signals seen across multiple tumor types in Europe and in earlier studies with IHP PHP treats the entire liver and is not dependent on tumor location Liver mets
Slide 35: FOCUS Study Upcoming News Flow
NDA Submission 1Q-2023 FOCUS Study – Upcoming News Flow Launch Initiate Multiple Trials in 2023 2H 2023 Potential Approval 3Q 2023 6 Month PDUFA for NDA Resubmission
Slide 36: Capital Structure and Share Information
Capital Structure and Share Information Share Listing - Current DCTH (NASDAQ) Shares Outstanding1 10.58M Cash and Cash Equivalents2 $14.0M Warrants Outstanding3 3.61M Stock Options Granted 2.2M 2022 Q3 Cash Burn (YTD)4 $17.6M Debt5 $17.6M 52 week Low – High6 $2.34 - $11.95 30d Average Daily Volume7
Slide 37: Multi-Disciplinary, Experienced Leadership Team
GERARD MICHEL Chief Executive Officer JOHN PURPURA Chief Operating Officer JOHNNY JOHN, MD SVP Clinical Development & Medical Affairs KEVIN MUIR VP, Commercial Operations Multi-Disciplinary, Experienced Leadership Team BOARD OF DIRECTORS Dr. Roger G. Stoll, Ph.D. Chairman John R. Sylvester Director
Slide 38: 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 Delcath: A Unique Opportunity Plat
Slide 39: Thank You
THANK YOU
Slide 40: References
References Cancer.net Editorial Board (2020) Eye Cancer - Statistics. In: Cancer.Net. https://www.cancer.net/cancer-types/eye-cancer/statistics. Accessed 22 Jun 2020. Ocular Melanoma Foundation. Treatment of Metastatic Disease. In: OMF – Metastatic Treatment. http://www.ocularmelanoma.org/metstreatm
Slide 41: References
References 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. Isolated hepatic perfusion for patie
Slide 42: References
References 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. 2000;82
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