Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (December 2021)
50 slides from Delcath Systems's investor presentation, Dec 2, 2021
Slide 1: Corporate Presentation
Corporate Presentation (NASDAQ: DCTH) December 2021 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 year2-14,29 Current local/regional treatments Cannot treat the whole liver Target
Slide 4: Liver-Dominant Cancers
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) Y
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: PHP Advances IHP Clinical Benefits
PHP Advances IHP Clinical Benefits Overall Survival Progression-Free Survival Comparable OS & PFS Between Techniques30 There was no difference in overall survival (OS) or progression-free survival (PFS) between IHP and PHP for patients with uveal melanoma liver metastases, but patients have signific
Slide 8: 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 9: HEPZATO Kit: Percutaneous Hepatic Perfusion (PHP)
HEPZATO™ Kit: Percutaneous Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control The only minimally invasive cancer treatment that isolates the liver from systemic circulation, allowing for repeated delivery of high-dose chemo to the entire liver while limiting systemic
Slide 10: 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, enabling 12x increased dose Melphalan (chemo) treats micro and macro lesions simultaneously
Slide 11: 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/EU13,17 50% metastasize, 90% to the liver3,14 Median survival up to 12 mont
Slide 12: Competitive Landscape for mOM
Competitive Landscape for mOM Minimally Invasive – Liver Directed Infusion – Systemic Minimally Invasive HEPZATO™ TACE23 Y90/SIRT21 Mono/Combo IO24 Tebentafusp22* High Efficacy 31.4% <21% <17% 5.5% Up to 9%25 ORR % OS at 12 months (% surviving) 75%** - - - 73%*** Repeatable (>3x) ü X / ü X ü ü Prese
Slide 13: 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 14: 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 201620 % n Anemia 62.9% 44 Neutropenia 85.7% 60 Thrombocytopenia 80.0% 56 Adverse Event G3/4 Gen 2 Karydis 201815 % Impro
Slide 15: 2nd Registration Clinical Trial for Patients with mOM
2nd Registration Clinical Trial for Patients with mOM OVERVIEW: Multinational, multicenter, single-arm trial Endpoints: Primary: Objective Response Rate compared to historic control Secondary: Duration of response, disease control rate, overall survival, progression free survival, safety, PK, QoL 10
Slide 16: FOCUS Trial Analysis: Prespecified Endpoint Met
FOCUS Trial Analysis: Prespecified Endpoint Met Primary Effectiveness Endpoint19 PHP (N=91 treated + 11 untreated) 95% CI* Objective Response Rate 31.4% [22.55-41.31] Intent to Treat: Lower bound 22.55% far exceeds 8.3% upper bound prespecified threshold. PRELIMINARY DATA - SUBJECT TO CHANGE *A meta
Slide 17: Hematological Toxicities - Comparison with Previous Trials
Hematological Toxicities - Comparison with Previous Trials Grade 3 or higher Adverse Events Focus Trial (n=91) Hughes 2016 (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
Slide 18: 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 tolerabil
Slide 19: Recent Initial Approvals Using ORR in Single-Arm Oncology Trials
Recent 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) Pemazyre (pemigatinib) Koselugo (selumetinib) Accelerated Accelera
Slide 20: Supportive Evidence: Comparison Versus BAC
Supportive Evidence: Comparison Versus BAC Best Alternative Care (BAC) Arm Enrolled N=42 Treated N=32 Dacarbazine 1 0 Ipilimumab 7 1 Pembrolizumab 8 6 Transarterial Chemoembolization (TACE) 26 25 Amended Study FOCUS was initially a RCT against Best Alternative Care (BAC) Due to enrollment challenges
Slide 21: FOCUS Trial Exploratory Analyses vs BAC
FOCUS Trial – Exploratory Analyses vs BAC *Chi-square ** mITT Population – any patient who received at least one study treatment Efficacy Endpoint PHP (N=102) BAC (N=42) P-Value* 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 6
Slide 22: Exploratory Analyses vs BAC: Duration of Response
FOCUS Trial – Exploratory Analyses vs BAC ORR Advantage Coupled With Meaningful Duration of Response mITT Population PHP (N=91) BAC (N=32) Duration of Response (DOR, median) 14.00 mos. NC 95% CI [8.54 - NC] [6.93 - NC] Patients with Confirmed CR or PR 32 4 Patients with Subsequent PD 14 (43.7%) 1 (2
Slide 23: Exploratory Analyses vs BAC: Progression-Free Survival
FOCUS Trial - Exploratory Analyses vs BAC PHP Progression-Free Survival ~3X that of BAC19 Secondary Endpoint PHP (N=91)* BAC (N=32)* P-Value* 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 OS Rate
Focus Trial Results – 12-month OS Rate Secondary Endpoint PHP (N=102) BAC (N=42) % Surviving at 12 months 68% 36% Hazard Ratio** 0.42 95% CI 0.20 - 0.88 p-value 0.0215 Intent to Treat: Focus Trial Results – 12 Month Survival* Secondary Endpoint PHP (N=91) BAC (N=32) % Surviving at 12 months 75% 47%
Slide 25: Focus Trial Results – Overall Survival
*Chi-square ** mITT Population – any patient who received at least one study treatment Intent to Treat: Focus Trial Results – Overall Survival Secondary Endpoint PHP (N=102)* BAC (N=42)* P-Value* Overall Survival (OS, Median) 19.25 mos. 14.06 mos. 0.2021 95% CI [16.30 – 24.35] [9.99 – 19.78] OS Stat
Slide 26: 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 over other therapies Payer & hospital finance stakeholders suggest pricing ex
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 Head of Medical
Slide 28: Specialized, Targeted Sales Team
Specialized, Targeted Sales Team Will Leverage Expanded Access Protocol (EAP) and Longitudinal Data 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 ac
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
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 directly
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 Currently distributed by MEDAC Pharma MEDAC has been notified of our intent to terminate – discussions ongoing CHEMOSAT Used In 13 Tumor Types ~70%:
Slide 32: Market Expansion: Liver Disease
Market Expansion: Liver Disease BEACHHEAD MARKET | mOM LIVER DISEASE US TAM >$1B Per Year U.S. Incidence FOCUS Trial Extensive EU Experience26 Phase 2 Data ~10 EU Cases27 Limited, but High Unmet Need IHP Efficacy Well Documented28 Possible Areas for Further PHP Development Limited, but High Unmet Ne
Slide 33: 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 34: Near Term HEPZATO Development Plan
Near Term HEPZATO Development Plan Ongoing 2022 Trial Starts 2023+ Pan Tumor Other ICC CRC OM Ongoing Investigator Interest Confirmed Pending I/O Combination FOCUS Investigator Initiated Multi-Center Sponsored No Radiological Disease - ctDNA+ LD 2nd Line Additive Stage IV Post Resection ctDNA+ Hepat
Slide 35: Liver Dominant CRC IHP Results Provide Strong Rationale
Liver Dominant CRC IHP Results Provide Strong Rationale for CRC PHP Trials mOM Results Similar Between IHP and PHP 31. Vogl et al (2017). 32. Olofsson et al (2014). 33. Varghese et al (2010). 34. Rizell et al (2008). 35. Alexander et al (2000). 36. Alexander et al (2003). 37. Varghese et al (2010).
Slide 36: 2nd Line Therapy Liver Metastatic CRC
2nd Line Therapy Liver Metastatic CRC NCCN Standard of Care National Cancer Institute. Cancer Stat Facts: Colon and Rectum Cancer. https://seer.cancer.gov/statfacts/html/colorect.html Bulut G etal PLoS ONE 16(11): e0259622. https://doi.org/10.1371/journal.pone.0259622. Therapy Goal = Disease control
Slide 37: Hepzato in Stage IV Unresectable mCRC
Hepzato + Best Physician Choice vs Best Physician Choice Stage IV mCRC Unresectable Failed 1st line systemic chemo HEPZATO (2 cycles) BPC Systemic Chemo R 1:1 FU 24 mo Post surgery Radiographic assessments 10 Endpoint: ORR hPFS 20 Endpoints: PFS @ 6 & 12 mo OS QoL Inclusion Criteria: Liver-metastase
Slide 38: Adjuvant Therapy: CRC Post Liver Resection
Adjuvant Therapy : CRC Post Liver Resection NCCN Standard of Care Siegel et al CA CANCER J CLIN 2020;70:145–164 National Cancer Institute. Cancer Stat Facts: Colon and Rectum Cancer. https://seer.cancer.gov/statfacts/html/colorect.html. Holch et al Visc Med 2017;33:70–75 DOI: 10.1159/000454687 Thera
Slide 39: HEPZATO in Post-resection Stage IV ctDNA Positive Patients
HEPZATO in Post-resection Stage IV ctDNA Positive Patients Stage IV mCRC Curative intent Surgery SOC HEPZATO (2 cycles) BPC systemic (3-6 months) R 1:1 FU 24 mo Post surgery +12 wks every 12 wks ctDNA monitoring Radiographic assessments 10 Endpoint: DFS 20 Endpoints: PFS by ctDNA status OS Toxicity
Slide 40: Standard of Care & Epidemiology for iCC
Standard of Care & Epidemiology for iCC NCCN Standard of Care US Incidence = 3.5k new iCC Cases TAM 90-95% Unresectable or resection with recurrence 3.2-3.3K Therapy Goal = Disease control 80% respond to 1st line therapy 75% will have disease progression by 1 year Current Treatment Options Populatio
Slide 41: Advanced ICC – 2nd Line Hepzato
Inclusion criteria Liver dominant disease 1 prior line of CTx (e.g. gemcitabine or 5FU-containing based regimen) Adequate liver function ECOG 0-1 R 1:1 HEPZATO (up to 6 cycles) N=tbd BPC 2nd line CTx (e.g. FOLFOX) 10 Endpoint: PFS@ 6 mo and 12 mo 20 Endpoints: OS ORR QoL Safety Advanced ICC – 2nd Li
Slide 42: Critical IITs Hepatic ctDNA Validation
Critical IITs Hepatic ctDNA Validation The liver clears 70% - 80% of ctDNA Systemic ctDNA levels should be higher than hepatic vein levels unless there is residual disease in the liver The study will collect samples from CRC patients with confirmed liver and non liver mets Validation will enable a s
Slide 43: Detecting Liver Minimal Residual Disease
Detecting Liver Minimal Residual Disease Enabling Technology = ctDNA ~20-30K/year Stage II & III patients recur with liver metastases Greater Hepatic Vein ctDNA Lower Peripheral ctDNA Greater Peripheral ctDNA Hepatic Micro/Macro Metastases No Hepatic Metastases Lower Hepatic Vein ctDNA
Slide 44: FOCUS Study – Upcoming News Flow
ORR, DCR, PFS, updated DOR, OS released Details on new indications Prelim Analysis Update 6 Month PDUFA for NDA Resubmission NDA Submission Dec 2021 Mid-2022 FOCUS Study – Upcoming News Flow Potential Approval 4Q 2022 Launch Possible IIT Data 1Q 2023 6 Month PDUFA for NDA Resubmission
Slide 45: Capital Structure and Share Information
Capital Structure and Share Information - September 30, 2021 Share Listing - Current DCTH (NASDAQ) Shares Outstanding1 8.81M Cash and Cash Equivalents2 $29.0M Warrants Outstanding3 3.61M Stock Options Granted 1.70M 2020 Cash Burn (YTD)4 $16.2M Debt5 $17.0M 52 week Low – High6 $8.28 - $25.18 30d Aver
Slide 46: 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 47: 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 48: Thank You
THANK YOU
Slide 49: References
References https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107710/ 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 – Metastati
Slide 50: References
References Oweira H, Petrausch U, Helbling D, Schmidt J, Mannhart M, Mehrabi A, Schöb O, Giryes A, Decker M, Abdel-Rahman O. Prognostic value of site-specific metastases in pancreatic adenocarcinoma: A Surveillance Epidemiology and End Results database analysis. World J Gastroenterol. 2017 Mar 14;23
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