Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (August 2023)
42 slides from Delcath Systems's investor presentation, Aug 15, 2023
Slide 1: Corporate Presentation
Exhibit 99.2 Corporate Presentation (NASDAQ: DCTH) August 14, 2023 1
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 HEPATIC DELIVERY COMPANY & LARGE MARKET LIVER CANCER SYSTEM (HDS) CLINICAL PROGRAM OPPORTUNITY Incidence US/EU HDS + Melphalan enabl
Slide 4: Limitations of Current Liver-Directed Therapies
Limitations of Current Liver-Directed Therapies 1 2 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) Effecti
Slide 5: HEPZATO KIT: Enables Percutaneous Hepatic Perfusion (PHP)
HEPZATO KIT™: Enables Percutaneous Hepatic Perfusion (PHP) Repeatable, safe & effective liver-focused disease control ISOLATION Blood Return Hepatic venous flow is isolated, Catheter enabling 12x increased dose Chemo Chemo Isolation Filtration (Balloon) Catheter SATURATION Melphalan (chemo) treats m
Slide 6: Liver-Dominant Cancers
Liver-Dominant Cancers High incidence with poor prognosis UIIU S n nS c cIiin d d In c e ec in n d id c c ee e e n n c o o c ef f e L L o o iif v vf L e eL ir r v iv D D ee ro o r D m m D o iin n o m a a m in n n it t n aa n C Cn t a at C n nC c c ae e a nr r n cs s c ee rs rs* (p (p(p a art rt a(p
Slide 7: mUM: Beachhead Market Opportunity
mUM: Beachhead Market Opportunity High Unmet Need, Favorable Reimbursement Environment Unmet Need Low Risk Commercial Opportunity 18 » >5,000 cases of primary ocular melanoma per year in the US/EU » FDA Approved 8/14/23 4,19 ~50% metastasize to the liver » Commercial launch 4Q ’23 » US TAM ~800 pati
Slide 8: Patient Journey (Pre-Metastatic)
Patient Journey (Pre- Metastatic) Screening frequency dependent on risk level • Higher risk patients (50%) are ~1,000 patients screened at a high frequency ~2,000 patients Initial diagnosis & treatment • Lower risk patients (50%) are • Enucleation screened at a lower frequency • Radiation • Photodyn
Slide 9: Patient Journey (Post Metastatic)
Patient Journey (Post Metastatic) HEPZATO TAM: ~800 patients Most patients receive both systemic and liver-directed therapies ~1000 patients Surgical resection Surgical oncologist Treatment Liver-directed therapy Interventional radiologist Decision Systemic therapy Medical oncologist 9
Slide 10: Liver metastases: a significant clinical problem in mUM
Liver metastases: a significant clinical problem in mUM Half of all patients with UM develop mUM patients have micrometastases with or 21,22 systemic metastases without the presence of radiologically visible 23 metastases • The liver is involved in 90% of cases of 21,22 metastatic disease • In 50% o
Slide 11: Diffuse/Miliary Metastatic Pattern in mUM
Diffuse/Miliary Metastatic Pattern in mUM Diffuse disease is difficult to treat with current options Solitary liver lesions are often treated with surgery or ablation Radiographically metastatic Uveal Melanoma can initially present only as focal lesions As is often the case, the true nature of the d
Slide 12: Estimated 80%+ of mUM Patients Are Eligible
Estimated 80%+ of mUM Patients Are Eligible Treatment naïve and No HLA genotype Indicated Patient Population includes previously treated patients restrictions 12
Slide 13: Box Warnings Managed By REMS
Box Warnings Managed By REMS European experience has shown that the procedure can Risk Evaluation and Mitigation Strategy Program be safely conducted by Interventional Radiology team = Training & Monitoring after appropriate training REMS program goals are to standardize training, ensure consistent
Slide 14: FOCUS Trial Registration Clinical Trial for Patients with mUM
FOCUS Trial • Multinational, multicenter, single-arm trial Registration Clinical Trial for Patients with mUM • 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 (
Slide 15: FOCUS Trial Single Arm Trial Efficacy Data
FOCUS Trial • 91 treated patients Single Arm Trial Efficacy Data in PI • Trial powered to show an ORR advantage over a meta-analysis of Best Alternative Care (checkpoint Efficacy Endpoint N (%) inhibitors, chemotherapy, other liver directed therapy) ORR, n (%) 33 (36.3) • Lower bound of FOCUS ORR (2
Slide 16: HEPZATO Response Predicts Survival
HEPZATO Response Predicts Survival Kaplan Meier Curves in Treated Populations* Exploratory Analyses* CR PR SD PD/ND ( (N=7) (N=26) N=34) (N=24) Status of OS, N (%) 1 (14.3) 17 (65.4) 29 (85.3) 20 (83.3) Events 6 (85.7) 9 (34.6) 5 (14.7) 4 (16.7) Censored † Median OS (Months) NC 28.16 19.25 11.99 95%
Slide 17: OS and PFS Trend Favorable Relative to Historical Results
OS and PFS Trend Favorable Relative to Historical Results Pre-Specified Exploratory Analyses* Secondary Endpoint N (%) Median OS, months 20.53 [95% CI] [16.79, 25.26] 1 Year OS, K-M Probability Point Estimate 0.80 [95% CI] [0.70, 0.87] Median PFS, Months 9.03 [95% CI] [6.34, 11.56] * 02-Dec-2022 dat
Slide 18: Published mUM Prospective and Retrospective Studies
Published mUM Prospective and Retrospective Studies* Clinical Median OS Median PFS Study Type Treatment N 1 year OS Study/Publication (months) (months) AL FOCUS Single-Arm Hepzato 91 20.53 80% 9.03 systemic and liver- 33 Khoja et al 2019 Meta-Analysis 912 10.2 NA 3.3 directed therapies Rantala et al
Slide 19: All Adverse Reactions
All Adverse Reactions Adverse Events N=95 Primarily Hematological All Grades (%) Grades 3 or 4 (%) Hypotension 13 3 Dyspnea 23 2 Abdominal Pain 39 1 Diarrhea 17 1 Musculoskeletal Pain 46 1 Hemorrhage 15 1 Most hematological side effects Nausea 57 0 result from melphalan Vomiting 35 0 Fatigue 65 0 Py
Slide 20: Referring Centers and HEPZATO Treating Center
Referring Centers HEPZATO Treating Center Patients Referred to Multidisciplinary Anesthesiologist Treatment Teams Medical Medical Oncologist Oncologist Perfusionist Interventional Radiologist Oncologists Are Generally Trained Treating Team Medical Medical the Decision Makers Oncologist Oncologist 20
Slide 21: Training Key to Expanding Number of Treating Sites
Training Key to Expanding Number of Treating Sites and Capacity Multidisciplinary Teams to Be Expanded To Increase Both Training Capacity and Patient Flow Expanded Treatment Expand Treatment Teams Today Increase # Sites Increase # HCP Trainers & Treatment Capacity Capacity Moffit UT Memphis Duke 21
Slide 22: Plan To Launch at Treating Sites
Plan To Launch at 10 Treating Sites Leveraging EAP and Longitudinal Data to Build Referral Networks EAP – Currently 3 Sites • Provide immediate access to patients • First Commercial Sites • Train new medical teams to use Hepzato after launch Leverage Longitudinal Data • Partnered with data provider
Slide 23: Treating Centers – Current Targets for Launch
Treating Centers – Current Targets for Launch Institution City Status Moffitt Cancer Center Tampa, Florida EAP - Open and Enrolling Duke University Durham, North Carolina EAP - Open and Enrolling University of Tennessee Memphis, Tennessee EAP - Open and Enrolling Stanford University Stanford, Califo
Slide 24: Specialized, Targeted Sales Team
Referring Centers Specialized, Targeted Sales Team Two Complementary Teams of Representatives HEPZATO Treating Center Hospital Representative Responsibilities • Manage Treating Centers Including VAC/Formulary Anesthesiologist • Support Treating Teams • Facilitate REMS Compliance Medical Medical • Ge
Slide 25: Reimbursement
Reimbursement HEPZATO will be billed as a drug with a J-Code Medicare Private Payer Patients Patients • Initially a C-Code • Private Payers for rare disease generally follow Medicare guidelines and we expect these patients to be treated as outpatients • Majority of patients will be outpatient (2 mid
Slide 26: PHP Is Already Part of Current NCCN Guidelines for mUM
PHP Is ALREADY Part of Current NCCN Guidelines for mUM 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 Drug Healthcare “Physician” Facility Fee payment • ASP+6% (CMS) • Highly variable based • Actually goes to hospital • Likely similar for on coding – we do not but still matters to MD commercial payers “map” to a
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 $19,289 24 $462,936 Hepzato t.b.d. 2 t.b.d. Mean HEPepzato treatment vs. mean treatment duration of Kimmtrak Drug Dose
Slide 29: Rapid Uptake for FDA Approved Treatment in mUM
Rapid Uptake for FDA Approved Treatment in mUM Kimmtrak US Quarterly Sales (USD) Demonstrated demand for FDA approved treatments for mUM 50,000,000 • KIMMTRAK - $41.7 million in Q2 2023 US sales ($167M annualized revenue) 40,000,000 • Only 45% of mUM patients are eligible for treatment with KIMMTRAK
Slide 30: Clinical Rationale for Broad Development Effort
Clinical Rationale for Broad Development Effort PHP treats the entire liver and is not dependent on Promising ORR, DCR and PFS signals seen across multiple tumor tumor location or number types with CHEMOSAT in Europe and in earlier studies with IHP of lesions HEPZATO is the only liver directed treat
Slide 31: Strong Correlation of IHP and PHP Efficacy in mUM Patients
Strong Correlation of IHP and PHP Efficacy in mUM Patients IHP activity in CRC and NET IHP in mCRC 27 Meta-analysis of 8 mUM clinical studies ORR 50% 28 Van Iersel mPFS 7.4 months mOS 24.8 months Endpoint IHP (%) PHP (%) ORR 82% 29 Magge 1-year OS rate 91% 2-year OS rate 72% mOS 17.1 17.3 ORR 59% 30
Slide 32: Chemosat Has Been Used Across Multiple Tumor Types
Chemosat Has Been Used Across Multiple Tumor Types » CE Marked - available in ~23 centers in 4 countries CHEMOSAT Used In 13 Tumor Types » Delcath resumed direct sales on 3/1/22 » ~1,400 commercial Chemosat kits shipped to the EU ~70%: Metastatic Ocular Melanoma (mUM) Other Types Treated: » Strong i
Slide 33: Rationale for Combining HEPZATO with IO Therapy
Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy 33
Slide 34: CHOPIN: Phase 1b/2 randomized study of PHP vs PHP+IO
CHOPIN: Phase mUM 1b/2 randomized study of PHP vs PHP+IO Ipilimumab + Ipilimumab + Ipilimumab + Ipilimumab + nivolumab melphalan liver nivolumab nivolumab melphalan liver nivolumab Inclusion c1: 1+1mg/kg chemo-saturation c1: 1+1mg/kg c1: 1+1mg/kg chemo-saturation c1: 1+1mg/kg c2: 1+3mg/kg c2: 1+3mg/
Slide 35: Market Expansion: Significant Investigator Interest
Market Expansion: Significant Investigator Interest 50,000 Limited, but High Liver Dominant Patients By Cancer Type* Unmet Need IHP Efficacy Well 41 Documented Combination Therapy – IO Agents 40,000 Limited, but High Unmet Need 30,000 US TAM 40 ~10 EU Cases >$1B Phase 2 Data 20,000 Extensive EU Per
Slide 36: Multi-Disciplinary, Experienced Leadership Team
Multi-Disciplinary, Experienced Leadership Team JOHN PURPURA GERARD MICHEL BOARD OF DIRECTORS Chief Executive Officer Chief Operating Officer John R. Sylvester Chairman » Past VP and Exec Director roles of » 30+ yrs. pharma/medtech experience Dr. Roger G. Stoll, Ph.D. Director Reg. Affairs for Bracc
Slide 37: Capital Structure and Share Information
Capital Structure and Share Information DCTH (NASDAQ) Share Listing - Current a. As of June 30, 2023; includes 15.3M of Common plus 1.1M Preferred E & E-1, 2.9M of Preferred F-2 & 1.0M Pre-funded Warrants as converted a 20.3M Shares Outstanding b. As of June 30, 2023; (10-Q filing on August 9, 2023)
Slide 38: Delcath: Investment Summary
Delcath: Investment Summary 4Q launch in mUM KIMMTRAK proving out significant commercial opportunity (~$167M run rate) with 45% of the HEPZATO TAM High penetration likely due to NCCN guidelines including PHP and equivalent OS as KIMMTRAK in more advance patient population Management team experienced
Slide 39: Thank You
THANK YOU 39
Slide 40: References
References 1. Xu L, T, Funchain P, F, Bena J, F, Li M, Tarhini A, Berber E, Singh A, D: Uveal Melanoma Metastatic to the Liver: Treatment Trends and Outcomes. Ocul Oncol Pathol 2019;5:323-332. doi: 10.1159/000495113. 2. Lane AM, Kim IK, Gragoudas ES. Survival Rates in Patients After Treatment for Me
Slide 41: References
References 16. 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. 17. Reddy S, et al. Isolated hep
Slide 42: References
References 34. Ranjala, E, et al. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res. 2019 Dec; 29(6): 561–568 35. Piulats, J, et al. Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter,
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