Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (September 2023)
42 slides from Delcath Systems's investor presentation, Sep 6, 2023
Slide 1: Corporate Presentation
Corporate Presentation (NASDAQ: DCTH) September 6, 2023 1 Exhibit 99.1
Slide 2: 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 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. HDS + Melphalan enables the Percutaneous Hepatic Perfusion (PHP) Procedure Delivers high dose chemotherapy to the entire liver Limits systemic
Slide 4: Limitations of Current Liver-Directed Therapies
Limitations of Current Liver-Directed Therapies Majority of Treatment 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)1
Slide 5: 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, enabling 12x increased dose SATURATION Melphalan (chemo) treats micro and macro lesions simultaneously FILTRATION Proprietary filters remov
Slide 6: 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 7: Low Risk Commercial Opportunity
Low Risk Commercial Opportunity FDA Approved 8/14/23 Commercial launch 4Q ’23 Commercial team led by TheraSphere (BSX) veterans Focused commercial effort: 20 US treatment centers @ 2 patients/week = ~70% TAM Favorable US Commercial Economics Favorable US reimbursement environment for ultra orphan ou
Slide 8: Patient Journey (Pre-Metastatic)
Patient Journey (Pre- Metastatic) Ophthalmology Optometrists Eye specialist Milestone: Surveillance decision made Caregiver Patient Initial screening ~2,000 patients Initial diagnosis & treatment Enucleation Radiation Photodynamic therapy Ophthalmologist/ Ocular oncologist Ophthalmologist/ Ocular on
Slide 9: Patient Journey (Post Metastatic)
Patient Journey (Post Metastatic) Treatment Decision Liver-directed therapy Surgical resection Surgical oncologist Interventional radiologist Medical oncologist Systemic therapy Milestone: Metastases detected ~1000 patients Most patients receive both systemic and liver-directed therapies HEPZATO TAM
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 systemic metastases 21,22 The liver is involved in 90% of cases of metastatic disease 21,22 In 50% of mUM patients, the liver is the only site of metastasis 21,22 Most patients with mUM die from liver failur
Slide 11: Diffuse/Miliary Metastatic Pattern in mUM
Diffuse/Miliary Metastatic Pattern in mUM 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 disease may only be seen upon visual confirmation Traditiona
Slide 12: Estimated 80%+ of mUM Patients Are Eligible
Estimated 80%+ of mUM Patients Are Eligible Indicated Patient Population includes Treatment naïve and previously treated patients No HLA genotype restrictions
Slide 13: Box Warnings Managed By REMS
Box Warnings Managed By REMS Risk Evaluation and Mitigation Strategy Program = Training & Monitoring European experience has shown that the procedure can be safely conducted by Interventional Radiology team after appropriate training REMS program goals are to standardize training, ensure consistent
Slide 14: Registration Clinical Trial for Patients with mUM
Registration Clinical Trial for Patients with mUM 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 Free
Slide 15: FOCUS Trial Single Arm Trial Efficacy Data in PI
FOCUS Trial Single Arm Trial Efficacy Data in PI Efficacy Endpoint N (%) ORR, n (%) 33 (36.3) [95% CI] [26.44, 47.01] Median DOR, months 14 [95% CI] [8.31-17.74] DCR, n (%) 67 (73.6) [95% CI] [63.35, 82.31] 91 treated patients Trial powered to show an ORR advantage over a meta-analysis of Best Alter
Slide 16: HEPZATO Response Predicts Survival
HEPZATO Response Predicts Survival † Kaplan-Meier estimates. ‡ Log-Rank test. Analysis Supports that ORR is Clinically Meaningful Exploratory Analyses* CR (N=7) PR (N=26) SD (N=34) PD/ND (N=24) Status of OS, N (%) Events 1 (14.3) 17 (65.4) 29 (85.3) 20 (83.3) Censored 6 (85.7) 9 (34.6) 5 (14.7) 4 (1
Slide 17: OS and PFS Trend Favorable Relative to Historical Results
OS and PFS Trend Favorable Relative to Historical Results Pre-Specified Exploratory Analyses* * 02-Dec-2022 data cut, patients followed through May, 2023 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] Medi
Slide 18: Published mUM Prospective and Retrospective Studies
Published mUM Prospective and Retrospective Studies* Clinical Study/Publication Study Type Treatment N Median OS (months) 1 year OS Median PFS (months) FOCUS Single-Arm Hepzato 91AL 20.53 80% 9.03 Khoja et al 201933 Meta-Analysis systemic and liver-directed therapies 912 10.2 NA 3.3 Rantala et al 20
Slide 19: Adverse Events Primarily Hematological
Adverse Events Primarily Hematological All Adverse Reactions N=95 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 Nausea 57 0 Vomiting 35 0 Fatigue 65 0 Pyrexia 16 0 Groin Pain 11 0 Cough 15 0 Headache 19 0 Le
Slide 20: Patients Referred to Multidisciplinary Treatment Teams
Patients Referred to Multidisciplinary Treatment Teams Oncologists Are Generally the Decision Makers HEPZATO Treating Center Referring Centers Medical Oncologist Medical Oncologist Medical Oncologist Medical Oncologist Anesthesiologist Perfusionist Interventional Radiologist Trained Treating Team
Slide 21: Training Key to Expanding Number of Treating Sites and Capacity
Training Key to Expanding Number of Treating Sites and Capacity Multidisciplinary Teams to Be Expanded To Increase Both Training Capacity and Patient Flow Today Moffit UT Memphis Duke Expand Treatment Teams Increase # HCP Trainers & Treatment Capacity Increase # Sites Expanded Treatment Capacity
Slide 22: Plan To Launch at Treating Sites
Plan To Launch at 10 Treating Sites Leveraging EAP and Longitudinal Data to Build Referral Networks Planned Initial Hepzato Treatment Sites Active EAP sites EAP – Currently 3 Sites Provide immediate access to patients First Commercial Sites Train new medical teams to use Hepzato after launch Leverag
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
Specialized, Targeted Sales Team Two Complementary Teams of Representatives HEPZATO Treating Center Referring Centers Medical Oncologist Medical Oncologist Medical Oncologist Medical Oncologist Trained Treating Team Hospital Representative Responsibilities Manage Treating Centers Including VAC/Formu
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 and we ex
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 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 28: HEPZATO Pricing Consistent with Other Approved Therapy
HEPZATO Pricing Consistent with Other Approved Therapy At First Assessment (first time to discontinue treatment because of progression) Drug Dose Cost* Treatments # Total cost Kimmtrak $19,289 24 $462,936 Hepzato $182,500 2 $365,000 Mean Hepzato treatment vs. mean treatment duration of Kimmtrak (per
Slide 29: Rapid Uptake for FDA Approved Treatment in mUM
Rapid Uptake for FDA Approved Treatment in mUM Demonstrated demand for FDA approved treatments for mUM KIMMTRAK - $41.7 million in Q2 2023 US sales ($167M annualized revenue) Only 45% of mUM patients are eligible for treatment with KIMMTRAK (unique MOA) KIMMTRAK captured an estimated 40% share of el
Slide 30: Clinical Rationale for Broad Development Effort
Clinical Rationale for Broad Development Effort PHP treats the entire liver and is not dependent on tumor location or number of lesions Liver mets are often life limiting and reduce I/O efficacy Converting unresectable liver metastases into resectable Promising ORR, DCR and PFS signals seen across m
Slide 31: Strong Correlation of IHP and PHP Efficacy in mUM Patients
Strong Correlation of IHP and PHP Efficacy in mUM Patients IHP, or Intrahepatic Perfusion, is an invasive surgical technique for delivering high doses of chemotherapy to the liver; procedure related mortality and morbidity prevented common usage. PHP is a minimally invasive, safer procedure which ac
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 Delcath resumed direct sales on 3/1/22 ~1,400 commercial Chemosat kits shipped to the EU CHEMOSAT Used In 13 Tumor Types ~70%: Metastatic Ocular Melanoma (mUM) Other Types Treated: Intrahepatic Cho
Slide 33: Rationale for Combining HEPZATO with IO Therapy
Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy
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 N=7 in Phase 1b portion of the trial38 RP2D: IPI 1mg/kg and NIVO 3mg/kg. Well tolerated, no DLTs or deaths. 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
Slide 35: Market Expansion: Significant Investigator Interest
FOCUS Trial Phase 2 Data ~10 EU Cases40 Limited, but High Unmet Need Limited, but High Unmet Need Extensive EU Experience39 IHP Efficacy Well Documented41 Market Expansion: Significant Investigator Interest Liver Dominant Patients By Cancer Type* U.S. Incidence U.S. Incidence Combination Therapy – I
Slide 36: Multi-Disciplinary, Experienced Leadership Team
Multi-Disciplinary, Experienced Leadership Team BOARD OF DIRECTORS John R. Sylvester Chairman Dr. Roger G. Stoll, Ph.D. Director Elizabeth Czerepak Director Steven Salamon Director Dr. Gil Aharon, Ph.D. Director Gerard Michel CEO GERARD MICHEL Chief Executive Officer 30+ yrs. pharma/medtech experien
Slide 37: Capital Structure and Share Information
Capital Structure and Share Information Share Listing - Current DCTH (NASDAQ) Shares Outstanding a 20.3M Cash and Cash Equivalents b $14.6M Cash from 3Q Warrant Exercisesc $35.0M Warrants Outstanding d 15.56M Stock Options Granted 2.9M 2023 Q2 Cash Burn e $9.6M Debt f $9.8M 52 week Low – High g $2.3
Slide 38: Delcath: Investment Summary
4Q launch in mUM Multiple 2023/2024 catalysts (Launch, CHOPIN data, Revenue Build) Delcath: Investment Summary Potential high value follow-on indications and strategic interest creates significant upside KIMMTRAK proving out significant commercial opportunity (~$167M run rate) with 45% of the HEPZAT
Slide 39: Thank You
THANK YOU
Slide 40: References
References 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. Lane AM, Kim IK, Gragoudas ES. Survival Rates in Patients After Treatment for Metastas
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. Reddy S, et al. Isolated hepatic per
Slide 42: References
References 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 Piulats, J, et al. Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II
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