Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (July 2024)
40 slides from Delcath Systems's investor presentation, Jul 23, 2024
Slide 1: Corporate Presentation
Corporate Presentation NASDAQ: DCTH July 2024
Slide 2: Table of Contents
Table of Contents Forward-Looking Statement 3 Investment Summary 4 Unmet Need: Liver-Dominant Cancers 5 HEPZATO KIT™ 8 Metastatic Uveal Melanoma (mUM) 11 FOCUS Trial 16 Commercialization 20 Reimbursement & Pricing 25 Next Steps: Future Indications 30 Financials and Team 36 References 40 2
Slide 3: Forward-Looking Statement
Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for ability to successfully enter into any necessary purchase and sale agreements forward-looking statements made by the Company or on its behalf. This with users of the HEPZATO KIT; the timing and
Slide 4: Delcath Investment Summary
Delcath Investment Summary HEPZATO KIT Commercial High Penetration • FDA approval for Opportunity • Included in NCCN mUM* 8/14/23 • Ultra orphan pricing Guidelines • 1Q 2024 US Launch • J-Code active April 1 • First and only FDA approved whole-liver • Focused call points directed therapy • US mUM TA
Slide 5: High Unmet Need: Liver-Dominant Cancers
HIGH UNMET NEED: Liver-Dominant Cancers 5
Slide 6: Liver-Dominant Cancers: High Incidence with High Unmet Medical Need
Liver-Dominant Cancers: High Incidence with High Unmet Medical Need US Incidence of Liver-Dominant Cancers* Up to of patients with liver metastases are (partial set shown) 80% not amenable to surgical resection largely due to extensive tumor burden1 50,000 Delcath Opportunity 40,000 • Limited Overal
Slide 7: Current Liver-Directed Therapies
Current Liver-Directed Therapies MAJORITY OF TREATMENT Trans Arterial Chemo SIRT (Y90)3 Embolization (TACE)2 • Beads obstruct blood flow to tumor and elute chemo • Radioactive beads delivered into a portion of the liver • 50-60k treatments and rising per year in US • 10-15k treatments and rising per
Slide 8: HEPZATO KIT
HEPZAT@ KIT” (melphalan) for Injection/ Hepatic Delivery System (HDS) Deleath:
Slide 9: Percutaneous Hepatic Perfusion (PHP)
Percutaneous Hepatic Perfusion (PHP) Effective, Safe & Repeatable Liver-focused Disease Control 1. Isolation Hepatic venous flow is isolated, enabling >6X greater local concentration of chemo Filtration Isolation 2. Saturation Melphalan (chemo) treats micro and macro lesions simultaneously regardles
Slide 10: Indication Statement
Indication Statement HEPZATO KIT (melphalan) for Injection/Hepatic Delivery System HEPZATO KIT is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic dise
Slide 11: Metastatic Uveal Melanoma (mUM)
Metastatic Uveal Melanoma (mUM) 11
Slide 12: mUM: Beachhead Market Opportunity
mUM: Beachhead Market Opportunity • ~2,000 newly diagnosed cases of primary uveal melanoma per year in the US2 • 50% metastasize with the liver involved in >90% of cases of metastatic disease5,6 (1,000 mUM patients)2,3 • In 50% of mUM patients, the liver is the only site of metastasis5,6 • Most pati
Slide 13: mUM: Beachhead Market Opportunity
mUM: Beachhead Market Opportunity • Liver-directed treatment achieves better efficacy compared to systemic therapy8 • 55% of patients have no approved systemic treatment option • Most patients treated with multiple lines of therapy ~50% metastasize to the liver1,2 1 Reddy S, et al. Isolated hepatic
Slide 14: Diffuse/Miliary Metastatic Pattern in mUM
Diffuse/Miliary Metastatic Pattern in mUM Diffuse Disease is Difficult to Treat with Other Liver Directed Options • Solitary liver lesions are often treated with surgery or ablation. • True nature of the disease may only be seen upon visual confirmation. • Radiographically, metastatic Uveal Melanoma
Slide 15: Patient Journey
Patient Journey MILESTONE MILESTONE Surveillance Decision Metastases Detected Initial Screening • Ophthalmologist/ • Surgical Oncologist Screening frequency Ocular Oncologist Initial diagnosis & treatment Treatment Decision Surgical Resection dependent on risk level Surveillance • Enucleation • Radi
Slide 16: U.S. Registration Trial for the Treatment of Patients with mUM
U.S. Registration Trial for the Treatment of Patients with mUM 16
Slide 17: FOCUS Trial: Summary of Efficacy Results
FOCUS TRIAL Summary of Efficacy Results9 Endpoints HEPZATO KIT (N=91) ORR, n 33 (36.3%) DOR, Median in months 14.0 DCR, n 67 (73.6%) PFS, Median in months 9.0 OS, Median in months 20.53 • Full analysis with final data cut pending publication • HEPZATO Tx every 6-8 weeks up to a maximum of 6 cycles •
Slide 18: Published mUM Prospective and Retrospective Studies
FOCUS TRIAL Published mUM Prospective and Retrospective Studies* Median OS Median PFS Clinical Study/Publication Study Type Treatment N 1 year OS (months) (months) FOCUS Single-Arm HEPZATO 91AL 20.53 80% 9.03 systemic and liver- Khoja et al 201910 Meta-Analysis 912 10.2 NA 3.3 directed therapies sys
Slide 19: FOCUS Trial: Adverse Events
FOCUS TRIAL Adverse Reactions Related to Study Treatment Occurring in ≥10% Adverse Events ALL GRADES (%) of Patients (N=95) GRADES 3 OR 4 (%) Thrombocytopenia* 64 55 Leukopenia* 44 34 Anemia* 61 33 Neutropenia* 35 29 International normalized ratio increased 29 8 Activated partial thromboplastin time
Slide 20: HEPZATO KIT: Commercialization
HEPZATO KIT: Commercialization 20
Slide 21: Delivering an Innovative Treatment with a Well-Trained Team
Delivering an Innovative Treatment with a Well-Trained Team Treatment with HEPZATO KIT involves training and a team approach. The team members below complete a preceptorship and proctorship as well as a risk evaluation and mitigation strategy (REMS) training. Interventional radiologist leads and per
Slide 22: Sites Accepting Patient Referrals
Sites Accepting Patient Referrals* • First commercial use of HEPZATO KIT on January 12 at Moffitt • ~11 sites are accepting referrals and are on the Healthcare Setting Locator • 4 sites conducted their 1st commercial treatment by end of Q1 Healthcare Setting Locator HEPZATOKIT.COM • Active conversat
Slide 23: Specialized, Targeted Sales Teams
Referring Centers HEPZATO Medical Oncologist Treating Center Medical Oncologist Specialized, Targeted Sales Teams Trained Treating Team Three Complementary Representatives: Perfusionist Interventional Radiologist Clinical Specialists Anesthesiologist Medical Medical Liver-Directed Therapy Representa
Slide 24: Demonstrated Demand for FDA Approved Treatment in mUM
Demonstrated Demand for FDA Approved Treatment in mUM KIMMTRAK • $50.0 million in Q1 2024 US sales ($200M annualized revenue) • Captured an estimated 40% share of eligible patients within KIMMTRAK U.S. Quarterly Sales 12 months (USD) • Approximately 360* patients are eligible for KIMMTRAK 60,000,000
Slide 25: HEPZATO KIT: Reimbursement & Pricing
HEPZATO KIT: Reimbursement & Pricing 25
Slide 26: Reimbursement
Reimbursement Medicare Patients Private Payer Patients • J-Code assigned and active • Follow Medicare guidelines April 1, 2024 o For rare disease • Majority of patients will be o Patients to be treated as outpatients outpatient • Medical Prior-Authorization of patients likely required o Drug directl
Slide 27: 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 28: Components of Hospital Reimbursement
Components of Hospital Reimbursement Assuming Outpatient Pass Through Status with J-Code HEALTHCARE FACILITY FEE “PHYSICIAN” PAYMENT DRUG • The existing CPT codes should capture all • MDs primarily on salary but physician payments and associated RVUs are still relevant • ASP+6% (CMS) steps of the pr
Slide 29: HEPZATO KIT Pricing
HEPZATO KIT Pricing Consistent with Only Other Approved mUM Therapy At First Assessment (first time to discontinue treatment because of progression) DRUG DOSE COST* TREATMENTS #** TOTAL COST KIMMTRAK $19,289 24 weeks $462,936 HEPZATO $182,500 2 kits $365,000 Mean HEPZATO treatment vs. mean treatment
Slide 30: Next Steps: Future Indications
NEXT STEPS: Future Indications 30
Slide 31: Clinical Rationale for Broad Development Effort
Clinical Rationale for Broad Development Effort Melphalan has demonstrated clinical activity in multiple tumor types Promising ORR, DCR and PFS signals seen across multiple tumor types with CHEMOSAT in Europe and in earlier studies with IHP In many solid tumor patients, liver metastases are often li
Slide 32: 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 / Melphalan in mCRC Meta-analysis of 8 mUM clinical studies 15 N=154 ORR 50% Endpoint IHP (%) PHP (%) Van Iersel16 mPFS 7.4 months mOS 24.8 months mOS 17.1 17.3 N=120 ORR 61% Alexander 17 mOS 17.4 months mPFS
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: Encouraging Signal of Efficacy for PHP and I/O Drug Combination
Encouraging Signal of Efficacy for PHP and I/O Drug Combination From Phase 1b Part of the Chopin Trial % Change of Target Lesions from Baseline by Response Category • N=7 in Phase 1b portion of the trial19 • RP2D: IPI 1mg/kg and NIVO 3mg/kg. Well tolerated, no DLTs or deaths. • 1CR, 6 PR and 1 PD (8
Slide 35: Market Expansion >$1B
Market Expansion U.S. TAM Significant Upside >$1B per year 50,000 U.S. Incidence of Liver-Dominant Cancers* 40,000 30,000 20,000 10,000 0 mUM ICC mBC mNET mPC mCRC HCC *Metastatic Uveal Melanoma (mUM) 35
Slide 36: HEPZATO KIT: Financials and Team
HEPZATO KIT: Financials and Team 36
Slide 37: Capital Structure and Share Information
Capital Structure and Share Information Capitalization DCTH (NASDAQ) a. As of March 31, 2024; includes 25.4M of Common* plus; 1.1M Shares Outstandinga 30.5M Preferred E & E-1, 0.8M of Preferred F-2; 0.7M of Preferred F- 3; Conversion of convertible notes 0.5M; & 2.0M Pre-funded Warrants as converted
Slide 38: Multi-Disciplinary, Experienced Leadership Team
Multi-Disciplinary, Experienced Leadership Team Gerard Michel Martha S. Rook, PhD David Hoffman CHIEF EXECUTIVE OFFICER CHIEF OPERATING OFFICER GENERAL COUNSEL, CORP SECRETARY & CHIEF COMPLIANCE OFFICER • 30+ yrs. pharma/medtech • 25+ yrs. molecular bio., process dev., experience manufacturing, supp
Slide 39: Thank You
Deleath’ Thank You
Slide 40: References
References 1. Reddy S, et al. Isolated hepatic perfusion for patients with liver metastases, Ther Adv Med Oncol. 2014 Jul; 6(4): 180-194. 2. 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 Pat