Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2025)
39 slides from Delcath Systems's investor presentation, Jan 13, 2025
Slide 1: Corporate Presentation
Exhibit 99.2 Corporate Presentation NASDAQ: DCTH January 2025
Slide 2: 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 with users of forward-looking statements made by the Company or on its behalf. This the HEPZATO KIT; the timing and
Slide 3: Delcath Corporate Summary
Delcath Corporate Summary HEPZATO/CHEMOSAT Commercial Opportunity Strong Financial Position • 1Q 2024 HEPZATO (drug/device) US • Ultra orphan pricing with J-Code • Cash and investments as of launch for mUM*, CHEMOSAT 12/31/2024 = $53.2M • Focused call points (device only) in EU • At $11.2M of Revenu
Slide 4: High Unmet Need: Liver-Dominant Cancers
HIGH UNMET NEED: Liver-Dominant Cancers 4
Slide 5: 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 (partial set shown) of patients with liver metastases are not amenable to surgical resection % 50,000 80 1 largely due to extensive tumor burden Delcath Opportunity 40,000 • Limited Overa
Slide 6: Diffuse Disease and Whole Liver Treatment
Diffuse Disease and Whole Liver Treatment Liver metastases in mUM and other Cancers are Often Multi-focal • Solitary liver lesions are often treated with surgery or ablation. • Radiographically, metastatic disease can initially present only as focal lesions. • Micrometastases are difficult to detect
Slide 7: Major Liver-Directed Therapies
Major Liver-Directed Therapies MAJORITY OF TREATMENT 3 SIRT (Y90) Trans Arterial Chemo 2 Embolization (TACE) • 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 Isolation Filtration 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: Patient Journey
Patient Journey MILESTONE MILESTONE Initial Screening Surveillance Decision Metastases Detected • Ophthalmologist/ • Surgical Oncologist Ocular Oncologist Screening frequency Surgical Resection Initial diagnosis & treatment Treatment Decision Surveillance dependent on risk level • Enucleation • Radi
Slide 13: mUM: Beachhead Market Opportunity
mUM: Beachhead Market Opportunity • Liver involved in >90% of cases of metastatic disease 2,3 (1,000 mUM patients) • In 50% of mUM patients, the liver is the only site of 5,6 metastasis 6 • Most patients with mUM die from liver failure o 1-year OS rate of patients with metastatic disease in the live
Slide 14: Competitive Landscape
Competitive Landscape • 55% of patients have no approved systemic treatment option • Most patients treated with multiple lines of therapy Primary Systemic Competitors Primary LDT Competitors • Kimmtrak (tebentafusp) for HLA + (~45% of patients) • TACE (limited efficacy data, not suited for diffuse d
Slide 15: Demonstrated Demand for FDA Approved Treatment in mUM
Demonstrated Demand for FDA Approved Treatment in mUM KIMMTRAK KIMMTRAK U.S. Quarterly Sales • Reported $57.3 million in Q3 2024 US sales ($230M annualized (USD) revenue) 70,000,000 60,000,000 • Only 45% of mUM patients (~400) are eligible for treatment due 50,000,000 to HLA restriction 40,000,000 3
Slide 16: HEPZATO KIT: Commercialization
HEPZATO KIT: Commercialization 16
Slide 17: 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 18: Referring Centers and Sales Teams
Referring Centers HEPZATO Medical Medical Specialized, Targeted Treating Center Oncologist Oncologist Sales Teams Trained Treating Team Three Complementary Representatives: Perfusionist Interventional Radiologist Clinical Specialists Anesthesiologist Liver-Directed Therapy Representatives Medical Me
Slide 19: Current and Pending Commercial Centers
Current and Pending Commercial Centers As of 01/09/2025 First commercial use of HEPZATO KIT January 12, 2024 at Moffitt 22 sites are accepting referrals Healthcare Setting Locator HEPZATOKIT.COM 14 sites active as of December 31, 2024 Cleveland Clinic Main Campus - Cleveland, OH * Regional One Healt
Slide 20: HEPZATO KIT: Reimbursement & Pricing
HEPZATO KIT: Reimbursement & Pricing 20
Slide 21: Reimbursement
Reimbursement Medicare Patients Private Payer Patients • Follow Medicare guidelines • J-Code assigned and active April 1, 2024 o For rare disease o Patients to be treated as outpatients • Majority of patients expected to be outpatient • Medical Prior-Authorization of patients likely required o Drug
Slide 22: 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 23: Components of Hospital Reimbursement
Components of Hospital Reimbursement Assuming Outpatient Pass Through Status with J-Code HEALTHCARE FACILITY FEE “PHYSICIAN” PAYMENT DRUG • MDs primarily on salary but physician payments • The existing CPT codes should capture all • ASP+6% (CMS) and associated RVUs are still relevant steps of the pr
Slide 24: Next Steps: Future Indications
NEXT STEPS: Future Indications 24
Slide 25: 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 26: 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 15 IHP / Melphalan in mCRC Meta-analysis o f 8 mUM clinical studies N=154 ORR 50% 16 Endpoint IHP (%) PHP (%) Van Iersel mPFS 7.4 months mOS 24.8 months mOS 17.1 17.3 N=120 ORR 61% 17 Alexander mOS 17.4 months mPF
Slide 27: Rationale for Combining HEPZATO with IO Therapy
Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy 27
Slide 28: Encouraging Signal of Efficacy for PHP and I/O Combination: CHOPIN Trial
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 19 • N=7 in Phase 1b portion of the trial • RP2D: IPI 1mg/kg and NIVO 3mg/kg. Well tolerated, no DLTs or deaths. • 1CR, 6 PR and 1 PD (
Slide 29: Planned Market Expansion
Planned Market Expansion U.S. TAM Potential Significant Upside >$1B per year U.S. Incidence of Liver-Dominant Cancers 50,000 40,000 Approved Phase 2* Initiation planned in 2025 30,000 Potential future opportunity 20,000 10,000 0 mUM ICC mBC mNET mPC mCRC HCC rd *mBC and mCRC planned trials will addr
Slide 30: Delcath: Financials
DELCATH: Financials 30
Slide 31: Financial Metrics (unaudited)
Financial Metrics (unaudited) Total revenues: quarterly progression ($ in millions) $16.0 Highlights – Preliminary Q4 and YE 2024 (unaudited) $1.4 $14.0 $12.0 • Fourth Quarter Revenue to be Approximately $15.1 $1.2 $10.0 Million $8.0 • Full Year Total Revenue to be Approximately $37.2 39% $1.2 $13.7
Slide 32: Capital Structure and Share Information
Capital Structure and Share Information DCTH (NASDAQ) Capitalization a. As of December 31, 2024; includes 33.0M of Common plus; 1.8M Preferred E, E-1 a 36.2M and F Series & 1.4M Pre-funded Warrants Shares Outstanding as converted. b. 1.8M warrants at a $10 exercise price b 1.8M Warrants Outstanding
Slide 33: Multi-Disciplinary, Experienced Leadership Team
Multi-Disciplinary, Experienced Leadership Team David Hoffman Gerard Michel Martha S. Rook, PhD GENERAL COUNSEL, CORP SECRETARY & CHIEF EXECUTIVE OFFICER CHIEF OPERATING OFFICER CHIEF COMPLIANCE OFFICER • 30+ yrs. pharma/medtech • 25+ yrs. molecular bio., process dev., manufacturing, supply chain an
Slide 34: U.S. Registration Trial for the Treatment of Patients with mUM
U.S. Registration Trial for the Treatment of Patients with mUM 34
Slide 35: FOCUS Trial Summary of Efficacy Results
FOCUS TRIAL 9 Summary of Efficacy Results 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 36: FOCUS Trial: 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) AL FOCUS Single-Arm HEPZATO 91 20.53 80% 9.03 systemic and liver- 10 Khoja et al 2019 Meta-Analysis 912 10.2 NA 3.3 directed therapies
Slide 37: FOCUS Trial Adverse Reactions Related to Study Treatment
FOCUS TRIAL Adverse Reactions Related to Study Treatment Occurring in ≥10% of Patients (N=95) Adverse Events ALL GRADES (%) 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 38: Thank You
Deleath: Thank You
Slide 39: 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
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