Slide 1: Corporate Presentation
Corporate Presentation NASDAQ: DCTH August 6, 2025
Slide 2: Forward-Looking Statement
Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for to successfully enter into any necessary purchase and sale agreements with users of the forward-looking statements made by the Company or on its behalf. This HEPZATO KIT; the timing and results
Slide 3: Delcath Corporate Summary
Delcath Corporate Summary HEPZATO/CHEMOSAT Commercial Opportunity Strong Financial Position • 1Q 2024 HEPZATO (drug/device) • Ultra orphan pricing with J-Code • Cash and investments as of 6/30/2025 US launch for mUM*, CHEMOSAT = $81.0M • Focused call points (device only) in EU • Q2 2025 Positive Ope
Slide 4: High Unmet Need: Liver-Dominant Cancers
HIGH UNMET NEED: Liver-Dominant Cancers 4
Slide 5: Approved Products and Pipeline
Approved Products and Pipeline Line of Pre-Clinical Phase 1 Phase 2 Phase 3 Approved Therapy/Indication mUM (metastatic uveal melanoma) -Liver dominant US FDA Approved August 2023 -Any line of therapy mCRC* (metastatic colorectal cancer) -Liver-dominant Patient Enrollment Q3/Q4 2025 -Third-Line Trea
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 (partial set shown) Up to of patients with liver metastases are 50,000 80% not amenable to surgical resection largely due to extensive tumor burden1 40,000 Delcath Opportunity 30,000 • Limited
Slide 7: Major Liver-Directed Therapies
Major 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 y
Slide 8: 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. • Micro metastases are difficult to detec
Slide 9: HEPZATO KIT
HEPZAT@ KIT” (melphalan) for Injection/ Hepatic Delivery System (HDS) Deleath:
Slide 10: 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 11: 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 12: Best Percent Change in Target Lesion Volume: FOCUS Pivotal Trial
Best Percent Change in Target Lesion Volume: FOCUS Pivotal Trial 225 Best overall response (BOR)a 200 Change from baseline, % PD PR 175 SD CR 150 125 100 75 50 25 0 −25 −50 −75 −100 1 10 20 30 40 50 60 70 80 90 Melphalan/HDS patients (n = 91b) CR, complete response; HDS, hepatic delivery system; NE,
Slide 13: Metastatic Uveal Melanoma (mUM)
Metastatic Uveal Melanoma (mUM) 13
Slide 14: Patient Journey
Patient Journey MILESTONE MILESTONE Initial Screening Surveillance Decision Metastases Detected • Ophthalmologist/ • Surgical Oncologist Screening frequency Ocular Oncologist Initial diagnosis & treatment Treatment Decision Surgical Resection dependent on risk level Surveillance • Enucleation • Radi
Slide 15: mUM: Beachhead Market Opportunity
mUM: Beachhead Market Opportunity • Liver involved in >90% of cases of metastatic disease (1,000 mUM patients)2,3 • In 50% of mUM patients, the liver is the only site of metastasis5,6 • Most patients with mUM die from liver failure6 o 1-year OS rate of patients with metastatic disease in the liver i
Slide 16: 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 17: HEPZATO KIT: Commercialization
HEPZATO KIT: Commercialization 17
Slide 18: Current and Pending Commercial Centers
Current and Pending Commercial Centers As of 8/6/2025 • City of Hope - Duarte, CA* • Cleveland Clinic Main Campus - Cleveland, OH • Duke Cancer Center - Durham, NC • Emory University Hospital - Atlanta, GA* • HonorHealth Scottsdale Shea - Scottsdale, AZ • Massachusetts General Hospital - Boston, MA
Slide 19: 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 20: 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 21: HEPZATO KIT: Reimbursement
HEPZATO KIT: Reimbursement 21
Slide 22: Reimbursement
Reimbursement Medicare and Medicaid Patients Private Payer Patients • Follow Medicare guidelines • J-Code assigned and active April 1, 2024 o For rare disease • NTAP Status Approval October 1, 2024 o Patients to be treated as outpatients • Majority of patients expected to be • Medical Prior-Authoriz
Slide 23: PHP is Part of Current NCCN Guidelines for mUM
PHP is 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-balloon cathe
Slide 24: 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 • ASP+6% (CMS) steps of the procedure and associated RVUs are still r
Slide 25: Next Steps: Future Indications
NEXT STEPS: Future Indications 25
Slide 26: 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 27: 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 28: Rationale for Combining HEPZATO with IO Therapy
Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy 28
Slide 29: 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 30: Planned Market Expansion
Planned Market Expansion U.S. TAM Potential Significant Upside >$1B per year 50,000 U.S. Incidence of Liver-Dominant Cancers 40,000 Approved Phase 2* Initiation in 2025; FDA IND Clearance Received 30,000 Potential future opportunity 20,000 10,000 0 mUM ICC mNET mBC mPC mCRC HCC *mBC and mCRC planned
Slide 31: Delcath: Financials
DELCATH: Financials Deleath:
Slide 32: Financial Metrics
Financial Metrics $30.0 Financial Highlights Total Revenues: Quarterly Progression $25.0 ($ In Millions) +22% (unaudited) $1.7 $20.0 +31% $1.8 • Revenue growth driven HEPZATO CHEMOSAT $15.0 primarily by HEPZATO site $1.4 activation $10.0 $1.2 +39% $13.7 $18.0 • Full year revenue guidance of $5.0 $10
Slide 33: Capital Structure and Share Information
Capital Structure and Share Information Capitalization DCTH (NASDAQ) a. As of June 30, 2025; includes 34.8M of Common plus; 1.8M Preferred E, E-1 and F Shares Outstandinga 38M Series & 1.4M Pre-funded Warrants as converted. Stock Options Outstanding 8M b. Used NASDAQ closing price information starti
Slide 34: 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 35: U.S. Registration Trial for the Treatment of Patients with mUM
U.S. Registration Trial for the Treatment of Patients with mUM 35
Slide 36: 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 • HEPZATO Tx every 6-8 weeks up to a maximum of 6 cycles • Prescribing Information includes ORR, DOR and response
Slide 37: 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 38: 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 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