Delcath Systems, Inc. · NASDAQ:DCTH

Delcath Systems — Q2 2026 Earnings Presentation

41 slides from Delcath Systems's earnings presentation, Aug 6, 2026

  1. Slide 1: Corporate Presentation

    Corporate Presentation NASDAQ: DCTH August 6, 2026

  2. Slide 2: Forward-Looking Statement

    Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for the impact of the presentations at major medical conferences and future clinical forward-looking statements made by the Company or on its behalf. This results consistent with the data presented;

  3. Slide 3: Delcath Corporate Summary

    Delcath Corporate Summary HEPZATO/CHEMOSAT Commercial Opportunity • Q1 2024 HEPZATO (drug/device) US launch for mUM*, • Ultra orphan pricing with J-Code CHEMOSAT (device only) in EU • Focused call points • Included in NCCN Guidelines • US mUM TAM ~$500M • First and only FDA approved whole-liver dire

  4. Slide 4: High Unmet Need: Primary/Metastatic Liver Cancers

    HIGH UNMET NEED: Primary/Metastatic Liver Cancers 4

  5. 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 Began Q3 2025 -Third-Line T

  6. Slide 6: Primary/Metastatic Liver Cancers: High Incidence with High Unmet Medical Need

    Primary/Metastatic Liver Cancers: High Incidence with High Unmet Medical Need US Incidence of Primary/Metastatic Liver Involved 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

  7. 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

  8. 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

  9. Slide 9: HEPZATO KIT

    HEPZAT@ KIT” (melphalan) for Injection/ Hepatic Delivery System (HDS)

  10. 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

  11. 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

  12. 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, % 175 PD PR 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,

  13. Slide 13: Metastatic Uveal Melanoma (mUM)

    Metastatic Uveal Melanoma (mUM) 13

  14. 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

  15. 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

  16. 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

  17. Slide 17: HEPZATO KIT: Commercialization

    HEPZATO KIT: Commercialization 17

  18. Slide 18: Healthcare Centers

    Healthcare Centers 37 As of 8/6/26 • AdventHealth Orlando - Orlando, FL • Providence Saint John's Health Center - Santa Monica, CA* • Cleveland Clinic Main Campus - Cleveland, OH* • Regional One Health - Memphis, TN* active centers targeted in 2026 • City of Hope - Duarte, CA* • Stanford Health Care

  19. 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

  20. Slide 20: Specialized, Targeted Sales Teams

    Referring Centers HEPZATO Medical Medical Oncologist Treating Center Oncologist Trained Specialized, Targeted Treating Team Sales Teams Three Complementary Representatives: Perfusionist Interventional Radiologist Clinical Specialists Anesthesiologist Medical Medical Liver-Directed Therapy Representa

  21. Slide 21: HEPZATO KIT: Reimbursement

    HEPZATO KIT: Reimbursement 21

  22. 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

  23. 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

  24. 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 • ASP+6% (CMS) steps of the procedure payments and associated RVUs are still r

  25. Slide 25: Next Steps: Future Indications

    NEXT STEPS: Future Indications 25

  26. 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

  27. 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 mPFS 7.2 9.6 mOS 17.4

  28. Slide 28: Rationale for Combining HEPZATO with IO Therapy

    Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy 28

  29. Slide 29: Synergy Between PHP and I/O Drug Combination

    Synergy Between PHP and I/O Drug Combination Phase 2 CHOPIN Trial: Rationale and Design Rationale: Limited results of ipilimumab and nivolumab in mUM can be improved by combining with liver-directed therapy (PHP) Treatment scheme: MTD was determined in phase 1b of CHOPIN: IPI 1mg/kg and NIVO 3mg/kg

  30. Slide 30: Synergy Between PHP and I/O Drug Combination

    Synergy Between PHP and I/O Drug Combination Phase 2 CHOPIN Trial: Improved PFS and ORR with PHP and I/O Combination Endpoint Combination (n = 38) Perfusion (n = 38) P-value Best Overall Response (ORR) Best overall response rate, % (95% CI) 76.3 (59.4–88.0) 39.5 (24.5–56.5) < 0.001 Complete response

  31. Slide 31: Planned Market Expansion

    Planned Market Expansion U.S. TAM Potential Significant Upside >$1B per year 50,000 U.S. Incidence of Primary/Metastatic Liver Cancers 40,000 Approved 30,000 Phase 2* Initiation in 2025; FDA IND Clearance Received Potential future opportunity 20,000 10,000 0 mUM* mCCA mNET mBC** mNSCLC mPC mCRC** HC

  32. Slide 32: Financials

    Financials 32

  33. Slide 33: Financial Metrics

    Financial Metrics 35.0 Total Revenues: Quarterly Progression ($ In Millions) $5.7 Financial Highlights 30.0 $2.0 • Total Q2 2026 Revenue of 25.0 $8.3 $0.9 $29.1M $1.7 $4.8 • Gross Margins 90% Q2 2026 20.0 $1.3 $1.7 • Stock repurchase and 15.0 retirements of .9M shares for $27.1 $9.0M to date 21% $23

  34. Slide 34: Capital Structure and Share Information

    Capital Structure and Share Information Capitalization DCTH (NASDAQ) a. As of August 6, 2026; includes approximately 34.6M of Common plus; 1.8M Preferred E, E-1 and F Series & 1.3M Shares Outstandinga 37.7M Pre-funded Warrants as converted. b. Used NASDAQ closing price information Stock Options/RSUs

  35. Slide 35: 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

  36. Slide 36: U.S. Registration Trial for the Treatment of Patients with mUM

    U.S. Registration Trial for the Treatment of Patients with mUM 36

  37. Slide 37: 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

  38. Slide 38: 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

  39. Slide 39: 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

  40. Slide 40: Thank You

    Deleath Thank You

  41. Slide 41: 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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