Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (January 2024)
41 slides from Delcath Systems's investor presentation, Jan 8, 2024
Slide 1: Corporate Presentation
Exhibit 99.1 Corporate Presentation NASDAQ: DCTH January 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 HEPZATO KIT: Commercialization 20 Reimbursement & Pricing 25 Next Steps: Future Indications 30 References 39 2
Slide 3: Forward-Looking Statement
Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward- ability to successfully enter into any necessary purchase and sale agreements with looking statements made by the Company or on its behalf. This presentation contains users of the HEPZA
Slide 4: Delcath Investment Summary
Delcath Investment Summary HEPZATO KIT Commercial Opportunity High Penetration • FDA approval for • Ultra orphan pricing • Included in NCCN Guidelines mUM* 8/14/23 • Focused call points • First and only FDA approved • 1Q 2024 US Launch whole-liver directed therapy • US mUM TAM ~$600M Experienced Sig
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 (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 Ove
Slide 7: Current Liver-Directed Therapies
Current 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 • 10-15k treatments and rising per yea
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 Isolation concentration of chemo 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: mUM: Beachhead Market Opportunity
mUM: Beachhead Market Opportunity • ~2,000 newly diagnosed cases of primary uveal 2 melanoma per year in the US • 50% metastasize with the liver involved in >90% of 5,6 2,3 cases of metastatic disease (1,000 mUM patients) ~50% metastasize • 1-year OS rate of patients with metastatic disease 1,2 to t
Slide 13: mUM: Beachhead Market Opportunity
mUM: Beachhead Market Opportunity 6 • Most patients with mUM die from liver failure • In 50% of mUM patients, the liver is the only site of 5,6 metastasis • Liver-directed treatment achieves better efficacy compared 8 to systemic therapy ~50% metastasize • 55% of patients have no approved systemic t
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 Ocular Oncologist Screening frequency Surgical Resection Initial diagnosis & treatment Treatment Decision Surveillance dependent on risk level • 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 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 18: 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 19: FOCUS Trial Adverse Events
FOCUS TRIAL Adverse Events Adverse Reactions (N=95) >10% 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 • Most hematological side effects re
Slide 20: FOCUS Trial Adverse Reactions Related to Study Treatment
FOCUS TRIAL Adverse Reactions Related to Study Treatment Occurring in ≥10% of Patients (N=95) ALL GRADES (%) GRADES 3 OR 4 (%) Adverse Events Thrombocytopenia* 64 55 Leukopenia* 44 34 Anemia* 61 33 Neutropenia* 35 29 International normalized ratio increased 29 8 Activated partial thromboplastin time
Slide 21: HEPZATO KIT: Commercialization
HEPZATO KIT: Commercialization 21
Slide 22: 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 23: Referring Centers and Specialized Sales Teams
Referring Centers HEPZATO Medical Medical Specialized, Targeted Sales Treating Center Oncologist Oncologist Teams Trained Treating Team Three Complementary Teams of Representatives: Perfusionist Interventional Radiologist Clinical Specialists Anesthesiologist Liver-Directed Therapy Representatives M
Slide 24: Treatment Sites
CENTER CITY STATE Treatment Sites FULLY TRAINED Duke University Durham NC Interest from 20+ sites Moffitt Cancer Center Tampa Bay FL Ohio State University Columbus OH • Focused on a subset of sites to ensure we University of Tennessee Memphis TN achieve our planned activation targets throughout the
Slide 25: Demonstrated Demand for FDA Approved Treatment in mUM
Demonstrated Demand for FDA Approved Treatment in mUM KIMMTRAK • $42.1 million in Q3 2023 US sales ($168M annualized revenue) • Captured an estimated 40% share of eligible patients within 12 months • Approximately 360* patients are eligible for KIMMTRAK KIMMTRAK U.S. Quarterly Sales (USD) • Only 45%
Slide 26: HEPZATO KIT: Reimbursement & Pricing
HEPZATO KIT: Reimbursement & Pricing 26
Slide 27: Reimbursement
Reimbursement Medicare Patients Private Payer Patients • Follow Medicare guidelines • C-Code and J-Code under review and expected 2024 H1 o For rare disease o Patients to be treated as outpatients • Majority of patients will be outpatient • Medical Prior-Authorization of patients likely required o D
Slide 28: PHP is Already Part of Current NCCN Guidelines for mUM
PHP is Already Part of Current NCCN Guidelines for mUM NCCN Guidelines Version 1.2023 Melanoma: Uveal TREATMENT OF METASTATIC DISEASE WORKUP Clinical trial, if available Clinical Trial (preferred) No evidence of or Observation 99 OR • Biopsy if clinically appropriate disease (Follow-up, UM-4) Consid
Slide 29: Components of Hospital Reimbursement
Components of Hospital Reimbursement Assuming Outpatient Pass Through Status with C-Code DRUG HEALTHCARE FACILITY FEE “PHYSICIAN” PAYMENT • MDs primarily on salary but physician payments • ASP+6% (CMS) • The existing CPT codes should capture all and associated RVUs are still relevant steps of the pr
Slide 30: HEPZATO KIT Pricing Consistent with Only Other Approved mUM Therapy
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 $462,936 HEPZATO $182,500 2 $365,000 Mean HEPZATO treatment vs. mean treatment duration o
Slide 31: Next Steps: Future Indications
NEXT STEPS: Future Indications 31
Slide 32: 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 33: 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 of 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 mPFS
Slide 34: Rationale for Combining HEPZATO with IO Therapy
Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy 34
Slide 35: 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 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 36: Market Expansion U.S. TAM Significant Upside
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) 36
Slide 37: HEPZATO KIT: Financials and Team
HEPZATO KIT: Financials and Team 37
Slide 38: Capital Structure and Share Information
Capital Structure and Share Information DCTH (NASDAQ) Share Listing - Current a. As of September 30, 2023; includes 19.7M of Common plus; 1.1M Preferred E & E-1, 1.5M of Preferred F-2; 4.8M of Preferred F-3; Conversion of convertible notes .5M; & a 28.6M Shares Outstanding 1.0M Pre-funded Warrants a
Slide 39: Multi-Disciplinary, Experienced Leadership Team
Multi-Disciplinary, Experienced Leadership Team Gerard Michel John Purpura BOARD OF DIRECTORS CHIEF EXECUTIVE OFFICER CHIEF OPERATING OFFICER John R. Sylvester Chairman • Past VP and Exec Director roles of Reg. • 30+ yrs. pharma/medtech experience Affairs for Bracco Diagnostics Dr. Roger G. Stoll, P
Slide 40: Thank You
Deleath: Thank You
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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