Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic cancers in the liver. The company develops and sells innovative hepatic delivery systems designed to administer high-dose chemotherapy directly to the liver. Delcath's products aim to address significant unmet medical needs in liver cancer treatment both in the United States and Europe.
- HEPZATO KIT - A drug/device combination product consisting of melphalan for injection and the Hepatic Delivery System, approved by the FDA for treating uveal melanoma with unresectable hepatic metastases in adults.
- CHEMOSAT Hepatic Delivery System - A stand-alone medical device used in Europe for liver-directed cancer treatments, sharing device components with HEPZATO KIT but excluding melphalan hydrochloride.
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Gerard Michel ExecutiveBoard | Chief Executive Officer (CEO) | CEO of Delcath Systems, Inc. since October 1, 2020, previously served as CFO at Vericel Corporation from June 2014 to September 2020. | View Report → | |
David Hoffman Executive | General Counsel, Chief Compliance Officer, and Corporate Secretary | David Hoffman serves as General Counsel, Chief Compliance Officer, and Corporate Secretary at Delcath Systems, Inc since January 2022. He brings over 20 years of experience advising biotechnology companies and holds degrees in Civil Engineering, Environmental Engineering, and Law. | ||
Kevin Muir Executive | General Manager, Interventional Oncology | Kevin Muir is the General Manager of Interventional Oncology at Delcath Systems since December 2020. With over 20 years of experience in sales and marketing within the biotherapeutics and medical technology industries, he previously held leadership roles at BTG, ClearFlow Inc., and Aragon Surgical. | ||
Martha Rook Executive | Chief Operating Officer | Martha Rook is the Chief Operating Officer at Delcath Systems, Inc. since March 18, 2024. She previously held senior roles at Insitro, Sigilon Therapeutics and MilliporeSigma. | ||
Sandra Pennell Executive | Chief Financial Officer | Sandra Pennell is the Chief Financial Officer at Delcath Systems, Inc. since May 2023. She has over twenty years of finance experience, previously serving as Senior Vice President of Finance at Delcath and holding leadership roles at Invivyd, Inc. and Vericel Corporation. | ||
Vojislav Vukovic Executive | Chief Medical Officer | Chief Medical Officer at Delcath Systems, Inc. since June 2023, with extensive experience in clinical development and oncology from previous roles at Aileron Therapeutics, Taiho Oncology Inc, and Synta Pharmaceuticals Inc. | ||
Bridget Martell Board | Independent Director | Independent Director at Aligos Therapeutics; Independent Director at Achieve Life Sciences; Biotechnology Operating Partner at Two Bear Capital; Founder of BAM Consultants | Bridget Martell, M.A., M.D., is an independent director at DCTH since May 2024 and brings extensive experience in senior management and board roles across the biotechnology industry. | |
Elizabeth Czerepak Board | Director and Chair of the Audit Committee | Acting CEO and CFO at Mirror Biologics, Inc. | Elizabeth Czerepak has served as a Director at Delcath Systems, Inc. since February 2020 and is currently the Chair of the Audit Committee. She brings extensive financial leadership experience from previous CFO and board roles in the pharmaceutical and biotech sectors. | |
Gilad Aharon Board | Director | Co-founder and Portfolio Manager at Rosalind Advisors, Inc.; Equity Analyst at Infinium Securities Inc. | Gilad Aharon, Ph.D., has served as a Director at Delcath Systems, Inc. since May 2020, leveraging his expertise in biophysics and finance. Previously, he co-founded and has been the Portfolio Manager at Rosalind Advisors, Inc. since 2006 and worked as an equity analyst at Infinium Securities Inc.. | |
John R. Sylvester Board | Non-Executive Chairman of the Board | John R. Sylvester has served as Non-Executive Chairman of the Board since February 2023 and has been a Director at DCTH since July 2019, providing strategic oversight and guidance. Previously, he held leadership roles at Curium Pharma, BTG plc, and Biocompatibles plc. | ||
Steven Salamon Board | Director | Co-founder and Portfolio Manager at Rosalind Advisors, Inc. | Director at DCTH since May 2020 ; previously, he co-founded and serves as the Portfolio Manager at Rosalind Advisors, Inc. since 2006. |
- Given the variability in center activations and the unpredictability mentioned in Q1—how are you refining your processes to ensure a more consistent quarterly ramp-up toward the 30 active centers target?
- With the price increase from $182.5 to $187.5 mid-quarter, can you detail the expected impact on unit sales and how this might affect revenue stability in upcoming quarters?
- Considering SG&A expenses are projected to increase by 60% and R&D by 150% over last year, what specific initiatives are in place to maintain profitability while scaling clinical trials and expanding center activations?
- Since site activation for your Phase II trials can take between 6 to 12 months post-FDA clearance, what accelerated strategies are you implementing to reduce this lag and ensure timely patient enrollment?
- With European market challenges such as low reimbursement and pricing pressures limiting revenue contributions to roughly 1/7 of U.S. pricing, what detailed plans do you have to overcome these barriers and drive sustainable growth in Europe?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
Announced FDA approval for KIMMTRAK (tebentafusp-tebn) in January 2022, which is the first drug approved specifically for patients with metastatic uveal melanoma (mUM). It targets HLA-A *02:01-positive adult patients, representing approximately 45% of the uveal melanoma population. This drug competes with HEPZATO, which is approved to treat all mUM patients, including the remaining 55% of patients. | |
Develops and markets devices for local regional procedures such as trans-arterial chemoembolization (TACE, DEBTACE) and Radioembolization (SIRT, TARE, or Y90), which are alternatives to HEPZATO and CHEMOSAT. These procedures are not approved for the treatment of mUM. | |
Markets devices for local regional procedures like TACE and Radioembolization, which compete with HEPZATO and CHEMOSAT in the treatment of liver cancers. These procedures are not approved for mUM. | |
Offers devices for local regional procedures such as TACE and Radioembolization, which are alternatives to HEPZATO and CHEMOSAT for liver cancer treatments. These procedures are not approved for mUM. | |
Varian Medical Systems, Inc. | Develops devices for local regional procedures like TACE and Radioembolization, which compete with HEPZATO and CHEMOSAT in liver cancer treatments. These procedures are not approved for mUM. |
Sirtex Medical Limited | Markets devices for local regional procedures such as TACE and Radioembolization, which are alternatives to HEPZATO and CHEMOSAT for liver cancer treatments. These procedures are not approved for mUM. |
Provides devices for local regional procedures like TACE and Radioembolization, which compete with HEPZATO and CHEMOSAT in the treatment of liver cancers. These procedures are not approved for mUM. | |
Developing darovasertib, an oral protein kinase C (PKC) inhibitor, in combination with crizotinib, a cMET inhibitor, targeting first-line HLA-A2 negative mUM patients. This combination has received FDA Fast Track designation and is being evaluated in a potentially registration-enabling Phase 2/3 trial. Additionally, a Phase 3 study for darovasertib as a neoadjuvant therapy in primary uveal melanoma is planned for the first half of 2025. | |
Investigating RP2, an oncolytic immunotherapy, for mUM. A randomized Phase 2/3 trial has been initiated to compare RP2 combined with nivolumab versus the combination of ipilimumab and nivolumab in immune checkpoint inhibitor-naïve adult patients with mUM. This product has not yet been approved for the treatment of mUM. |
| Customer | Relationship | Segment | Details |
|---|---|---|---|
Customer 1 (2024) | Purchases HEPZATO in the US | HEPZATO & CHEMOSAT | Revenue: $7.48M (20.1% of $37.2M ); AR: $1.10M (10.1% of $10.89M ) |
Customer 2 (2024) | Purchases HEPZATO in the US | HEPZATO & CHEMOSAT | Revenue: $6.58M (17.7% of $37.2M ); AR: $3.29M (30.2% of $10.89M ) |
Customer 3 (2024) | Purchases HEPZATO in the US | HEPZATO & CHEMOSAT | Revenue: $4.91M (13.2% of $37.2M ); AR: $0.37M (3.4% of $10.89M ) |
Customer 4 (2024) | Purchases HEPZATO in the US | HEPZATO & CHEMOSAT | Revenue: $4.20M (11.3% of $37.2M ); AR: $1.83M (16.8% of $10.89M ) |
Customer 1 (2023) | Purchases CHEMOSAT in Europe | CHEMOSAT | Revenue: $0.37M (17.4% of $2.1M ); AR: 0% |
Customer 2 (2023) | Purchases CHEMOSAT in Europe | CHEMOSAT | Revenue: $0.35M (16.6% of $2.1M ); AR: 0% |
Customer 3 (2023) | Purchases CHEMOSAT in Europe | CHEMOSAT | Revenue: $0.28M (13.2% of $2.1M ); AR: 21.1% |
Customer 4 (2023) | Purchases CHEMOSAT in Europe | CHEMOSAT | Revenue: $0.28M (13.1% of $2.1M ); AR: 10.5% |
Customer 5 (2023) | Purchases CHEMOSAT in Europe | CHEMOSAT | Revenue: $0.25M (11.9% of $2.1M ); AR: 10.5% |
Customer 6 (2023) | Purchases CHEMOSAT in Europe | CHEMOSAT | Revenue: $0.22M (10.7% of $2.1M ); AR: 20.2% |
Customer 7 (2023) | Purchases CHEMOSAT in Europe | CHEMOSAT | Revenue: $0.12M (5.5% of $2.1M ); AR: 10.9% |
Recent press releases and 8-K filings for DCTH.
- Delcath Systems issued full year 2025 financial guidance, forecasting total CHEMOSAT and HEPZATO KIT revenue of $94 to $98 million, an increase of over 150% from 2024.
- The company expects gross margins between 83% to 85% and anticipates achieving positive adjusted EBITDA and cashflow in each quarter of 2025.
- Delcath announced its intention to enter into a National Medicaid Drug Rebate Agreement (NDRA), effective beginning Q3 2025, to expand patient access and accelerate HEPZATO adoption, projecting a 200% increase in HEPZATO treatment volume in 2025 versus 2024.