Delcath Systems Announces Two Investigator-Initiated Trial Abstracts
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Delcath Systems announced the publication of two investigator-initiated trials-in-progress abstracts on May 21, 2026. These abstracts will be presented at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago. The abstracts highlight ongoing clinical investigations evaluating the use of Delcath's percutaneous hepatic perfusion with melphalan using the HEPZATO KIT(TM) Hepatic Delivery System in metastatic melanoma involving the liver - a common and difficult-to-treat site of disease progression. One abstract, titled "Phase 2 sequential treatment of percutaneous hepatic perfusion with melphalan/hepatic delivery system followed by tebentafusp in the treatment of metastatic uveal melanoma," describes an investigator-initiated Phase 2 trial evaluating sequential treatment with HEPZATO followed by tebentafusp in patients with metastatic uveal melanoma (mUM) who are HLA-A*02:01 positive and have isolated or liver-dominant metastases. The study is designed to assess progression-free survival and additional measures including safety, objective response, overall survival, and biomarker analyses. The study opened for enrollment in November 2025. A second abstract, titled "Phase 1b/2 trial of melphalan-percutaneous hepatic perfusion (PHP) therapy and nivolumab/relatlimab in patients with metastatic melanoma and liver metastasis," outlines a single-center Phase 1b/2 study evaluating HEPZATO in combination with nivolumab/relatlimab as a first-line treatment approach for patients with metastatic non-uveal melanoma involving the liver. The trial is intended to assess safety, tolerability, and preliminary efficacy, with secondary objectives including disease control rate, progression-free survival, overall survival, duration of response, and tumor reduction. The study opened for enrollment in January 2026.
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Current: 10.950
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Current: 10.950
Low
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Averages
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About DCTH
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. HEPZATOTM KIT is a drug/device combination product. HEPZATO KIT comprises the chemotherapeutic drug melphalan and the Company’s proprietary Hepatic Delivery System (HDS). In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan. In the United States, HEPZATO is regulated as a drug by the United States Food and Drug Administration (FDA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Delcath Systems Grants Equity Awards to New Employees
- Equity Award Program: Delcath Systems granted a total of 24,500 Restricted Stock Units (RSUs) to four new employees on May 1, 2026, aimed at attracting and retaining talent while enhancing the company's competitive edge in liver cancer treatment.
- Vesting Conditions: One-third of the RSUs will vest on the first anniversary of the grant date, with the remaining two-thirds vesting in equal annual installments over the next two years, ensuring employee retention on each vesting date.
- Compliance: The equity awards comply with Nasdaq Listing Rule 5635(c)(4), demonstrating Delcath's commitment to attracting high-quality talent with transparency, thereby boosting investor confidence.
- Product Background: Delcath's HEPZATO KIT and CHEMOSAT systems focus on high-dose chemotherapy for liver cancer, aiming to minimize systemic side effects and enhance tumor response rates, aligning with the company's long-term strategic goals to drive business growth.
See More
Delcath Systems Q1 2026 Earnings Call Highlights
- Patient Activation Innovation: Delcath Systems achieved record new patient starts in Q1 2026, with CEO Gerard Michel highlighting that activations at four centers and utilization rates are core growth drivers, indicating the company's proactive market expansion.
- Strong Financial Performance: The total revenue for Q1 reached $25 million, with HEPZATO KIT revenue at $23.3 million and a gross margin maintained at 85%, demonstrating the company's solid performance in revenue growth and cost control, with expectations of at least $100 million in total revenue for 2026.
- Increased R&D Investment: R&D expenses in Q1 were $9.8 million, significantly up from $5 million in the prior quarter, reflecting the company's commitment to new product development while indicating potential future spending pressures.
- Optimistic Market Outlook: Despite management lowering the center activation target, now expecting 40 active centers by Q1 2027, they maintain confidence in profitability for 2026, anticipating positive adjusted EBITDA, showcasing the company's ongoing commitment to future growth.
See More
Delcath Systems Q1 Earnings Exceed Expectations
- Earnings Highlights: Delcath Systems reported a Q1 GAAP EPS of -$0.03, beating expectations by $0.07, indicating an improvement in profitability despite still being in the red.
- Revenue Growth: The company achieved $24.99 million in revenue for the first quarter, a 26.3% year-over-year increase that surpassed market expectations by $1.58 million, demonstrating strong demand for its products, particularly HEPZATO KIT.
- HEPZATO KIT Sales: Revenue from HEPZATO KIT™ reached $23.3 million, significantly up from $18.0 million in Q1 2025, reflecting the product's market acceptance and growth potential.
- Future Outlook: The company projects total revenue from CHEMOSAT and HEPZATO KIT to exceed $100 million in fiscal year 2026, with HEPZATO KIT volume expected to increase by at least 20%, while gross margins are anticipated to remain between 84% and 87%, indicating strong profitability and market expansion potential.
See More
Delcath Systems Presents New Data at ESMO Congress
- Clinical Challenge: Liver-dominant metastatic breast cancer poses significant clinical challenges, and the M-PHP procedure aims to deliver high-dose melphalan directly to the liver while minimizing systemic exposure, thereby enhancing treatment efficacy.
- Patient Data: Independent investigators retrospectively analyzed 15 patients treated with M-PHP across three European centers, with a median of four prior systemic therapy lines, indicating the treatment's potential in heavily pretreated populations.
- Safety Analysis: 67% of patients required blood transfusions, with 60% experiencing procedure-related adverse events, and 80% suffering grade 3-4 adverse reactions, primarily bone marrow suppression, highlighting the need for careful monitoring of treatment risks.
- Survival Outcomes: The median overall survival post-treatment was 6.0 months, with 33% of patients alive at last follow-up, suggesting that despite high risks, M-PHP may offer new survival opportunities for patients with liver-dominant metastatic breast cancer.
See More
Delcath Systems to Announce Q1 Earnings on May 7
- Earnings Announcement: Delcath Systems (DCTH) is set to announce its Q1 2023 earnings on May 7 before market open, with a consensus EPS estimate of -$0.09, reflecting a significant 400% year-over-year decline, indicating ongoing profitability challenges for the company.
- Revenue Growth Expectations: Despite the weak EPS outlook, the consensus revenue estimate stands at $23.41 million, representing an 18.4% year-over-year increase, suggesting potential improvement in product demand and revenue generation capabilities.
- Performance Beat History: Over the past year, Delcath has beaten EPS estimates 50% of the time and revenue estimates 75% of the time, demonstrating a degree of resilience in navigating market fluctuations and meeting investor expectations.
- Estimate Revision Trends: In the last three months, EPS estimates have seen no upward revisions and four downward adjustments, while revenue estimates experienced three upward revisions and two downward adjustments, indicating a cautious market sentiment regarding the company's future profitability.
See More
Delcath Systems to Host Q1 2026 Earnings Call on May 7
- Earnings Call Announcement: Delcath Systems, Inc. will host an earnings call on May 7, 2026, at 8:30 AM Eastern Time to discuss its Q1 results ending March 31, 2026, which is expected to provide investors with insights into the latest financial performance and business developments.
- Participation Details: Participants are advised to dial in 5 to 10 minutes before the call, with toll-free number 1-800-717-1738 for U.S. and international number 1-646-307-1865, ensuring timely access to critical information for investors.
- Webcast and Replay: The event will be available via webcast, allowing investors to join through the provided link, and a replay will be accessible shortly after the call, enabling those unable to attend live to catch up on the discussion.
- Company Overview: Delcath Systems focuses on interventional oncology for liver cancer treatment, with its HEPZATO KIT and CHEMOSAT systems designed to deliver high-dose chemotherapy while minimizing systemic exposure and side effects, showcasing potential in treating metastatic liver cancers.
See More
Delcath Systems Grants Equity Awards to New Employees
- Equity Award Program: Delcath Systems granted a total of 24,500 Restricted Stock Units (RSUs) to four new employees on May 1, 2026, aimed at attracting and retaining talent while enhancing the company's competitive edge in liver cancer treatment.
- Vesting Conditions: One-third of the RSUs will vest on the first anniversary of the grant date, with the remaining two-thirds vesting in equal annual installments over the next two years, ensuring employee retention on each vesting date.
- Compliance: The equity awards comply with Nasdaq Listing Rule 5635(c)(4), demonstrating Delcath's commitment to attracting high-quality talent with transparency, thereby boosting investor confidence.
- Product Background: Delcath's HEPZATO KIT and CHEMOSAT systems focus on high-dose chemotherapy for liver cancer, aiming to minimize systemic side effects and enhance tumor response rates, aligning with the company's long-term strategic goals to drive business growth.
See More
Delcath Systems Q1 2026 Earnings Call Highlights
- Patient Activation Innovation: Delcath Systems achieved record new patient starts in Q1 2026, with CEO Gerard Michel highlighting that activations at four centers and utilization rates are core growth drivers, indicating the company's proactive market expansion.
- Strong Financial Performance: The total revenue for Q1 reached $25 million, with HEPZATO KIT revenue at $23.3 million and a gross margin maintained at 85%, demonstrating the company's solid performance in revenue growth and cost control, with expectations of at least $100 million in total revenue for 2026.
- Increased R&D Investment: R&D expenses in Q1 were $9.8 million, significantly up from $5 million in the prior quarter, reflecting the company's commitment to new product development while indicating potential future spending pressures.
- Optimistic Market Outlook: Despite management lowering the center activation target, now expecting 40 active centers by Q1 2027, they maintain confidence in profitability for 2026, anticipating positive adjusted EBITDA, showcasing the company's ongoing commitment to future growth.
See More
Delcath Systems Q1 Earnings Exceed Expectations
- Earnings Highlights: Delcath Systems reported a Q1 GAAP EPS of -$0.03, beating expectations by $0.07, indicating an improvement in profitability despite still being in the red.
- Revenue Growth: The company achieved $24.99 million in revenue for the first quarter, a 26.3% year-over-year increase that surpassed market expectations by $1.58 million, demonstrating strong demand for its products, particularly HEPZATO KIT.
- HEPZATO KIT Sales: Revenue from HEPZATO KIT™ reached $23.3 million, significantly up from $18.0 million in Q1 2025, reflecting the product's market acceptance and growth potential.
- Future Outlook: The company projects total revenue from CHEMOSAT and HEPZATO KIT to exceed $100 million in fiscal year 2026, with HEPZATO KIT volume expected to increase by at least 20%, while gross margins are anticipated to remain between 84% and 87%, indicating strong profitability and market expansion potential.
See More
Delcath Systems Presents New Data at ESMO Congress
- Clinical Challenge: Liver-dominant metastatic breast cancer poses significant clinical challenges, and the M-PHP procedure aims to deliver high-dose melphalan directly to the liver while minimizing systemic exposure, thereby enhancing treatment efficacy.
- Patient Data: Independent investigators retrospectively analyzed 15 patients treated with M-PHP across three European centers, with a median of four prior systemic therapy lines, indicating the treatment's potential in heavily pretreated populations.
- Safety Analysis: 67% of patients required blood transfusions, with 60% experiencing procedure-related adverse events, and 80% suffering grade 3-4 adverse reactions, primarily bone marrow suppression, highlighting the need for careful monitoring of treatment risks.
- Survival Outcomes: The median overall survival post-treatment was 6.0 months, with 33% of patients alive at last follow-up, suggesting that despite high risks, M-PHP may offer new survival opportunities for patients with liver-dominant metastatic breast cancer.
See More
Delcath Systems to Announce Q1 Earnings on May 7
- Earnings Announcement: Delcath Systems (DCTH) is set to announce its Q1 2023 earnings on May 7 before market open, with a consensus EPS estimate of -$0.09, reflecting a significant 400% year-over-year decline, indicating ongoing profitability challenges for the company.
- Revenue Growth Expectations: Despite the weak EPS outlook, the consensus revenue estimate stands at $23.41 million, representing an 18.4% year-over-year increase, suggesting potential improvement in product demand and revenue generation capabilities.
- Performance Beat History: Over the past year, Delcath has beaten EPS estimates 50% of the time and revenue estimates 75% of the time, demonstrating a degree of resilience in navigating market fluctuations and meeting investor expectations.
- Estimate Revision Trends: In the last three months, EPS estimates have seen no upward revisions and four downward adjustments, while revenue estimates experienced three upward revisions and two downward adjustments, indicating a cautious market sentiment regarding the company's future profitability.
See More
Delcath Systems to Host Q1 2026 Earnings Call on May 7
- Earnings Call Announcement: Delcath Systems, Inc. will host an earnings call on May 7, 2026, at 8:30 AM Eastern Time to discuss its Q1 results ending March 31, 2026, which is expected to provide investors with insights into the latest financial performance and business developments.
- Participation Details: Participants are advised to dial in 5 to 10 minutes before the call, with toll-free number 1-800-717-1738 for U.S. and international number 1-646-307-1865, ensuring timely access to critical information for investors.
- Webcast and Replay: The event will be available via webcast, allowing investors to join through the provided link, and a replay will be accessible shortly after the call, enabling those unable to attend live to catch up on the discussion.
- Company Overview: Delcath Systems focuses on interventional oncology for liver cancer treatment, with its HEPZATO KIT and CHEMOSAT systems designed to deliver high-dose chemotherapy while minimizing systemic exposure and side effects, showcasing potential in treating metastatic liver cancers.
See More
