On January 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported preliminary financial results and business updates for the fourth quarter and year-ended December 31, 2025.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Preliminary Fourth Quarter and Full-Year 2025 Financial Results (unaudited)
Total fourth quarter and full year revenue expected to be approximately $20.7 million and $85.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue expected to be approximately $19.0 million and $78.8 million, respectively
CHEMOSAT fourth quarter and full year revenue expected to be approximately $1.7 million and $6.4 million, respectively
628,572 common shares repurchased for $6.0 million through December 31, 2025 under the approved $25.0 million Share Buyback Program
As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt compared to cash and short-term investments of $88.9 million as of September 30, 2025
Final financial results for the fourth quarter and full year 2025 and a detailed business update will be provided during Delcath’s annual financial results release and business update call.
Recent Business Highlights
Currently 25 active centers
Approximately 140% growth in HEPZATO procedure volume in 2025 versus 2024
Independent investigators presented results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
Recent publications have highlighted the application, enhanced outcomes, and associated efficacy of percutaneous hepatic perfusion (PHP) in the management of metastatic uveal melanoma (mUM):
"Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021" in International Journal of Cancer
"Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience" in Cancers
"Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" in Journal of Cancer Research and Clinical Oncology
"In 2026 we will continue to drive increased adoption and utilization of HEPZATO by raising awareness among treating physicians of the CHOPIN study findings," said Gerard Michel, Chief Executive Officer of Delcath. "Our strong financial position enables us to invest in both commercial expansion and the initiation of additional clinical programs in 2026."
Preliminary and Unaudited Nature of Reported Results
The Company has not yet completed its financial close process for the fourth quarter and full year 2025 and, as a result, actual results may vary from the estimated preliminary results set forth in this press release due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2025, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the Company’s full, interim or annual audited financial statements.
(Press release, Delcath Systems, JAN 9, 2026, View Source [SID1234661892])