Delcath Systems, Inc. reported financial results for the third quarter ended September 30, 2026, and updated its full-year outlook. The company announced total revenue of $35.1 million for the quarter, a significant increase compared to $20.6 million in the prior year. This revenue was driven by $32.7 million in HEPZATO KIT sales and $2.4 million in CHEMOSAT revenue.
For the nine months ended September 30, 2026, total product revenue was $89.2 million, compared to $64.5 million in the same period in 2025. The company reported a net income of $7.0 million for the third quarter, up from $0.8 million in the prior year. Gross margins for the quarter were 89%, compared to 87% in the third quarter of 2025. Non-GAAP adjusted EBITDA for the quarter was $11.5 million, compared to $5.3 million in the prior year.
As of September 30, 2026, Delcath held $104.3 million in cash and investments with no debt. The company also noted that it currently has 33 active treatment centers and approximately 72% growth in HEPZATO volume compared to the third quarter of 2025.
Regarding its 2026 financial guidance, Delcath raised its total HEPZATO KIT and CHEMOSAT revenue outlook to a range of $115 million to $117 million. This guidance reflects an increase in HEPZATO KIT volume of at least 41% over 2025. The company also expects full-year gross margins to remain in the range of 87% to 89% and anticipates positive adjusted EBITDA for the year.
In clinical news, Delcath advanced the global Phase 2 DELUMA trial, evaluating HEPZATO in combination with standard-of-care therapy versus standard of care alone in liver-dominant HER2-negative metastatic breast cancer. The randomized trial is designed to enroll approximately 90 patients at more than 20 U.S. and European sites. The first patient was dosed on July 9, 2026, at the European Institute of Oncology in Milan, Italy.
