Delcath Systems, Inc. (NASDAQ:DCTH) reported third-quarter 2026 revenue of $35.1 million, an increase of approximately 70% from $20.6 million in the corresponding period last year, supported by higher sales of its liver cancer treatment products.
The oncology company also raised its full-year revenue guidance to between $115 million and $117 million, reflecting continued growth in HEPZATO KIT treatment volumes.
Net income increased to $7.0 million from $0.8 million a year earlier, while gross margin improved to 89% from 87%.
HEPZATO KIT Revenue Rises to $32.7 Million
HEPZATO KIT generated $32.7 million in US revenue during the quarter, compared with $19.3 million in the third quarter of 2025, representing growth of approximately 69%.
European revenue from CHEMOSAT increased to $2.4 million from $1.3 million.
Delcath reported approximately 72% year-on-year growth in HEPZATO treatment volumes and ended September with 33 active treatment centres.
Adjusted EBITDA, a non-GAAP financial measure, increased to $11.5 million from $5.3 million in the prior-year period.
Research and development expenses rose to $11.0 million from $8.0 million, reflecting increased clinical staffing and trial activity. Selling, general and administrative expenses increased to $13.1 million from $10.3 million, primarily due to commercial expansion.
Operating cash flow reached $8.2 million, compared with $4.8 million a year earlier.
At September 30, 2026, Delcath held $104.3 million in cash and investments and reported no debt.
Clinical Development Programme Advances
Delcath continued advancing its Phase 2 DELUMA trial, which evaluates HEPZATO in combination with standard-of-care treatment against standard-of-care therapy alone in patients with liver-dominant HER2-negative metastatic breast cancer.
The first patient was dosed on July 9, 2026, at the European Institute of Oncology in Milan, Italy.
The randomised study is designed to enrol approximately 90 patients across more than 20 clinical sites in the United States and Europe.
The company also plans to submit an Investigational New Drug application for cholangiocarcinoma in early 2027.
Separately, Delcath expects to complete preclinical development of an oxaliplatin-based percutaneous hepatic perfusion product by mid-2027, subject to agreement with the US Food and Drug Administration.
Full-Year Revenue Guidance Increased
Delcath now expects combined HEPZATO KIT and CHEMOSAT revenue of $115 million to $117 million for 2026.
The forecast assumes HEPZATO KIT treatment volume growth of at least 41% compared with 2025.
The company anticipates full-year gross margins between 87% and 89% and expects to generate positive adjusted EBITDA.
Delcath’s HEPZATO KIT is approved in the United States for certain adults with metastatic uveal melanoma involving the liver, while CHEMOSAT is marketed in Europe for hepatic chemotherapy delivery.