On November 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the third quarter ended September 30, 2026.

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Third Quarter 2026 Financial Results
•Total revenue of $35.1 million, compared with $20.6 million in the third quarter of 2025
◦HEPZATO KIT revenue of $32.7 million, compared to $19.3 million in the third quarter of 2025
◦CHEMOSAT revenue of $2.4 million, compared to $1.3 million in the third quarter of 2025
•Gross margins of 89%, compared to 87% in the third quarter of 2025
•Net income of $7.0 million, compared to $0.8 million in the third quarter of 2025
•Non-GAAP adjusted EBITDA of $11.5 million, compared to $5.3 million in the third quarter of 2025
•Cash provided by operations of $8.2 million in the quarter; compared to $4.8 million in the third quarter of 2025
•Cash and investments of $104.3 million as of September 30, 2026; and no debt

Business Highlights
•Currently 33 active treatment centers
•Approximately 72% growth in HEPZATO volume in the third quarter 2026 compared to the third quarter 2025
•Advanced the global Phase 2 DELUMA trial (NCT06875128), evaluating HEPZATO in combination with standard-of-care therapy versus standard of care alone in liver-dominant HER2-negative metastatic breast cancer; first patient dosed July 9, 2026, at the European Institute of Oncology in Milan, Italy. The randomized trial is designed to enroll approximately 90 patients at more than 20 U.S. and European sites.

"We are pleased with the continued momentum in our business, with meaningful progress across both commercial operations and clinical development," said Gerard Michel, Chief Executive Officer of Delcath Systems. "Growing physician experience with HEPZATO, strong engagement across our treatment center network, and increasing interest in its use alongside systemic therapies reinforce our confidence in the long-term opportunity. We are also expanding our pipeline, with a planned IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, completion of ongoing preclinical development of an oxaliplatin-based PHP product by mid-2027."

2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:
•Total HEPZATO KIT and CHEMOSAT revenue to range from $115 million to $117 million, reflecting an increase in HEPZATO KIT volume of at least 41% over 2025
•Full year gross margins in the range of 87% to 89%
•Positive adjusted EBITDA

Third Quarter 2026 Results
Total revenue for the quarter ending September 30, 2026 was $35.1 million compared to $20.6 million for the same period in the prior year. Revenue in the quarter includes sales of $32.7 million of HEPZATO in the U.S. and $2.4 million of CHEMOSAT in Europe.
Research and development expenses for the quarter ending September 30, 2026, were $11.0 million compared to $8.0 million for the same period in the prior year. The increase is primarily due to increased clinical headcount and increased clinical trial activity.

Selling, general and administrative expenses for the quarter ended September 30, 2026, were $13.1 million compared to $10.3 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities.
Net income was $7.0 million for the quarter ended September 30, 2026, compared to $0.8 million for the same period in the prior year.
Non-GAAP adjusted EBITDA for the quarter ended September 30, 2026 was $11.5 million compared to adjusted EBITDA of $5.3 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
As of September 30, 2026, the Company had $104.3 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Monday, November 9, 2026
Time: 8:30 AM Eastern Time

(Press release, Delcath Systems, NOV 9, 2026, View Source [SID1234674469])