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Delcath Systems Reports Third Quarter 2026 Results and Business Highlights

  • Delcath Systems raised its 2026 full-year revenue guidance to a range of $115 million to $117 million.
  • Third quarter 2026 total revenue reached $35.1 million, up from $20.6 million in the same period of 2025.
  • HEPZATO KIT revenue was $32.7 million in Q3 2026, representing approximately 72% growth compared to the prior year quarter.
  • CHEMOSAT revenue totaled $2.4 million in Q3 2026, compared to $1.3 million in Q3 2025.
  • Gross margins for the quarter were 89%, an increase from 87% in the third quarter of 2025.
  • Net income for Q3 2026 was $7.0 million, compared to $0.8 million in the prior year period.
  • Non-GAAP adjusted EBITDA for the quarter was $11.5 million, up from $5.3 million in Q3 2025.
  • Cash provided by operations in the quarter was $8.2 million, compared to $4.8 million in the prior year quarter.
  • As of September 30, 2026, the company held $104.3 million in cash & investments with no debt.
  • The company currently operates 33 active treatment centers.
  • The global Phase 2 DELUMA trial for HEPZATO in breast cancer dosed its first patient on July 9, 2026, at the European Institute of Oncology in Milan.
  • The DELUMA trial is designed to enroll approximately 90 patients at over 20 U.S. & European sites.
  • Research & development expenses for Q3 2026 were $11.0 million, driven by increased clinical headcount & trial activity.
  • Selling, general, & administrative expenses for Q3 2026 were $13.1 million, due to continued commercial expansion.
  • The company plans an IND submission for cholangiocarcinoma in early 2027.
  • Pending FDA agreement, preclinical development of an oxaliplatin-based PHP product is targeted for completion by mid-2027.
  • Full-year 2026 gross margins are projected to range between 87% & 89%.
  • Full-year 2026 guidance includes positive adjusted EBITDA.
  • A conference call to discuss results is scheduled for November 9, 2026, at 8:30 a.m. Eastern Time.