Trevi's Third-Quarter Loss Widens to $21.5 Million

The Tip Desk · November 12, 2026 · 3 min read

Third-quarter 2026 R&D expenses rose to $19.1 million and net loss widened to $21.5 million. The company ended September with $299.4 million in cash, cash equivalents and marketable securities as both OCEAN studies recruited.

Trevi Therapeutics (TRVI) reported third-quarter 2026 research and development expenses of $19.1 million, up from $10.1 million a year earlier, and a net loss that widened to $21.5 million from $11.8 million. The clinical-stage biopharmaceutical company, which is developing oral nalbuphine ER (Haduvio) for chronic cough, initiated the second of two parallel Phase 3 trials in idiopathic pulmonary fibrosis-related chronic cough during the quarter. Both OCEAN studies are now actively recruiting.

The 12-week fixed-dose OCEAN-2 trial was the next step after OCEAN-1 started in the second quarter. Topline results from OCEAN-2 are expected in the second half of 2027. The 52-week OCEAN-1 trial is expected to report topline results in the first half of 2028.

President and CEO Jennifer Good said the company is opening sites globally and enrolling patients across all three active trials. She said Trevi recently aligned with the FDA on the non-IPF ILD-related chronic cough program and expects to start a Phase 2 dose-ranging trial in the first quarter of 2027.

That FDA alignment changed the non-IPF ILD plan. In October 2026 the company had a positive meeting and gained overall agreement on the development path, including the Phase 2 dose-ranging design. The trial will compare 54 mg twice daily and 27 mg twice daily of nalbuphine ER with placebo in about 120 patients, using relative change from baseline in 24-hour cough frequency at 12 weeks of fixed dosing. Initiation remains subject to FDA review of the protocol. Topline results are expected in the first half of 2028.

The company also received a USPTO Notice of Allowance for a patent covering nalbuphine ER dosing in hepatically impaired patients with non-IPF ILD-related chronic cough. Once issued, the patent is expected to expire in 2041. Trevi said it believes the patent will be listable on the Orange Book for that indication.

In refractory chronic cough, the Phase 2b LAKE trial, started in the second quarter, is still enrolling. Based on projected enrollment, the company now expects to report the sample-size re-estimation outcome early in the first quarter of 2027. Full-trial topline results remain expected in the second half of 2027.

Research and development expenses for the three months ended September 30, 2026, rose to $19.1 million from $10.1 million a year earlier. The company said the increase was primarily due to clinical development on OCEAN-1, LAKE and OCEAN-2, plus higher stock-based compensation and personnel costs, partly offset by lower costs for Phase 1 NDA-supportive studies and the Phase 2b CORAL trial. General and administrative expenses were $5.4 million. Other income, net, was $3.0 million, which the company attributed mainly to higher interest income on invested cash.

Net loss widened to $21.5 million, or $0.13 a share, from $11.8 million, or $0.08 a share, in the year-ago quarter. Weighted-average shares were 159.7 million.

Cash, cash equivalents and marketable securities were $299.4 million at September 30, down from $318.9 million at the end of the second quarter after an April common-stock offering that raised about $162.3 million in net proceeds. The company said it expects those resources to provide cash runway into 2030 and to fund Haduvio development in IPF-related chronic cough through potential FDA approval, plus Phase 2 work in non-IPF ILD and the ongoing LAKE trial.