Trevi Therapeutics, Inc. (TRVI), a clinical-stage biopharmaceutical company, reported fourth-quarter and full-year 2025 financial results reflecting a narrower loss. In addition, the firm provided updates on the trials of its lead investigational therapy, Haduvio (Nalbuphine ER).
For the fourth quarter, Trevi incurred a net loss of $8.32 million or $0.06 per share, compared to a net loss of $11.42 million or $0.11 per share a year ago.
For the full year 2025, net loss narrowed to $42.76 million or $0.32 per share from $47.91 million or $0.47 per share in the prior year.
Trevi is developing the investigational therapy Haduvio, an oral Nalbuphine extended-release (ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Nalbuphine ER is currently in phase 2 trials for IPF and RCC.
Nalbuphine ER's 2026 Trial Updates
According to Trevi, following the End-of-Phase 2 meeting with the FDA, the company has gained alignment for Nalbuphine ER's Phase 3 program for patients with IPF-related chronic cough.
Trevi plans to conduct two pivotal Phase 3 clinical trials and has obtained agreement on the remaining Phase 1 clinical studies to support a New Drug Application submission in IPF-related chronic cough. Also, the company plans to conduct the two Phase 3 trials in parallel and is on track to initiate the first Phase 3 trial in the second quarter of 2026 and the second Phase 3 trial in the second half of 2026.
Trevi also noted that it is on track to initiate a Phase 2b clinical trial of Nalbuphine ER for the treatment of patients with RCC in the second quarter of 2026.
In addition, the firm plans to initiate an adaptive design Phase 2b trial of Nalbuphine ER for the treatment of patients with non-IPF ILD-related chronic cough in the second half of 2026, subject to the FDA's review of the trial protocol.
Trevi ended 2025 with $188.3 million in cash, cash equivalents and marketable securities, with expected cash runway into 2028.
Trevi plans to host an Investor and Analyst Day on May 7, 2026, from 10:00 a.m. to 12:00 p.m. ET, to discuss its clinical and commercial strategy.
TRVI has traded between $4.85 and $14.39 in the last year. The stock closed Tuesday's trade at $11.19, up 0.27%.
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