Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $42.8 million for the year ended December 31, 2025, compared to a net loss of $47.9 million for the previous year. The company, focused on developing Haduvio (oral nalbuphine ER) for chronic cough treatment in IPF, non-IPF ILD, and RCC patients, has not generated any revenue from product sales. Research and development expenses decreased to $33.5 million in 2025 from $39.4 million in 2024, primarily due to decreased clinical development expenses for the HAP study, Phase 2a RIVER trial, and Phase 2b CORAL trial, partially offset by increased costs associated with a Phase 1 drug-drug interaction study.
General and administrative expenses increased to $15.9 million in 2025 from $12.1 million in 2024, driven by higher outside services, professional fees, personnel-related expenses, and stock-based compensation. Interest income, net, rose to $6.5 million in 2025 from $3.6 million in 2024, reflecting higher invested cash equivalent and marketable securities balances. As of December 31, 2025, Trevi Therapeutics held $188.3 million in cash, cash equivalents, and marketable securities.
Key operational developments included positive topline results from the Phase 2b CORAL trial for IPF-related chronic cough and the Phase 2a RIVER trial for RCC. The company completed an End-of-Phase 2 meeting with the FDA, gaining alignment on plans for two pivotal Phase 3 clinical trials for nalbuphine ER. Trevi Therapeutics plans to initiate the first Phase 3 trial in the second quarter of 2026 and the second in the second half of 2026. Additionally, the company intends to initiate a Phase 2b trial of Haduvio for RCC in the second quarter of 2026 and an adaptive design Phase 2b clinical trial for non-IPF ILD-related chronic cough in the second half of 2026, both subject to regulatory review.
Trevi Therapeutics anticipates that its existing cash resources will fund operations into 2028, supporting the planned Phase 3 trials for IPF-related chronic cough, the Phase 2b trial for non-IPF ILD-related chronic cough, the Phase 2b trial for RCC, and Phase 1 NDA supportive studies. The company expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. The company had 34 employees as of December 31, 2025, with 21 in research and development and 13 in general management and administration.
About Trevi Therapeutics, Inc.
Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio, an oral extended-release nalbuphine formulation targeting chronic cough associated with IPF, non-IPF ILD, and refractory chronic cough. Leveraging opioid receptor modulation, it aims to address unmet medical needs with potential advantages over existing therapies. The company focuses on clinical development, regulatory approval, and commercialization, competing with other innovative treatments in respiratory and dermatologic indications.
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