Trevi Therapeutics Inc. (TRVI), a clinical-stage biopharmaceutical company, announced on Tuesday its first-quarter financial results and provided updates on advancing Haduvio for the treatment of various chronic cough indications.
The company is developing its lead investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough caused by idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC).
Q1 2026
The company recorded a net loss of $13.19 million, or $0.09 per share, in Q1 2026, while in the same period of 2025, the net loss was $10.34, or $0.09 per share.
Other income, net for the first quarter of 2026, was $1.70 million, up from $1.12 million in the first quarter of 2025.
Research and development expenses (R&D) were $9.94 million, compared to $7.81 million in the previous year.
Cash, cash equivalents, and marketable securities on March 31, 2026, amounted to $171.80 million.
The company completed an underwritten public offering in April, the gross proceeds of which were over $162 million.
Business Updates:
The company completed an End-of-Phase 2 meeting with the FDA for the treatment of chronic cough in IPF using Haduvio, reaching overall alignment regarding clinical development plans for two Phase 3 trials.
The first phase 3 trial is scheduled to begin in the second quarter of 2026, with topline results expected in the first half of 2028. The second trial is planned for the second half of 2026, with topline results in the second half of 2027.
A European patent was also acquired for nalbuphine ER in treating IPF, which will expire in 2039.
In the indication of non-IPF ILD for Haduvio, the company is submitting an adaptive Phase 2 design for review by the FDA. Initiation of the trial is planned for the second half of 2026, with topline results to be reported in the second half of 2027.
A Phase 2 trial for treating RCC with Haduvio may begin in the fourth quarter of 2026, with a sample size re-estimation (SSRE) included in the protocol. Topline results are expected for the second half of 2027.
TRVI closed Tuesday at $14.66, up 1.95%.
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