Trevi Therapeutics, Inc.

What they do

Trevi is developing Haduvio, an oral extended-release formulation of nalbuphine, which acts as a kappa receptor agonist and mu receptor antagonist (KAMA) on the cough reflex arc. Nalbuphine has been marketed as an injectable for pain for decades in the U.S. and Europe, but Trevi's extended-release oral formulation is investigational. The lead program is IPF-related chronic cough, with additional programs planned in non-IPF ILD-related chronic cough and refractory chronic cough.

Revenue drivers

• Haduvio in IPF-related chronic cough — Lead program and only indication with Phase 3 trials underway; if approved, would be the company's first commercial product. No revenue has been generated to date.
• Haduvio in non-IPF ILD-related chronic cough — Earlier-stage program; the company submitted an FDA meeting request to discuss the development plan and regulatory requirements for registration.
• Haduvio in refractory chronic cough (RCC) — Phase 2b LAKE trial initiated in the second quarter of 2026; potential future revenue source but no Phase 3 trial is currently planned or funded.
• Financing, not product sales — The company has no product revenue; operations are funded by equity raises, including an April 2026 underwritten offering with net proceeds of approximately $162.3 million.

Recent performance

Trevi reported a net loss of $42.8 million for 2025 and negative operating cash flow of $42.1 million; net losses have been $47.9 million (2024), $29.1 million (2023), $29.2 million (2022) and $33.9 million (2021). As of June 30, 2026, total assets were $330.5 million, total liabilities $9.0 million, and shareholder equity $321.5 million, with cash and equivalents of $54.3 million. The company reported ending the second quarter of 2026 with $318.9 million in cash, cash equivalents and marketable securities. There is no product revenue; results reflect research and development spending and the April 2026 financing.

Strategy

Trevi's stated priority is executing two parallel Phase 3 trials of Haduvio in IPF-related chronic cough: OCEAN-1 (initiated in the second quarter of 2026, roughly 300 patients, 52 weeks of fixed dosing with 54 mg BID, primary endpoint at 24 weeks) and OCEAN-2 (planned to initiate in the third quarter of 2026, roughly 130 patients, 12 weeks of fixed dosing). The company also initiated the Phase 2b LAKE trial in refractory chronic cough, with a sample size re-estimation analysis expected in the fourth quarter of 2026. For non-IPF ILD-related chronic cough, Trevi submitted an FDA meeting request to align on the development plan and registration requirements. Management expects current cash, cash equivalents and marketable securities to fund operations into 2030, excluding commercial launch expenses and any Phase 3 trial in RCC.

Risks

• Clinical and regulatory failure — Haduvio is investigational with no approved product; the Phase 3 IPF trials, the LAKE RCC trial, and the non-IPF ILD program could fail to replicate the Phase 2b CORAL results or fail to obtain FDA approval.
• No revenue and continued losses — The company has no product revenue and reported net losses each year from 2021 through 2025, with negative operating cash flow every year in that period.
• Dependence on financing — Operations depend on external capital, as shown by the April 2026 offering raising approximately $162.3 million in net proceeds; cash runway guidance into 2030 excludes commercial launch expenses and any Phase 3 RCC trial.
• Competitive landscape — Management cited recent changes in the competitive landscape and noted there are currently no FDA-approved therapies for IPF-related chronic cough, meaning any competitor approval could change the market opportunity.

Outlook

Management says OCEAN-2 is expected to initiate in the third quarter of 2026, with topline results in the second half of 2027; OCEAN-1 topline is expected in the first half of 2028. LAKE sample size re-estimation results are expected in the fourth quarter of 2026, with topline RCC results in the second half of 2027. The company expects its current cash, equivalents and marketable securities to extend its cash runway into 2030 and fund IPF development through potential FDA approval and the non-IPF ILD and RCC programs.