Trevi Therapeutics, Inc. Q2 FY2025 earnings call

Key Milestones - Positive data from CORAL trial (IPF chronic cough) and RIVER trial (refractory chronic cough) led to $115M capital raise, boosting cash to $204M. - CORAL trial primary endpoint met with Haduvio reducing 24-hour cough frequency, secondary endpoints consistent, LCQ showed marked quality of life improvement. ### Clinical Activities - Ongoing Phase I studies: TIDAL (respiratory function/safety) and DDI (drug-drug interaction). - Planning end of Phase II FDA meeting in Q4 2025, initiating Phase III for IPF cough in H1 2026, non-IPF-ILD study in H1 2026, and RCC trial in H1 2026. ### Financials - Strong cash position provides runway into 2029, enabling multiple trials and pre-commercial activities.

For the second quarter of 2025, Trevi reported a net loss of $12.3 million compared to $12.4 million in the same quarter of 2024. R&D expenses decreased to $9.4 million from $10 million in the prior year, primarily due to decreased costs in certain trials but offset by increased costs in new Phase I studies. G&A expenses increased to $4.3 million from $3.3 million, driven by professional fees, personnel, and SOX-related costs. As of June 30, 2025, cash and investments totaled approximately $204 million, resulting from a $115 million public offering after positive trial data, providing strong runway for clinical activities.

- Strong cash position ($204M) provides runway into 2029 to fund Phase III trials, non-IPF-ILD study, RCC trial, and Phase I work. ### - Plan to request end of Phase II FDA meeting in Q4 2025, initiate Phase III for IPF cough in H1 2026, non-IPF-ILD study in H1 2026, and RCC trial in H1 2026.

Q: Faisal Khurshid on respiratory depression study progress A: James Cassella mentioned the respiratory safety study is ongoing, with 2 active sites, protocol tweaks, and on track for data by end of Phase II meeting Q: Jason Dorr on FDA meeting for Phase III IPF trial A: James Cassella stated end of Phase II meeting will discuss CORAL data, Phase III protocol, DDI studies, and safety database expectations Q: Annabel Samimy on non-IPF-ILD study design A: James Cassella explained non-IPF-ILD study will have parallel arm design, focusing on lung fibrosis and cough, aligning with IPF program Q: Deb Chatterjee on RCC trial implications of GSK's delay A: Farrell Simon and Jennifer Good stated GSK's delay has no impact on Trevi's RCC trial plans Q: Ryan Deschner on CORAL/RIVER dosing evolution and ERS/CHEST presentations A: James Cassella noted 54-mg BID dose is key, with abstracts accepted for ERS on RCC and IPF data at CHEST