Trevi Therapeutics, Inc. Q1 FY2025 earnings call

Jennifer Good highlighted the strong momentum continuing into Q1 2025, including positive data from the Phase 2a RIVER Trial in RCC patients where Haduvio met the primary endpoint with a significant reduction in 24-hour objective cough frequency, and completion of enrollment in the Phase 2b CORAL trial in IPF chronic cough patients. The FDA Type C request was responded to with clear guidance. Lisa Delfini discussed financial results: net loss of $10.4 million in Q1 2025 vs $10.9 million in Q1 2024, R&D expenses decreased due to reduced Human Abuse Potential study costs, G&A expenses increased due to personnel costs. Cash and investments totaled $103.3 million as of March 31, 2025, with runway into Q4 2026. There were 7.9 million common stock warrant exercises in the first four months of the year, with 1.9 million warrants outstanding and 137 million fully diluted shares.

Expects top line data from the Phase 2b CORAL trial this quarter. Plans to use cash to complete the CORAL trial and determine development path and financing needs. Catalyst path forward will be outlined after IPF data is received, including interaction with the FDA and preparation for an interstitial lung disease basket trial.

Uncertainties around trial outcomes, particularly for the IPF study. Regulatory risks with the FDA, though recent Type C request had positive response. Potential challenges with long-term patient safety monitoring and strategic partnership discussions.

Q: Remind on CORAL readout expectations, including efficacy and safety A: For CORAL, a statistically significant positive trial is the bar for moving forward, with safety within expectations and discontinuations less than 10% Q: Next catalysts after CORAL readout A: Dependent on IPF data; will involve interaction with the FDA and gearing up for an interstitial lung disease basket trial Q: Discontinuation rate in CORAL and powering details A: Powered for 30% discontinuation, actual rate less than 10%; discontinuations not primarily due to adverse events Q: Feedback on PACIFY study vs Trevi's data A: PACIFY had issues like zero-placebo effect and single-center nature; Trevi's mechanism is better with higher efficacy and no Schedule 2 substance issues Q: Status of respiratory physiology study A: On track to finish in the second half of the year, 108-mg dose consideration ongoing Q: ATS data from RIVER A: Plans to discuss AE timing, patient vignettes, QOL data from the Leicester cough questionnaire, and treatment period effect of crossover Q: RIVER dose exploration and ILD study design A: Waiting on IPF data to decide dose exploration and ILD study design; will leverage crossover design learnings from IPF work Q: FDA Type C meeting details and future engagement A: Type C meeting clarified primary endpoint validation; future engagement with FDA planned for both RCC and IPF programs Q: Long-term safety and partnerships A: Plan to include 52-week safety in Phase 3 trials; ongoing strategic partnerships considered for commercialization in Europe and Japan Q: RIVER patient baseline trends A: Analyzing patient by patient, drug worked in everyone, but specific trends not yet clear