Q4 2025 Trevi Therapeutics Inc Earnings Call Transcript
Key Points
- Trevi Therapeutics Inc (TRVI) reported positive data readouts from the CORAL and RIVER trials, which have driven growth and capital raising.
- The company had a successful end of Phase II meeting with the FDA for its IPF-related chronic cough program, gaining alignment on the path to NDA.
- Trevi Therapeutics Inc (TRVI) plans to initiate two pivotal Phase III clinical trials for IPF-related chronic cough, with clear timelines and trial designs.
- The company has a strong cash position with $188 million, providing a runway into 2028 to support key clinical milestones.
- Trevi Therapeutics Inc (TRVI) is expanding its clinical footprint into the U.S. and has received positive feedback from physicians and patient advocates, indicating strong interest in its trials.
- The requirement for 52 weeks of controlled safety data in the IPF trial means the 24-week endpoint cannot be read out until the end, potentially delaying data availability.
- There is uncertainty around the placebo effect in the longer 24-week IPF trial, which could impact trial outcomes.
- The company faces potential competition from other IPF drugs that may be approved by the time its trials are completed.
- Trevi Therapeutics Inc (TRVI) may need to conduct additional drug-drug interaction studies if new IPF drugs are approved during its trial period.
- The company is still finalizing plans for the non-IPF ILD trial, which could affect timelines and resource allocation.
Good afternoon, and welcome to the Trevi Therapeutics Fourth Quarter and Year-End 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent annual report on Form 10-K, which the company filed with the SEC this afternoon. In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date.
While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so even
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