Trevi Therapeutics, Inc. Q3 FY2025 earnings call

• Positive data readouts in CORAL and RIVER trials for chronic cough indications. Raised ~$100 million in June, giving cash runway into 2028. - Completed important Phase I studies for IPF cough program, FDA DDI study had no clinically meaningful changes. - Progress on TITLE study for IPF patients with no safety signals to date. - Planning non-IPF ILD study with ~228,000 patients, similar chronic cough criteria to other programs. - Preparing Phase 2b/3 study for RCC, drafting protocol and identifying sites.

For the third quarter of 2025, Trevi Therapeutics reported a net loss of $11.8 million compared to a net loss of $13.2 million in the same quarter in 2024. R&D expenses decreased to $10.1 million during the third quarter of 2025 from $11.2 million in the same quarter last year. The reduction was primarily due to decreased clinical trial work, partially offset by increased costs related to recent Phase I studies and personnel expenses. As of September 30, 2025, cash and investments totaled approximately $195 million, providing cash runway into 2028.

• Cash runway into 2028 allows funding of two Phase III trials for IPF chronic cough, Phase 2b/3 for non-IPF ILD, RCC trial, and ongoing Phase I studies.

Q: Have you narrowed down inclusion and exclusion criteria for the non-IPF ILD study, especially on chronic cough definition?

A: Jim Cassella said they're narrowing down, using standard chronic cough criteria like 10 coughs per hour, focusing on lung disease and cough amount.

Q: Anticipate more DDI studies?

A: Jim Cassella said there will be other DDI studies based on drug metabolism, including one for 2C19 inhibitor.

Q: Interim results from TITLE study and end of Phase II meeting?

A: Farrell Simon said data from TITLE study will be included in the end of Phase II package. Jennifer Good mentioned positive feedback from CHEST meeting.

Q: Incorporating non-IPF ILDs into IPF Phase III program?

A: Jennifer Good said they'll focus on end of Phase II meeting for IPF first, then target non-IPF ILD with Type C meeting after alignment.

Q: Orphan drug eligibility for IPF cough?

A: Jennifer Good said they'll request orphan drug for IPF cough after end of Phase II meeting.

Q: TITLE study results impact on Phase II discussion?

A: Jim Cassella said ideal outcome is no safety findings on respiratory parameters, which will align with safety database.

Q: Phase III details on doses, background anti-fibrotics, sites?

A: Jim Cassella said dose plan includes 27mg BID titration, 54mg BID treatment, allows background anti-fibrotics, will use successful CORAL sites and U.S. centers.

Q: End of Phase II package dissemination?

A: Jennifer Good said they'll update investors once minutes are available after the meeting.

Q: Inclusion criteria for IPF and RCC trials?

A: Jim Cassella said IPF Phase III will be broad, keeping inclusion/exclusion real-world like CORAL. For RCC Phase 2b, will explore QD dosing.

Q: Respiratory safety study long-term effects?

A: Jim Cassella said they'll do long-term data collection in Phase III, anticipating 52 weeks of safety data.