Trevi Therapeutics, Inc. Q1 FY2026 earnings call

1. Jennifer Good and team discussed 2026 as an important execution year, with finalized study protocols for IPF-related chronic cough phase three trials, intending to initiate first trial this quarter and second half of year. 2. Intend to submit meeting request to FDA for non-IPF-ILD related chronic cough program, propose adaptive phase two, three study. 3. Expect to initiate phase 2B parallel arm dose ranging trial for refractory chronic cough this quarter, with SSRE readout in fourth quarter. 4. Core method of treatment patent for IPF-related chronic cough issued in Europe, with additional US applications filed. 5. Upcoming events: Investor and Analyst Day on May 7th, and active participation in ATS meeting with six submissions accepted, with investor analyst event on May 18th. 6. Dave Hastings mentioned cash position: ended Q1 2026 with ~$172M in cash, etc., plus $162M net proceeds from stock offering in April 2026, extending cash runway into 2030.

No specific product segment financial performance details provided in the transcript

1. Expect to initiate first IPF-related chronic cough phase three trial this quarter, second half of year for second. 2. Intend to submit meeting request to FDA for non-IPF-ILD related chronic cough program in second half of year. 3. Expect SSRE readout in fourth quarter of 2026 for refractory chronic cough trial. 4. Cash runway extended into 2030, funding development program through critical points.

No specific risk and operational failure discussion provided in the visible transcript content

Q: What are your goals for the upcoming meeting with the FDA to talk about the protocol for your Phase IIb and non-IPF ILD chronic coughs?

A: Jim answered about discussing intention for ILD program, submitting full Phase 2B3 protocol, talking about patient population, dose selection, interim analysis. 2.

Q: How to balance resources and prioritize things for RCC and non-IPF-ILD?

A: Jim and Farrell talked about using internal expertise, experienced CRO, added 10 people recently. 3.

Q: Competitive landscape in RCC, impact of P2X3 readout?

A: Carol and Jim discussed competitive landscape, strong differentiation, enrollment excitement. 4.

Q: Data updates before second half of 2027?

A: Alexa was told about SSRE in fourth quarter of 2026 for RCC trial. 5.

Q: Key checkpoints in SSRE and IP expansion?

A: Jim talked about SSRE checkpoints, Farrell talked about IP expansion around label. 6.

Q: Impact of dyspnea on ILD and relevance for RCC?

A: Farrell talked about dyspnea being top complaint, complementing product uptake. 7.

Q: Minimize placebo in RCC and concern in IPF/non-IPF ILD?

A: Jim talked about placebo control in RCC trial. 8.

Q: Exciting developments at ATS?

A: Jim talked about sub-analyses from coral study, breathlessness data. 9.

Q: PEERS P2X3 readout impact?

A: Jim talked about not much impact on own program. 10.

Q: FDA expectations for non-IPF-ILD trials?

A: Mentioned ILD expert Dr. Toby Marr to speak on cough in IPF and ILD. 11.

Q: Enrolling addressable patient population in RCC and relative opportunity?

A: Farrell talked about strategy, Jim talked about eligibility for RCC trial