Trevi Therapeutics, Inc. Q3 FY2024 earnings call

Jennifer Good introduced Jim Cassella as the new Chief Development Officer, highlighting his background in neuroscience drug development. She discussed upcoming clinical data milestones: HAP study data expected in December 2024, sample size re-estimation (SSRE) for IPF cough trial CORAL Phase 2b by year-end, and RIVER Phase 2a top-line data in Q1 2025. Lisa Delfini provided financial update: net loss of $13.2 million in Q3 2024 vs. $7.7 million in Q3 2023, R&D expenses at $11.2 million, G&A expenses at $2.9 million, cash position at $65.5 million as of September 30, 2024, with cash burn projection between $41M-$43M in 2024 and cash runway into second half of 2026.

• Cash burn for 2024, excluding proceeds from share issuances and interest/investment income, is expected to be between $41 million and $43 million. • Cash runway is projected into the second half of 2026, more than a year past current projected data readouts. • Expected data readouts: HAP data in December 2024, CORAL Phase 2b SSRE by year-end, RIVER Phase 2a top-line data in Q1 2025, and full CORAL Phase 2b study top-line data in first half 2025 (assuming no increase in sample size).

Q: Faisal Khurshid asked about butorphanol drug liking and evidence supporting nalbuphine's unscheduled designation.

A: James Cassella explained the HAP study involves experts, butorphanol has different scheduling due to abuse history, and the study will look at drug liking scale, relative abuse liability vs butorphanol, and absolute abuse potential vs placebo.

Q: Leland Gershell inquired about SSRE fixed increase in sample size.

A: Jennifer Good stated the range for SSRE is original N of 160 to a total N of 400, with an unblinded statistician rerunning power calculations to determine exact number.

Q: Deb Chatterjee asked if RCC trial arms are balanced.

A: James Cassella responded that stratification was done, enrollment period was extended, but overall analysis isn't impacted by subgroup balancing.

Q: William Wood asked about next steps after HAP trial results.

A: Jennifer Good and James Cassella stated results will be submitted to FDA, wrapped into midyear 2025 end of Phase 2 meeting, and don't gate ongoing trials.

Q: Brandon Folkes asked about TIDAL respiratory physiology study.

A: Jennifer Good said the study is enrolling, data needed by second half of 2025 for end of Phase 2 meeting on IPF.

Q: Ryan Deschner asked about DEA decision timeline for HAP results and butorphanol dose.

A: Jennifer Good replied DEA decision comes with NDA review, and butorphanol is dosed at 6 milligram infusion over an hour to mimic market version.