Trevi Therapeutics (TRVI) Q4 2025 earnings summary

Executive summary

• Achieved major growth inflection in 2025 with positive Phase 2 data from CORAL (IPF-related chronic cough) and RIVER (RCC) trials, setting the stage for pivotal Phase 3 trials in 2026.

• Secured capital following positive trial results, enabling initiation of next clinical trial phases and providing a cash runway into 2028.

• Positive end-of-phase II FDA meeting for IPF-related cough program, with clear registration trial pathway and alignment on Phase 3 design.

• Preparing to launch multiple pivotal and adaptive clinical trials across chronic cough indications, including two pivotal Phase 3 trials in 2026.

• Strong engagement with physicians and patient advocacy groups, supporting trial enrollment.

Financial highlights

• Ended 2025 with $188.3 million in cash, cash equivalents, and marketable securities.

• Cash runway expected to fund operations into 2028, covering key clinical milestones.

• R&D expenses for Q4 2025 were $6.2M; full year 2025 R&D was $33.5M.

• G&A expenses for Q4 2025 were $4.0M; full year 2025 G&A was $15.9M.

• Net loss for 2025 was $42.8M, improved from $47.9M in 2024.

Outlook and guidance

• Initiation of first pivotal Phase 3 IPF-related chronic cough trial planned for Q2 2026; second confirmatory Phase 3 to start in H2 2026.

• Adaptive Phase 2b trial for non-IPF ILD-related chronic cough to begin by year-end 2026, pending FDA meeting in Q3.

• Phase 2b RCC trial to start in Q2 2026, with sample size re-estimation readout expected later in the year.

• Investor and Analyst Day scheduled for May 7, 2026, with additional data presentations at ATS in May.