Trevi Therapeutics (TRVI) Q4 2025 earnings summary

Executive summary

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

• Secured capital following positive trial results, enabling initiation of next clinical trial phases.

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

• Preparing to launch multiple pivotal and adaptive clinical trials across chronic cough indications.

• Ended 2025 with $188.3 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028.

Financial highlights

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

• R&D expenses for Q4 2025 decreased to $6.2M from $9.3M in Q4 2024; full year 2025 R&D was $33.5M, down from $39.4M in 2024.

• G&A expenses for Q4 2025 increased to $4.0M from $2.9M in Q4 2024; full year 2025 G&A was $15.9M, up from $12.1M in 2024.

• Other income, net, for Q4 2025 rose to $1.9M from $0.8M in Q4 2024; full year 2025 was $6.5M, up from $3.6M in 2024.

• Net loss for Q4 2025 was $8.3M, improved from $11.4M in Q4 2024; full year 2025 net loss was $42.8M, improved from $47.9M in 2024.

Outlook and guidance

• Initiation of first global Phase 3 trial in IPF-related chronic cough planned for Q2 2026, enrolling ~300 patients with a 52-week duration and 24-week primary endpoint.

• Second confirmatory Phase 3 trial to start in H2 2026, enrolling ~130 patients with a 12-week primary endpoint.

• Adaptive Phase 2b trial for non-IPF ILD-related chronic cough planned for H2 2026, with Phase 3 to follow upon FDA alignment.

• Phase 2b dose-ranging trial for RCC to initiate in Q2 2026, with interim sample size re-estimation readout expected later in the year.

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