Trevi Therapeutics (TRVI) Q1 2025 earnings summary

Executive summary

• Positive topline results from Phase 2a RIVER trial in refractory chronic cough (RCC), meeting primary and all secondary endpoints, and completion of enrollment in Phase 2b CORAL trial for IPF chronic cough; topline CORAL results expected Q2 2025.

• Cash, cash equivalents, and marketable securities totaled $103.3 million as of March 31, 2025, supporting operations into Q4 2026.

• Engagement with FDA provided timely guidance on technical matters and clarity on primary endpoint validation.

• Trevi Therapeutics is focused on Haduvio (oral nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and RCC, with no product revenue to date.

Financial highlights

• Net loss for Q1 2025 was $10.3 million, compared to $10.9 million in Q1 2024.

• R&D expenses decreased to $7.8 million from $8.8 million year-over-year, mainly due to lower clinical development costs.

• G&A expenses increased to $3.7 million from $3.1 million, driven by higher personnel and stock-based compensation.

• Interest income rose to $1.1 million from $1.0 million year-over-year due to higher average balances.

• Net cash used in operating activities was $13.5 million for Q1 2025; $8.7 million provided by financing activities, mainly from warrant and option exercises.

Outlook and guidance

• Awaiting topline CORAL trial data in Q2 2025; positive results will determine next development steps and regulatory engagement.

• Cash runway expected to last into Q4 2026; additional funding will be needed for full development and commercialization.

• Plans to advance RCC and IPF programs, with further dose exploration and potential basket trial in ILD under consideration.

• Strategic partnerships for ex-U.S. commercialization are being explored, while U.S. commercialization preparations continue.