Trevi Therapeutics (TRVI) Q1 2026 earnings summary

Executive summary

• Finalized phase III protocols for IPF-related chronic cough, with first study initiation expected in Q2 2026 and a second in H2 2026; achieved FDA alignment on pivotal trial designs.

• Adaptive phase II/III study for non-IPF ILD-related chronic cough planned for H2 2026, pending FDA meeting.

• Phase II-B parallel arm dose-ranging trial for RCC to begin in Q2 2026, with sample size re-estimation readout expected in Q4 2026.

• Intellectual property portfolio strengthened with new European patent for IPF-related chronic cough, extending protection through 2039, and additional U.S. applications could extend coverage to 2046.

• Active engagement with the medical community through upcoming Investor Day, analyst events, and multiple presentations at the ATS meeting.

Financial highlights

• Ended Q1 2026 with $171.8 million in cash, cash equivalents, and marketable securities.

• Raised $162 million in net proceeds from an underwritten common stock offering in April 2026.

• Net loss for Q1 2026 was $13.2 million, compared to $10.3 million in Q1 2025, driven by increased R&D and G&A expenses.

• R&D expenses rose to $9.9 million from $7.8 million year-over-year; G&A expenses increased to $5.0 million from $3.7 million.

• Interest income increased to $1.7 million from $1.1 million, reflecting higher invested balances.

Outlook and guidance

• Cash resources expected to fund operations and clinical development through potential FDA approval for IPF-related chronic cough and phase II-B/III trials for non-IPF ILD and RCC into 2030.

• Additional funding will be required for commercial launch and to complete development for non-IPF ILD and RCC indications.

• Topline results from the first Phase 3 IPF trial expected in H1 2028, and from the second Phase 3 and Phase 2b RCC/non-IPF ILD trials in H2 2027.

• Pre-commercial activities included in spending plans, but not commercial launch expenses.