Trevi Therapeutics (TRVI) Q4 2024 earnings summary

Executive summary

• Achieved three positive clinical data readouts in 2024, including the HAP study, SSRE for the CORAL study in IPF chronic cough, and the RIVER study in RCC, positioning Haduvio as a first-in-class therapy for IPF and potentially best-in-class for chronic cough.

• Reported positive topline data from the Phase 2a RIVER trial in RCC, showing a statistically significant reduction in 24-hour cough frequency (57% placebo-adjusted, p<0.0001).

• Completed enrollment in the Phase 2b CORAL trial for IPF chronic cough, with topline data expected in Q2 2025.

• Ended 2024 with $107.6 million in cash, cash equivalents, and marketable securities, supported by a $50 million offering in December.

• Planning for pivotal programs and regulatory meetings with the FDA for both IPF and RCC indications.

Financial highlights

• Q4 2024 net loss was $11.4 million, up from $7.8 million in Q4 2023; full-year 2024 net loss was $47.9 million, compared to $29.1 million in 2023.

• R&D expenses rose to $9.3 million in Q4 2024 from $6.5 million in Q4 2023; full-year R&D expenses were $39.4 million, up from $23.7 million.

• G&A expenses increased to $2.9 million in Q4 2024 from $2.4 million in Q4 2023; full-year G&A expenses were $12.1 million, up from $10.2 million.

• Cash, cash equivalents, and marketable securities totaled $107.6 million at year-end 2024.

• Cash runway expected into the second half of 2026, funding ongoing and next planned trials.

Outlook and guidance

• Phase II-B CORAL trial data in IPF chronic cough expected in Q2 2025.

• Cash burn guidance for 2025 is $12–14 million per quarter in Q1 and Q2; additional guidance to be provided as trial designs and start dates are finalized.

• Planning for end-of-phase II FDA meeting for IPF program by end of 2025.

• Next RCC trial protocol in development, with regulatory input to be sought.