Trevi Therapeutics (TRVI) Q3 2024 earnings summary

Executive summary

• Advanced clinical development for chronic cough and idiopathic pulmonary fibrosis (IPF), with multiple ongoing trials including Phase 2b CORAL (IPF), Phase 2a RIVER (RCC), and a human abuse potential (HAP) study, with key data readouts expected in late 2024 and early 2025.

• Completed enrollment and dosing in key trials, including the CORAL phase 2b IPF cough trial and the RIVER phase 2a RCC trial; reached 50% enrollment in CORAL trial as of October 2024.

• Ended Q3 2024 with $65.5 million in cash, cash equivalents, and marketable securities, with cash runway projected into the second half of 2026.

• Welcomed a new Chief Development Officer with extensive CNS drug development and regulatory experience.

• The company has not generated revenue from product sales and has incurred net losses since inception, with an accumulated deficit of $275.6 million as of September 30, 2024.

Financial highlights

• Net loss for Q3 2024 was $13.2 million, compared to $7.7 million in Q3 2023; net loss for the nine months ended September 30, 2024 was $36.5 million, up from $21.2 million for the same period in 2023.

• R&D expenses rose to $11.2 million in Q3 2024 from $6.3 million in Q3 2023, reflecting increased clinical activity and personnel costs.

• General and administrative expenses increased to $2.9 million in Q3 2024 from $2.7 million in Q3 2023.

• Cash, cash equivalents, and marketable securities totaled $65.5 million as of September 30, 2024, down from $83 million at year-end 2023.

• Working capital at September 30, 2024 was $58.2 million, down from $81.7 million at December 31, 2023.

Outlook and guidance

• Topline data from the HAP study expected in December 2024; CORAL phase 2b sample size re-estimation outcome also expected by year-end.

• RIVER phase 2a RCC topline data anticipated in Q1 2025; full CORAL phase 2b data expected in the first half of 2025, pending SSRE outcome.

• Cash runway projected into the second half of 2026, not including the cost of any additional clinical trials.