Trevi Therapeutics (TRVI) Q3 2024 earnings summary

Executive summary

• Advanced clinical development for chronic cough and idiopathic pulmonary fibrosis (IPF), with key data readouts from the CORAL phase 2b and RIVER phase 2a trials expected in late 2024 and early 2025.

• Completed enrollment in the RIVER phase 2a trial (RCC) and reached 50% enrollment in the CORAL phase 2b trial (IPF); sample size re-estimation for CORAL due December 2024.

• Human Abuse Potential (HAP) study completed dosing, with topline results expected December 2024, critical for regulatory pathway.

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

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

Financial highlights

• Reported Q3 2024 net loss of $13.2 million, up from $7.7 million in Q3 2023; net loss for the nine months ended September 30, 2024 was $36.5 million.

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

• 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

• HAP study results and CORAL phase 2b sample size re-estimation expected by year-end 2024.

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

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