Trevi Therapeutics Reports $47.9 Million Net Loss for 2024, Increases R&D Spending

Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $47.9 million for the year ended December 31, 2024, compared to a net loss of $29.1 million in 2023. This increase in net loss is primarily attributable to a $15.7 million (66.3%) rise in research and development expenses to $39.4 million, driven by increased clinical development costs for several ongoing trials (Phase 2b CORAL, Phase 2a RIVER, HAP, and Phase 1b TIDAL) and higher personnel and stock-based compensation expenses. General and administrative expenses also increased by $1.9 million (18.6%) to $12.1 million. Offsetting these increases was a $1.2 million decrease in other income, primarily due to lower interest income from reduced cash and marketable securities balances. As of December 31, 2024, the company had an accumulated deficit of $287.0 million and cash, cash equivalents, and marketable securities totaling $107.6 million.

The company's key operational developments during the year included the completion of enrollment in the Phase 2b CORAL clinical trial for Haduvio (oral nalbuphine ER) in chronic cough patients with IPF in February 2025, with topline results expected in the second quarter of 2025. A sample size re-estimation analysis in December 2024 confirmed the targeted sample size of 160 patients. Additionally, Trevi announced positive topline data from its Phase 2a RIVER trial of Haduvio in refractory chronic cough (RCC) patients in March 2025 and positive topline results from a human abuse potential study in December 2024. The company also initiated screening for its Phase 1b TIDAL study to evaluate Haduvio's effect on respiratory physiology in IPF patients. As of December 31, 2024, Trevi employed 26 individuals, with 16 in research and development.

Significant financing activities during the year included a December 2024 offering that generated gross proceeds of approximately $50 million and at-the-market sales of common stock that yielded gross proceeds of $14.1 million. The company also fully extinguished its term loan with Silicon Valley Bank in May 2023, paying off $6.5 million. Net cash used in operating activities was $38.3 million in 2024, compared to $31.7 million in 2023. Net cash used in investing activities was $21.5 million in 2024, while net cash provided by financing activities was $61.5 million.

Trevi anticipates continued significant expenses in the foreseeable future related to ongoing and planned clinical trials for Haduvio across multiple indications (IPF, non-IPF ILD, and RCC). The company expects to request an end-of-Phase 2 meeting with the FDA in 2025 and to initiate a Phase 3 program in the first half of 2026, contingent on the Phase 2b CORAL trial results. The company plans to fund its operations through equity sales, debt financing, collaborations, and licensing arrangements, acknowledging that adequate financing may not be available on acceptable terms or at all. The company does not expect to generate significant revenue until Haduvio receives marketing approval and is successfully commercialized.