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Trevi Therapeutics Inc. (TRVI-1.19%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing includes information on the company's strategy and clinical development of Haduvio, an investigational therapy for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough (RCC).
Trevi reported positive data from its Phase 2 CANAL trial for chronic cough in IPF patients and is conducting a Phase 2b CORAL trial, which is a dose-ranging study evaluating Haduvio's efficacy, safety, and tolerability. Enrollment for the CORAL trial was completed in February 2025, with topline results expected in the second quarter of 2025.
The company is also conducting a Phase 1b TIDAL study to evaluate Haduvio's effect on respiratory physiology in IPF patients, with plans to use the data to define the patient population for potential Phase 3 trials.
In March 2025, Trevi announced positive topline data from its Phase 2a RIVER trial for RCC, demonstrating a significant reduction in 24-hour cough frequency. The company is designing its next trial for RCC to determine dose response and select doses for a pivotal clinical trial.
Trevi has retained worldwide commercial rights for Haduvio and plans to commercialize it in the U.S. with its own sales force targeting specialists. The company also expects to utilize third-party collaborations for commercialization outside the U.S.
The report details the company's financial position, highlighting a net loss of $47.9 million for 2024 and an accumulated deficit of $287.0 million as of December 31, 2024. Trevi's cash, cash equivalents, and marketable securities totaled $107.6 million at year-end.
Trevi anticipates its existing cash will fund operations into the second half of 2026, with plans to raise additional capital through public or private equity offerings, debt financings, or collaborations to support ongoing and future clinical trials.
The filing also outlines various risks, including the potential need for additional funding, reliance on third-party manufacturers, and regulatory challenges in obtaining approval for Haduvio.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Trevi Therapeutics Inc. annual 10-K report dated March 18, 2025. To report an error, please email earnings@qz.com.