Trevi Therapeutics Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Updates

Core Insights - Trevi Therapeutics has gained alignment with the FDA on its Phase 3 program for treating idiopathic pulmonary fibrosis-related chronic cough, with plans to initiate pivotal trials in 2026 [1][5][2] Financial Highlights - The company ended 2025 with $188.3 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028 [1][8] - Research and development (R&D) expenses for Q4 2025 decreased to $6.2 million from $9.3 million in Q4 2024, primarily due to reduced clinical development expenses [9] - General and administrative (G&A) expenses for Q4 2025 increased to $4.0 million from $2.9 million in Q4 2024, mainly due to higher professional fees and personnel-related expenses [10] - The net loss for Q4 2025 was $8.3 million, an improvement from a net loss of $11.4 million in Q4 2024 [11] Clinical Development Updates - The company plans to initiate a Phase 2b trial for refractory chronic cough (RCC) in Q2 2026, with the primary efficacy endpoint being the mean change in 24-hour cough frequency [4][6] - Two pivotal Phase 3 trials for IPF-related chronic cough are set to begin in 2026, with the first trial enrolling approximately 300 patients and the second enrolling around 130 patients [5] - Key Phase 2b CORAL trial results for IPF-related chronic cough were published in JAMA in January 2026, supporting the company's clinical strategy [5] Market Opportunity - Chronic cough in patients with IPF and non-IPF ILD represents a significant unmet medical need, with approximately 150,000 U.S. patients with IPF and two-thirds experiencing uncontrolled chronic cough [18] - There are around 2-3 million U.S. patients with RCC, which is highly debilitating and lacks FDA-approved therapies [19]