Trevi Therapeutics(TRVI) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of $10.4 million, an improvement from a net loss of $10.9 million in Q1 2024 [12] - R&D expenses decreased to $7.8 million from $8.8 million in the same quarter of 2024, primarily due to reduced costs related to a human abuse potential study [12] - G&A expenses increased to $3.7 million from $3.1 million in Q1 2024, mainly due to higher personnel-related expenses [13] - As of March 31, 2025, cash and investments totaled $103.3 million, providing a runway into Q4 2026 [13] Business Line Data and Key Metrics Changes - The Phase 2a RIVER trial in refractory chronic cough (RCC) patients showed a 57% placebo-adjusted reduction in cough frequency, achieving a p-value of less than 0.0001 [6] - The Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF) patients completed enrollment with approximately 160 patients across 10 countries [7] Market Data and Key Metrics Changes - RCC affects approximately 2 to 3 million patients in the U.S. with no approved therapies currently available [4] - The company is preparing for the release of top-line data from the CORAL trial this quarter, which is expected to provide insights into treatment options for IPF patients [8] Company Strategy and Development Direction - The company aims to advance its development programs based on the data from the ongoing trials, particularly focusing on chronic cough conditions in both RCC and IPF [8] - There is an emphasis on the importance of the central mechanism underlying neurogenic chronic cough conditions, which differentiates the company's approach from others in the market [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's responsiveness and guidance, which is critical for the development programs [9] - The company plans to be active at the upcoming ATS conference, sharing insights from the RCC data set and engaging with key opinion leaders [10] Other Important Information - The company has received positive feedback from the FDA regarding a Type C request, which is crucial for the development of their programs [9] - The company is considering strategic partnerships for commercialization in Europe and Japan, depending on the data and timing [68] Q&A Session Summary Question: What would be considered a positive readout for the CORAL trial? - A statistically significant positive trial would be necessary for continued development, with no unusual adverse events expected [17][19] Question: What are the next catalysts for the company following the CORAL readout? - The company plans to outline future catalysts after receiving the IPF data, which will inform their path forward [21] Question: Can you clarify the discontinuation rate powered for the study? - The study was powered for a 30% discontinuation rate, but the actual rate was less than 10% [28] Question: What are the long-term patient safety monitoring protocols? - The company plans to include 52 weeks of safety data in their Phase III program, as advised by the FDA [65] Question: What are the trends observed in the RIVER study regarding patient baseline characteristics? - It is too early to determine specific trends, but the drug showed significant efficacy across a broad patient population [71][72]