Trevi Therapeutics(US:TRVI)2025-11-13 22:30Financial Data and Key Metrics Changes - For Q3 2025, the company reported a net loss of $11.8 million, an improvement from a net loss of $13.2 million in Q3 2024 [9] - R&D expenses decreased to $10.1 million from $11.2 million year-over-year, primarily due to reduced clinical trial work [9] - G&A expenses increased to $3.8 million from $2.9 million, mainly due to higher professional fees and personnel costs [10] - As of September 30, 2025, cash and investments totaled approximately $195 million, providing a cash runway into 2028 [10] Business Line Data and Key Metrics Changes - The company has made significant progress in its chronic cough programs, particularly in the CORAL trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and the RIVER trial for refractory chronic cough (RCC) [3][4] - Recent phase one studies for the IPF cough program showed no clinically meaningful changes in pharmacokinetics when nalbuphine was co-administered with standard anti-fibrotic treatments [5] Market Data and Key Metrics Changes - The company estimates approximately 228,000 patients with non-IPF interstitial lung diseases (ILD) have chronic cough, with 50-60% experiencing uncontrolled cough, significantly expanding the market opportunity [7] Company Strategy and Development Direction - The company is preparing to initiate multiple phase three trials in the first half of next year, focusing on chronic cough in both IPF and non-IPF ILD patients [8] - The strategy includes aligning with regulatory authorities and ensuring efficient clinical and commercial efforts [7][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position, citing strong data in chronic cough conditions and a solid financial foundation to advance therapies closer to patients [11] - The management highlighted the lack of FDA-approved therapies for chronic cough, indicating a significant market opportunity [11] Other Important Information - The company plans to request a meeting with the FDA to discuss the phase three program for chronic cough in patients with IPF and non-IPF ILD [7] - Management indicated that they will apply for orphan drug designation for Haduvio in IPF [46] Q&A Session Summary Question: Inclusion/exclusion criteria for non-IPF ILD study - Management confirmed that the criteria will focus on the amount of cough and lung damage, with no current plans to exclude specific ILDs [13][15] Question: Need for additional drug-drug interaction studies - Management acknowledged the necessity for further DDI studies based on the drug's metabolism mechanisms [20] Question: Completion of the respiratory study before the end of phase two meeting - Management clarified that the study does not need to be completed before the end of phase two meeting, as they will have available data for submission [25] Question: Feedback from the CHEST meeting - Management reported strong interest from pulmonologists and investigators regarding the data presented, indicating a significant burden of chronic cough [26][27] Question: Plans for broader eligibility criteria in future trials - Management stated that they aim to keep the phase three population as broad as possible to reflect real-world patients [67] Question: Long-term data collection in phase three - Management confirmed that long-term safety data collection will be part of the phase three program, anticipating a requirement for 52 weeks of data [74]