Trevi Therapeutics(TRVI) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended 2025 with approximately $188 million in cash equivalents and marketable securities, providing a runway into 2028 to fund key clinical trials [15][14] - The cash runway is expected to support top-line data in pivotal phase 3 clinical trials for IPF-related chronic cough and phase 2B trials for RCC and non-IPF ILD [15] Business Line Data and Key Metrics Changes - The company is preparing to initiate two pivotal phase 3 clinical trials for Haduvio in IPF-related chronic cough, with the first trial expected to start in Q2 2026 [6][4] - The second phase 3 trial is anticipated to begin in the second half of 2026, focusing on a 12-week primary efficacy endpoint [6][7] Market Data and Key Metrics Changes - In the US, there are approximately 150,000 IPF patients, with two-thirds experiencing uncontrolled chronic cough, indicating a significant unmet medical need [8] - The market opportunity for non-IPF ILD patients is estimated to be around 228,000, with 50%-60% suffering from uncontrolled cough, effectively doubling the market potential [10] Company Strategy and Development Direction - The company aims to become a leader in chronic cough treatment, focusing on developing therapies for patients with high unmet needs [12] - The strategy includes conducting adaptive phase 2B trials for non-IPF ILD and refractory chronic cough, with plans to file supplemental NDAs for these indications [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clarity of the path forward for registration trials following positive FDA interactions [5][4] - The company is optimistic about the enrollment demand for the IPF chronic cough pivotal study, citing increased awareness among physicians and patient advocacy groups [78][77] Other Important Information - The company plans to hold an investor and analyst day on May 7, 2026, to discuss clinical and commercial strategies in detail [12] - The company will also participate in the American Thoracic Society meeting, sharing new data from various trials [12] Q&A Session Summary Question: Can you elaborate on the remaining phase 1 studies discussed with the FDA? - The studies are label-informative, focusing on drug-drug interactions and metabolism, which are not rate-limiting and can be conducted in parallel with phase 3 trials [17][19] Question: What design features are being aligned with the FDA for the non-IPF ILD trial? - The company plans to propose an adaptive phase 2B trial design, leveraging insights from the IPF end-of-phase 2 meeting [20][22] Question: Will the label dose in RCC be the same as in IPF? - The company is exploring the dosing strategy and may require additional IP if the dosing differs significantly [58] Question: What are the expectations for recruitment pace in the phase 3 IPF cough trial? - The company anticipates a one-year enrollment period for the phase 3 trial, focusing on 80 to 100 sites primarily in the US [102] Question: Will there be any pre-specified analyses for dyspnea and exacerbations in the phase 3 trial? - The company will track various metrics related to cough, breathlessness, and other patient concerns, but the primary focus remains on cough [116][115]