Trevi Therapeutics(TRVI) - 2022 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2022, the company reported a net loss of $7.3 million, an improvement from a net loss of $8.4 million in Q1 2021 [22] - R&D expenses decreased to $4.6 million in Q1 2022 from $5.6 million in the same period of 2021, primarily due to reduced clinical trial subject recruitment costs [22] - G&A expenses were $2.4 million in Q1 2022, slightly down from $2.5 million in Q1 2021, mainly due to lower legal fees [23] - The company raised $55 million through the sale of common stock and prefunded warrants, increasing cash and investments to over $80 million, providing a cash runway into Q1 2024 [18][19] Business Line Data and Key Metrics Changes - The most advanced program is in severe chronic pruritus in prurigo nodularis (PN), with the PRISM trial reaching important milestones, including the last patient completing their final visit [11] - The other clinical program focuses on chronic cough in idiopathic pulmonary fibrosis (IPF), with a positive interim analysis showing a 77% reduction in daytime cough frequency [12][14] Market Data and Key Metrics Changes - The global chronic cough market is estimated to be approximately $10 billion [15] - The company anticipates conducting a second Phase 3 trial in PN, estimating costs between $20 million to $30 million [35] Company Strategy and Development Direction - The company aims to target debilitating aspects of diseases with potential for disease modification over time [7] - The strategy includes exploring how relief from significant disease symptoms may improve the underlying disease itself [8] - The company is preparing for potential expansion into other indications beyond the current focus on pruritus and cough [54] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about upcoming data readouts and the potential for growth based on Haduvio's mechanism [16] - The company is focused on ensuring successful execution of ongoing trials while preparing for future opportunities [54] Other Important Information - The company has approximately 15 million warrants outstanding, which could provide up to $20 million if exercised [20] Q&A Session Summary Question: Expectations for the PRISM trial readout - Management expects to provide top-line results along with some secondary endpoints and safety overview in June [29] Question: Cost and timeline for a second Phase 3 trial in PN - Estimated cost for the second trial is between $20 million to $30 million, with a timeline of about two years for completion [35] Question: Size and management of the chronic cough trial in IPF - The next study is estimated to involve about 300 patients, with an enrollment period of 18 to 24 months [39] Question: Disease modification assessment for chronic cough - Management plans to measure hospitalization rates and respiratory function changes, alongside cough counts [46] Question: Potential for monetizing ex-U.S. opportunities - The company is in discussions with partners for potential monetization strategies in international markets [47]