Trevi Therapeutics(TRVI)2024-11-07 04:54Financial Data and Key Metrics Changes - For Q3 2024, the company reported a net loss of 7.7 million in Q3 2023, indicating a significant increase in losses [27] - R&D expenses rose to 6.3 million in the same quarter of 2023, reflecting increased clinical development activities [27] - G&A expenses were 2.7 million in Q3 2023, primarily due to increased stock-based compensation [28] - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled 83 million at the end of 2023 [28] - The company expects a cash burn of 43 million for 2024, projecting a cash runway into the second half of 2026 [28] Business Line Data and Key Metrics Changes - The company is advancing clinical development for chronic cough and idiopathic pulmonary fibrosis (IPF), with significant upcoming data readouts expected [9][25] - The CORAL trial for IPF chronic cough is a Phase 2b study with 160 patients, and a sample size re-estimation is expected in December 2024 [17][19] - The RIVER trial for refractory chronic cough (RCC) is fully enrolled, with top-line data expected in Q1 2025 [21][24] Market Data and Key Metrics Changes - The RCC affects approximately 2 to 3 million U.S. adults, with a significant unmet need for approved therapies [21][22] - The company believes its unique mechanism of action could address the failures seen in previous RCC drug developments [22] Company Strategy and Development Direction - The company is focused on advancing late-stage development and preparing for NDA submissions, with a strong emphasis on addressing unmet medical needs in chronic cough and IPF [8][25] - The recent hiring of a Chief Development Officer with extensive experience in CNS therapies is expected to enhance the company's development capabilities [6][8] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing failures of competitors in both IPF and RCC, underscoring the need for new therapies [10] - The company anticipates a strong news flow in the upcoming months, representing important value inflection points [25] Other Important Information - The Human Abuse Potential (HAP) study is being conducted to meet FDA guidance, with results expected in December 2024 [11][15] - The company is preparing for an end-of-Phase 2 meeting with the FDA, which will include discussions on the HAP study results [44] Q&A Session Summary Question: Clarification on butorphanol drug liking and nalbuphine's HAP study - Management explained the complexity of the studies and the criteria for patient qualification, emphasizing the importance of differentiating nalbuphine from butorphanol in terms of abuse potential [31][34] Question: Sample size increase for SSRE - Management confirmed that the sample size for the SSRE could range from 160 to 400, depending on the actual data observed [38] Question: Balancing of RCC trial arms - Management assured that while the RCC trial arms may not be perfectly balanced, sufficient numbers exist for statistical analysis [40][42] Question: Timing of TIDAL respiratory physiology study - Management indicated that the TIDAL study is ongoing and aims to provide data by the end of the Phase 2 meeting in the second half of next year [48] Question: DEA decision timeline post-HAP results - Management clarified that the DEA's decision would follow the NDA submission and is not guaranteed to occur [52]