Trevi Therapeutics(TRVI)2024-08-11 05:28Financial Data and Key Metrics Changes - For Q2 2024, the company reported a net loss of 7.1 million in Q2 2023 [14] - R&D expenses increased to 5.8 million in Q2 2023, reflecting strong clinical activity across all trials [14] - G&A expenses rose to 2.5 million in Q2 2023, primarily due to increases in personnel and related expenses [14] - As of June 30, 2024, cash, cash equivalents, and marketable securities totaled 83 million as of December 31, 2023 [14] Business Line Data and Key Metrics Changes - The Phase 2a RIVER trial for refractory chronic cough (RCC) is expected to read out in Q4 2024, with approximately 80% of subjects enrolled [5][7] - The IPF chronic cough trial, CORAL, is a Phase 2b study involving approximately 160 patients, with enrollment progressing well [8][9] - The human abuse potential (HAP) study is 95% enrolled, with data expected in Q4 2024 [10] Market Data and Key Metrics Changes - The company estimates that there are approximately 2 million to 3 million treatable patients in the U.S. for RCC, with about 7 million diagnosed [55] - There is a significant unmet need for therapies in both RCC and IPF chronic cough, with no currently approved treatments for chronic cough in IPF [6][8] Company Strategy and Development Direction - The company is focused on executing clinical development plans for chronic cough and IPF, with a commitment to prioritize IPF as the lead indication [31] - The company aims to optimize the value of Haduvio by potentially positioning it as a third-line therapy behind other treatments in the RCC market [31] - The company is conducting supportive studies to inform the development path for Haduvio in chronic cough conditions [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for Haduvio to address significant unmet needs in chronic cough conditions [4][6] - The company anticipates steady news flow of data in the upcoming months and plans to participate in several investor conferences [63] Other Important Information - The company issued approximately 1.5 million shares from its ATM during the quarter, strengthening its cash runway post-data readouts [14] - The company expects cash burn to average between 12 million per quarter in 2024, with a cash runway extending into 2026 [14] Q&A Session Summary Question: Regarding the RIVER chronic cough trial, were different powering assumptions used for different severity groups? - Management confirmed that the same assumptions were made for the effect size in subgroup analyses [17] Question: Can you confirm the scheduling status of nalbuphine and its implications? - Management indicated that nalbuphine remains unscheduled and expressed confidence that it should remain so based on existing data [18] Question: What are the expectations for enrollment in the respiratory physiology study? - Management stated that the study will start with the same population as the CORAL study and will expand to include sleep-disordered breathing subtypes [24] Question: How does the outcome of the RCC trial impact plans for IPF? - Management emphasized that IPF remains the lead indication, but the outcome of the RCC trial will be considered in future strategies [31] Question: What is the current patent coverage for nalbuphine? - Management detailed that method of treatment patents extend through 2039, with additional applications being prosecuted to extend coverage further [52] Question: How many patients are diagnosed with RCC and seeking treatment? - Management estimated that there are about 2 million to 3 million treatable patients in the U.S. for RCC [55] Question: What is the anticipated delay for the RCC readout due to enrollment imbalance? - Management does not expect any delay and reaffirmed guidance for Q4 2024 for data readout [59]