Trevi Therapeutics(US:TRVI)2022-11-14 00:41Financial Data and Key Metrics Changes - In Q3 2022, the company reported a net loss of $8.3 million, compared to a net loss of $7.3 million in Q3 2021, indicating a year-over-year increase in losses [17] - R&D expenses rose to $5.8 million in Q3 2022 from $4.7 million in the same period of 2021, primarily due to start-up activities for planned trials [17] - G&A expenses increased to $2.6 million in Q3 2022 from $2.2 million in Q3 2021, attributed to higher legal fees and increased market research costs [18] - The company raised approximately $55 million in gross proceeds from a public offering and received an additional $5.9 million from warrant exercises during the quarter [18] - As of October, the cash and investments balance was approximately $125.7 million, providing a cash runway into 2026 [19] Business Line Data and Key Metrics Changes - The CANAL trial for chronic cough and idiopathic pulmonary fibrosis (IPF) reported positive results, confirming significant reductions in cough frequency and severity [6][10] - The company is preparing for the next phase of development for Haduvio, focusing on chronic cough and IPF, with plans to initiate a new study in the first half of 2023 [9][14] - The Phase IIb/III PRISM trial for prurigo nodularis (PN) achieved statistical significance on all key endpoints, with ongoing work to prepare for an end of Phase II meeting with the FDA [11][12] Market Data and Key Metrics Changes - The company is expanding its clinical trial sites beyond the UK to include the US and Germany, which is expected to enhance enrollment capabilities for future studies [27] - The positive trial data for IPF cough has garnered attention from key opinion leaders (KOLs) and pulmonologists globally, indicating strong market interest [10][40] Company Strategy and Development Direction - The company is focused on advancing Haduvio for chronic cough and IPF, while also exploring additional chronic cough indications, with a Phase II refractory chronic cough study planned for mid-2023 [29][30] - Discussions are ongoing with potential partners for the PN program, with a preference to find a partner rather than conducting the final study independently [31][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of business plans and the positive trial results, positioning the company well for continued development [14] - The company is actively preparing for regulatory meetings and designing protocols for the next phase of development, indicating a proactive approach to future challenges [13] Other Important Information - The company is preparing a manuscript to publish trial results and has presented data at various medical meetings, enhancing visibility in the medical community [10][12] Q&A Session Summary Question: What are the plans for the future IPF trial design and enrollment? - Management is in discussions with regulatory agencies and plans to use an objective cough monitor as an endpoint, with a focus on validating it in the IPF population [24][25] - Enrollment is expected to improve with more sites available in the US and Germany, mitigating previous challenges faced during the UK-only study [27] Question: Is there interest in exploring additional chronic cough indications? - The company is interested in initiating a Phase II refractory chronic cough study by mid-2023, while prioritizing the IPF cough program [29][30] Question: What is the status of the PN program and potential partnerships? - The company is actively seeking partners for the PN program and does not plan to run the final study independently, focusing resources on the cough portfolio [31][41]