Trevi Therapeutics(TRVI) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In Q4 2021, the company reported a net loss of $8.5 million, an improvement from a net loss of $9.5 million in Q4 2020 [21] - The company raised $14.8 million in financing during the fourth quarter, ending the year with a cash balance of $36.8 million [21] Business Line Data and Key Metrics Changes - The CANAL trial in chronic cough and idiopathic pulmonary fibrosis (IPF) showed a statistically significant reduction in cough, allowing the trial to be stopped early [7] - The PRISM trial for severe chronic pruritus and prurigo nodularis (PN) completed enrollment as of January 31, 2022, with top-line data expected in Q2 2022 [8] Market Data and Key Metrics Changes - The global prevalence of PN is estimated at approximately 730,000 patients, with 300,000 in the U.S. and 430,000 in the rest of the world [9] - The global chronic cough market is estimated to be approximately $10 billion [14] Company Strategy and Development Direction - The company aims to focus on advancing its lead programs in chronic cough and PN, with plans for indication expansion in both areas [16] - The company is considering both refractory chronic cough and other interstitial lung disease cough as it moves forward [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Haduvio in treating chronic cough and PN, highlighting the lack of approved therapies in these indications [8][15] - The company plans to engage with regulatory authorities and initiate discussions with interstitial lung disease centers in the U.S. [30] Other Important Information - The company will host a call on March 30, 2022, to review interim results and provide additional analyses [17] - Management emphasized the importance of mindful cash runway planning for future clinical trials [33] Q&A Session Summary Question: What is the expected development path for the CANAL program? - Management indicated that they believe their mechanism could work broadly in cough and are planning to engage with the FDA for next steps [26][30] Question: How will the company fund future programs given the cash balance? - Management acknowledged the need to raise funds for the next clinical trial and will consider the cost of programs and unmet needs in their planning [32][33] Question: Did the CANAL trial use the same dose and titration protocol as the PRISM study? - The dosing protocol was slightly altered in the CANAL study to gather dose data, but the final dosage remained consistent [41][42] Question: When can the market expect the PRISM trial readout? - The readout for the PRISM trial is anticipated at the end of Q2 2022 [44] Question: What are the implications of Haduvio being used prior to biologics? - Management noted that Haduvio could serve as a step-through therapy, potentially being more cost-effective and easier for patients compared to biologics [49] Question: What is the company's strategy regarding partnerships? - The company is focusing on geographic partnerships, particularly in Asia and Europe, to advance its marketing efforts [50]