Trevi Therapeutics(TRVI) - 2020 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q4 2020, the company reported a net loss of $9.5 million, compared to a net loss of $6.5 million in Q4 2019, indicating a deterioration in financial performance [15] - R&D expenses increased to $6.6 million in Q4 2020 from $4.8 million in Q4 2019, primarily due to heightened activity in the Phase IIb/III PRISM trial [15] - For the full year 2020, the net loss was $32.8 million, up from $26.1 million in 2019, reflecting increased operational costs [17] - Cash and cash equivalents as of December 31, 2020, totaled $45 million, down from $57.3 million a year earlier, but sufficient to fund operations into Q2 2022 [17] Business Line Data and Key Metrics Changes - The PRISM trial for prurigo nodularis is currently in Phase IIb/III, with 240 of the planned 360 subjects randomized, despite COVID-19 impacting enrollment [7][9] - The chronic cough trial in idiopathic pulmonary fibrosis (IPF) is facing challenges due to COVID-19 restrictions, but enrollment is expected to resume in Q2 2021 [12] Market Data and Key Metrics Changes - The global prevalence of prurigo nodularis is estimated at 730,000 patients, with 300,000 in the US and 430,000 in the rest of the world [7] - The estimated prevalence of IPF exceeds 1 million patients worldwide, with approximately 130,000 patients in the US and an equal number in Europe [11] Company Strategy and Development Direction - The company is focused on completing enrollment in both clinical trials this year and reporting data, as both conditions have no approved therapies [13] - There is an ongoing strategy to add high-quality centers for the PRISM study to enhance enrollment rates [23] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by COVID-19 but expressed optimism about resuming enrollment and achieving timelines for the PRISM trial [9][22] - The company has not provided formal guidance for the chronic cough trial but is striving to complete enrollment by year-end [24][31] Other Important Information - Chris Seiter, the Chief Financial Officer, will be leaving the company in April for a new opportunity [13] - The company plans to participate in various dermatology meetings to present clinical evidence related to their trials [10] Q&A Session Summary Question: Will additional sites be needed for the PRISM study to meet timelines? - Management confirmed that they are in the process of adding a few high-quality centers to the PRISM study to enhance enrollment [23] Question: How are the discontinuation rates and adverse events in the study? - Management indicated that the strategies to manage discontinuation rates are working, and adverse events reported are consistent with previous studies [27][28] Question: Can the chronic cough trial data still be expected by year-end despite challenges? - Management has not reinstated formal guidance but is internally striving to complete enrollment by year-end [24][31] Question: Is there a plan to expand the IPF trial to sites outside of Europe? - Currently, the focus remains on completing the trial in Europe due to existing expertise, with no immediate plans to expand to the US [27]