Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of $10.4 million, an improvement from a net loss of $10.9 million in Q1 2024 [14] - R&D expenses decreased to $7.8 million in Q1 2025 from $8.8 million in Q1 2024, primarily due to reduced costs related to a human abuse potential study [14] - G&A expenses increased to $3.7 million in Q1 2025 from $3.1 million in Q1 2024, mainly due to higher personnel-related expenses [15] - As of March 31, 2025, cash and investments totaled $103.3 million, providing a runway into Q4 2026 [15] Business Line Data and Key Metrics Changes - The Phase 2a RIVER trial in RCC patients showed a 57% placebo-adjusted reduction in cough frequency, achieving a p-value of less than 0.0001 [7][8] - The Phase 2b CORAL trial for IPF chronic cough patients completed enrollment with approximately 160 patients across 10 countries [9] Market Data and Key Metrics Changes - RCC affects approximately 2 to 3 million patients in the U.S. with no approved therapies currently available [5] - The company is preparing for data release from the CORAL trial, which is expected to provide insights into treatment options for a patient group with limited innovation over the past decade [12] Company Strategy and Development Direction - The company aims to advance its development programs based on the upcoming data from the CORAL trial and is considering a basket trial in interstitial lung disease [23][57] - The management emphasizes the importance of FDA feedback and plans to engage with the agency based on the results of the IPF trials [11][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from the CORAL trial and the potential for positive outcomes, which would allow for continued development [20][30] - Concerns remain regarding the complexity of trials and the challenges faced in treating difficult patient populations [30] Other Important Information - The company plans to actively participate in the ATS conference, sharing insights from the RCC data set and engaging with key opinion leaders [12][52] - The management is in strategic discussions for potential partnerships, particularly for commercialization in Europe and Japan [71] Q&A Session Summary Question: What would be considered a positive readout for the CORAL trial? - A statistically significant positive trial would be the bar for success, with no unusual adverse events expected [20] Question: What are the next catalysts for the company following the CORAL readout? - The company will outline a catalyst path forward after receiving the IPF data [23] Question: What was the powered discontinuation rate for the study? - The study was powered for a 30% discontinuation rate, but the actual rate was less than 10% [29] Question: What are the thoughts on long-term patient outcomes and safety findings? - The company plans to include 52 weeks of safety data in the Phase III program and is preparing for long-term safety monitoring [68] Question: Are there any updates on the respiratory physiology study? - The study is on track to finish in the second half of the year [46] Question: What data points can be expected at ATS from the RIVER study? - The presentation will include analyses around timing of adverse events, discontinuations, and quality of life questionnaires [50]