Belite Bio(BLTE)2025-05-20 22:00Financial Data and Key Metrics Changes - The company currently has USD 157 million available, which is sufficient to complete all ongoing Phase III clinical trials [32] Business Line Data and Key Metrics Changes - The lead candidate, telarabant, is being evaluated in two Phase III trials named Dragon and Dragon II, with the first Dragon trial expected to complete in Q4 2025 [13][18] - The Dragon II trial is currently enrolling patients, with 16 out of a target of 60 patients already enrolled [19] Market Data and Key Metrics Changes - The estimated prevalence of Stargardt disease in the U.S. is between 43,000 and 59,000 patients, indicating a significant market opportunity [12] - The prevalence of Stargardt disease is approximately 1 in 6,500 for populations of European descent and 1 in 11,000 to 12,000 for East Asians [11] Company Strategy and Development Direction - The company aims to expedite the approval process for telarabant, having received breakthrough designation from the FDA based on interim data [15][17] - The company is also exploring opportunities in Japan, with the PMDA showing interest in telarabant's market authorization [21] Management's Comments on Operating Environment and Future Outlook - Management expressed high expectations for the final study data from the Dragon trial, which is anticipated by the end of the year [15] - The management is closely monitoring the regulatory environment and market conditions, particularly in relation to pricing policies [24] Other Important Information - Telarabant's mechanism of action is unique as it addresses vitamin A availability in photoreceptors, which is crucial for treating Stargardt disease [7][9] - The company is aware of competitors in the geographic atrophy space but believes telarabant could be transformative due to its oral administration [31] Q&A Session Summary Question: Does BELIBA currently have sufficient capital to complete all ongoing Phase III trials? - The company confirmed it has USD 157 million available, which is sufficient to complete all clinical trials currently running [32]