Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported $77.2 million in cash, cash equivalents, and marketable securities, which is expected to cover all known aspects of the ongoing U.S. registration-directed PALISADE program for fascidinol [7] Business Line Data and Key Metrics Changes - The PALISADE III Phase III trial for fascidinol, aimed at treating social anxiety disorder, has completed the randomized double-blind portion, with top-line results expected by the end of the calendar year [4][5] - The company is also preparing for the PALISADE IV Phase III trial results, which share a similar design and primary efficacy endpoint as the previously successful PALISADE II trial [6] Market Data and Key Metrics Changes - The company is focused on addressing significant unmet needs in mental health, particularly in social anxiety disorder, major depressive disorder, and menopausal hot flashes, indicating a strong market potential for its products [6] Company Strategy and Development Direction - The company aims to redefine neuroscience and improve emotional well-being through innovative treatments, with a diverse pipeline and several key milestones approaching [9] - The addition of Paul Edick to the Board of Directors is expected to enhance the company's strategic direction as it prepares for growth [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming top-line results and the potential for fascidinol to become the first FDA-approved acute treatment for social anxiety disorder [4][9] - The company is evaluating commercialization strategies, considering both independent launch and potential partnerships, to maximize the value of its innovative assets [40][41] Other Important Information - The company is committed to maintaining high-quality assessments for subject eligibility in its studies, which has led to enhancements in the PALISADE III and IV trials [16] Q&A Session Summary Question: Timeline for top-line data release - Management confirmed that top-line results are expected by the end of the calendar year [12] Question: Discontinuation rates and safety profile - Management indicated that safety data will be provided alongside top-line results, similar to PALISADE II [14] Question: Registration filing requirements - Management outlined that an NDA submission could occur around mid-2026 if the PALISADE III trial is positive, contingent on completing necessary studies and interactions with the FDA [22] Question: Eligibility for priority review voucher - Management acknowledged the unmet need in social anxiety disorder but does not currently expect fascidinol to qualify for the priority review voucher program [29] Question: Usage patterns from open-label studies - Management noted that usage patterns are expected to vary based on individual circumstances, with increased utilization during weekdays [35] Question: Commercialization strategy - Management emphasized the importance of having a solid commercial plan and the potential for strategic partnerships to enhance value [40][41]