BioXcel Therapeutics (NasdaqCM:BTAI) FY Conference Transcript

Summary of BioXcel Therapeutics FY Conference Call Company Overview - Company: BioXcel Therapeutics (NasdaqCM:BTAI) - Founded: Became a public company in March 2018 - Focus: Development of transformative medicines in neuroscience utilizing artificial intelligence platforms [2][3] Key Product Information - Product: IGALMI - Indication: Acute treatment of agitation related to schizophrenia and bipolar disorder - Current Approval: Approved under medical supervision, not available in retail settings [3][4] - Market Potential: Initially estimated at 23 million episodes, revised to 57 to 77 million episodes in home settings [5][9] Recent Developments - Phase 3 Trial: Announced pivotal Phase 3 data for IGALMI, with plans to file a supplemental New Drug Application (sNDA) [2][8] - Alzheimer's Agitation Program: Positive Phase 3 trial completed; FDA has requested another confirmatory Phase 3 trial [5][20] Market Expansion Strategy - Home Setting: Focus on expanding IGALMI's use into home settings, targeting a larger patient population [5][9] - Commercial Strategy: Developing a strategy to bring IGALMI to patients, with potential approval in 2026 [9][19] Clinical Trial Insights - SERENITY At-Home Trial: Completed safety trial using the lowest approved dose of IGALMI; demonstrated safety and tolerability in home settings [8][16] - Patient Data: 2,437 agitation episodes treated in 208 patients; average of 11.7 episodes over 12 weeks [15][16] - Safety Profile: No treatment-emergent adverse events leading to discontinuation; consistent with approved IGALMI label [16][18] Future Plans - sNDA Submission: Expected in Q1 of 2026; non-clinical sections completed, clinical and CMC sections in progress [9][18] - Alzheimer's Trial: Plans to conduct a second confirmatory Phase 3 trial for Alzheimer's agitation in in-care settings [20] Market Opportunity - Agitation as a Medical Need: Significant unmet medical need for agitation treatment, especially in home settings; no FDA-approved therapies currently available for home use [10][17] - Patient Distribution: Approximately 50% of agitation episodes occur in in-care settings, highlighting the need for effective home treatment options [19][20] Conclusion - Overall Outlook: Positive momentum with ongoing trials and market expansion strategies; significant potential for IGALMI in both schizophrenia and Alzheimer's agitation [20][21]