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BioXcel Therapeutics (BTAI) investor relations material
BioXcel Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
SERENITY At-Home Phase 3 trial for BXCL501 met its primary safety and efficacy endpoints, supporting a planned sNDA for IGALMI® label expansion to at-home use in early Q1 2026.
Positive topline data and high correlation between clinician assessments and mCGI-S scale reinforce BXCL501's benefit and support regulatory submission.
Workforce reductions and clinical reprioritization in 2024 focused resources on BXCL501, with other programs paused or deprioritized.
IGALMI® commercialization continues with minimal resources, maintaining market presence and brand awareness while seeking partners.
Advancing TRANQUILITY In-Care Phase 3 trial for agitation in Alzheimer's dementia, with FDA feedback received and preparations underway.
Financial highlights
Net loss for Q3 2025 was $30.9 million, compared to $13.7 million in Q3 2024; nine-month net loss was $57.4 million, up from $48.7 million year-over-year.
Product revenue for Q3 2025 was $98,000, down from $214,000 in Q3 2024; nine-month revenue was $386,000, down from $1.9 million year-over-year.
Operating expenses for Q3 2025 were $14.3 million, down from $15.5 million in Q3 2024; R&D expenses rose to $8.7 million, SG&A decreased to $5.4 million.
Cash, cash equivalents, and restricted cash totaled $37.3 million as of September 30, 2025, with $4.9 million raised post-quarter via ATM program.
Net cash used in operating activities for the nine months ended September 30, 2025 was $43.4 million; $18.8 million used in Q3 2025.
Outlook and guidance
Cash runway is expected to last into Q1 2026, assuming compliance with credit covenants; additional capital will be required to fund operations beyond Q1 2026.
sNDA submission for IGALMI® at-home use planned for early Q1 2026, pending FDA review.
TRANQUILITY In-Care Phase 3 trial for BXCL501 in Alzheimer's agitation to initiate upon funding, with preparations ongoing.
Company anticipates significant long-term growth from expanded at-home market opportunity.
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Next BioXcel Therapeutics earnings date
AGM 202512 Dec, 2025
Next BioXcel Therapeutics earnings date
AGM 202512 Dec, 2025
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BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on utilizing artificial intelligence to discover and develop new therapies in neuroscience and immuno-oncology. The company leverages its proprietary AI platform to identify and advance drug candidates for the treatment of complex conditions, including psychiatric disorders and cancers. BioXcel Therapeutics is engaged in both clinical and preclinical development. The company is headquartered in New Haven, United States, and its shares are listed on the NASDAQ.
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