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BioXcel Therapeutics (BTAI) investor relations material
BioXcel Therapeutics Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Submitted sNDA to FDA for IGALMI label expansion to at-home use for acute agitation in bipolar disorders and schizophrenia, with potential approval by year-end 2026.
Advancing commercial launch plans for IGALMI in the at-home setting, supported by third-party market assessment indicating up to 86 million annual addressable episodes.
Focused on expanding BXCL501 clinical programs, including Alzheimer's dementia and opioid withdrawal indications.
Financial highlights
Net revenue from IGALMI was $256,000 for Q4 2025 (down from $366,000 in Q4 2024) and $642,000 for full-year 2025 (down from $2.3 million in 2024).
Cost of goods sold for Q4 2025 was $32,000 (down from $832,000 in Q4 2024); full-year was $164,000 (down from $2.1 million in 2024), mainly due to lower inventory reserve charges.
R&D expenses were $6.7 million for Q4 2025 (up from $5.9 million in Q4 2024) and $30.3 million for full-year 2025 (flat vs. $30.4 million in 2024).
SG&A expenses were $3.8 million for Q4 2025 (down from $4.1 million in Q4 2024) and $20.5 million for full-year 2025 (down from $34.5 million in 2024), reflecting lower personnel and marketing costs.
Operating loss was $10.3 million for Q4 2025 (vs. $10.5 million in Q4 2024); net loss was $12.5 million for Q4 2025 (vs. $10.9 million in Q4 2024).
Full-year 2025 operating loss was $50.5 million (vs. $67.2 million in 2024); net loss was $69.9 million (vs. $59.6 million in 2024).
Cash used in operations for 2025 was $57.6 million, down from $72.0 million in 2024; cash and equivalents totaled $28.8 million at year-end 2025.
Outlook and guidance
sNDA timeline supports potential IGALMI at-home approval by year-end 2026.
Commercial and launch plans for IGALMI at-home are advancing, with market research supporting a large addressable market.
Continued focus on Alzheimer's dementia and opioid withdrawal programs.
- BXCL501 offers a rapid, safe, and easy-to-administer solution for acute agitation in Alzheimer's dementia.BTAI
Status update27 Feb 2026 - IGALMI revenue surged and losses narrowed, but urgent capital needs remain.BTAI
Q2 20242 Feb 2026 - Pivotal trials for BXCL501 target at-home and Alzheimer's agitation, with strong FDA alignment.BTAI
Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 20242 Feb 2026 - Pivotal trials aim to expand BXCL501 into home settings for major agitation markets.BTAI
Jefferies Global Healthcare Conference1 Feb 2026 - BXCL501 Phase III trials progress as net loss narrows but liquidity risks remain.BTAI
Q3 202414 Jan 2026 - AI-driven drug developer registers 5.1M shares for resale amid financial and listing risks.BTAI
Registration Filing16 Dec 2025 - All proposals passed, including director elections and a reverse stock split precaution.BTAI
AGM 202513 Dec 2025 - Vote on a reverse stock split to maintain Nasdaq listing and authorize meeting adjournment.BTAI
Proxy Filing2 Dec 2025 - Vote on a reverse stock split to maintain Nasdaq listing and authorize meeting adjournment.BTAI
Proxy Filing2 Dec 2025
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