BioXcel Therapeutics, Inc. (Nasdaq: BTAI) reported a net loss of $69.9 million for the year ended December 31, 2025, compared to a net loss of $59.6 million for the previous year. The company's product revenue, net, decreased from $2.3 million in 2024 to $0.6 million in 2025, primarily due to a reduction in bulk sales to existing customers, an increase in GPO discounts, and a reduction in commercial activities due to the Clinical Reprioritization in May 2024 and September 2024. Research and development expenses remained relatively stable at $30.3 million in 2025, compared to $30.4 million in 2024, with increased clinical trial expenses offset by decreased personnel and professional fees. Selling, general, and administrative expenses decreased by 41% to $20.5 million in 2025, from $34.5 million in 2024, due to workforce reductions and lower professional fees.
The company's strategic developments in 2025 included the submission of a supplemental New Drug Application (sNDA) to the FDA for IGALMI® for at-home use in treating agitation associated with schizophrenia and bipolar disorders. BioXcel also announced positive topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, demonstrating continued effects and consistent benefits with repeat dosing of BXCL501. The company has deprioritized the development of BXCL501 for certain other proposed indications and continues to evaluate strategic options for its neuroscience assets, including licensing, partnering, and co-commercialization.
Key operational developments included the completion of the SERENITY At-Home Pivotal Phase 3 trial, which enrolled 246 patients and collected data on 2,628 agitation episodes. The 120 mcg dose of BXCL501 was well-tolerated, with an adverse event profile consistent with the approved IGALMI® label. The company also announced positive results from a correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial, demonstrating a strong correlation between clinician assessments and patient/caregiver assessments. As of December 31, 2025, the company had 29 full-time employees, compared to 37 at the end of 2024, reflecting workforce reductions as part of the Clinical Reprioritization.
BioXcel's management believes that its cash, cash equivalents, and restricted cash of $28.8 million as of December 31, 2025, plus $0.5 million of gross proceeds from sales pursuant to the Company ATM Program after December 31, 2025, as well as the $7.8 million of gross proceeds received by the Company in its registered direct offering in March 2026, will allow the Company to fund its operations and meet its liquidity requirements into the second quarter of 2026. The company is actively seeking additional funding through various means, including equity offerings, debt financing, and strategic collaborations. However, the company acknowledges that its ability to continue as a going concern is dependent on obtaining additional financing, and there is no assurance that such financing will be available on acceptable terms or at all.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a biopharmaceutical company leveraging artificial intelligence to develop transformative neuroscience and immuno-oncology medicines. Its core business involves repurposing existing drugs using AI-driven platforms to identify new therapeutic indications, focusing on neuropsychiatric disorders and cancer. Key products include IGALMI®, an FDA-approved sublingual film for agitation in schizophrenia and bipolar disorder, and investigational candidates like BXCL501. The company targets patients with unmet medical needs through clinical development and potential partnerships.
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