--- title: "BioXcel reports first quarter 2026 results" url: "https://aibio.space/news/bioxcel-reports-first-quarter-2026-results-engages-mts-health-partners/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-05-15" section: "Company Updates" tickers: "OTC:BTAIQ" source: "https://www.sec.gov/Archives/edgar/data/1720893/000110465926061773/tm2614679d1_ex99-1.htm" summary: "The company said the FDA accepted its IGALMI at-home sNDA with a November 14, 2026 PDUFA date, and that it is reviewing strategic options. First quarter ne" --- By the aibio.space news desk. Sources - [BioXcel Therapeutics, Inc. 8-K (2026-05-15)](https://www.sec.gov/Archives/edgar/data/1720893/000110465926061773/tm2614679d1_ex99-1.htm) - [BioXcel Therapeutics, Inc. financial data (SEC XBRL)](https://www.sec.gov/Archives/edgar/data/1720893/000110465926036214/) [BTAIQ](https://aibio.space/companies/bioxcel-therapeutics-btaiq/) 2026-05-15 # BioXcel reports first quarter 2026 results and engages MTS Health Partners Tickers [BTAIQ](https://aibio.space/companies/bioxcel-therapeutics-btaiq/) The company said the FDA accepted its IGALMI at-home sNDA with a November 14, 2026 PDUFA date, and that it is reviewing strategic options. First quarter net loss was $12.7 million. ## Key facts - **Company**: BioXcel Therapeutics, Inc. (OTC: BTAIQ) - **News type**: Company Updates - **Primary source**: [BioXcel Therapeutics, Inc. 8-K (2026-05-15)](https://www.sec.gov/Archives/edgar/data/1720893/000110465926061773/tm2614679d1_ex99-1.htm) *Researchers loading samples into an automated instrument. Photo: Centers for Disease Control and Prevention, CC0, via rawpixel. The picture shows the field, not the companies named.* BioXcel Therapeutics, Inc. provided a business update and reported first quarter 2026 financial results on May 15, 2026. In the quarter ended March 31, the FDA accepted the company's supplemental New Drug Application for IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia, and assigned a PDUFA target action date of November 14, 2026. The release also says the company engaged MTS Health Partners as an advisor to evaluate strategic options. ## Strategic options The company engaged MTS Health Partners to evaluate strategic options to maximize shareholder value and advance the commercial and development plans for IGALMI. The release lists the possible outcomes as a sale of the company, a merger or other business combination, a collaboration, joint venture, royalty or license agreement covering all or part of its assets, a recapitalization or other financing transaction, or continued execution of its standalone operating plan. The company says it has not made a decision on any specific transaction, has set no timetable for the process, and cannot assure that it will produce any transaction. ## The regulatory and clinical programs If approved, the at-home label would be the first FDA-approved treatment option for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting, according to the release. The BXCL501 program for Alzheimer's dementia continues through the TRANQUILITY In-Care Phase 3 trial. The trial is designed as a double-blind, placebo-controlled study of a 60 mcg dose of BXCL501 for the acute treatment of agitation associated with Alzheimer's dementia. BXCL501 has Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders and dementia. The release says the safety and efficacy of BXCL501 for these uses have not been established. ## First quarter financial results IGALMI net revenue was $206,000 for the first quarter of 2026, compared with $168,000 for the same period in 2025. Cost of goods sold was $283,000, compared with $14,000 a year earlier, mainly because of higher charges for reserves for excess or obsolete inventory. Research and development expense was $3.0 million, down from $4.6 million, mainly because the SERENITY At-Home pivotal Phase 3 safety trial was completed in 2025. Selling, general and administrative expense was $7.2 million, up from $5.7 million, mainly because of higher professional fees. The company reported an operating loss of $10.2 million and a net loss of $12.7 million for the first quarter of 2026, compared with an operating loss of $10.1 million and a net loss of $7.3 million a year earlier. Cash and cash equivalents and restricted cash totaled $17.2 million as of March 31, 2026. The release says the company remains in compliance with the covenants in its Credit Agreement. ## The annual figures and the business The 10-K filed March 27, 2026 reports revenue of $642,000 for 2025 and $2.3 million for 2024. Research and development expense was $30.3 million in 2025 and $30.4 million in 2024, and the net loss was $69.9 million and $59.6 million in those years. Year-end cash and cash equivalents were $29.9 million at the end of 2024. BioXcel describes itself as a biopharmaceutical company built on artificial intelligence to develop medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, focuses on immuno-oncology. ## What comes next IGALMI sales remain tiny next to the losses: $206,000 of net revenue against a $12.7 million net loss for the quarter, with $17.2 million of cash and restricted cash at March 31. The release gives no cash runway estimate, and approval of the at-home label is not assured. The next milestone the release names is the PDUFA target action date of November 14, 2026 for the at-home sNDA. The company says it is preparing for the IGALMI launch in the at-home setting while keeping brand awareness up with minimal commercial resources. It is also pursuing strategic options with MTS Health Partners, but the release sets no timetable for that process. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story BTAIQ BioXcel Therapeutics, Inc. 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Cite as: aibio.space, "BioXcel reports first quarter 2026 results", 2026-05-15, https://aibio.space/news/bioxcel-reports-first-quarter-2026-results-engages-mts-health-partners/