BioXcel Therapeutics, Inc. (BTI) reported a net loss of $59.6 million for the year ended December 31, 2024, compared to a net loss of $179.1 million in 2023. Net revenue increased to $2.3 million in 2024 from $1.4 million in 2023, driven by sales of IGALMI®, its FDA-approved sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder. The company revised its commercial strategy for IGALMI® in the third quarter of 2023, reducing in-hospital commercialization expenses and focusing on BXCL501 development for at-home and care facility settings. Research and development expenses decreased significantly to $30.4 million in 2024 from $84.3 million in 2023, primarily due to the completion of certain clinical trials and a reduction in workforce. Selling, general, and administrative expenses also decreased to $34.5 million in 2024 from $83.4 million in 2023, largely due to workforce reductions.
Significant workforce reductions, totaling approximately 60% of its workforce, were implemented in 2023 and 2024 as part of a strategic reprioritization to conserve cash and focus on core clinical programs. This included a reduction of approximately 15% in May 2024 and an additional 28% reduction in September 2024. The company also initiated the SERENITY At-Home trial in September 2024 to evaluate the safety of BXCL501 for at-home treatment of agitation associated with bipolar disorders or schizophrenia, with 127 patients enrolled by March 27, 2025. The company also submitted a protocol to the FDA in September 2024 for the TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501 for agitation associated with Alzheimer's dementia. In October 2024, a U.S. Department of Defense grant was awarded to fund a study of BXCL501 for Acute Stress Disorder.
The company received a Nasdaq delisting notice in September 2024 for failing to meet minimum bid price and market value requirements. A 1-for-16 reverse stock split was implemented in February 2025 to regain compliance with the minimum bid price requirement. The company's common stock remains listed pending a hearing before the Nasdaq Hearings Panel to appeal the delisting determination related to market value. The company also underwent several amendments to its Credit Agreement throughout the year, including modifications to covenants, capital raising requirements, and interest rates. These amendments reflect the company's efforts to manage its financial position and extend its cash runway.
As of December 31, 2024, BTI had $29.8 million in cash and cash equivalents and a stockholders' deficit of $93.1 million. The company's cash and cash equivalents, along with proceeds from a March 2025 registered direct offering, are projected to fund operations into the third quarter of 2025. However, the company acknowledges substantial doubt about its ability to continue as a going concern for at least 12 months from the issuance date of its financial statements due to its history of losses, negative cash flows, and dependence on future financing. The company is actively pursuing various strategies to improve its liquidity, including equity and debt financing, collaborations, and strategic options for its subsidiary, OnkosXcel.
The company's 10-K filing details numerous risk factors, including those related to its financial position, product development, commercialization, reliance on third parties, intellectual property, and regulatory compliance. These risks highlight the uncertainties inherent in the biopharmaceutical industry and the challenges BTI faces in achieving profitability and long-term sustainability. The company's outlook is contingent upon successful clinical trial outcomes, regulatory approvals, market acceptance of its products, and securing additional funding.
About BioXcel Therapeutics, Inc.
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