BioXcel Therapeutics Reports $7.254 Million Net Loss and Decreased Product Revenue in Q1 2025

BioXcel Therapeutics, Inc. (BTAI) reported a net loss of $7.254 million for the three months ended March 31, 2025, compared to a net loss of $26.791 million for the same period in 2024. Product revenue, net, decreased to $168,000 from $582,000 during this period, primarily due to reduced bulk sales and decreased commercial activities following workforce reductions in 2024. The company's cash and cash equivalents totaled $31.013 million as of March 31, 2025, with an accumulated deficit of $657.451 million. Management noted that these figures, along with the company's history of significant losses and dependence on additional financing, raise substantial doubt about its ability to continue as a going concern for at least 12 months.

Operating expenses decreased significantly year-over-year. Research and development expenses fell by 60% to $4.554 million, primarily due to reduced clinical trial costs and lower personnel expenses. Selling, general, and administrative expenses also decreased by 57% to $5.699 million, reflecting the impact of workforce reductions and a revised commercialization strategy for IGALMI®. Interest expense increased to $3.993 million due to higher debt balances and interest rates under the company's Credit Agreement, partially offset by lower interest income.

The company's strategic reprioritization, implemented in 2023 and furthered in 2024, involved workforce reductions of approximately 15% and 28%, respectively, aiming to extend its cash runway and prioritize core clinical programs. Further restructuring costs of $475,000 were paid in Q1 2025, with an additional $128,000 expected in Q2 2025. The company is advancing plans for the initiation of the TRANQUILITY In-Care Phase 3 trial upon securing funding. The SERENITY At-Home Phase 3 trial, initiated in September 2024, was fully enrolled by May 12, 2025, with topline data expected in the second half of 2025.

Several amendments to the company's Credit Agreement were executed during the reporting period, modifying covenants, interest rates, and capital raising requirements. The company received net proceeds of approximately $12.957 million from a March 2025 registered direct offering. As of March 31, 2025, the company was in compliance with all restrictive and financial covenants under the Credit Agreement. The company also noted ongoing legal proceedings, including class action and derivative lawsuits, and is cooperating with an SEC investigation.

The company's outlook includes continued efforts to raise additional capital through various means, including equity sales and potential strategic options for its subsidiary, OnkosXcel Therapeutics. The company emphasized the uncertainties associated with its clinical trials, regulatory approvals, and market acceptance of its products, reiterating substantial doubt about its ability to continue as a going concern. The company also highlighted the risks associated with its reliance on third-party manufacturers and the competitive landscape of the biopharmaceutical industry.