BioXcel Therapeutics, Inc. (BTAI) SEC Filings, Aug-Sep 2025

Frank Yocca, Chief Scientific Officer of BioXcel Therapeutics, Inc. (BTAI), reported Form 4 transactions showing restricted stock units converting to shares on September 14 and 15, 2025. Table II lists 163 underlying shares from RSUs reported 09/14/2025 and 317 underlying shares from RSUs reported 09/15/2025, each recorded at $0. The form explains that each RSU equals one share and notes prior grants of 521 RSUs on March 14, 2022 and 562 RSUs on March 15, 2023 with scheduled vesting (25% after one year, then 6.25% quarterly). The filing was signed by an attorney-in-fact on 09/16/2025.

BioXcel Therapeutics, Inc. reported that it has completed enrollment, on September 13, 2025, in an open-label clinical study of approximately 30 patients evaluating the correlation between the mCGI-S measurement and the PEC scale in agitation. The company expects to release results in the fourth quarter of 2025, and to include these data, together with SERENITY At-Home Phase 3 safety results, in a supplemental new drug application planned for the first quarter of 2026.

Between July 1, 2025 and September 15, 2025, BioXcel raised an aggregate of $37.3 million, including approximately $27.6 million from selling 9,312,892 shares under its at-the-market equity program and approximately $9.7 million from the exercise of warrants for 2,300,000 shares. As of September 12, 2025, the company had 19,646,801 shares outstanding and believes its cash and cash equivalents will fund operating and capital needs into the first quarter of 2026, subject to various assumptions and risk factors.

BioXcel Therapeutics reported results from the SERENITY At-Home Phase 3 trial showing 246 patients randomized and data collected on 2,628 agitation episodes over 12 weeks in 215 patients. Of those, 2,437 episodes were treated in 208 patients and 168 patients (81%) completed the full 12-week trial. Treated patients averaged 11.7 agitation episodes each; episodes were classified as mild (664), moderate (1,369) or severe (395). All patients successfully self-administered the film. Enrolled patients were 45% bipolar and 55% schizophrenia. The company now estimates a total addressable market of 57–77 million annual agitation episodes versus a prior estimate of 23 million, citing higher episode frequency supported by trial and survey data. Patient and physician feedback indicated a significant unmet need for an effective fast-acting at-home treatment; patients said they would take BXCL501 for 80% of episodes and 90% would take it at onset.

David J. Mack, a director of BioXcel Therapeutics, Inc. (BTAI), reported the vesting and acquisition of 1,693 Restricted Stock Units (RSUs) on 08/31/2025. Each RSU converts to one share of common stock and the vested shares were issued at $0 per share. Following the reported transactions, the filing shows 16,930 shares of common stock beneficially owned and 3,387 RSUs (derivative securities) beneficially owned. The RSUs originated from a grant of 20,317 RSUs awarded on November 21, 2024, which vest in twelve equal monthly installments beginning November 30, 2024, subject to continued service as a director. The form was signed by an attorney-in-fact on behalf of Mr. Mack on 09/02/2025.

BioXcel Therapeutics reported topline operational and safety observations from its SERENITY At-Home Pivotal Phase 3 trial of BXCL501 for agitation. The company randomized 246 patients and collected data on 2,628 agitation episodes, treating 2,437 episodes in 208 patients; 168 patients (81%) completed the 12-week trial and treated patients averaged 11.7 episodes each. All patients could self-administer the film and there were no drug-related serious adverse events, syncopes, falls, or severe treatment-emergent adverse events reported. Based on episode frequency seen in the trial and external surveys, the company estimates 57 million to 77 million annual agitation episodes in U.S. at-home settings and cites strong patient interest in using BXCL501.

The company is registering the offer and sale of up to $80,000,000 of its common stock under an at-the-market offering program with Canaccord Genuity. This increases the maximum amount it can sell under an existing equity distribution agreement, under which it has already sold $11,635,000 of common stock. As of the date immediately prior to this supplement, the aggregate market value of common stock held by non-affiliates exceeded $75 million, based on 16,009,124 outstanding shares and a closing price of $6.80 per share on August 12, 2025. The stock trades on the Nasdaq Global Market under the symbol “BTAI”, and the last reported sale price on August 15, 2025 was $5.48 per share.

BioXcel Therapeutics, Inc. filed a prospectus supplement for the offer and sale of up to $80,000,000 shares of common stock under its at-the-market program with Canaccord Genuity LLC. This program allows the company to sell common stock from time to time through Canaccord Genuity acting as sales agent. The filing also notes that Honigman LLP issued a legal opinion on the validity of the shares issuable under the Equity Distribution Agreement and the prospectus supplement, and this opinion is included as an exhibit to the report.

BioXcel Therapeutics reported that it received positive pre-sNDA meeting comments from the U.S. FDA for its planned supplemental new drug application (sNDA) for BXCL501 to treat agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. Based on this written feedback, the company believes its planned regulatory package will be sufficient to support the sNDA submission, which remains on track for the first quarter of 2026.

The pre-sNDA interaction focused on aligning with the FDA on the content and format of the submission, including clinical, nonclinical, and chemistry, manufacturing and controls requirements. BioXcel considers the meeting objectives achieved through the FDA’s written responses and cancelled the previously scheduled in-person meeting, with the preliminary written comments now serving as the official record. Acceptance of the sNDA will still depend on the FDA’s review of the complete filing.

BioXcel Therapeutics, Inc. reported receiving positive preliminary meeting comments from the U.S. Food and Drug Administration (FDA) ahead of a planned pre-supplemental New Drug Application (pre-sNDA) meeting scheduled for August 20, 2025. The company is reviewing this feedback and plans to provide an update next week. The upcoming pre-sNDA meeting is intended to align with the FDA on the proposed format and content of BioXcel’s planned sNDA submission, covering clinical, nonclinical, and chemistry, manufacturing and controls (CMC) requirements.