Welcome to our dedicated page for BioXcel Therapeutics SEC filings (Ticker: BTAI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
BioXcel Therapeutics filings document regulatory, financing, governance, and operating disclosures for a Nasdaq-listed biopharmaceutical company focused on AI-supported drug re-innovation in neuroscience. The company’s Form 8-K reports include IGALMI regulatory updates, business and financial results, and exhibits tied to press releases and material corporate events.
The filing record also covers registered direct offerings, common stock, pre-funded warrants and accompanying warrants, credit agreement amendments, registration rights, unregistered equity issuances, and retention or milestone-based compensation arrangements. These disclosures describe BioXcel’s capital structure, contractual obligations, Nasdaq-listed common stock, and formal updates connected to its approved IGALMI product and BXCL501 development program.
BioXcel Therapeutics (BTAI) reported Q3 2025 results marked by continued losses and tight liquidity. The company posted a net loss of $30.9M for the quarter and $57.4M year-to-date, with Q3 product revenue of $98K and nine-month revenue of $386K. Operating cash outflow was $43.4M for the nine months ended September 30, 2025.
Cash, cash equivalents and restricted cash were $37.3M as of September 30, 2025, versus total debt of $109.1M and derivative liabilities of $3.6M. Stockholders’ deficit was $(88.9)M. Management concluded there is “substantial doubt” about the company’s ability to continue as a going concern within 12 months, citing ongoing losses, negative operating cash flows, limited liquidity, and debt covenant dynamics.
The credit facility with Oaktree/QIA was amended multiple times, including a fixed interest rate of 13% effective September 30, 2024, modified minimum liquidity thresholds, quarterly amortization beginning in 2026, and waivers of certain covenants. Shares outstanding were 19,996 as of September 30, 2025; the company later reported 21,869,491 outstanding as of November 11, 2025.
BioXcel Therapeutics, Inc. filed a Form 8-K stating that it issued a press release with its financial results for the three months ended September 30, 2025 and a business update. The press release is attached as Exhibit 99.1 and is incorporated by reference for those details.
The company notes that the information in this Form 8-K under Item 2.02, including Exhibit 99.1, is being furnished rather than filed under securities laws, which affects how it is treated for certain legal purposes.
BioXcel Therapeutics announced a scientific poster presentation on BXCL501, a sublingual dexmedetomidine film for treating agitation associated with bipolar disorder or schizophrenia in the home setting. The Phase 3 study poster was presented at the Neuroscience Education Institute Conference on November 7, 2025 by Dr. Leslie Citrome.
The poster is furnished as Exhibit 99.1 and incorporated by reference. This 8-K provides visibility into the ongoing clinical program but does not detail trial results or financial terms.
BioXcel Therapeutics (BTAI) director David J. Mack reported the vesting and settlement of 1,694 shares of Common Stock on 10/31/2025 from previously granted RSUs. Following the transaction, he beneficially owned 20,317 shares, held directly.
The RSUs were part of a grant made on November 21, 2024, totaling 20,317 RSUs, scheduled to vest in twelve equal monthly installments beginning November 30, 2024, subject to continued service as a Director.
BioXcel Therapeutics (BTAI) filed preliminary proxy materials for its 2025 annual meeting. Stockholders will vote on: electing three Class I directors (June Bray, Sandeep Laumas, M.D., and David Mack), ratifying Ernst & Young LLP as auditor for 2025, an advisory say‑on‑pay vote, authorizing a reverse stock split within 12 months if the Board determines it is necessary to regain compliance with Nasdaq’s minimum bid price requirement, and a related adjournment proposal.
The meeting is scheduled for December 12, 2025 at 9:00 a.m. ET and will be held virtually at www.virtualshareholdermeeting.com/BTAI2025. The record date is October 31, 2025. The Board recommends voting FOR all proposals. The proxy notes the company is currently in compliance with Nasdaq’s bid price rule but seeks flexibility should conditions change.
BioXcel Therapeutics (BTAI) updated its regulatory timeline, stating it now expects to complete submission of a supplemental New Drug Application (sNDA) for an IGALMI® label expansion early in the first quarter of 2026.
The filing highlights two recently completed studies that will anchor the sNDA package: the SERENITY At-Home pivotal Phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia, which delivered positive topline safety and exploratory efficacy data in August 2025, and an October 2025 correlation study that also reported positive results. IGALMI® is currently FDA‑approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings, and the planned sNDA seeks to expand use to at‑home settings.
BioXcel Therapeutics (BTAI) announced positive correlation results linking the patient/caregiver-rated mCGI-S scale with the clinician-rated PEC from the SERENITY At Home program, supporting its planned supplemental NDA in the first quarter of 2026.
The prospective, open-label, in-clinic study in 33 patients showed strong, statistically significant correlations between PEC and mCGI-S (ρ=0.89; p<0.0001 for patients and ρ=0.88; p<0.0001 for informants). No serious adverse events were reported, and the safety profile remains consistent with the IGALMI® label.
Multiple Millennium-related entities report passive stakes in BioXcel Therapeutics, Inc. Integrated Core Strategies (US) LLC reports beneficial ownership of 1,026,054 shares and Millennium Management LLC, Millennium Group Management LLC and Israel A. Englander each report beneficial ownership of 1,028,053 shares, representing 5.2% of the outstanding common stock for each reporting person. The filing is submitted on Schedule 13G, indicating the holders state their position is passive and not intended to influence control of the issuer. The filing includes a joint filing agreement among the reporting parties.
BioXcel Therapeutics insider activity: Vimal Mehta, CEO and President and a director, reported two small acquisitions of common stock and corresponding restricted stock units in mid-September 2025. On 09/14/2025 he received 163 RSUs (vesting contingent) and 163 shares were recorded as acquired; on 09/15/2025 he received 219 RSUs and 219 shares were recorded as acquired. Following these transactions Mr. Mehta directly beneficially owned 20,493 shares. He also discloses indirect ownership of 480,343 shares held of record by BioXcel LLC, of which he is a manager, and one shareholding is reported as held by spouse.
Richard I. Steinhart, Chief Financial Officer of BioXcel Therapeutics, Inc. (BTAI), reported the acquisition of shares from vesting restricted stock units. On 09/14/2025 he received 163 shares upon vesting of RSUs and on 09/15/2025 he received 317 shares, increasing his direct beneficial ownership by those amounts. The RSUs were originally granted on March 14, 2022 (521 RSUs) and March 15, 2023 (562 RSUs) with staged vesting schedules tied to continued employment. The transactions were reported on a Form 4 signed 09/16/2025.