BioXcel Therapeutics Files 8-K

TL;DR

BioXcel filed an 8-K, no juicy details yet, just corporate housekeeping.

AI Summary

BioXcel Therapeutics, Inc. filed an 8-K on October 14, 2025, reporting an 'Other Event'. The filing does not contain specific details about the event itself, but it confirms the company's reporting status and basic corporate information. The company is incorporated in Delaware and its principal executive offices are located at 555 Long Wharf Drive, New Haven, CT.

Why It Matters

This filing indicates BioXcel Therapeutics is making a required disclosure to the SEC, which could relate to significant corporate events. Investors should monitor for subsequent filings for details.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for 'Other Events' and does not contain specific financial or operational information that would immediately indicate high risk.

Key Numbers

• 001-38410 — Commission File Number (SEC identifier for BioXcel Therapeutics)
• 82-1386754 — EIN (Employer Identification Number)

Key Players & Entities

• BioXcel Therapeutics, Inc. (company) — Registrant
• October 14, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• 555 Long Wharf Drive, New Haven, CT 06511 (address) — Principal executive offices

FAQ

Key Financial Figures

• $0.001 B — ch registered Common Stock, par value $0.001 BTAI The Nasdaq Capital Market Indic

Filing Documents

• tm2528636d1_8k.htm (8-K) — 31KB
• 0001104659-25-098992.txt ( ) — 194KB
• btai-20251014.xsd (EX-101.SCH) — 3KB
• btai-20251014_lab.xml (EX-101.LAB) — 33KB
• btai-20251014_pre.xml (EX-101.PRE) — 22KB
• tm2528636d1_8k_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On October 14, 2025, BioXcel Therapeutics, Inc. (the "Company") announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At Home trial. The results, along with the data from the SERENITY At Home trial, will be included in the supplemental New Drug Application (sNDA) submission that is planned for the first quarter of 2026. The standard method for measuring acute agitation associated with schizophrenia and bipolar disorder is the Positive and Negative Syndrome Scale – Excited Component (PEC) administered by a trained clinician, which was used in the Serenity I & II Pivotal Trials. In order to evaluate BXCL501 for continued clinical effect with repeat dosing in the at-home setting using an exploratory efficacy measurement, the Company, in consultation with FDA, developed the modified CGI-S (mCGI-S) scale, which can be scored by patients and/or caregivers. The study assessed the correlation between PEC and mCGI-S in this prospective, open label, in-clinic trial in 33 patients. The results demonstrated a strong correlation between the clinician assessments and the patient or caregiver (informant) rated outcomes, providing support for using mCGI-S to assess efficacy in the outpatient setting. A statistically significant and strong correlation between the PEC and mCGI-S with a correlation of =0.89; p<0.0001 for patients and =0.88; p<0.0001 for informants was observed. There were no serious adverse events reported and the safety profile remains consistent with the IGALMI label.

Forward-Looking Statements

Forward-Looking Statements This current report includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this current report other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the planned sNDA submission. When used herein, words including "anticipate," "believe," "can," "continue," "could," "designed," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, though not all forward-looking objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, a

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: October 14, 2025 BIOXCEL THERAPEUTICS, INC. /s/ Richard Steinhart By: Richard Steinhart Title: Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR