BioXcel Therapeutics Files 8-K: Other Events

TL;DR

BioXcel filed an 8-K for 'Other Events' - details TBD.

AI Summary

On September 10, 2025, BioXcel Therapeutics, Inc. filed an 8-K report. The filing indicates an 'Other Events' item, but the specific details of this event are not elaborated upon in the provided text. 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 signals a material event has occurred for BioXcel Therapeutics, requiring disclosure to investors. The nature of this event could impact the company's operations or stock.

Risk Assessment

Risk Level: medium — The filing indicates an 'Other Events' disclosure, which could range from minor administrative changes to significant operational or strategic developments, creating uncertainty.

Key Numbers

• 001-38410 — Commission File Number (Identifies the company's SEC filings)
• 82-1386754 — I.R.S. Employer Identification No. (Company's tax identification number)

Key Players & Entities

• BioXcel Therapeutics, Inc. (company) — Registrant
• September 10, 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

• tm2525736d1_8k.htm (8-K) — 46KB
• 0001104659-25-088800.txt ( ) — 211KB
• btai-20250910.xsd (EX-101.SCH) — 3KB
• btai-20250910_lab.xml (EX-101.LAB) — 33KB
• btai-20250910_pre.xml (EX-101.PRE) — 22KB
• tm2525736d1_8k_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On September 10, 2025, BioXcel Therapeutics, Inc. (the "Company") announced positive topline exploratory efficacy data from SERENITY At-Home Pivotal Phase 3 safety trial for agitation associated with bipolar disorders or schizophrenia The SERENITY At-Home study is a Pivotal Phase 3, double-blind, placebo-controlled, 12-week clinical trial designed to evaluate the safety of BXCL501 (120 mcg dose) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in an at-home setting. The trial also included an exploratory objective of assessing the continued efficacy of BXCL501 in the treatment of episodes of agitation. SERENITY At-Home Topline Summary A total of 246 patients randomized Data collected on 2,628 agitation episodes in 215 patients over a 12 week period o Treated 2,437 episodes in 208 patients o 168 patients (81%) completed the full 12-week trial o Average of 11.7 agitation episodes recorded per treated patient o Reported agitation episodes were classified as mild (664), moderate (1,369) or severe (395) All patients were able to successfully self-administer the film Distribution of enrolled patients was 45% bipolar disorders and 55% schizophrenia Protocol allowed for concomitant interventions to self-regulate or manage agitation episodes SERENITY AT-Home Topline Exploratory Efficacy Results The efficacy of IGALMI has already been established in the institutional setting in the SERENITY I and II trials that led to the approval by FDA (see label). In addition to the primary objective of evaluating the safety of BXCL501, the SERENITY At-Home trial also had an exploratory objective of assessing continued efficacy of BXCL501 with repeat dosing. The trial was not powered for these assessments. The positive results demonstrated continued effects and consistent benefits with repeat dosing of BXCL501, reinforcing the potential of BXCL501 in the outpatient setting. Effect Across Total Number

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, submission, bringing a safe and effective outpatient treatment to patients suffering from agitation and transforming the treatment paradigm. 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 refer to expectations, beliefs, plans, projections, 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 statements as a result of various important factors, including, without limitation: its lim

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: September 10, 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