BTAI hits Phase 3 trial milestone; top-line BXCL501 data due this month

BioXcel Therapeutics (BTAI) filed an 8-K to disclose completion of the “last-patient-last-visit” milestone in its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 120 mcg for the acute treatment of agitation in bipolar disorder and schizophrenia.

Rhea-AI Filing Summary

BioXcel Therapeutics (BTAI) filed an 8-K to disclose completion of the “last-patient-last-visit” milestone in its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 120 mcg for the acute treatment of agitation in bipolar disorder and schizophrenia.

• Randomized, double-blind, placebo-controlled design; >200 patients treated across 22 U.S. sites, with no site >11 % of enrollment.
• Patient mix was balanced between the two indications and the “vast majority” completed the 12-week study.
• >2,200 agitation episodes were captured, providing a sizable safety data set.
• Top-line results are expected later this month; management reiterates plans for a subsequent sNDA submission.

No financial metrics were provided. The filing consists mainly of forward-looking statements outlining regulatory intentions and associated risks.

Positive

• Phase 3 SERENITY At-Home trial reached last-patient-last-visit, eliminating enrollment risk.
• Robust dataset generated: >200 patients, >2,200 agitation episodes, high completion rate.
• Top-line data expected this month, positioning for near-term sNDA submission.

Negative

• No efficacy or safety outcome data yet disclosed, maintaining binary event risk.
• Forward-looking statements highlight regulatory and clinical uncertainties that could materially impact results.

Insights

Biopharma Analyst

TL;DR – Trial completion de-risks safety dataset; value hinges on impending top-line read-out.

Completion of the Phase 3 SERENITY At-Home study removes a key execution risk and supplies a large (>2,200 episodes) safety database, an FDA priority for at-home use of BXCL501. Balanced enrollment across indications improves generalizability, while multisite distribution mitigates site-specific bias. However, without efficacy data investors still face binary risk when top-line results arrive. Positive data could fast-track an sNDA and expand BXCL501 beyond institutional settings, materially enlarging the addressable market. Conversely, any safety or efficacy signal outside prior expectations would impair the asset’s commercial outlook.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did BioXcel Therapeutics (BTAI) announce in its August 1 2025 8-K?

The company completed the last-patient-last-visit in its Phase 3 SERENITY At-Home safety trial of BXCL501 for agitation.

How many patients were enrolled in the SERENITY At-Home Phase 3 trial?

The study enrolled more than 200 patients across 22 U.S. sites.

When are the top-line Phase 3 results for BXCL501 expected?

BioXcel stated that top-line data will be released later this month (August 2025).

What indications were studied in the SERENITY At-Home trial?

The trial evaluated BXCL501 for agitation associated with bipolar disorders and schizophrenia.

Is BioXcel planning a regulatory submission based on this trial?

The 8-K notes intent to file a supplemental NDA (sNDA) after data read-out.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 08/01/2025 - 07:12 AM Learn about SEC filing dates

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 1, 2025

BioXcel Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-38410		82-1386754
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

555 Long Wharf Drive

New Haven, CT 06511

(Address of principal executive offices, including Zip Code)

(475) 238-6837

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001		BTAI		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   ¨

Item 8.01 Other Events. 

On August 1, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced the last patient last visit in the SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia. The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than 11% of the total patient population. Distribution of patients was balanced between the two patient populations, bipolar disorders and schizophrenia, and the vast majority of patients dosed completed the full 12-week study. The Company collected data from more than 2,200 agitation episodes in the trial, with topline results expected to be announced this month.

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 Company’s upcoming data release and 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 statements use these words or expressions. In addition, any statements or information that 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 the factors discussed under the caption “Risk Factors” in its most recent Quarterly Report on Form 10-Q, as such factors may be updated from time to time in its other filings with the SEC. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this current report. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this current report. 

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: August 1, 2025	BIOXCEL THERAPEUTICS, INC.
		/s/ Richard Steinhart
	By:	Richard Steinhart
	Title:	Chief Financial Officer