BTAI 8-K: BXCL501 Phase 3 poster on agitation in home setting

Rhea-AI Filing Summary

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.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

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

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): November 10, 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 November 10, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced that the Company’s poster entitled “BXCL501 (Sublingual Dexmedetomidine) for Treatment of Agitation Associated With Bipolar Disorder or Schizophrenia in the Home Setting: a Phase 3 Study” was presented at the Neuroscience Education Institute Conference on November 7, 2025 by Dr. Leslie Citrome.

A copy of the poster is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d)   Exhibits.

Ex. No. Description

99.1	BXCL501 Poster
104	Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document

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: November 10, 2025	BIOXCEL THERAPEUTICS, INC.
		/s/ Richard Steinhart
	By:	Richard Steinhart
	Title:	Chief Financial Officer

FAQ

What did BioXcel Therapeutics (BTAI) announce in this 8-K?

The company announced a poster presentation on BXCL501 from a Phase 3 study of agitation in bipolar disorder or schizophrenia.

When and where was the BXCL501 Phase 3 poster presented?

It was presented at the Neuroscience Education Institute Conference on November 7, 2025.

Who presented the BXCL501 poster for BTAI?

The poster was presented by Dr. Leslie Citrome.

What exhibit contains the BXCL501 poster?

The poster is filed as Exhibit 99.1 and incorporated by reference.

What is BXCL501?

BXCL501 is sublingual dexmedetomidine, studied for treating agitation associated with bipolar disorder or schizophrenia in the home setting.

On which exchange is BTAI listed?

BTAI common stock trades on The Nasdaq Capital Market.