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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 6, 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 6, 2025,
BioXcel Therapeutics, Inc. announced the publication of a study in the peer-reviewed journal Frontiers in Pharmacology, entitled
“Dexmedetomidine potently and reversibly regulates stress-mediated behaviors.” The study evaluated the effects of
Dexmedetomidine (the active ingredient in BXCL-501) on stress-mediated behaviors in non-clinical studies and demonstrated a
significant effect in translatable behavioral models related to psychiatric disorders, suggesting potential applications of BXCL501
in chronic conditions in addition to treatment of acute agitation.
Key findings from the non-clinical studies include:
| | · | Dexmedetomidine exhibited higher in vitro potency and activity than other alpha2-adrenergic receptor agonists
(clonidine, lofexidine or guanfacine).
|
| | · | Dexmedetomidine significantly mitigated responses to both acute and repeated stress after both acute and repeated
dosing.
|
| · | Effects of dexmedetomidine were consistent across multiple models of stress. |
| · | Dexmedetomidine exhibited favorable attributes for potential daily administration,
including no loss of effect after repeat doses, and no withdrawal effects after stopping dosing. |
| | · | Dexmedetomidine at efficacious doses did not affect motor function or cognition compared with
diazepam or scopolamine, respectively. |
| | · | Dexmedetomidine had a favorable effect on sleep patterns. |
The published results provide
further support for BXCL501’s mechanism of action and potential suitability for broadly addressing stress-related disorders in addition
to agitation.
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 6, 2025 |
BIOXCEL THERAPEUTICS, INC. |
| |
|
|
| |
|
/s/ Richard Steinhart |
| |
By: |
Richard Steinhart |
| |
Title: |
Chief Financial Officer |
