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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 | |