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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) December 18, 2023

 

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)   (IRS 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   x

 

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.   x

 

 

 

 

 

Item 8.01Other Events.

 

On December 18, 2023, BioXcel Therapeutics, Inc. (the “Company”) announced that it had received a new patent from the U.S. Patent and Trademark Office, U.S. Patent No. 11,839,604 (the “Patent”). The Patent pertains to the method of treating agitation associated with bipolar disorders using an oromucosal film containing 60 mcg of dexmedetomidine and is listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) under the following use code:

 

ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION

 

The Patent is set to expire no earlier than December 29, 2037, subject to the patent term adjustment, patent term extension, and terminal disclaimers, and is the seventh patent listed in the Orange Book for IGALMI™.

 

 

 

 

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: December 18, 2023   BIOXCEL THERAPEUTICS, INC.
     
    /s/ Javier Rodriguez
  By:  Javier Rodriguez
  Title:  SVP, Chief Legal Officer