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 5, 2018

 


 

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)

 

 

(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:

 

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

 

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

 

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

 

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

 

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 8.01 Other Events.

 

On November 5, 2018, BioXcel Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”), has accepted its Investigational New Drug (“IND”) application for its lead immuno-oncology candidate, BXCL701. BTI plans to evaluate BXCL701 in combination with pembrolizumab (Keytruda®) as a potential therapy for treatment-emergent neuroendocrine prostate cancer (“tNEPC”), with the trial expected to initiate in the fourth quarter of 2018. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)          Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release, dated November 5, 2018

 

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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 5, 2018

BIOXCEL THERAPEUTICS, INC.

 

 

 

/s/ Richard Steinhart

 

Richard Steinhart

 

Chief Financial Officer

 

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