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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): July 21, 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
July 21, 2025, BioXcel Therapeutics, Inc. (the “Company”) announced the submission of a pre-supplemental New Drug Application
(pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA) for IGALMI® in support of a potential label expansion for
outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia.
The primary purpose of the pre-sNDA meeting, scheduled
for August 20, 2025, is to gain alignment with the FDA regarding the content and format of the planned sNDA submission, which the Company
is preparing. Additionally, the Company plans to reconfirm the understanding reached during the Type C meeting with the FDA on March 6,
2024, that FDA views the Company’s current development plans as a reasonable approach to support expanding the label to include
at-home (outpatient) use of 120 mcg BXCL501 for the acute treatment of agitation associated with schizophrenia or bipolar disorders in
the at-home setting.
Forward-Looking Statements
This current report includes
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking
statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of
1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this current report other
than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related
to: the Company’s upcoming sNDA meeting and sNDA submission. When used herein, words including “anticipate,” “believe,”
“can,” “continue,” “could,” “designed,” “estimate,” “expect,”
“forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements
use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives,
performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All
forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there
is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations,
and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking
statements as a result of various important factors, including the factors discussed under the caption “Risk Factors” in its
most recent Quarterly Report on Form 10-Q, as such factors may be updated from time to time in its other filings with the SEC. These and
other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in
this press release. Any such forward-looking statements represent management’s estimates as of the date of this current report.
While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims
any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon
as representing the Company’s views as of any date subsequent to the date of this current report.
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: July 21, 2025 |
BIOXCEL THERAPEUTICS, INC. |
| |
|
|
| |
|
/s/ Richard Steinhart |
| |
By: |
Richard Steinhart |
| |
Title: |
Chief Financial Officer |
