Form 8-K - Current report
December 12 2023 - 7:00AM
Edgar (US Regulatory)
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2023-12-12
2023-12-12
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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 12, 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.
On December 12, 2023, in connection with
its previously announced Research and Development Day, BioXcel Therapeutics, Inc. (the “Company”) provided an update
on is clinical development pipeline, which is now as follows:
In addition, on December 12, 2023, the Company
announced that it had received the final minutes from its meeting with the U.S. Food and Drug Administration (“FDA”) held
on November 8, 2023. Based on the feedback from the FDA meeting, the Company plans to evaluate BXCL501 in the at-home setting for
the acute treatment of agitation in bipolar disorders and scizophrenia using a 120 mcg dose, with safety as the primary endpoint and with
efficacy evaluations as exploratory endpoints.
Forward-Looking Statements
This Current Report on Form 8-K (“Form 8-K”)
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 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). All statements contained in this Form 8-K other than statements of historical fact should
be considered forward-looking statements, including, without limitation, statements regarding the Company's regarding its clinical development
pipeline and future clinical trials. 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, without limitation, its need for substantial additional funding and ability to raise capital
when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of IGALMI™,
BXCL501, BXCL502 and BXCL503 and other product candidates; and the other important factors discussed under the caption “Risk Factors”
in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, as such factors may be updated from
time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important
factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this Form 8-K.
Any such forward-looking statements represent management’s estimates as of the date of this Form 8-K. 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 Form 8-K.
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 12, 2023 |
BIOXCEL THERAPEUTICS, INC. |
|
|
|
/s/ Richard Steinhart |
By: |
Richard Steinhart |
Title: |
Chief Financial Officer |
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