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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) January 12, 2026
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) (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. ¨
On January 12, 2026, BioXcel Therapeutics, Inc.
(the “Company”) announced that Mark Pavao is joining the Company as Interim Chief Commercial Officer to support the potential
launch of IGALMI in the at-home setting. The Company plans to submit a supplemental New Drug Application (sNDA) this month seeking the
FDA’s approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.
Forward-Looking Statements
This Current Report on 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 and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this Current Report on
Form 8-K other than statements of historical fact should be considered forward-looking statements, including, without limitation,
statements related to: the completion of the comprehensive market research study of IGALMI for the at-home market; the submission of an
sNDA; bringing IGALMI® directly to patients in the at-home setting; transforming neuroscience through the strategic use
of AI-driven drug discovery and human insight; reimagining existing medicines and accelerating the development of innovative therapies;
transforming the standard of care in neuropsychiatry and improve lives around the world. 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 limited operating history; its incurrence of significant
losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its
significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and
other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue
as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence
on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the
number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the
Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug
products; the risk that IGALMI® or the Company’s product candidates may not be accepted by physicians or the medical
community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI®;
the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical
studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll
patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the
discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure
to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it;
impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and
governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability
to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its
Annual Report on Form 10-K for the fiscal year ended December 31, 2024, 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 and the Investors section of the Company’s website
at . These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements
made in this Current Report on Form 8-K. Any such forward-looking statements represent management’s estimates as of the date
of this Current Report on 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 Current Report
on 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: January 12, 2026 |
BIOXCEL THERAPEUTICS, INC. |
| |
|
|
| |
|
/s/ Richard Steinhart |
| |
By: |
Richard Steinhart |
| |
Title: |
Chief Financial Officer |
