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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 11, 2025
MAIA
Biotechnology, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-41455 |
|
83-1495913 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
| 444
West Lake Street, Suite 1700 |
|
|
| Chicago, IL |
|
60606 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
(312)
416-8592
(Registrant’s
telephone number, including area code)
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 |
|
MAIA |
|
NYSE
American |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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.
1.
On December 11, 2025, MAIA Biotechnology, Inc. (the “Company”) issued a press release entitled “MAIA Leadership
Continues Insider Buying in 2025 and Trial Data Signals Breakout Potential” A copy of the press release is attached hereto as
Exhibit 99.1 and is incorporated herein by reference.
2.
On December 11, 2025, the Company issued a press release entitled “MAIA Biotechnology Announces First Patient Dosed in THIO-104
Phase 3 Pivotal Trial Evaluating Ateganosine as Third-Line Treatment for Advanced Non-Small Cell Lung Cancer” A copy of the press
release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
3
On December 11, 2025, the Company issued a press release entitled “MAIA’s Ateganosine Surges Ahead with Breakthrough Momentum
as Pivotal Phase 3 Trial Initiates” A copy of the press release is attached hereto as Exhibit 99.3 and is incorporated herein
by reference.
Forward-looking
Statements
The
Company cautions that all statements, other than statements of historical facts, contained in this Current Report on Form 8-K, or furnished
herewith, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other
factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different
from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,”
“could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,”
“project,” “intend,” “future,” “potential,” or “continue,” and other similar
expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are
not forward-looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that,
although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as
to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However,
these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control
that may cause actual results to differ materially from those expressed in any forward-looking statement, including, but not limited
to: (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs,
(ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory
filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing
process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for
our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain
intellectual property protection for our product candidates. Any forward-looking statement speaks only as of the date on which it was
made. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release dated December 11, 2025 (Insider buying) |
| 99.2 |
|
Press Release dated December 11, 2025 (First Patient Dosed in THIO-104 Phase 3 Pivotal Trial) |
| 99.3 |
|
Press Release dated December 11, 2025 (MAIA’s Ateganosine Surges Ahead) |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
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.
Dated:
December 11, 2025
| |
MAIA
BIOTECHNOLOGY, INC. |
| |
|
|
| |
By: |
/s/
Vlad Vitoc |
| |
Name: |
Vlad
Vitoc |
| |
Title: |
Chief
Executive Officer |
