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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): September 7, 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
7.01 Regulation FD Disclosure.
MAIA
Biotechnology, Inc. (the “Company”) has prepared a poster (the “Poster”) showing the efficacy data from its Phase
2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients
with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens. The Poster was selected as an
abstract titled Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS”
and originally presented and displayed at the 2025 IASLC World Conference on Lung Cancer (WCLC) on September 7, 2025. The Poster will
also be posted to the Company’s website on September 8, 2025, a copy of which is filed as Exhibit 99.1 to this Current Report on
Form 8-K (this “Report”) and is hereby incorporated by reference.
The
Poster contains forward-looking statements, and as a result, investors should not place undue reliance on these forward-looking statements.
Item
8.01 Other Events
Reference
is made to the disclosure under Item 7.01 above which is hereby incorporated in this Item 8.01 by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Poster |
| 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:
September 8, 2025
| |
MAIA
BIOTECHNOLOGY, INC. |
| |
|
|
| |
By: |
/s/
Vlad Vitoc |
| |
Name:
|
Vlad
Vitoc |
| |
Title: |
Chief
Executive Officer |
