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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): October
19. 2025
MAIA
Biotechnology, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware
DE |
|
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.
On
October 23, MAIA Biotechnology, Inc. (the “Company”) issued a press release entitled “MAIA Biotechnology Details
30-Month Patient Survival in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer.” Pursuant to Regulation FD, the
press release is furnished with this Current Report on Form 8-K (this “Report”) as Exhibit 99.1.
The
information set forth in Item 7.01 of this Report and in the attached Exhibit 99.1 is deemed to be “furnished”
and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liabilities of that Section. The information set forth in Item 7.01 of this
Report, including Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities
Act of 1933, as amended, regardless of any general incorporation language in such filing.
Item 8.01 Other Events
| 1. |
The
Company has prepared a poster (the “Poster”) entitled “Presentation 1: A Phase 2 Study of Ateganosine (THIO; 6-thio-2’-deoxyguanosine)
in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior
ICI and Chemotherapy: THIO-101 Trial (“THIO-101 Trial Poster”). The THIO-101 Poster was presented at the European Society
for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany starting on October 19, 2025 and posted to the Company’s website
on such date, a copy of which is filed as Exhibit 99.2 to this Report and is hereby incorporated by reference. |
| 2. |
The
Company has prepared a poster (the “Poster”) entitled • Presentation 2: A Phase 3 Study of Ateganosine (THIO) Sequenced
with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress
(“THIO-104Trial Poster”). The THIO-104 Poster was presented ESMO starting on October 19, 2025 and posted to the Company’s
website on such date, a copy of which is filed as Exhibit 99.3 to this Report and is hereby incorporated by reference. |
Each
of the THIO-101 Trial Poster and THIO-104 Trial Poster contain forward-looking statements, and as a result, investors should not place
undue reliance on these forward-looking statements.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press
Release dated October 23, 2025 |
| 99.2 |
|
THIO-101
Trial Poster |
| 99.3 |
|
THIO-104
Trial 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:
October 23, 2025
| |
MAIA
BIOTECHNOLOGY, INC. |
| |
|
|
| |
By: |
/s/
Vlad Vitoc |
| |
Name: |
Vlad
Vitoc |
| |
Title: |
Chief
Executive Officer |
