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    MAIA Biotechnology Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

    9/8/25 6:11:22 AM ET
    $MAIA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $MAIA alert in real time by email
    false 0001878313 0001878313 2025-09-07 2025-09-07 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

     

     

     

    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.

     

    -2-

     

     

    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)

     

    -3-

     

     

    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

     

    -4-

     

     

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