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    Xilio Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits

    11/7/25 9:05:24 AM ET
    $XLO
    Biotechnology: Pharmaceutical Preparations
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    Get the next $XLO alert in real time by email
    8-K
    false000184023300018402332025-11-072025-11-07

     

    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): November 7, 2025

     

     

    Xilio Therapeutics, Inc.

    (Exact Name of Registrant as Specified in Charter)

     

     

     

     

     

     

     

     

    Delaware

    001-40925

    85-1623397

    (State or Other Jurisdiction

    of Incorporation)

    (Commission

    File Number)

    (IRS Employer

    Identification No.)

     

     

     

     

     

    828 Winter Street, Suite 300

    Waltham, Massachusetts

    02451

    (Address of Principal Executive Offices)

    (Zip Code)

     

    Registrant’s telephone number, including area code: (857) 524-2466

     

    Not applicable

    (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 (see General Instruction A.2. below):

     

    ☐ 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 $0.0001 per share

    XLO

    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. ☐

     

     

     


     

    Item 7.01. Other Events.

     

    On November 7, 2025, Xilio Therapeutics, Inc. (the “Company”) issued a press release announcing new data related to high plasma tumor mutational burden from its ongoing Phase 2 clinical trial evaluating vilastobart in combination with atezolizumab in patients with microsatellite stable metastatic colorectal cancer, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

    Also on November 7, 2025, the Company issued a press release announcing updated data across its portfolio, including preclinical data for the Company's masked T cell engager platform and programs, as well as updated Phase 1 data for efarindodekin alfa, and Phase 2 data related to circulating tumor DNA for vilastobart, a copy of which is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

    These data are presented in poster presentations at the Society for Immunotherapy of Cancer (SITC) 40thAnnual Meeting. The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, is being furnished and shall not be deemed "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, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

     

    Item 9.01. Financial Statements and Exhibits.

    (d) Exhibits.

     

    Exhibit

    Number

     

    Description

    99.1

     

    Press release issued by Xilio Therapeutics, Inc. on November 7, 2025

    99.2

     

    Press release issued by Xilio Therapeutics, Inc. on November 7, 2025

    104

     

     

    Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101)

     

     

     


     

    SIGNATURES

     

    Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

     

     

     

     

     

    XILIO THERAPEUTICS, INC.

    Date: November 7, 2025

    By:

    /s/ Caroline Hensley

    Caroline Hensley

    Chief Legal Officer

     

     

     


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