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    BioAge Labs Inc. filed SEC Form 8-K: Other Events

    6/4/25 9:00:26 AM ET
    $BIOA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $BIOA alert in real time by email
    8-K
    0001709941false00017099412025-06-042025-06-04

     

     

    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): June 4, 2025

     

     

    BIOAGE LABS, INC.

    (Exact name of Registrant as Specified in Its Charter)

     

     

    Delaware

    001-42279

    47-4721157

    (State or Other Jurisdiction
    of Incorporation)

    (Commission File Number)

    (IRS Employer
    Identification No.)

     

     

     

     

     

    5885 Hollis Street

    Suite 370

     

    Emeryville, California

     

    94608

    (Address of Principal Executive Offices)

     

    (Zip Code)

     

    Registrant’s Telephone Number, Including Area Code: 510 806-1445

     

     

    (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:

    ☐

    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, $0.00001 Par Value Per Share

     

    BIOA

     

    Nasdaq Global Select 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 8.01 Other Events.

    On June 4, 2025, the Company announced, in its corporate presentation, updates related to anticipated timing of certain milestones, including the following:

    NLRP3 Program Updates

     

    •
    IND submission and initiation of a Phase 1 SAD/MAD trial planned for mid-2025, with initial SAD data anticipated by end of year.
    •
    Full Phase 1 SAD/MAD data anticipated mid-2026
    •
    Obesity proof-of-concept data anticipated in the second half of 2026

     

    APJ Agonist Program Updates

     

    •
    The Company is continuing to advance APJ agonist programs for both oral and parenteral administration and expects to submit an IND application by the end of 2026.

     

    Cautionary Note Regarding Forward-Looking Statements

     

    This Current Report on Form 8-K contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the Company’s plans to develop and commercialize its product candidates, including BGE-102 and its APJ program, the timing and results of its planned clinical trials, including the APJ nanobody developed with JiKang, risks associated with clinical trials, including the Company’s ability to adequately manage clinical activities, the timing of the Company’s IND filing for BGE-102 or its APJ program and its ability to obtain and maintain regulatory approvals, the clinical utility of its product candidates, and general economic, industry and market conditions. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: the Company’s ability to develop, obtain regulatory approval for and commercialize its product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including its ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of its drug candidates; the occurrence of adverse safety events; failure to protect and enforce its intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of its strategic and growth initiatives; risks relating to technology failures or breaches; its dependence on collaborators and other third parties for the development of product candidates and other aspects of its business, which are outside of the Company’s full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 6, 2025, and Company’s other filings with the SEC filed from time to time. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.


     

     

     

     


     

    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.

     

     

     

    BIOAGE LABS, INC.

     

     

     

     

    Date:

    June 4, 2025

    By:

    /s/ Dov Goldstein

     

     

     

    Dov Goldstein, M.D.
    Chief Financial Officer

     


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