Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 320

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 320
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, or are associated
with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:

    ●
    regulatory
    authorities may interrupt, delay or halt clinical trials;

    ●
    regulatory
    authorities may deny regulatory approval of our product candidates;

35

    ●
    regulatory
    authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for
    use, and/or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”) in
    connection with approval or post-approval;

    ●
    regulatory
    authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive REMS, or require us
    to recall any product that is approved;

    ●
    we
    may be required to change the way the product is administered or conduct additional clinical trials;

    ●
    our
    relationships with our collaboration partners may suffer;

    ●
    we
    could be sued and held liable for harm caused to patients; or

    ●
    our
    reputation may suffer. The reputational risk is heightened with respect to those of our product candidates that are being developed
    for pediatric indications.

We
may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants
or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be successfully
commercialized. Following receipt of approval for commercial sale of a product we may voluntarily withdraw or recall that product from
the market if at any time we believe that its use, or a person’s exposure to it, may cause adverse health consequences or death.
To date we have not withdrawn, recalled, or taken any other action, voluntary or mandatory, to remove an approved product from the market.
In addition, regulatory agencies, IRBs, or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation
of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are
not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants.
Although we have never been asked by a regulatory agency, IRB, or data safety monitoring board to discontinue a clinical trial temporarily
or permanently, if we elect or are forced to suspend or terminate a clinical trial of any of our product candidates, the