Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 315

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 315
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 policies and regulation, including changes to requirements imposed on the extent, nature, or timing of studies;

    ●
    delays
    or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

    ●
    uncertainty
    regarding proper dosing;

    ●
    delay
    or failure to supply product for use in clinical trials which conforms to regulatory specification;

    ●
    unfavorable
    results from ongoing pre-clinical studies and clinical trials;

    ●
    failure
    of our contract research organizations, or CROs, or other third-party contractors to comply with all contractual requirements or
    to perform their services in a timely or acceptable manner;

    ●
    failure
    by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to
    the conduct of clinical trials or the handling, storage, security, and recordkeeping;

    ●
    scheduling
    conflicts with participating clinicians and clinical institutions;

32

    ●
    failure
    to design appropriate clinical trial protocols;

    ●
    insufficient
    data to support regulatory approval;

    ●
    inability
    or unwillingness of medical investigators to follow our clinical protocols; or

    ●
    difficulty
    in maintaining contact with patients during or after treatment, which may result in incomplete data.

Any
of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

Any
failure by us to comply with existing regulations could harm our reputation and operating results.

We
are subject to extensive regulation by U.S. federal and state governments in each of the markets where we have product candidates progressing
through the approval process.

We
must also adhere to all regulatory requirements including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good
Manufacturing Practices requirements (“cGMP”) pharmacovigilance requirements, advertising, and promotion restrictions, reporting
and recordkeeping requirements. If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval
cGMP requirements, then FDA could sanction us. Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions
on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials. Telomir-1,
and any of our product candidates that may be approved in the U.S. in the future, will be subject to ongoing regulatory requirements
for manufacturing, labeling