Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 434

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 434
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, 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, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission
of safety and other post-market information, including both federal and state requirements in the U.S. In addition, manufacturers and
manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing
procedures conform to GMP. As such, we, and our contract manufacturers (in the event contract manufacturers are appointed in the future)
are subject to continual review and periodic inspections to assess compliance with GMP. Accordingly, we and others with whom we work
must continue to spend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, quality control
and quality assurance. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and
to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect