Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 424

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 424
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 Any of our product candidates may fail
to achieve their specified endpoints in clinical trials.

Furthermore,
product candidates may not be approved even if they achieve their specified endpoints in clinical trials. The FDA may disagree with our
trial design and our interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed
and commented on the design for our clinical trials. The FDA may also approve a drug for fewer or more limited indications than we request
or may grant approval contingent on the performance of costly post-approval clinical trials (i.e., Phase IV trials). In addition, the
FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product
candidates.

If
we are unable to expand our pipeline and obtain regulatory approval for our product candidates within the timelines we anticipate, we
will not be able to execute our business strategy effectively and our ability to substantially grow our revenues will be limited, which
would have a material adverse impact on our long-term business, results of operations, financial condition, and prospects.

We
are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.

Our
ability to progress our plan will depend on our ability to clinically develop, gain regulatory approval for and ultimately commercialize
our product candidates. Our ability to successfully commercialize our product candidates will depend on, among other things, our ability
to:

    ●
    complete
    pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress our studies;

    ●
    receive
    IND acceptance and regulatory approvals from the FDA;

    ●
    produce,
    through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently
    large quantities of product candidates to permit successful commercialization;

    ●
    obtain
    reimbursement from payers such as government health care programs and insurance companies and achieve commercially attractive levels
    of pricing;

    ●
    secure
    acceptance of our product candidates from physicians, health care payers, patients, and the medical community;

    ●
    create
    positive publicity surrounding our product candidates;

    ●
    manage
    our spending as costs and expenses increase due to clinical trials and commercialization; and

    ●
    obtain
    and enforce sufficient intellectual property for our product candidates.

26

Our
failure or delay with respect to any of the factors above could have a material adverse