Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 306

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 306
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 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 effect on our business, results of operations
and financial condition.

Results
of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.

Any
positive results from future pre-clinical testing of our product candidates and potential future clinical trials may not necessarily
be predictive of the results from Phase I, Phase II or Phase III clinical trials. In addition, our interpretation of results derived
from clinical data or our conclusions based on our pre-clinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology
companies have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase
clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that pre-clinical
and clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain product candidates may perform satisfactorily
in pre-clinical studies and clinical trials but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory
authorities in other countries. If we fail to produce positive results in our clinical trials for our product candidates, the development
timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects, would
be materially adversely affected.

We
have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement
capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.

Our
ability to generate revenues ultimately depends on our ability to sell