Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 425

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 425
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 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 our approved products and secure adequate third-party reimbursement.
We currently have limited experience in marketing and selling our products. We currently do not have any products approved for sale in
the United States or in any other country.

The
commercial success of our product candidates will not happen for the foreseeable future and will depend on a number of factors beyond
our control, including the willingness of physicians to prescribe our products to patients, payers’ willingness and ability to
pay for the drugs, the level of pricing achieved, patients’ response to our drugs and the ability of our marketing partners to
generate sales. There can be no guarantee that we will be able to establish or maintain the personnel, systems, arrangements and capabilities
necessary to successfully commercialize Telomir-1 or any product candidate approved by the FDA in the future. If we fail to establish
or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements with third