Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 305

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 305
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 must demonstrate through pre-clinical testing and clinical trials that the product candidate
is safe and effective for its specific application. This process can take many years and may include post- marketing studies and surveillance,
which would require the expenditure of substantial resources. Of the large number of drugs in development for approval in the United
States (and the rest of the world), only a small percentage will successfully complete the FDA regulatory approval financing to fund
our planned research, development, and clinical programs, we cannot assure you that any of our product candidates will be successfully
developed or commercialized.

We
may be unable to formulate or scale up any or all of our product candidates. There is no guarantee that any of the product candidates
will be or are able to be manufactured or produced in a manner to meet the FDA’s criteria for product stability, content uniformity
and all other criteria necessary for product approval in the United States and other markets. 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