Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 423

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 423
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X than the decisions have
for us. Furthermore, in light of the license agreement that we have with MIRALOGX, if a dispute were to arise between MIRALOGX and us
relating to our past or future relationship with MIRALOGX or with respect to intellectual property matters, these potential conflicts
of interest may make it more difficult for us to favorably resolve such disputes.

25

Risks
Relating to Our Business and Our Industry

Our
future success will largely depend on the success of Telomir-1 and any future product candidates, which development will require significant
capital resources and years of clinical development effort.

We
currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development. Our
business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization
of our product candidates, principally Telomir-1. Our stockholders need to be aware that substantial additional investments including
pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before we are permitted to
undertake clinical studies and market and commercialize our product candidates, if ever. It may be several years before we can commence
clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities
in the United States and other jurisdictions where we intend, if approved, to market our product candidates. Before obtaining regulatory
approvals for any of our product candidates, we 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.