Company: TELO
Filing Date: 2025-11-20
Form Type: PREM14A
Source: 0001493152-25-024463
Chunk: 32

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-11-20
Form: PREM14A
Chunk 32
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 and clinical development and FDA regulatory submission and approval efforts will be required before TELI is permitted to undertake clinical studies and market and commercialize TELI’s product candidates, if ever. It may be several years before TELI 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 TELI intends, if approved, to market TELI’s product candidates. Before obtaining regulatory approvals for any of TELI’s product candidates, TELI 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 TELI’s planned research, development, and clinical programs. TELI cannot assure you that any of TELI’s product candidates will be successfully developed or commercialized.

We may be unable to formulate or scale up any or all of TELI’s 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 TELI’s 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 TELI’s trial design and TELI’s interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for TELI’s clinical trials. The FDA may also approve a drug for fewer or more limited indications than TELI requests 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 TELI believe is necessary or desirable for the successful commercialization of TELI’s product candidates.

If TELI is unable to obtain regulatory approval for its drug candidates within the timeline TELI anticipates, TELI will not be able to execute TELI’s business strategy effectively and TELI’s ability to