Company: TELO
Filing Date: 2025-02-14
Form Type: S-3
Source: 0001493152-25-006943
Chunk: 36

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-14
Form: S-3
Chunk 36
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As a result of these factors, we may not succeed in our business, and we could go out of business.

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We have yet to achieve a profit and will not achieve a profit in the near future, if at all.

We have not yet produced any revenues or profit and will not in the near future, if at all. We cannot be certain that we will be able to realize sufficient revenue to achieve profitability. Further, many of our competitors have a significantly larger industry presence and revenue stream but have yet to achieve profitability. Our ability to continue as a going concern in the future is dependent upon raising capital from financing transactions, in addition to this offering, increasing revenue and keeping operating expenses below our revenue levels in order to achieve positive cash flows, none of which can be assured.

Any failure by us to comply with existing regulations could harm our reputation and operating results.

We are subject to extensive regulation by U.S. federal and state governments in each of the markets where we have product candidates progressing through the approval process.

We must also adhere to all regulatory requirements including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good Manufacturing Practices requirements (“cGMP”) pharmacovigilance requirements, advertising, and promotion restrictions, reporting and recordkeeping requirements. We do not believe Telomir-1 is subject to the federal Food, Drug and Cosmetic Act or its implementing regulations (the “FDCA”) at our current pre-IND stage. However, the FDA may disagree with this view and find that, even if our preclinical studies are not required to comply with FDA’s IND or INAD regulations, any actions taken with respect to, and/or online or other public statements made about, Telomir-1 are, nonetheless, subject to FDA enforcement if in violation of any FDCA provisions pertaining to investigational drugs intended for human or animal use. Any FDA enforcement action at this stage could adversely impact the timing and/or likelihood of success of Telomir-1’s regulatory approval and/or require us to devote additional time and resources to address such matter(s).

If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval cGMP requirements, then FDA could sanction us. Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials. Telomir-1, and any of our product candidates that may