Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 318

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 318
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    ●
    the
    FDA may disagree with the interpretation of data from pre-clinical studies and clinical trials; and

    ●
    the
    FDA may change their approval policies or adopt new regulations.

Any
of these factors, many of which are beyond our control, could increase development time and / or costs or jeopardize our ability to obtain
regulatory approval for our drug candidates.

34

There
is a high rate of failure for drug candidates proceeding through clinical trials.

Generally,
there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical
trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving
promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, FDA may disagree with our
interpretation of the data. In the event that we obtain negative results from clinical trials for product candidates or other problems
related to potential chemistry, manufacturing and control issues or other hurdles occur and our product candidates are not approved,
we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to execute on our current
business plan may be materially impaired, our reputation in the industry and in the investment community might be significantly damaged
and the price of our common stock could decrease significantly. In addition, our inability to properly design, commence and complete
clinical trials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.

If
we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended
from participation in federal or state health care programs, which may adversely affect our business, financial condition, and results
of operations.

In
the United States, we are subject to various federal and state health care “fraud and abuse” laws, including anti-kickback
laws, false claims laws and other laws intended to reduce fraud and abuse in federal and state health care programs, which could affect
us particularly upon successful commercialization of our products in the U.S. The Medicare and Medicaid Patient Protection Act of 1987,
or federal Anti-Kickback Statute, makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its
behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce