Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 438

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 438
---
 the government under the federal False Claims Act as well as under the false claims laws of several states.

Many
states have adopted laws similar to the federal anti-kickback statute, some of which apply to the referral of patients for health care
services reimbursed by any source, not just governmental payers. There are ambiguities as to what is required to comply with these state
requirements and if we fail to comply with an applicable state law requirement, we could be subject to penalties.

Neither
the government nor the courts have provided definitive guidance on the application of fraud and abuse laws to our business. Law enforcement
authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these
laws. While we believe we have structured our business arrangements to comply with these laws, it is possible that the government could
allege violations of, or convict us of violating, these laws. If we are found in violation of one of these laws, we could be required
to pay a penalty and could be suspended or excluded from participation in federal or state health care programs, and our business, results
of operations and financial condition may be adversely affected.

Serious
adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates,
limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already
marketed.

If
any of our product candidates prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated
with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:

    ●
    regulatory
    authorities may interrupt, delay or halt clinical trials;

    ●
    regulatory
    authorities may deny regulatory approval of our product candidates;

35

    ●
    regulatory
    authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for
    use, and/or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”) in
    connection with approval or post-approval;

    ●
    regulatory
    authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive REMS, or require us
    to recall any product that is approved;

    ●
    we
    may be required to change the way the product is administered or conduct