Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 443

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1A
Chunk 443
---
 manner and
in compliance with cGMP or other regulatory requirements could adversely affect our business in a number of ways, including:

    ●
    an
    inability to initiate or complete clinical trials of Telomir-1 or any future product candidates in a timely manner;

    ●
    delay
    in submitting regulatory applications, or receiving marketing approvals, for Telomir-1 or any future product candidates;

    ●
    subjecting
    third-party manufacturing facilities or our potential future manufacturing facilities to additional inspections by regulatory authorities;

    ●
    requirements
    to cease development or to recall batches of Telomir-1 or any future product candidates; and

    ●
    in
    the event of approval to market and commercialize Telomir-1 or any future product candidates, an inability to meet commercial demands
    for Telomir-1 or any future product candidates.

In
addition, we do not have any long-term commitments or supply agreements with any third-party manufacturers. We may be unable to establish
any long-term supply agreements with third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to
timely obtain sufficient quantities of Telomir-1 or such quantities at an acceptable cost. Even if we are able to establish agreements
with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

    ●
    failure
    of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;

    ●
    breach
    of the manufacturing agreement by the third party;

    ●
    failure
    to manufacture our product candidates according to our specifications;

    ●
    failure
    to obtain adequate raw materials and other materials required for manufacturing;

    ●
    failure
    to manufacture our product according to our schedule or at all;

    ●
    failure
    to successfully scale up manufacturing capacity, if required;

    ●
    misappropriation
    of our proprietary information, including any potential trade secrets and know-how; and

    ●
    termination
    or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

38

Any
performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval or jeopardize
our ability to commence or continue commercialization of Telomir-1 or any future product candidates, and any related remedial measures
may be costly or time consuming to implement. We do not