Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 307

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 307
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 our approved products and secure adequate third-party reimbursement.
We currently have limited experience in marketing and selling our products. We currently do not have any products approved for sale in
the United States or in any other country.

The
commercial success of our product candidates will not happen for the foreseeable future and will depend on a number of factors beyond
our control, including the willingness of physicians to prescribe our products to patients, payers’ willingness and ability to
pay for the drugs, the level of pricing achieved, patients’ response to our drugs and the ability of our marketing partners to
generate sales. There can be no guarantee that we will be able to establish or maintain the personnel, systems, arrangements and capabilities
necessary to successfully commercialize Telomir-1 or any product candidate approved by the FDA in the future. If we fail to establish
or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements with third
parties, our product revenues may suffer.

We
will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing
our growth and executing our growth strategy.

Our
management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth.
As a result, we may need to further expand certain areas of our organization.

Our
need to effectively manage our operations, growth and various projects requires that we:

    ●
    continue
    to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;

    ●
    attract
    and retain enough talented employees;

    ●
    manage
    our clinical trials effectively;

    ●
    manage
    our external manufacturing operations with contract research organizations effectively and in a cost-effective manner;

    ●
    manage
    our development efforts effectively while carrying out our contractual obligations to contractors and other third parties; and

27

In
addition, we may utilize the services of part-time outside consultants and contractors to perform several tasks for us, including tasks
related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions.
Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward. If
we are not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors,
we may be unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing,
and commercialization activities