Company: TELO
Filing Date: 2025-11-28
Form Type: PRER14A
Source: 0001493152-25-025406
Chunk: 39

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-11-28
Form: PRER14A
Chunk 39
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 values of TELO and TELI may not be indicative of the price at which the shares of TELI Common Stock may have been traded on a public market.

Failure to meet regulatory or ethical requirements for medicine development or approval.

We are subject to laws and regulations that control our ability to market our pharmaceutical products. Our development programs must meet many standards to prove our products are safe, effective and of high quality. Health authorities, such as the FDA in the United States and the European Medicines Agency in the European Union, can refuse to approve our products or require us to conduct additional clinical trials or scientific testing before they will approve them for marketing. Many factors influence health authority decisions to approve or reject a marketing application for a pharmaceutical product. These include advances in science and technology, new laws, regulations and policies, and different standards for evaluating safety and effectiveness.

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Delays in regulatory approvals could delay our ability to market our products and may adversely affect our revenue. Also, post-approval requirements, including additional clinical trials, could cause increased costs. We seek to manage these risks, but policymaking by governments and health authorities can be unpredictable and unforeseen circumstances, such as public health emergencies, may strain health authority resources and delay the approval of our products.

Following approval, a health authority may require us to conduct additional clinical trials or scientific testing to address concerns raised after patients have used our products in the marketplace. New data may impact a product’s approval status or lead to labelling changes that limit the use of a product.

All aspects of our business, including preclinical research, clinical trials, marketing and commercialization, arehighly regulated, and any delay by relevant regulatory authorities could jeopardize our development and approval process and/or result in suspensions of marketing authorizations, refusals to approve our products, or withdrawal of existing approvals.

Before we can commence clinical trials for a product candidate, we must complete extensive preclinical testing tosupport our IND or
planned IND applications in the U.S. or Japan, or our clinical trial applications (CTAs) in the UK or in the EU, or comparable
applications in other jurisdictions. We cannot be sure that we will be able to submit INDs or CTAs or comparable applications for
our development programs on the timelines we expect, if at all. We also cannot guarantee that submission of INDs or CTAs or
comparable applications will result in the Relevant Regulatory Authorities or other regulatory authorities allowing clinical trials
to begin.

Clinical trials must be conducted in accordance with