Company: TELO
Filing Date: 2025-11-28
Form Type: PRER14A
Source: 0001493152-25-025406
Chunk: 41

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-11-28
Form: PRER14A
Chunk 41
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. Further, the Relevant Regulatory Authorities or other comparable regulatory authorities may impose extensive and ongoing unique regulatory requirements, such as granting approval contingent on the performance of costly post-marketing clinical trials, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product.

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The costs of compliance with all Relevant Regulatory Authorities’ and other applicable authorities’ regulations, requirements or guidelines could be substantial, and failure to comply could result in sanctions, including fines, injunctions, civil penalties, denial of applications for marketing authorization of our products, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could significantly increase our and/or our collaborative partners’ costs or delay or prevent the development and commercialization of our product candidates. At this time, we cannot guarantee or know the exact nature, precise timing and detailed costs of the efforts that will be necessary to complete the remainder of the development of our research programs and product candidates.

Business interruptions could delay the process of developing TELI’s product candidates and could disrupt product sales.

TELI’s research and development activities are conducted through outside contractors and manufacturers. Loss of TELI’s contracted manufacturing facilities, stored inventory or laboratory facilities through fire, theft or other causes, or loss of access to raw materials, could have an adverse effect on TELI’s ability to continue product development activities and to conduct its business. Failure to supply TELI’s partners with commercial product may lead to adverse consequences, including the right of partners to take over responsibility for product supply. TELI currently does not have insurance coverage to compensate it for such business interruptions.

If product liability lawsuits are successfully brought against TELI, it will incur substantial liabilities and may be required to limit the commercialization of TELI’s product candidates.

Although TELI has never had any product liability claims or lawsuits brought against it, TELI faces potential product liability exposure related to the testing of its product candidates in human clinical trials. TELI may face exposure to claims by an even greater number of persons when it begins to market and distribute or products commercially in the U.S., Europe and elsewhere. Now, and in the future, an individual may bring a liability claim against TELI alleging that one of its product candidates caused an injury. While TELI continues to take what it believes are appropriate precautions, it may be unable to avoid significant liability if any product liability lawsuit is brought against it. Large judgments have been awarded in