Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 61

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 61
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 countries and languages involved in such trials. In addition, the design of a clinical trial can determine whether
its results will support approval of a drug candidate, and flaws in the design of a clinical trial may not become apparent until the clinical
trial is well advanced and significant expense has been incurred.

A number of companies in the
pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials due to lack of demonstrated
efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Clinical trials of potential products often
reveal that it is not practical or feasible to continue development efforts. Furthermore, if the trials we conduct fail to meet their
primary statistical and clinical endpoints, they will not support the approval from the FDA, NMPA, EMA, Health Canada or other comparable
regulatory authorities for our drug candidates. If this occurs, we would need to replace the failed study with new trials, which would
require significant additional expense, cause substantial delays in commercialization and materially adversely affect Aptorum’s
business, financial condition, cash flows and results of operations.

If clinical trials of our drug candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities, or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates.

Before applying for and obtaining
regulatory approval for the sale of any of our drug candidates, we must conduct extensive clinical trials to demonstrate the safety and
efficacy of our drug candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years
to complete and may fail. A failure of one or more of our clinical trials can occur at any stage of testing and successful interim results
of a clinical trial do not necessarily predict successful final results.

We and our CROs are required
to comply with current Good Clinical Practices (“cGCP”) requirements, which are regulations and guidelines enforced by the
FDA, NMPA, EMA, Health Canada and other comparable regulatory authorities for all drugs in clinical development. Regulatory authorities
enforce these cGCP through periodic inspections of trial sponsors, principal investigators and trial sites. Compliance with cGCP can be
costly and if we or any of our CROs fail to comply with applicable cGCP, the clinical data generated in our clinical trials may be deemed
unreliable and the