Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 51

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 51
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 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 our 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 FDA, NMPA, EMA, Health Canada or comparable regulatory authorities may require us to perform additional clinical trials
before approving our marketing applications.

We may experience numerous
unexpected events during, or as a result of, clinical trials that could delay or prevent our ability to receive regulatory approval or
commercialize our drug candidates, including but not limited to:

| ● | regulators, institutional review boards (“IRBs”) or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;                                  |
| ● | clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs;                      |
| ● | the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment may be