Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 8

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 8
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 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 ...  
  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 devel...  
  the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment may be insufficient or slower than we anticipate or patients may drop out...  
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  our contractors and investigators may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;                                          
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  we might have to suspend or terminate clinical trials of our drug candidates for various reasons, including a lack of clinical response or a determination that participants are being exposed to...  
  regulators, IRBs or ethics committees may require that we or our investigators suspend or terminate clinical research for various reasons, including non-compliance with regulatory requirements;     
  the cost of clinical trials of our drug candidates may be greater than we anticipate;                                                                                                                 
  the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may