Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 11

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 11
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 NMPA, EMA, Health Canada or other comparable regulatory authorities for many
reasons, including but not limited to:

  disagreement with regulators regarding the design or implementation of our clinical trials;                                                                                                           
  failure to demonstrate that a drug candidate is safe and effective or safe, pure and potent for its proposed indication;                                                                              
  failure of clinical trial results to meet the level of statistical significance required for approval;                                                                                                
  failure to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks;                                                                                                 
  disagreement with regulators regarding our interpretation of data from studies in animals or clinical trials;                                                                                         
  insufficiency of data collected from clinical trials of our drug candidates to support the submission and filing of a New Drug Application (“ NDA”), or other submission or to obtain marketing a...  
  the FDA, NMPA, EMA, Health Canada or a comparable regulatory authority’s finding of deficiencies related to the manufacturing processes or facilities of third-party manufacturers with whom we c...  
  changes in approval policies or regulations that render our preclinical studies and clinical data insufficient for approval.                                                                          

Any of the FDA, NMPA, EMA,
Health Canada or other comparable regulatory authorities may require more information, including additional preclinical studies or clinical
data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development
program. If we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited indications
than we request. Regulatory authorities also may grant approval contingent on the performance of costly post-marketing clinical trials,
or may approve a drug candidate with a label that is not desirable for the successful commercialization of that drug candidate. In addition,
if our drug candidate produces undesirable side effects or involves other safety issues, the FDA may require the establishment of a Risk
Evaluation Mitigation Strategy (“ REMS”), or NMPA, EMA, Health Canada or other comparable regulatory authorities may require
the establishment of a similar strategy. Such a strategy may, for instance, restrict distribution of our drug candidates, require patient
or physician education, or impose other burdensome implementation requirements on us.

Regulatory approval may be substantially
delayed or may not be obtained for one or all of our drug candidates if regulatory authorities require additional time or studies to assess
the safety or efficacy of our drug candidates.

We currently do not have any
drug candidates that have gained approval for sale by the FDA, NMPA