Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 64

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 64
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 to the satisfaction of the FDA, NMPA, EMA, Health Canada or comparable regulatory authorities, that the drug candidate is safe
and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate.

The time required to obtain
approval from the FDA, NMPA, EMA, Health Canada and other comparable regulatory authorities is unpredictable but typically takes many years
following the commencement of studies in animals and clinical trials and depends upon numerous factors, including the substantial discretion
of the regulatory authorities.

In addition, approval policies,
regulations or the type and amount of clinical data necessary to gain approval can differ among regulatory authorities and may change
during the course of the development of a drug candidate. We have not obtained regulatory approval for any drug candidate. It is possible
that neither our existing drug candidates nor any drug candidates we may discover or acquire for development in the future will ever obtain
regulatory approval. Even if we obtain regulatory approval in one jurisdiction, we may not obtain it in other jurisdictions.

Aptorum’s drug candidates
could fail to receive regulatory approval from any of the FDA, 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 Aptorum’s                                                        
 drug candidates to support the submission and filing of a New Drug Application (“NDA”), or other submission or to obtain 
 marketing approval;                                                                                                      |

| ● | 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 contract for clinical and commercial supplies; and                                                                           |

| ● | 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