Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 54

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 54
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 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.

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Our 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 our 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 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