Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 57

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 57
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 problems with manufacturing or timely obtaining from third parties sufficient quantities of a drug candidate for use in a clinical trial;                                                               |
| ● | ambiguous or negative interim results, or results that are inconsistent with earlier results;                                                                                                                                           |

| ● | feedback from the FDA, NMPA, EMA, Health Canada, an IRB, data safety monitoring boards, or comparable entities, or results from earlier stage or concurrent studies in animals and clinical trials, regarding our drug candidates, including which might require modification of a trial protocol; |
| ● | unacceptable risk-benefit profile or unforeseen safety issues or adverse side effects; and                                                                                                                                                                                                         |
| ● | a decision by the FDA, NMPA, EMA, Health Canada, an IRB, comparable entities, or the Company, or recommendation by a data safety monitoring board or comparable regulatory entity, to suspend or terminate clinical trials at any time for safety issues or for any other reason.                  |

Changes in regulatory requirements
and guidance may also occur, and we may need to amend clinical trial protocols submitted to applicable regulatory authorities to reflect
these changes. Amendments may require us to resubmit clinical trial protocols to IRBs or ethics committees for re-examination, which may
increase the costs or time required to complete a clinical trial.

If we experience delays in
the completion of, or the termination of, a clinical trial, of any of our drug candidates, the commercial prospects of our drug candidates
will be harmed, and our ability to generate product sales revenues from any of those drug candidates will be delayed. In addition, any
delay in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process, and jeopardize
our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects
significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may
also ultimately lead to the denial of regulatory approval of our drug candidates.

If we are required to conduct
additional clinical trials or other studies with respect to any of our drug candidates beyond those that we initially contemplated, if
we are unable to successfully complete our clinical trials or other studies or if the results of these studies are not positive or are
only modestly positive, we may be delayed in obtaining regulatory approval for that drug candidate, we may not be able to obtain regulatory
approval at all or we may obtain approval for indications that are not as broad as intended.