Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 58

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 58
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 Our product development costs will also increase
if we experience delays in testing or approvals, and we may not have sufficient funding to complete the testing and approval process.
Significant clinical trial delays could allow our competitors to bring their products to market before we do and impair our ability to
commercialize our drugs, if and when approved. If any of this occurs, our business will be materially harmed.

Our drug candidates may cause undesirable adverse events or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any regulatory approval.

Undesirable adverse events
caused by our drug candidates or any future drug candidates we may develop could cause us or regulatory authorities to interrupt, delay
or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, NMPA, EMA,
Health Canada or other comparable regulatory authorities. Results of our potential clinical trials could reveal a high and unacceptable
severity or prevalence of adverse effects. In such event, our trials could be suspended or terminated and the FDA, NMPA, EMA, Health Canada
or other comparable regulatory authorities could order us to cease further development of, or deny approval of, our drug candidates for
any or all target indications. Drug-related adverse events could also affect patient recruitment or the ability of enrolled subjects to
complete the trial, could result in potential product liability claims and may harm our reputation, business, financial condition and
business prospects significantly.

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Additionally, if any of our
current or future drug candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such
drugs, a number of potentially significant negative consequences could result, including but not limited to:

| ● | suspending the marketing of the drug;                                                                                                                                                                      |
| ● | having regulatory authorities withdraw approvals of the drug;                                                                                                                                              |
| ● | adding warnings on the label;                                                                                                                                                                              |
| ● | developing a REMS for the drug or, if a REMS is already in place, incorporating additional requirements under the REMS, or to develop a similar strategy as required by a comparable regulatory authority; |

| ● | conducting post-market studies;                                         |
| ● | being sued and held liable for harm caused to subjects or patients; and |
| ● | damage to our reputation.                                               |

Any of these events could
prevent us from achieving or maintaining market acceptance of the particular drug candidate, if approved,