Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 14

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 14
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, 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. 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