Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 40

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 40
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. Additionally, our manufacturers may experience manufacturing difficulties due to resource
constraints, or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter any of these
difficulties, or otherwise fail to comply with their contractual obligations, our ability to provide our drug candidate to patients in
clinical trials would be jeopardized. Any delay or interruption in the manufacturing of clinical trial supplies could delay the completion
of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require
us to begin new clinical trials with additional costs or terminate clinical trials completely.

Review of changes in the manufacturing process
of our drug candidates could cause delays resulting from the need for additional regulatory approvals.

Changes in a process or procedure
for manufacturing one of our drug candidates, including a change in the location where the drug candidate is manufactured or a change
of a contract manufacturer, could require prior review by the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities
and approval of the manufacturing process and procedures in accordance with the FDA, NMPA, EMA, or Health Canada’s regulations,
or comparable requirements. This review may be costly and time-consuming and could delay or prevent the launch of a product. The new facility
will also be subject to pre-approval inspection. In addition, we would have to demonstrate that the product made at the new facility is
equivalent to the product made at the former facility by physical and chemical methods, which are costly and time-consuming. It is also
possible that the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities may require clinical testing as a way to prove
equivalency, which would result in additional costs and delay.

Risks Related to Our Diagnostics Technology

Our products could in the future be subject
to additional regulation by the U. S. Food and Drug Administration or other domestic and international regulatory agencies, which could
increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results of operations.

The FDA has statutory authority
to assure that medical devices and in vitro diagnostics, including those where the PathsDxTest technology may
be utilized, are safe and effective for their intended uses. Should the PathsDxTest technology be utilized in U. S. as a Laboratory
Developed Test (LDT), the FDA has historically exercised its enforcement discretion and may not enforce applicable provisions of the FDC
Act and regulations with respect to L