Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 95

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 95
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, 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 Aptorum’s Industry, Business and Operation

If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.

Our research and development
operations involve the use of hazardous materials, chemicals and various radioactive compounds/radiation. Our R&D Center may maintain
quantities of various flammable and toxic chemicals in our facilities that are required for our research, development and manufacturing
activities. We are subject to local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous
materials and of medical waste at the jurisdictions where we operate our research facilities, which are currently limited to Hong Kong.
We believe our procedures for storing, handling and disposing of these materials comply with the relevant guidelines and laws of the jurisdictions
in which our facilities are located. Although we believe that our safety procedures for handling and disposing of these materials comply
with the standards mandated by applicable regulations, the risk of accidental contamination or injury from these materials cannot be eliminated.
If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental,
health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and
the handling of biohazardous materials and medical waste.

We do not maintain workers’
compensation insurance or insurance for environmental liability or toxic tort claims that may be asserted against us in connection with
our storage or disposal of biological, hazardous or radioactive materials. Additional federal, state and local laws and regulations affecting
our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties, if we
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