Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 82

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 82
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 including those governing laboratory
procedures and the handling, use, storage, treatment and disposal of hazardous materials and waste. In the event of contamination or injury
resulting from our use of hazardous materials, we might be held liable for any resulting damages, and any liability could exceed our resources.
We could also be subject to civil or criminal fines and penalties, and significant associated costs.

If an IND for one of our drug candidates requires significantly larger quantities of the candidate to be tested, we expect to rely on unrelated parties to manufacture supplies of that candidate. If those unrelated parties fail to provide us with sufficient quantities of clinical supply on that candidate or fail to do so at acceptable quality levels or prices, or fail to maintain required cGMP licenses, we may not be able to manufacture that candidate in sufficient quantities to conduct the necessary human trials. Should the failure by the CRO occur in anticipation of or after marketing approval of that candidate, we may be unable to generate as much revenue as rapidly (and such revenue may not be as profitable) as we had anticipated.

The manufacture of many drug
products, particularly in commercial quantities, can be complex and may require significant expertise and capital investment, particularly
if the development of advanced manufacturing techniques and process controls are required. We intend to contract with outside contractors
to manufacture clinical supplies and process our drug candidates. We have not yet had our drug candidates to be manufactured or processed
on a commercial scale and may not be able to do so for any of our drug candidates.

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As we expect to engage contract
manufacturers, the Company will be exposed to the following risks:

| ● | we might be unable to identify manufacturers on acceptable terms or at all because the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities must approve any manufacturers we determine to use and any potential manufacturer may be unable to satisfy federal, state or international regulatory standards;                                                                                                                                           |
| ● | although we would be choosing manufacturers with the type of experience most suitable for our drug candidates, it is possible that our contract manufacturers may not be able to execute unique manufacturing procedures and other logistical support requirements we have developed and they might require a significant amount of support from us to implement and maintain the infrastructure and processes required to manufacture our particular drug candidates;     |
| ● | our contract manufacturers might be unable to reproduce the quantity and quality of the drugs we need to meet our clinical and commercial needs within the time frames when we require those drugs;                                                                                                                                                                                                                                                                        |
|