Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 93

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 93
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 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; |

| ● | our contract manufacturers may breach their contracts with us,                                                                            
 including by not performing as agreed or not devoting sufficient resources to our drug candidates, or they may not remain in the contract 
 manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products; |

| ● | even if initially accepted by regulatory authorities, a manufacturer                                                                       
 remains subject to ongoing periodic unannounced inspection by regulatory authorities to ensure strict compliance with cGMP and other       
 government regulations, and our contract manufacturers may fail to comply with these regulations and requirements, resulting in rescission 
 of cGMP licenses and our inability to continue using their services, requiring us to find a replacement manufacturer;                      |

| ● | depending on the terms of our agreement with a manufacturer,                                                                          
 we may not own, or may have to share, the IP rights to any improvements made by the manufacturer in the manufacturing process for our 
 drug candidates; and                                                                                                                  |

| ● | our contract manufacturers may have unacceptable or inconsistent 
 product quality success rates and yields.                        |

Each of these