Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 176

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 176
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 requires us to report certain security   
 breaches to health care provider customers with respect to such information where DiamiR is acting as a HIPAA business associate to that 
 customer.                                                                                                                                |

| ● | The federal Physician Payment Sunshine Act, which requires applicable                                                                    
 manufacturers of certain medical devices that may be reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program,       
 among others, to annually track and report payments or other transfers of value provided to U.S. licensed physicians, physician          
 assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants and certified     
 nurse-midwives, and U.S. teaching hospitals, as well as certain ownership and investment interest held in the manufacturer by physicians 
 and their immediate family members.                                                                                                      |

Similar requirements have been adopted by many states and foreign countries.
Violations of any of these laws can lead to additional legal risk such as risk of plaintiff class actions, state Attorney General actions,
and investigations by the Federal Trade Commission, among others.

Failure to comply with applicable requirements, or later discovery
of previously unknown problems with DiamiR’s products or manufacturing processes, including DiamiR’s failure or the failure
of one of DiamiR’s contract manufacturers to take satisfactory corrective action in response to an adverse inspection, can result
in, among other things:

| ● | administrative or judicially imposed sanctions; |

| ● | injunctions or the imposition of civil penalties; |

| ● | recall or seizure of DiamiR’s products; |

| ● | corrective field actions for DiamiR’s products; |

| ● | submission of reports to FDA or other regulatory authorities; |

| ● | total or partial suspension of production or distribution; |

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| ● | withdrawal or suspension of marketing clearances or approvals; |

| ● | clinical holds for investigations; |

| ● | untitled letters or warning letters; |

| ● | refusal to permit the import or export of DiamiR’s products; |

| ● | criminal prosecution; and |

| ● | exclusion or debarment from participation in federal health 
 care programs such as Medicare and Medicaid.                |

Any of these actions, in combination or alone, could prevent DiamiR
from marketing, distributing and selling DiamiR’s products.

In addition, a product defect or regulatory violation could lead to
a government-mandated or voluntary recall by DiamiR. DiamiR believes that the FDA would request that D