Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 173

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 173
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 to phase out its general enforcement discretion over LDTs, which would
have introduced new compliance obligations over a four-year period. The court’s ruling underscores that oversight of LDTs falls
under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services (CMS),
not the FDA.

The FDA announced in May 2025 that it will not appeal this decision.
If the FDA changes its position on this appeal, and wins on appeal, risks associated with the new landscape of LDTs include but are not
limited to:

| ● | DiamiR’s inability to implement quality standards included 
 in the new guidelines                                      |

| ● | DiamiR’s inability to implement all FDA requirements for 
 LDTs                                                     |

| ● | Backlog at the FDA for review of submission |

| ● | Additional regulations being adopted by the FDA |

| ● | Increased timeline to product launch, delaying revenue for the 
 company                                                        |

| ● | Increased regulatory oversight resulting in delays for product 
 launch                                                         |

| ● | Increased costs of product development and regulatory compliance |

| ● | Increase costs may arise from: |

<div align='center'>91</div>

| ● | More expansive validation study design |

| ● | Hiring additional regulatory compliance talent |

| ● | Hiring additional statistical experts |

| ● | Other unanticipated costs |

Sales of its diagnostic product candidates outside the United States
are subject to foreign regulatory requirements governing clinical studies, vigilance reporting, marketing approval, manufacturing, product
licensing, pricing and reimbursement. These regulatory requirements vary greatly from country to country. DiamiR may not be able to obtain
foreign regulatory approvals on a timely basis or at all. Marketing authorization from the FDA does not ensure approval by regulatory
authorities in other countries, and approval by one foreign regulatory authority does not ensure clearance or approval by regulatory authorities
in other countries or by the FDA. Foreign regulatory authorities could require additional testing. Failure to comply with foreign
regulatory requirements, or to obtain required clearances or approvals, could impair its ability to commercialize its diagnostic product
candidates outside of the United States.

Global health crises may divert regulatory resources and attention
away from approval processes for its products. This could materially lengthen the regulatory approval process of new products, which would
delay expected commercialization of such new products.

DiamiR and their suppliers, contract manufacturers and customers are subject to various governmental laws and regulations, and DiamiR may incur significant expenses to comply with, and experience delays in