Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 63

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 63
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| ● | not obtain regulatory approval at all; |

| ● | obtain approval for indications that are not as broad as intended; |

| ● | have a drug removed from the market after obtaining regulatory 
 approval;                                                      |

| ● | be subject to additional post-marketing testing requirements; |

| ● | be subject to restrictions on how a drug is distributed or used; 
 or                                                               |

| ● | be unable to obtain reimbursement for use of a drug. |

Delays in testing or approvals
may result in increases in our drug development costs. We do not know whether any clinical trials will begin as planned, will need to
be restructured, or will be completed on schedule, or at all.

Clinical trials may produce
negative or inconclusive results. Moreover, these trials may be delayed or proceed less quickly than intended. Delays in completing our
clinical trials will increase our costs, slow down our drug candidate development and approval process, and jeopardize our ability to
commence product sales and generate revenues and we may not have sufficient funding to complete the testing and approval process. Any
of these events may significantly harm Aptorum’s business, financial condition and prospects, lead to the denial of regulatory approval
of our drug candidates or allow our competitors to bring drugs to market before we do, impairing our ability to commercialize our drugs
if and when approved.

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Significant clinical trial
delays also could shorten any periods during which we have the exclusive right to commercialize our drug candidates or allow our competitors
to bring products to market before we do, impair our ability to commercialize our drug candidates and may harm Aptorum’s business
and results of operation

Risks Related to Aptorum’s Obtaining Regulatory Approval for Its Drug Candidates

The regulatory approval processes of the FDA, NMPA, EMA, Health Canada and other comparable regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our current drug candidates or any future drug candidates we may develop, Aptorum’s business will be substantially harmed.

We cannot commercialize drug
candidates without first obtaining regulatory approval to market each drug from the FDA, NMPA, EMA, Health Canada or comparable regulatory
authorities. Before obtaining regulatory approvals for the commercial sale of any drug candidate for a target indication, we must demonstrate
in studies in animals and well-controlled clinical trials, and, with respect to approval in the United States and other regulatory
agencies,