Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 53

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 53
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 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 our 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.

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 our business and results
of operations.

We may in the future conduct clinical trials for our drug candidates in sites outside the U.S. and the FDA may not accept data from trials conducted in such locations.

We may in the future conduct
certain of our clinical trials outside the U.S. Although the FDA may accept data from clinical trials conducted outside the U.S. for our
New Drug Application (“NDA”), acceptance of this data is subject to certain conditions imposed by the FDA. There can be no
assurance the FDA will accept data from any of the clinical trials we conduct outside the U.S. If the FDA does not accept the data from
any of our clinical trials conducted outside the U.S., it would likely result in the need for additional clinical trials in the U.S.,
which would be costly and time-consuming and could delay or prevent the commercialization of any of our drug candidates.

Risks Related to Obtaining Regulatory Approval for Our 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, our 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,
to the satisfaction of the FDA, NMPA, EMA, Health Canada or comparable regulatory authorities, that the drug candidate is safe and effective
for use for that target indication and that the manufacturing facilities, processes and controls are