Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 94

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 94
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 risks could delay
or prevent the completion of our clinical trials or the approval of any of our drug candidates by the FDA, NMPA, EMA, Health Canada or
other comparable regulatory authorities, result in higher costs or adversely impact commercialization of our drug candidates.

We are also responsible for
quality control by our manufacturers. We intend to rely on those unrelated-party manufactures to perform certain quality assurance tests
on our drug candidates prior to delivery to patients. If these tests are not appropriately done and test data are not reliable, patients
could be put at risk of serious harm and the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities could place significant
restrictions on our Company until deficiencies are remedied.

Manufacturers of drug products
often encounter difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability
of the manufacturing process (including the absence of contamination). These problems include logistics and shipping, difficulties with
production costs and yields, quality control, including stability of the product, product testing, operator error, availability of qualified
personnel, as well as compliance with strictly enforced federal, state and non-U.S. regulations. Furthermore, if contaminants are
discovered in our supply of our drug candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed
for an extended period of time to investigate and remedy the contamination. It is possible that stability failures or other issues relating
to the manufacture of our drug candidates may occur in the future. Additionally, our manufacturers may experience manufacturing difficulties
due to resource constraints, or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter
any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to provide our drug candidate to
patients in clinical trials would be jeopardized. Any delay or interruption in the manufacturing of clinical trial supplies could delay
the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period
of delay, require us to begin new clinical trials with additional costs or terminate clinical trials completely.

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Review of changes in the manufacturing process of our drug candidates could cause delays resulting from the need for additional regulatory approvals.

Changes in a process or procedure
for manufacturing one of our drug candidates, including a change in the location where the drug candidate is manufactured or a change
of a contract manufacturer, could require prior review by the FDA, NMPA