Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 62

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 62
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.

Note that if an entity does
not address observations found in an FDA Form 483 to FDA’s satisfaction, the FDA could take enforcement action, including any of
the following sanctions:

| ● | untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; |

| ● | customer notifications or recall, detention or seizure of our product; |

| ● | operating restrictions or partial suspension or total shutdown of production; |

| ● | refusing or delaying our requests for pre-market approval of new products; |

| ● | withdrawing pre-market approvals that have already been granted; |

| ● | refusal to grant export approval for our product; or |

| ● | criminal prosecution. |

Any of the foregoing actions
could have a material adverse effect on our reputation, business, financial condition and operating results.

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Risks Related to Commercialization of Our Drug Candidates

Even if any of our drug candidates receive regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

After we complete clinical
trials and receive regulatory approval for any of our drug candidates, which may not happen for some time, we recognize that such candidate(s)
may ultimately fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.
We may not be able to achieve or maintain market acceptance of our products over time if new products or technology are introduced that
are more favorably received than our products, are more cost effective or render our drug obsolete. We will face competition with respect
to our drug candidates from other pharmaceutical companies developing products in the same disease/therapeutic area and specialty pharmaceutical
and biotechnology companies worldwide. Many of the companies against which we may be competing have significantly greater financial resources
and expertise in research and development, manufacturing, animal testing, conducting clinical trials, obtaining regulatory approvals and
marketing approval for drugs than we do. Physicians, patients and third-party payors may prefer other novel products to ours, which means
that we may not generate significant sales revenues for that product and that product may not become profitable. The degree of market
acceptance of our drug candidates, if approved for commercial sale, will depend on a number of factors, including but not limited to:

| ● | clinical indications for which our drug candidates are approved; |

| ● | physicians, hospitals, and patients considering our drug candidates as a safe and effective