Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 70

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 70
---
. If, during the inspection, FDA identifies issues which, in FDA’s judgment, may constitute violations of the Federal Food, Drug, and Cosmetic Act or FDA’s regulations, the FDA inspector may issue an FDA Form 483 listing these observations. 37 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. Risks Related to Commercialization of Aptorum’s 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