Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 83

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 83
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 ● | our contract manufacturers may breach their contracts with us, including by not performing as agreed or not devoting sufficient resources to our drug candidates, or they may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products;                                                                                                                         |
| ● | even if initially accepted by regulatory authorities, a manufacturer remains subject to ongoing periodic unannounced inspection by regulatory authorities to ensure strict compliance with cGMP and other government regulations, and our contract manufacturers may fail to comply with these regulations and requirements, resulting in rescission of cGMP licenses and our inability to continue using their services, requiring us to find a replacement manufacturer; |
| ● | depending on the terms of our agreement with a manufacturer, we may not own, or may have to share, the IP rights to any improvements made by the manufacturer in the manufacturing process for our drug candidates; and                                                                                                                                                                                                                                                    |
| ● | our contract manufacturers may have unacceptable or inconsistent product quality success rates and yields.                                                                                                                                                                                                                                                                                                                                                                 |

Each of these 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