Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 92

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 92
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 fully cooperative or disagree with us as to the prosecution, maintenance or enforcement
of any patent rights, such patent rights could be compromised.

Risks Related to Aptorum’s Reliance on Unrelated Parties

We rely on unrelated parties to conduct discovery and further improvement of our innovations and licensed technologies, as well as our preclinical studies and clinical trials. If these unrelated parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates, and our business could be substantially harmed.

We have relied upon and plan
to continue to rely upon CROs and collaborating institutions to monitor and manage data for our ongoing preclinical studies and programs.
We rely on these parties for execution of preclinical studies and clinical trials, and control only certain aspects of their activities.
Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal,
and regulatory requirements and scientific standards, and our reliance on the CROs and collaborating institutions does not relieve us
of our regulatory responsibilities. If CROs, collaborating institutions or clinical investigators do not successfully carry out their
contractual duties or obligations or meet expected deadlines, development of our product candidates could be delayed and our business
could be adversely affected.

In addition, our CROs and collaborating
institutions, are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures
and the handling, use, storage, treatment and disposal of hazardous materials and waste. In the event of contamination or injury resulting
from our use of hazardous materials, we might be held liable for any resulting damages, and any liability could exceed our resources.
We could also be subject to civil or criminal fines and penalties, and significant associated costs.

If an IND for one of our drug candidates requires significantly larger quantities of the candidate to be tested, we expect to rely on unrelated parties to manufacture supplies of that candidate. If those unrelated parties fail to provide us with sufficient quantities of clinical supply on that candidate or fail to do so at acceptable quality levels or prices, or fail to maintain required cGMP licenses, we may not be able to manufacture that candidate in sufficient quantities to conduct the necessary human trials. Should the failure by the CRO occur in anticipation of or after marketing approval of that candidate, we may be unable to generate as much revenue as rapidly (and such revenue may not be as profitable) as we had anticipated.

The manufacture of many drug
products, particularly in commercial