Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 164

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 164
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If DiamiR cannot enter into new clinical study collaborations, its product development and subsequent commercialization could be delayed.

Historically, DiamiR has entered into clinical study collaborations
with academic and medical institutions for access to clinical samples and expertise related to its tests and services, and its success
in the future depends in part on its ability to enter into additional collaborations with highly regarded institutions. This can be difficult
due to internal and external constraints placed on these organizations, and on occasion DiamiR key contact may leave the organization.
Some organizations may limit the number of collaborations they have with any one company, so as to not be perceived as biased or conflicted.
Organizations may also have insufficient administrative and related infrastructure to enable collaboration with many companies at once,
which can extend the time it takes to develop, negotiate, and implement a collaboration. Moreover, it may take longer to obtain the samples
DiamiR needs which could delay its trials, publications, and product launches and reimbursement. Additionally, organizations often insist
on retaining the rights to publish the clinical data resulting from the collaboration. The publication of clinical data in peer-reviewed
journals is a crucial step in commercializing and obtaining reimbursement for its diagnostic tests, and its inability to control when
and if results are published may delay or limit its ability to derive sufficient revenue from them.

If DiamiR is unable to identify collaborators willing to work with us to conduct clinical utility studies, or the results of those studies do not demonstrate that a molecular diagnostic test do not impact patient treatment or physician behavior, commercial adoption of such test may be slow, which would negatively impact its business.

Clinical utility studies are designed to show the impact of the molecular
diagnostic test results on patient care and management. Clinical utility studies are typically performed with collaborating physicians
at medical centers and hospitals, and generally result in peer-reviewed publications. Sales and marketing representatives use these publications
to demonstrate to customers how to use a molecular diagnostic clinical test, as well as why they should use it. These publications are
also used with payers to obtain coverage for a molecular diagnostic test, helping to assure there is appropriate reimbursement. DiamiR
will need to conduct additional studies for its molecular diagnostic tests and other diagnostic tests it plans to introduce, to increase
the market adoption and obtain coverage and adequate reimbursement. Should DiamiR not be able to perform these studies, should the costs
or length of time required for these studies exceed their value, or should their results not provide clinically meaningful data