Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 149

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 149
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 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 and value for oncologists and other physicians, adoption of its molecular diagnostic tests
could be impaired, and DiamiR may not be able to obtain coverage and adequate reimbursement for them.

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In the future, DiamiR may rely on third parties to process and transmit claims to payers for its clinical services, and any delay in processing or transmitting could have an adverse effect on its revenue and financial condition.

As part of its future commercialization
efforts, DiamiR may hire third parties to provide overall processing of claims and to transmit actual claims to payers based on specific
payer billing formats. If claims for its clinical services are not submitted to payers on a timely basis, or if DiamiR is again required
to switch to a different third-party processor to handle claim submissions, DiamiR may experience delays in its ability to process claims
and receive payment from payers, which could have a material adverse effect on its