Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 145

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 145
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MIR and other assays in development, and demonstrate the
clinical utility of its technology. If Industry Advocates do not believe in DiamiR’s products, market acceptance of its products
could fail to increase or could decrease, and its business could be harmed. Additionally, a lack of support from Industry Advocates could
reduce the rate of coverage and reimbursement by both public and private third-party payors for DiamiR’s products and services,
which may further slow the market adoption of its product by physicians, significantly reduce its ability to achieve expected revenues
and prevent it from becoming profitable. Slow adoption of DiamiR’s products by Industry Advocates would significantly reduce its
ability to achieve expected sales and could prevent it from achieving and maintaining profitability.

New product development and clinical validation involves a lengthy and complex process, and DiamiR may be unable to commercialize CogniMIR® or any other products it may develop on a timely basis, or at all.

It takes significant time
to fully develop and commercialize CogniMIR for risk of early neurodegeneration, and therefore its launch may be delayed
or may not be successful. There can be no assurance that CogniMIR will be successful in the risk assessment of Mild Cognitive
Impairment and early Alzheimer’s disease for a variety of technical and market reasons. DiamiR’s other molecular diagnostic
products, which are currently in various stages of early development, will take time to develop and commercialize, if it is able to commercialize
them at all. Prior to commercializing any new products, DiamiR’s will need to conduct substantial research and development, including
validation studies. DiamiR’s product development efforts involve a high degree of risk and may fail for many reasons, including
failure to demonstrate the clinical utility of the product. As DiamiR develops products, it will have to make significant investments
in product development and marketing resources. In addition, competitors may develop and commercialize competing products faster than
DiamiR are able to do so. If DiamiR is unable to commercialize CogniMIR, it may not be able to carry out its business.

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DiamiR’s research and development efforts will be hindered if it is not able to acquire or contract with third parties for access to additional plasma samples.

DiamiR’s test development
relies on its ability to secure access to independent cohorts of plasma samples and related clinical data. Many academic/re