Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 266

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 266
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 patient, when absent
that test, a different treatment course, with worse results would be adopted.

<div align='center'>137</div>

While DiamiR plans on conducting
Clinical Utility studies for its CogniMIR, at this time DiamiR has no assurances that insurance companies will cover
its tests and if they do, how much they will pay for DiamiR’s tests. While coverage and contracting discussions with insurance
company typically take ~12 to 18 months, DiamiR cannot provide an estimated timeline, or guarantee of a positive outcome for these activities
at this time due to the nature of the reimbursement process and rules regarding same.

The timing of estimated completion dates noted
in the table above is based on DiamiR’s best estimate at this time, however, these dates are subject to change and potential delays
based on changes in DiamiR’s priorities and on factors outside of DiamiR control, such as supply chain disruptions, clinical study
results, and other factors discussed in the Risk Factors section are possible. DiamiR also has no control over the regulatory regime that
currently governs or will govern the products in the future and therefore cannot estimate whether or not DiamiR will need to comply with
any future regulations that could delay the commercialization of its products.

For all of DiamiR’s pipeline products DiamiR
plans on utilizing the LDT path to market.

DiamiR previously published proof-of-concept data for the Pulmonary
and GI panels (“Analysis of organ-enriched microRNAs in plasma as an approach to development of Universal Screening Test: feasibility
study”, by Sheinerman KS et al. J Transl Med 11:304 2013, PMID: 24330742).

miRNAs are Powerful and Patient-Friendly Biomarkers

DiamiR is an active participant in the burgeoning
field of microRNA (miRNA) biomarkers. miRNA biomarkers have already been used in clinical assays in the oncology, and evidence of their
utility in brain health and Alzheimer’s space has been growing every year since 2010. According to data compiled from pubmed.gov
in 1Q2023, 85 peer-reviewed papers published on the utility of miRNAs in Alzheimer’s disease in 2013 has increased to 310 by 2022.
Evidence of the role of miRNAs in AD biology and their utility as diagnostic targets has been published by labs in both industry and academic
settings. The