Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 290

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 290
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 analyzed for the test validation. Both results
were found to be reproducible, repeatable, and accurate in all the experimental settings, which demonstrated that the DiamiR lab developed APOE Genotyping
test is accurate in detecting APOE genotypes of a patient. This was further confirmed by a 100% accuracy measurement of the APOE Genotyping
test carried out in the lab. Furthermore, DiamiR’s APOE Genotyping test is highly robust as reproducible and accurate APOE genotypes
were obtained successfully in wide range of DNA concentrations (0.7ng-50ng). Based on the robustness, moving forward the lab could
set a criterion for minimal gDNA requirement to be 0.7ng or 1ng for testing clinical samples. Based on these data, APOE Genotyping
test is ready to be used in DiamiR lab for commercial purposes.

A recent paper published in Nature Medicine titled “APOE4 homozygosity represents a distinct genetic form of Alzheimer’s disease” (Nature Medicine, 2024, https://doi.org/10.1038/s41591-024-02931-w)
demonstrated that APOE4 homozygotes, i.e. people who carry two copies of this Alzheimer’s risk gene, represent a
genetic form of AD, suggesting the need for broader biomarker testing and “individualized prevention strategies” in clinical
trials. A number of companies, for example Alzheon, NextCure, and Switch Therapeutics are pursuing APOE4 as a target for therapeutic intervention.

For pharma services contract work, DiamiR may
use a 3 party lab for protein biomarker testing. This would free up capacity in its lab for clinical validation work while
generating near-term revenue for DiamiR. DiamiR has identified two potential partner labs for this work and are conducting its diligence
on their capabilities.

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Laboratory Information Management Systems

DiamiR’s future clinical services will be largely dependent on
its internally developed Laboratory Information Management System or LIMS, which is its automated basis of managing operations and storing
data and customer information. This LIMS was developed to meet its CLIA/CAP regulatory requirements and was reviewed as part of its most
recent CLIA inspection in 2024, which DiamiR passed. Currently the LIM System is fully operational.

Clinical Research Collaborators

Diami