Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 374

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 374
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’s APOEGenotyping test is highly robust as reproducible and accurate APOEgenotypes 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, APOEGenotyping 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 rdparty lab for protein biomarker testing. This would free up capacity in its lab for clinical validation work while generating near -termrevenue for DiamiR. DiamiR has identified two potential partner labs for this work and are conducting its diligence on their capabilities. 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 DiamiR currently has ongoing collaborations with: The Trustees of the University of Pennsylvania, Alzheimer’s Therapeutic Research Institute of University of Southern California, Brain Health Imaging Institute of Weill Cornell Medicine (BHII), and New York University School of Medicine. These institutions provide DiamiR with well -characterizedplasma samples and associated demographic and clinical data for the analysis. DiamiR previously collaborated with The Roskamp Institute Memory Center, Sarasota, FL; Washington University Alzheimer’s Disease Research Center; Center for Neurodegenerative Disease Research at University of Pennsylvania;