Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 311

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 311
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 it to a miRNA from a part of the organ that is thought to be relatively stable throughout the disease. Thus, DiamiR normalizes for differences in miRNA transport to the blood, stability of miRNA, our laboratory procedures, etc. DiamiR has developed a proprietary custom software and is currently developing a second -generationsoftware to support its LDTs in development. In July 2023, DiamiR announced entering into a service agreement with JADBio — Gnosis DA S.A (“JADBio”), a leading machine learning and AI tools provider, to use their machine learning based platform for analysis of our data and generation of additional algorithms, which are owned by DiamiR. •DiamiR has completed several proof -of -principlestudies and established the 24 -miRNApanel of brain -enrichedand inflammation -associatedmiRNAs detectable in plasma as promising biomarkers of neurodegeneration. •DiamiR plans on initiating a clinical validation study to demonstrate the diagnostic performance of its assay using large cohorts of well -characterizedclinical samples to satisfy CLIA and CAP requirements. Many of its plasma samples are stored in -80°C freezers located at DiamiR laboratory and will be available to DiamiR when its clinical validation work begins. These freezers have temperature control monitors and automated alarms capable of informing, including remotely, DiamiR lab personnel of any malfunctions and temperature drops. DiamiR has multiple freezers available to it and can move samples if any freezer goes offline. Plasma samples stored at -80°C remain stable and usable for years. 182 Offer well characterized protein biomarker tests.Over the past 15 years, significant progress has been made in the development of blood protein markers as valid diagnostic markers for MCI and AD, and recently as surrogate markers for disease monitoring and therapeutic response measurements. These biomarkers play critical roles in AD pathology and as such are useful diagnostic targets: Alzheimer’s disease is characterized by the accumulation of extracellular amyloid β(A β) plaques, intraneuronal inclusions (neurofibrillary tangles) composed of truncated and phosphorylated forms of the microtubule -stabilizingprotein tau, dystrophic neurites, loss of synapses and neurons, and a prominent gliosis that involves changes in the morphology and function of microglia and astrocytes. Currently, validated biomarkers exist for amyloid pathology (A βpositron emission tomography [PET] and the ratio of A β