Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 333

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 333
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 from a Rett microRNA biomarker study conducted between 2021 and 2024. Levels of 44 microRNAs were analyzed in plasma samples of 163 study participants, including 81 Rett syndrome patients and 82 age -matchedindividuals without Rett syndrome, of three age groups: younger than 5 years old, 5 to 15 years old, and older than 16 years old. The blood samples for the study were provided by the Tri -StateRett Syndrome Center, Montefiore Medical Center. In line with DiamiR’s previously described results (see Business section, Circulating Organ -enrichedmiRNAs as Biomarkers of Rett Syndrome), the microRNA panel effectively differentiated study participants with Rett syndrome. 198 To develop a marketable RTT diagnostic solution, DiamiR plans to offer both sequencing services (of the MECP2gene) and its proprietary miRNA panel. DiamiR is currently evaluating 3 rdparty vendors to develop a custom NGS assay for Rett syndrome on a MiSeQ platform (Illumina). BEYOND BRAIN HEALTH: UNIVERSAL SCREENING TEST DiamiR believes its core miRNA technology is robust and applicable to early detection of disease pathology in different organs, not only in the brain, which enables a novel approach to screening whereby a battery of screening tests relying on organ -enrichedmiRNAs detect the presence of pathology in a given organ; where the detection of a pathology in an organ can result in more specific (and possibly expensive and or invasive) testing for a differential diagnosis of the disease. In a proof -of -conceptstudy, miRNA pairs comprised of select miRNAs enriched in the organs of the gastrointestinal (GI) and pulmonary systems effectively differentiated respective pathologies of the GI (esophageal, gastric or colon cancers (stages I and II), and Crohn’s disease) and lung (pneumonia, asthma, and non -smallcell lung cancer (40% with stages I and II)) systems from age -matchedcontrols and from each other with an overall accuracy of 90 -96%. The figure below summarizes the approach and principal findings: (Journal of Translational Medicine, 2013, 11:304) ANALYTICAL PLATFORM FOR PLASMA miRNA DETECTION In 2023, DiamiR completed an analytical validation of plasma miRNA detection in DiamiR CLIA laboratory. The platform is based on Qiagen’s LNA q