Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 286

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 286
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, which enables a novel approach to screening whereby a battery of screening tests relying on organ-enriched miRNAs 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-concept study, 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-small cell lung cancer (40% with stages I and II)) systems from age-matched controls 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) 174 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 qPCR technology. In this study, published in a peer-reviewed publication and reported at several scientific meetings (below), DiamiR has demonstrated that the 24 miRNA biomarker candidates comprising CogniMIR ®panel, as well as additional miRNAs showing promise as RTT biomarker candidates, can be reliably and consistently detected in human plasma samples with the methods implemented at DiamiR CLIA laboratory. While stem-loop-based TaqMan and locked nucleic acid (LNA)-based qPCR assays are shown to produce highly consistent results, Qiagen’s LNA-based qPCR technology is better suited for a CAP/CLIA-certified clinical laboratory. (Diagnostics, 2023, 13:2170; Rett Syndrome Foundation Research Trust Conference, 2023, Boston MA, poster presentation; Alzheimer’s Association International Conference 2023, Amsterdam, Netherlands, poster presentation). Publications and Presentations During the last 12 years DiamiR has published a number of peer-reviewed papers describing its technology for identification of miRNA biomarker pairs (the contents of these publications are not part of, and are not incorporated by reference into, this proxy statement/prospectus):

| 1. | Analytical Validation of a Novel MicroRNA Panel for Risk Stratification                                                               
 of Cognitive Impairment