Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 366

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 366
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 sensitive assay for RTT staging/prognosis and disease and treatment monitoring.

208 Following the pilot study conducted by DiamiR using four mouse models of the disease and human plasma samples, DiamiR has defined a panel of 44 miRNA biomarker candidates and conducted a study evaluating their effectiveness as RTT biomarkers using plasma samples of 163 study participants, including 81 RTT patients and 82 age -matchedcontrols; all collected at the Montefiore Medical Center, Bronx, NY. miRNA pairs/classifiers were shown to effectively differentiate between RTT patients and control of three age groups (best classifier AUC=0.94 for <5 -yr-olds, AUC=0.91 for 6 -15-yr-olds, AUC=0.77 for >16 -yr-olds). Several miRNAs were also shown to present efficient biomarkers of secondary pathology: walking ability (AUC=0.82), hyperventilation/breathing problems (AUC=0.75), and epilepsy (AUC=0.89). The data supports the development of assays based on the analysis of cell -freebrain/other organ -enrichedmiRNAs detectable in blood plasma to facilitate better understanding of RTT -associatedpathophysiological processes and development of therapeutics for RTT. (PLoS One, 2019; doi: 10.1371/journal.pone.0218623; Rett Syndrome Foundation Research Trust Conference, 2023, Boston MA, poster presentation) On June19, 2024, DiamiR made an oral presentation at the 2024 Rett Syndrome Scientific Meeting titled “Circulating Organ -enrichedmicroRNAs as Biomarkers of Rett Syndrome” ( https://www.prnewswire.com/news -releases /DiamiR -announces-oral-presentation-on-recent-advances-of-its -
microrna -biomarker-platform-at-2024-international-rett-syndrome-foundation-scientific-meeting-302170263 .
html?tc= eml_cleartime). On behalf of DiamiR, Dr. Sheinerman presented findings 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