Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 382

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 382
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to commence in 2H 2025. This study will be designed to measure the test’s performance criteria including its Sensitivity, Specificity, and Negative and Positive Predictive Values. DiamiR’s ultimate goal is to make CogniMIR ®a risk assessment tool that incorporates miRNAs, blood protein biomarkers and demographic datapoints to generate a risk score that allows physicians and patients make treatment decisions based on each patient’s unique biomarker profile. DiamiR will work closely with KOLs to build a large database of clinical data. The database will include the data from both prospective studies conducted for clients and from archived samples already collected at academic research centers. DiamiR intends to publish the results of the analysis in peer -reviewedjournals. Competition The table below summarizes types of biomarkers, which are currently used and are being developed within the industry for the detection of MCI and AD. Based on the information available at the time of this proxy statement/prospectus, a number of companies are currently developing molecular assays for early detection of AD, including but not limited to: Fujirebio, Quanterix, C 2N Diagnostics, ALZPath, Cognoptix, Eli Lilly, LabCorp, NanoSomiX, NeuroTrack, Esya Labs, Brain Spec, Cogni.Dx, Roche, and Quest Labs. A number of academic groups are also pursuing identification of AD biomarkers. 221 Quanterix (via its subsidiary Lucent Diagnostics), C2N Diagnostics, and Quest Labs have launched commercial LDTs for AD based on select protein biomarkers (Ab42/40, p -Tau217, and p -Tau181). In May 2025, the FDA granted 510(k) clearance for Fujirebio’s Lumipulse ®G pTau 217/ β -Amyloid1 -42Plasma Ratio in -vitrodiagnostic (IVD) test for the assessment of amyloid pathology in patients presenting with signs and symptoms of cognitive decline being evaluated for Alzheimer’s disease and other causes of cognitive decline. DiamiR is not aware of any companies offering commercial miRNA -basedtests for brain health at this time. Advantages of DiamiR’s Technology Key advantages of DiamiR’s technology include the following: •DiamiR’s novel proprietary approach allows detecting molecular signatures of brain health in blood; •Liquid biopsy, blood -based, tests are minimally invasive, are potentially less expensive than current tests