Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 265

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 265
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β ) plaques, intraneuronal inclusions (neurofibrillary tangles) composed of truncated and phosphorylated forms of the microtubule-stabilizing protein 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 (Aβ positron emission tomography [PET] and the ratio of Aβ 42 over Aβ 40 peptides) and Aβ in cerebrospinal fluid [CSF Aβ 42/Aβ 40]). Also, pTau-181 and pTau-217 proteins have been gaining attention as potential biomarkers of tau dysfunction/aggregation and amyloid pathology for differential diagnosis of AD and MCI. These protein targets are involved in biological pathways that are different, but potentially synergistic, with DiamiR’s miRNA testing platform. DiamiR believes that offering biomarker testing will be critical in securing biopharma contract research work, while concurrently it has the potential to improve the clinical performance of DiamiR’s CogniMIR ®test by combining miRNA with blood protein markers. Specifically, DiamiR would offer its panel of miRNA and protein biomarkers to help identify and select MCI and early dementia participants for clinical studies. DiamiR could potentially use its assay to monitor progression and drug response in the studies as well. 159 DiamiR’s understanding of the market indicates a strong demand for such testing services from drug development companies. Clinical research collaborations with industry offer near-term revenue opportunity for DiamiR. Biopharma Services can incorporate DiamiR’s classifiers and customized panels of miRNA and protein biomarkers that address different scientific questions depending on disease stage (e.g. preclinical, prodromal, and/or mild/moderate), drug target (e.g. associated with synaptic dysfunction, neuroinflammation, vascular component, etc.), target population (e.g. amyloid-positive/APOE carriers), and intended use (e.g. screening and/or monitoring in clinical trials). These customized projects offer the potential, when appropriate, for new joint IP to be generated and for companion diagnostic test development. Additionally, they will provide revenue to support the expansion in operational capacity of DiamiR. Optimize blood collection methodology.Currently, DiamiR uses plasma, separated from whole blood at the clinical site of collection, as DiamiR’s primary source of liquid biopsy material