Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 283

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 283
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Over the past 15 years, significant progress has been made in the development
of blood protein markers as valid diagnostic markers for MCI and AD, and recently as surrogate markers for disease monitoring and therapeutic
response measurements. These biomarkers play critical roles in AD pathology and as such are useful diagnostic targets:

Alzheimer’s disease is characterized by the accumulation of extracellular amyloidβ (Aβ) 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 Aβ42 over Aβ40 peptides) and Aβ in cerebrospinal fluid [CSF Aβ42/Aβ40]). 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.

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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