Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 322

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 322
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 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-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (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. In October
2025, the FDA cleared Roche’s Elecsys pTau181 blood test for the initial assessment of Alzheimer’s-related amyloid pathology
among patients ages 55 and older with signs of cognitive decline in the primary care setting.

DiamiR is not aware of any
companies offering commercial miRNA-based tests for brain health at this time.

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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 that rely on neuroimaging technologies and analysis of biomarkers in cerebrospinal 
 fluid, and are therefore suitable for primary screening;                                                                             |

| ● | The proof-of-concept data generated to date indicates DiamiR’s                                 
 approach may allow detecting and differentiating pathologies with high degree of accuracy; and |

| ● | DiamiR’s technology is complementary, and potentially                                        
 synergistic, to other diagnostic platforms, such as imaging and/or blood protein biomarkers. |

DiamiR’s tests are currently
not commercially available. If the tests are successfully developed and launched, DiamiR believes that it will compete primarily on the
basis of:

| ● | Clinical validation of DiamiR’s biomarker panels using                                                                                    
 samples from large heterogeneous cohorts from both retrospective and prospective clinical studies, including demonstration of correlation 
 of DiamiR’s biomarkers with currently used biomarkers of AD and of the ability of DiamiR’s tests to specifically identify                 
 AD, and differentiate it from other NDs;                                                                                                  |

| ● | DiamiR’s ability to identify MCI, and predict whether 
 a patient is likely to progress to AD or other NDs;   |

| ● | DiamiR’s ability to monitor disease progression and 
 response