Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 287

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 287
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 once DiamiR chooses an appropriate kit/vendor, it will analytically validate those selected kits in its labs under CLIA 
 regulations.                                                                                                                             |

Typically, DiamiR’s diagnostic
tests go through the standard set of steps outlined below to evaluate their potential as a marketed product, which we use to satisfy the
CLIA and FDA’s clinical requirements. The data generated through these steps becomes part of the premarket submission and as explained
below, the FDA implemented New Rules (as defined below), which include quality systems and reporting requirements, for which DiamiR will
hire outside consultants and experts to help ensure that DiamiR is satisfying those requirements.

| Step 1: | Proof-of-Concept                                                                                                                              
 Study. In this phase, potential target analytes are identified and a plan for their detection is developed. In DiamiR’s case, DiamiR          
 focuses on miRNAs, and through literature searches and its own accumulated knowledge base identifies target miRNAs for a specific indication. 
 Once the target list is finalized, DiamiR checks the feasibility of testing for the expression of the target miRNAs and use synthetic         
 controls to develop a working assay.                                                                                                          |

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| Step 2: | Analytical                                                                                                                      
 Validation Study. In this step DiamiR’s goal is to determine key analytical validation metrics, as required by CLIA guidelines, 
 for the pipeline product. Using synthetic controls and/or call lines and clinical samples DiamiR establishes:                   |

| ● | Accuracy |

| ● | Precision |

| ● | Reproducibility; and |

| ● | Reportable ranges for the assay. |

DiamiR will also run the assay by multiple
operators over different days to establish the test’s inter and intra-run reproducibility metrics.

Test optimization refers to finalizing
the testing parameters and locking in the Standard Operating Procedures (SOPs) and finalizing algorithms used to analyze the raw data
from DiamiR’s runs.

| Step 3: | Clinical                                                                                                                              
 Validation Study. In this step, the tests’ performance characteristics will be determined using clinical samples with known outcomes. 
 By comparing DiamiR’s test results with clinical outcomes, DiamiR determined the assays:                                              |

| ● | Clinical 
 Accuracy |

| ● | Area Under the Curve (AUC, a measure of difference between 
 diseased and non-diseased samples)                         |

| ● | Sensitivity (a measure of