Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 349

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 349
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 Panel/MCI & AD(3)          |     | Vendor/Platform Selection        |     | Analytical Validation Study |     | 2H 2025              |
| Glioblastoma Panel         |     | Proof-of-Concept Study           |     | Analytical Validation Study |     | 2H 2025              |
| Pulmonary Cancer Panel     |     | Proof-of-Concept Study Completed |     | Analytical Validation Study |     | TBD                  |
| GI Cancer Panel            |     | Proof-of-Concept Study Completed |     | Analytical Validation Study |     | TBD                  |

____________ (1)This is DiamiR’s current estimated completion date for the tasks listed as “next steps” in the table above. (2)This is a commercial test available through multiple vendors that DiamiR has analytically validated in its lab under CLIA requirements, but the current plan is to launch it in conjunction with CogniMIR ®, as either a standalone product or part of the CogniMIR ®panel. (3)Multiple vendors offer commercial kits for a number of blood protein markets; once DiamiR chooses an appropriate kit/vendor, it will analytically validate those selected kits in its labs under CLIA regulations.

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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. |
| 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