Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 311

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 311
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 to identify microRNA biomarker candidates for differentiating Alzheimer’s
disease from Parkinson’s disease.

The Michael J. Fox Foundation for Parkinson’s
Research Grant Number 9477 2014

Title: Analysis of circulating brain-enriched
microRNAs as biomarkers for Parkinson’s disease.

The goal of this study was to test microRNA biomarker
candidates using plasma samples collected from Parkinson’s disease patients and age-matched controls from the BioFIND clinical study.

IRS-QTDP 2011

Title: Development of ADmiR, molecular test for
early detection and monitoring of Alzheimer’s Disease.

Early studies towards identification of microRNA
biomarker candidates for Alzheimer’s Disease.

Research & Development Strategy

DiamiR intends to conduct clinical
development and launch CogniMIR as a Laboratory Developed Test (LDT) using its CLIA-certified, CAP accredited laboratory
based in New Haven CT.

According to the FDA’s
guidance, “a laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within
a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds
like glucose or cholesterol, or DNA), in a sample taken from a human body. Some LDTs are relatively simple tests that measure single analytes,
such as a test that measures the level of sodium. Other LDTs are complex and may measure or detect one or more analytes. For example,
some tests can detect many DNA variations from a single blood sample, which can be used to help diagnose a genetic disease. Various levels
of chemicals can be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium. While the uses
of an LDT are often the same as the uses of FDA-cleared or approved in vitro diagnostic tests, some labs may choose to offer their own
test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on
the market.”

While DiamiR’s plan is to validate the CogniMIR ®miRNA panel in its lab, DiamiR is also studying the feasibility of offering protein biomarker testing, including but not limited to, pTau-181, pTau-217, Neurofilament Light (NfL), Aβ42/40 and TDP43 in it lab.