Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 321

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 321
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 99.6% in 2002-2012.
Drug developers are focusing now on developing treatments that can have an impact on AD earlier in the pathology if the disease, and hence,
diagnostic tools that could identify the disease early are needed to enable the development and use of such new treatments.

DiamiR’s plan for CogniMIR
is to be initially launched and performed in DiamiR’s CLIA lab facility with an expected capacity to perform at 3,500 to 5,000 tests
per year. The test will be used as a stratification tool for patient inclusion/exclusion into AD and MCI trials, allowing DiamiR to act
as a CRO to support such studies.

In parallel, DiamiR plans on
launching the clinical version of its test, and plan for a validation study of CogniMIR to commence in 2H 2025. This study
will be designed to measure the test’s performance criteria including its Sensitivity, Specificity, and Negative and Positive Predictive
Values. DiamiR’s ultimate goal is to make CogniMIR a risk assessment tool that incorporates miRNAs, blood protein
biomarkers and demographic datapoints to generate a risk score that allows physicians and patients make treatment decisions based on each
patient’s unique biomarker profile.

DiamiR will work closely with
KOLs to build a large database of clinical data. The database will include the data from both prospective studies conducted for clients
and from archived samples already collected at academic research centers. DiamiR intends to publish the results of the analysis in peer-reviewed
journals.

Competition

The table below summarizes
types of biomarkers, which are currently used and are being developed within the industry for the detection of MCI and AD.

Based on the information available
at the time of this proxy statement/prospectus, a number of companies are currently developing molecular assays for early detection of
AD, including but not limited to: Fujirebio, Quanterix, CN Diagnostics, ALZPath, Cognoptix, Eli Lilly, LabCorp, NanoSomiX,
NeuroTrack, Esya Labs, Brain Spec, Cogni.Dx, Roche, and Quest Labs. A number of academic groups are also pursuing identification of AD
biomarkers.

Quanterix (via its subsidiary
Lucent Diagnostics), C2N Diagnostics, and Quest Labs have launched commercial LDTs