Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 298

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 298
---
 Although
there is no guarantee, DiamiR believes that penetrating this market could result in near term revenues (within the next 12 months) for
DiamiR and provide a significant growth opportunity for DiamiR.

<div align='center'>157</div>

High screen failure rates (estimated: 50% for
mild to moderate Alzheimer’s trials and up to 80% for prodromal trials) result in lengthy recruitment and significantly increase
the cost of trials. A Cleveland Clinic study concluded that the failure rate for AD drug development reached 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 prospectus, a number of companies are currently developing molecular assays for early detection of AD, including but