Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 320

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 320
---
 guidelines. Should the FDA guidelines change in the future and require FDA approval of DiamiR’s CogniMIR test,
it will increase the time, costs, resources and risk of the test launch.

In this study, intra-run Ct
correlation between the replicates obtained from two days for two operators was determined by creating a scatterplot and identifying
the R2 value. For the intra-run analysis, each graph consisted of n = 192 Ct data points (4 samples × 24 miRNAs × 2 replicates).
For each operator, the Cts from the first replicates were plotted against the Cts from the second replicates for Day 1 and Day 2. The
R2 values were plotted against the Cts from the second replicates for Day 1 and Day 2. The R2 values between Replicate 1 and Replicate
2 on Day 1 and Day 2 for Operator 1 were 0.99 and 0.94. Similarly, the R2 values between Replicate 1 and Replicate 2 on Day 1 and Day
2 for operator 1 were .99 and .94, respectively. The R2 values between Replicate 1 and Replicate 2 on Day 1 and Day 2 for Operator
2 were both 0.95. The intra-run Ct correlation between the two replicates for the two operators on both days was R2 = 0.93 to 0.99.

According to clinicaltrials.gov,
there are more than 250 MCI trials in Phase 1 and Phase 2, and more than 400+ PD trials currently ongoing. Analyses of recent
trials indicate the need for a cost-efficient blood-based screening tool.

As of September 2023,
62 phase I and early phase I studies are listed as currently recruiting or are active on clinicaltrials.gov. An additional 94
trials are recruiting in phase 2. 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.

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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