Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 205

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 205
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, and altogether the SACT-1 patent portfolio has Nine (9) active national phase patent applications
all over the world.

Statistical Significance

The term statistical significance
is to define the probability that a measured difference between two groups (e.g. two treatment groups, treatment versus control groups)
is the result of a real difference in the tested variations and not the result of chance. It means that the result of a test does not
appear randomly or by chance, but because of a specific change that is tested, so it can be attributed to a specific cause.

The confidence level indicates
to what percentage the test results will not commit a type 1 error, the false positive. A false positive occurs when a change in the result
is due to randomness (or other noise) and not the change in variations. At a 95% confidence level (p = 0.05), there is a 5% chance that
the test results are due to a type 1 error. 95% has become the standard and usually be the minimum confidence level for the tests. To
make the test more stringent, a 99% confidence level (p = 0.01) is also commonly employed, which means that there is a 1% chance that
the test results are due to a type 1 error.

<div align='center'>105</div>

In other words, a p value
represents the confidence level. For example, if the p-value for a test is < 0.05, it means that there is less than 5% chance the difference
between two groups is due to random error or by chance. If the p-value is < 0.01, it means that there is less than 1% chance the difference
between two groups is due to random error or by chance.

We employed statistical testing
to compare different treatment groups in animal studies simply for proof of concept and to aid internal decision making for further development.
We do not intend to use this standard for any regulatory submission. The US FDA or other regulatory agencies may not necessarily employ
the same statistical standard to assess the efficacy in clinical trials, the results of which would be submitted for regulatory approval. Although
a p-value of 0.05 has become the standard, the US FDA or other regulatory agencies may also individualize their efficacy standard
for different clinical programs based on the indications, the purpose of a clinical trial, among others.

FDA Application Status

As of the date hereof, we