Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 254

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 254
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 on SACT -1. The EOP1 meeting was focused on gaining alignment with the US FDA regarding the clinical and regulatory pathway for SACT -1for the treatment of neuroblastoma in pediatric patients aged 2 -18. The FDA generally agreed with the chemistry -manufacturing-control(CMC) strategy and our proposed clinical development plan for Phase 1/2 trials. 131 Patent License In January 2022, the US Patent and Trademark Office granted the first patent regarding Aptorum’s SACT -1(through Aptorum’s subsidiary) repurposed drug for the treatment of various cancers including but not limited to neuroblastoma (US Patent 11,166,952 B2). Another US patent (US Patent 11,571,422) was granted in February 2023, and altogether the SACT -1patent 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. In other words, a p value represents the confidence level. For example, if the p -valuefor 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 -valueis < 0.01, it means that there is less than 1% chance the difference between two groups is due to random error