Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 203

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 203
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 and on a case-by-case basis, a 505(b)(2) Application can rely in part on existing information from approved products
(such as the FDA’s previous findings on safety and efficacy) or products in literature (such as data available). However, typically
speaking, the applicant is nonetheless required to carry out a Phase 1 bridging study to compare the Reference Listed Drug and reference
the established safety and efficacy information), SACT-1 also exhibits a well-established safety profile: at 150mg/day, the death rate
was 0% in prior clinical studies with no dosage related adverse events (Table 1). In addition, the pharmacokinetic profile of SACT-1 has
also been reported (Table 2).

<div align='center'>103</div>

Table 1: Safety Profiles of SACT-1 in Human Clinical
Trials

Table 2: The pharmacokinetic Profile of SACT-1
in Humans

We have developed a pediatric
formulation of SACT-1 to better address the needs of neuroblastoma patients who are exclusively children younger than 5. Positive data
from our latest internal in vivo studies show significant activity against neuroblastoma tumor reduction when treated
with the compound SACT-1 in combination with standard of care (SOC) chemotherapy.

Separately, we also screened
SACT-1 for its in vitro activity against over 300 cancer cell lines and showed positive results in a number of cancer
types including in particular colorectal cancer, leukemia and lymphoma, etc. Similar to our previous findings against neuroblastoma cell
lines, SACT-1 exhibits similar anti-tumor efficacy across one or more other major cancer types, including but not limited to colorectal
cancer, leukemia and lymphoma cell lines. As a result, in addition to treating neuroblastoma, SACT-1 may have potential applications in
the treatment of other cancers. Based on this discovery, we plan to carry out further in vivo studies to study the efficacy
of SACT-1 over other types of cancers to maximize the potential of SACT-1. Based on the initial 22 day data of a recent study we conducted
in a xenograft mouse model of neuroblastoma, SACT-1 was orally administered daily at 60mg/kg in combination of SOC chemotherapy brought
a statistically significant tumor shrinkage (unpaired student’s t-test, p<0.01) from Day 15 to Day 22, compared to