Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 22

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 22
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-1 and
traditional chemotherapy in vitro

In addition, in our study,
the maximum tolerable dose of SACT-1 in a rodent model was determined to be higher than 400mg/kg. Compared with the MTD of standard chemotherapy
such as paclitaxel (20-30mg/kg) (Clin Cancer Res. 5(11):3632-8) and cisplatin (6mg/kg) (BMC Cancer 17: 684 (2017)). Based on our internal
observations of pre-existing information from approved products, (subject to FDA’s approval 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 Drug and reference the established safety and efficacy information. At 150mg/day, the death rate
was 0% in prior clinical studies of the Reference Drug with no dosage related adverse events (Table 1). In addition, the pharmacokinetic
profile of the approved product (i.e., Reference Drug) has also been reported (Table 2).

<div align='center'>S-11</div>

Table 1: Safety Profiles of the Reference
Drug in Human Clinical Trials

Table 2: The pharmacokinetic Profile
of the Reference Drug in Humans

Positive data from our latest
internal in vivostudies show significant activity against neuroblastoma tumor reduction when treated with the compound SACT-1
in combination with standard of care (SOC) chemotherapy. We have developed a pediatric formulation (SACT-1) to better address the needs
of neuroblastoma patients who are exclusively children younger than 5. In the Phase 1 study where SACT-1 was compared to Reference
drug in healthy volunteers, no serious adverse events (SAEs) were reported. All reported adverse events were Grade 1 (“mild”)
with an outcome of “resolved”. No subjects were discontinued from the study due to adverse events. The safety data of the
Reference Drug and the Phase 1 data of SACT-1 will be included in the IND submission for the Phase 2 trials, when we are able
to submit same.

Separately, we also screened
SACT-1 for its in vitroactivity against over