Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 197

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 197
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4 from 0.3 to 30mg/kg twice a day for 7 days, compared to those who received vancomycin
only group (3mg/kg of vancomycin administered intravenously) and a no treatment control group.

At the conclusion of the study
on Day 7, ALS-4 brought a statistically significant reduction in bacterial counts in major organs such as the kidneys, lungs, liver and
spleen compared with the no drug control and vancomycin only groups (unpaired student’s t-test, p<0.05). This is in addition
to the previous in vivo results announced in February 2020, whereby ALS-4 demonstrated on a statistically significant
basis better survival rates (56% vs 0% control group) in the lethal MRSA bacteraemia rat model (Figure 3a) and higher reduction of bacterial
load (by 99.5% against the control group) in the non-lethal MRSA bacteraemia rat model (Figure 3b).

<div align='center'>99</div>

Figure 3a

Figure 3a: Oral Formulation of ALS-4 in an MRSA
Survival Study

Figure 3b

Figure 3b: Oral Formulation
of ALS-4 in a Non-Lethal Bacteremia Model

CFU = Colony Forming Unit, a unit used
to estimate the number of viable bacteria in a sample

A Clinical Trial Application
(“CTA”) was submitted with the Public Health Agency of Canada (Health Canada) to conduct a Phase 1 clinical trial of ALS-4,
an orally administered small molecule drug for the treatment of infections caused by Staphylococcus aureus including Methicillin-resistant
Staphylococcus aureus (MRSA) in Q4 2020. ALS-4 received clearance from Health Canada regarding the CTA to initiate a Phase 1 clinical
study in January 2021. In March 2021, we announced dosing the first human subject in its Phase 1 clinical trial evaluating ALS-4. In January
2022, we further announced the completion of our Phase I clinical trial for ALS-4. The first-in-human Phase 1 trial was a randomized,
double-blinded, placebo-controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics
of orally administered ALS-4 in healthy male and female adult volunteers. The single-ascending dose studies