Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 114

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 114
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 t-test, p<0.05). This is in addition
to the previous in vivoresults 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).

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 (SAD) and multiple-ascending
dose studies (MAD) have been completed for a total of 72 healthy subjects and no subjects were dropped from the studies. There were no
serious adverse events observed and no relevant clinical changes in respect of vital signs. In March 2023, we announced the completion
of the Pre-IND discussions with the US FDA. The Pre-IND discussions focused on overall development plan in preparation for the IND application
of ALS-4 targeting Acute Bacterial Skin and Skin Structure Infections (ABSSSI) initially