Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 246

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 246
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test). Similarly, there was no statistical difference in severity of lesions between test articles and non -infectedgroups or between test articles and vehicle groups (p > 0.05 by unpaired Student’s t -test) in kidney assessments. These studies were designed to establish proof -of-conceptand generate efficacy data, with comprehensive toxicology assessments subsequently completed during the IND -enablingstudies phase. 125 ALS -4demonstrated 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 -lethalMRSA bacteraemia rat model (Figure 3b). Figure 3a Figure 3a: Oral Formulation of ALS -4in an MRSA Survival Study Figure 3b Figure 3b: Oral Formulation of ALS -4in a Non -LethalBacteremia 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 -resistantStaphylococcus aureus (MRSA) in Q4 2020. ALS -4received 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-humanPhase 1 trial was a 126 randomized, double -blinded, placebo -controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS -4in healthy male and female adult volunteers. The single -ascendingdose studies (SAD) and multiple -ascendingdose 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