Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 221

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 221
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 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 randomized, double -blinded, placebo -controlled, single and multiple ascending dose study designed to evaluate safety, 119 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 completion of the Pre -INDdiscussions with the US FDA. The Pre -INDdiscussions focused on overall development plan in preparation for the IND application of ALS -4targeting Acute Bacterial Skin and Skin Structure Infections (ABSSSI) initially. With the positive feedback on the overall development strategy from the US FDA, we are proceeding towards the IND submission of ALS -4seeking to initiate a Phase 2 clinical study to assess the efficacy of ALS -4in patients. Currently, ALS -4and SACT -1are Phase 2 clinical trials ready. Patent License On October 18, 2017, the Company’s subsidiary, Acticule, entered into an exclusive