Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 217

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 217
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 included in Phase 1 studies varies with the drug, but is generally in the range of twenty to eighty. • Phase 2.Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short -termside effects and risks associated with the drug. Phase 2 studies are typically well -controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people. 114 • Phase 3.Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase2, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit -riskrelationship of the drug. Phase 3 studies are designed to provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand people. Our non -therapeuticsprojects can be sub -dividedinto the following stages: • Development and Experimentation: Early development work for proof -of -concept. • Product Optimization: The practice of making changes or adjustments to a product to make it more desirable. • Clinical Validation: Confirming the performance of a technology using clinical/patient samples. • Pre -commercialization preparation: The logistics that need to be accomplished before commercialization. • Formulation: Preparation of a marketed dosage form from active ingredients and excipients/additives. • Commercialization: The process of introducing a new product or production method into commerce — making it available on the market. ALS-4: Small molecule for the treatment of bacterial infections caused by Staphylococcus aureus including but not limited to Methicillin-resistant Staphylococcus aureus (“MRSA”) Just as certain strains of viruses, such as human immunodeficiency virus (“HIV”) and influenza have developed resistance to drugs developed to treat them, certain bacteria such as Staphylococcus aureus, Mycobacterium tuberculosisand Pseudomonas aeruginosahave become “superbugs”, having developed resistance to many, if not all, of the existing drugs available to treat them, rendering those treatments ineffective in many instances. MRSA is one such bacterium, a gram -positivebacterium that is genetically different from other strains of Staphylococcus aureus. Staph