Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 242

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 242
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 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. Even if we conclude that the product is safe, the applicable regulator, such as the FDA, may not accept our data; final safety and efficacy are determined by the FDA or an applicable foreign regulator as part of their approval process for the product. 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. Staphylococcus aureus and MRSA can cause a variety of problems ranging from skin infections and sepsis to pneumonia and bloodstream infections. It is estimated that about one out of every three people (33%) carry Staphylococcus aureus in their nose, usually without any illness; about two in a hundred (2%) carry MRSA (source: https://www.cdc.gov