Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 74

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 74
---
otechnology companies worldwide. Many of the companies against which we may be competing have significantly greater financial resources and expertise in research and development, manufacturing, animal testing, conducting clinical trials, obtaining regulatory approvals and marketing approval for drugs than we do. Physicians, patients and third -partypayors may prefer other novel products to ours, which means that we may not generate significant sales revenues for that product and that product may not become profitable. The degree of market acceptance of our drug candidates, if approved for commercial sale, will depend on a number of factors, including but not limited to: •clinical indications for which our drug candidates are approved; •physicians, hospitals, and patients considering our drug candidates as a safe and effective treatment; •the potential and perceived advantages of our drug candidates over alternative treatments; •the prevalence and severity of any side effects; •product labeling or product insert requirements of the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities; •limitations or warnings contained in the labeling approved by the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities; •the timing of market introduction of our drug candidates as well as competitive drugs; •the cost of treatment in relation to alternative treatments and their relative benefits; •the availability of adequate coverage, reimbursement and pricing by third -partypayors and government authorities; 29 •lack of experience and financial and other limitations on our ability to create and sustain effective sales and marketing efforts or ineffectiveness of our sales and marketing partners; and •changes in legislative and regulatory requirements that could prevent or delay regulatory approval of our drug candidates, restrict or regulate post -approvalactivities and affect our ability to profitably sell any drug candidates for which we obtain regulatory approval. We depend substantially on the success of the drug candidates being researched as our current Lead Projects. If we are unable to license or sublicense, sell or otherwise commercialize our drug candidates, or experience significant delays in doing so, our business will be materially harmed. Our business and the ability to generate revenue related to product sales, if ever achieved, will depend on the successful development, regulatory approval and licensing or sublicensing or other commercialization of our drug candidates or any other drug candidates we may develop. We have invested a significant amount of financial resources in the development of our drug candidates and we may invest in other drug candidates. The success of our drug candidates and any other potential drug candidates will depend on many factors, including but not limited to: •successful enrollment in, and completion of