Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 85

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 85
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 authorities; •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, studies in animals and clinical trials; •other parties’ ability in conducting our clinical trials safely, efficiently and according to the agreed protocol; •receipt of regulatory approvals from the FDA, NMPA, EMA, Health Canada and other comparable regulatory authorities for our drug candidates; •our ability to establish commercial manufacturing capabilities by making arrangements with third -partymanufacturers; •reliance on other parties to conduct our clinical trials swiftly and effectively; •launch of commercial sales of our drug candidates, if and when approved; •obtaining and maintaining patents, trade secrets and other IP protection and regulatory exclusivity, as well as protecting our rights in our own IP; •ensuring that we do not infringe, misappropriate or otherwise violate patents, trade secrets or other IP rights of other parties; •obtaining acceptance of our drug candidates by doctors and patients; •obtaining reimbursement from third -partypayors for our drug candidates, if and when approved; •our ability to compete with other drug candidates and drugs; and •maintenance of an acceptable safety profile for our drug candidates following regulatory approval, if and when received. We may not achieve regulatory approval and commercialization in a timely manner or at all. Significant delays in obtaining approval for and/or to successfully commercialize our drug candidates would materially harm our business and we may not be able to generate