Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 75

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 75
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, 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 sufficient revenues and cash flows to continue our operations. Risks Related to Aptorum’s Intellectual Properties A significant portion of our IP portfolio currently includes pending patent applications that have not yet been issued as granted patents and if the pending patent applications covering our product candidates fail to be issued, our business will be adversely affected. If we or our licensors are unable to obtain and maintain patent protection for our technology and drugs, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be adversely affected. Our success depends largely on our ability to obtain and maintain patent protection and other forms of IP rights for the composition of matter, method of use and/or method of manufacture for each of our drug candidates. Failure to obtain, maintain protection, enforce or extend adequate patent and other IP rights could materially adversely affect 30 our ability to develop and market one or more of our drug candidates. We also rely on trade secrets and know -howto develop and maintain our proprietary and IP position for each of our drug candidates. Any failure to protect our trade secrets and know -howwith respect to any specific drug and diagnostics technology candidate