Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 68

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 68
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 of new information regarding Aptorum’s drug candidates or other products; •delay or failure in obtaining authorization to commence a clinical trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial; •withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials; •unfavorable or inconclusive results of clinical trials and supportive non -clinicalstudies, including unfavorable results regarding effectiveness of drug candidates during clinical trials; •difficulty in maintaining contact with patients during or after treatment, resulting in incomplete data; •our inability to obtain approval from IRBs or ethics committees to conduct clinical trials at their respective sites; •our inability to enroll and retain a sufficient number of patients who meet the inclusion and exclusion criteria in a clinical trial; •our inability to conduct a clinical trial in accordance with regulatory requirements or our clinical protocols; 25 •clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, withdrawing from or dropping out of a trial, or becoming ineligible to participate in a trial; •failure of our clinical trial managers to satisfy their contractual duties or meet expected deadlines; •manufacturing issues, including problems with manufacturing or timely obtaining from third parties sufficient quantities of a drug candidate for use in a clinical trial; •ambiguous or negative interim results, or results that are inconsistent with earlier results; •feedback from the FDA, NMPA, EMA, Health Canada, an IRB, data safety monitoring boards, or comparable entities, or results from earlier stage or concurrent studies in animals and clinical trials, regarding Aptorum’s drug candidates, including which might require modification of a trial protocol; •unacceptable risk -benefitprofile or unforeseen safety issues or adverse side effects; and •a decision by the FDA, NMPA, EMA, Health Canada, an IRB, comparable entities, or the Company, or recommendation by a data safety monitoring board or comparable regulatory entity, to suspend or terminate clinical trials at any time for safety issues or for any other reason. Changes in regulatory requirements and guidance may also occur, and we may need to amend clinical trial protocols submitted to applicable regulatory authorities to reflect these changes. Amendments may require us to resubmit clinical trial protocols to IRBs or ethics committees for re -examination, which may increase the costs or time required to complete a clinical trial. If we experience delays in the completion of, or the termination of,