Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 66

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 66
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 to receive regulatory approval from any of the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities for many reasons, including but not limited to: •disagreement with regulators regarding the design or implementation of our clinical trials; •failure to demonstrate that a drug candidate is safe and effective or safe, pure and potent for its proposed indication; •failure of clinical trial results to meet the level of statistical significance required for approval; •failure to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks; •disagreement with regulators regarding our interpretation of data from studies in animals or clinical trials; •insufficiency of data collected from clinical trials of Aptorum’s drug candidates to support the submission and filing of a New Drug Application (“NDA”), or other submission or to obtain marketing approval; •the FDA, NMPA, EMA, Health Canada or a comparable regulatory authority’s finding of deficiencies related to the manufacturing processes or facilities of third -partymanufacturers with whom we contract for clinical and commercial supplies; and •changes in approval policies or regulations that render our preclinical studies and clinical data insufficient for approval. Any of the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities may require more information, including additional preclinical studies or clinical data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program. If we were to obtain approval, regulatory authorities may approve any of Aptorum’s drug candidates for fewer or more limited indications than we request. Regulatory authorities also may grant approval contingent on the performance of costly post -marketingclinical trials, or may approve a drug candidate with a label that is not desirable for the successful commercialization of that drug candidate. In addition, if Aptorum’s drug candidate produces undesirable side effects or involves other safety issues, the FDA may require the establishment of a Risk Evaluation Mitigation Strategy (“REMS”), or NMPA, EMA, Health Canada or other comparable regulatory authorities may require the establishment of a similar strategy. Such a strategy may, for instance, restrict distribution of Aptorum’s drug candidates, require patient or physician education, or impose other burdensome implementation requirements on us. 24 Regulatory approval may be substantially delayed or may not be obtained for one or all of Aptorum’s drug candidates if regulatory authorities require additional time or studies to assess the safety or efficacy of Aptorum’s drug candidates. Aptorum currently does not have any drug candidates that have gained approval for