Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 84

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 84
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; •withdrawing pre -marketapprovals that have already been granted; •refusal to grant export approval for our product; or •criminal prosecution. Any of the foregoing actions could have a material adverse effect on our reputation, business, financial condition and operating results. Risks Related to Commercialization of Aptorum’s Drug Candidates Even if any of our drug candidates receive regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. After we complete clinical trials and receive regulatory approval for any of our drug candidates, which may not happen for some time, we recognize that such candidate(s) may ultimately fail to gain sufficient market acceptance by physicians, patients, third -partypayors and others in the medical community. We may not be able to achieve or maintain market acceptance of our products over time if new products or technology are introduced that are more favorably received than our products, are more cost effective or render our drug obsolete. We will face competition with respect to our drug candidates from other pharmaceutical companies developing products in the same disease/therapeutic area and specialty pharmaceutical and biotechnology 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; 30 •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