Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 64

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 64
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 committees may require that we or our investigators suspend or terminate clinical research for various reasons, including non -compliancewith regulatory requirements; •the cost of clinical trials of our drug candidates may be greater than we anticipate; •the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; and •our drug candidates may cause adverse events, have undesirable side effects or other unexpected characteristics, causing us, our investigators, or regulators to suspend or terminate the trials. If we are required to conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our drug candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if they raise safety concerns, we may: •be delayed in obtaining regulatory approval for our drug candidates; •not obtain regulatory approval at all; •obtain approval for indications that are not as broad as intended; •have a drug removed from the market after obtaining regulatory approval; •be subject to additional post -marketingtesting requirements; •be subject to restrictions on how a drug is distributed or used; or •be unable to obtain reimbursement for use of a drug. Delays in testing or approvals may result in increases in our drug development costs. We do not know whether any clinical trials will begin as planned, will need to be restructured, or will be completed on schedule, or at all. Clinical trials may produce negative or inconclusive results. Moreover, these trials may be delayed or proceed less quickly than intended. Delays in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process, and jeopardize our ability to commence product sales and generate revenues and we may not have sufficient funding to complete the testing and approval process. Any of these events may significantly harm Aptorum’s business, financial condition and prospects, lead to the denial of regulatory approval of our drug candidates or allow our competitors to bring drugs to market before we do, impairing our ability to commercialize our drugs if and when approved. Significant clinical trial delays also could shorten any periods during which we have the exclusive right to commercialize our drug candidates or allow our competitors to bring products to market before we do, impair our ability to commercialize our drug candidates and may harm Aptorum’s business and results of operations. We may in the future conduct clinical trials for our drug candidates in sites outside the U.S. and the FDA may not accept