Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 146

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 146
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 as LDTs, and future changes in FDA enforcement discretion for LDTs could subject its operations to much more significant regulatory requirements. The FDA has historically operated under a policy of enforcement discretion with respect to LDTs whereby the FDA did not actively enforce its regulatory requirements for such tests. Changes to this policy could significantly increase the costs and expenses of conducting, or otherwise harm, DiamiR’s business, financial condition and results of operations. Even if such tests are authorized for marketing by the FDA, the agency could limit the test’s indications for use, which may significantly limit the market for that product and may adversely affect DiamiR’s business and financial condition. DiamiR has a limited operating history, which makes it difficult to predict future prospects and financial performance. Substantially all of DiamiR’s operations are conducted through its wholly -ownedsubsidiary, DiamiR LLC, which started operation in September 2009. DiamiR has been operating as a consolidated company since October 1, 2014. Due to this limited operating history, it may be difficult to evaluate DiamiR’s business prospects and future financial performance. As of the date of this filing, DiamiR has not yet generated revenues from its products. There is no guarantee that DiamiR will be able to generate any significant revenues. DiamiR faces numerous risks and uncertainties in the competitive markets. In particular, DiamiR has not proven that it can: •maintain relationships with key customers and strategic partners that will be necessary to optimize the market value of its products and services; •successfully identify and respond to emerging trends in DiamiR’s market areas; •raise sufficient capital in the public and/or private markets; or •respond effectively to competitive pressures. DiamiR’s ability to generate revenue and achieve profitability is dependent on its ability to complete the development of its product candidates, obtain necessary regulatory approvals, and have its products under development manufactured and successfully marketed, of which there can be no guarantee. Although DiamiR has received revenue in the past from providing testing services to life sciences companies, and may again in the future, DiamiR cannot be certain that such services will bring sufficient revenue to support its operation and R&D. Thus, DiamiR may not be able to generate a profit until its product candidates become profitable. 69 There is substantial doubt about DiamiR’s ability to continue as a going concern. DiamiR’s auditors have indicated in their audit opinion there is substantial doubt as to Diami