Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 383

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 383
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 that rely on neuroimaging technologies and analysis of biomarkers in cerebrospinal fluid, and are therefore suitable for primary screening; •The proof -of-conceptdata generated to date indicates DiamiR’s approach may allow detecting and differentiating pathologies with high degree of accuracy; and •DiamiR’s technology is complementary, and potentially synergistic, to other diagnostic platforms, such as imaging and/or blood protein biomarkers. DiamiR’s tests are currently not commercially available. If the tests are successfully developed and launched, DiamiR believes that it will compete primarily on the basis of: •Clinical validation of DiamiR’s biomarker panels using samples from large heterogeneous cohorts from both retrospective and prospective clinical studies, including demonstration of correlation of DiamiR’s biomarkers with currently used biomarkers of AD and of the ability of DiamiR’s tests to specifically identify AD, and differentiate it from other NDs; •DiamiR’s ability to identify MCI, and predict whether a patient is likely to progress to AD or other NDs; •DiamiR’s ability to monitor disease progression and response to treatment; •Ease of use of DiamiR’s tests: they are minimally invasive, based on analysis of plasma; •Potential cost advantage of DiamiR’s tests compared to imaging and analysis of cerebrospinal fluid biomarkers; •DiamiR’s collaborations with high profile academic clinical centers; and •Value to customers (e.g. asymptomatic subjects in high -riskgroups) promoting repeat testing (e.g. annual screening). DiamiR believes that its success will depend on its ability to expeditiously: •Launch the tests in the US and expand in countries outside of the US; •Continue to innovate and maintain scientifically advanced technology; •Market and sell DiamiR’s tests, initially as a clinical research tool for pre -selectionof patients for AD trials; •Expand DiamiR’s tests to provide information on other NDs; •Optimize DiamiR’s sample collection process; 222 •Publish clinical studies in peer -reviewedjournals; •Continue to validate DiamiR’s tests, especially with respect to treatment benefit; •Attract and retain skilled personnel; •Protect DiamiR’s products and technology with patents; •Assure the quality of DiamiR’s LDTs produced under FDA and CLIA guidelines; •Assure that the CLIA lab where tests are produced continue to maintain all appropriate licenses; and •Meet necessary regulatory requirements. Payment