Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 351

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 351
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 of a positive outcome for these activities at this time due to the nature of the reimbursement process and rules regarding same. The timing of estimated completion dates noted in the table above is based on DiamiR’s best estimate at this time, however, these dates are subject to change and potential delays based on changes in DiamiR’s priorities and on factors outside of DiamiR control, such as supply chain disruptions, clinical study results, and other factors discussed in the Risk Factors section are possible. DiamiR also has no control over the regulatory regime that currently governs or will govern the products in the future and therefore cannot estimate whether or not DiamiR will need to comply with any future regulations that could delay the commercialization of its products. For all of DiamiR’s pipeline products DiamiR plans on utilizing the LDT path to market. DiamiR previously published proof -of-conceptdata for the Pulmonary and GI panels (“Analysis of organ -enrichedmicroRNAs in plasma as an approach to development of Universal Screening Test: feasibility study”, by Sheinerman KS et al. J Transl Med 11:304 2013, PMID: 24330742). miRNAs are Powerful and Patient-Friendly Biomarkers DiamiR is an active participant in the burgeoning field of microRNA (miRNA) biomarkers. miRNA biomarkers have already been used in clinical assays in the oncology, and evidence of their utility in brain health and Alzheimer’s space has been growing every year since 2010. According to data compiled from pubmed.gov in 1Q2023, 85 peer-reviewedpapers published on the utility of miRNAs in Alzheimer’s disease in 2013 has increased to 310 by 2022. Evidence of the role of miRNAs in AD biology and their utility as diagnostic targets has been published by labs in both industry and academic settings. The graph below captures the number of peer -reviewedpapers listed on pubmed.ncbi.nih.gov on the role of miRNAs in AD by year, increasing from 46 publications in 2012 to over 300 in 2022. https://pubmed.ncbi.nlm.nih.gov/?term=alzhemiers+microRNA Biology of miRNAs miRNAs are a class of non -coding, approximately 22 nucleotide long, functional RNA molecules. They play important role in the regulation of gene expression by binding to complementary regions of messenger RNA transcripts, the type that encode proteins, to regulate their translation