Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 277

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 277
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 be targeting subjects too late in the disease progression for any meaningful impact on disease by the drug being tested. However, recently a number of high-profile positive study results, have brought hope for treatment options for AD, including the TRAILBLAZER-ALZ 2 Phase 3 study done by Eli Lilly and Company (NYSE: LLY) in May 2023 (( https://investor.lilly.com/news-releases/news-release-details/lillysdonanemab-significantly-slowed-cognitive-and-functional) and the Phase 3 randomized study data for lecanemab done by Eiasi and Biogen in November 2022 ( https://investors.biogen.com/news-releases/news-release-details/fda-grants-traditionalapproval- leqembir-lecanemab-irmb). On July 6, 2023, the FDA granted full approval for lecanemab, which was shown to moderately slow cognitive and functional decline in early-stage cases of the disease. On July 2024, Eli Lilly announced that the FDA has approved its anti-amyloid beta monoclonal antibody Kisunla (donanemab) for the treatment of patients with MCI and mild AD ( https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early). DiamiR believes that these approvals support DiamiR’s thesis that enrolling earlier stage MCI and/or mild dementia patients is an effective strategy for drug developers. In July 2023, CMS announced Medicare coverage for lecanemab priced at $26,500 per year. While DiamiR’s CogniMIR ®test was not used in either of these studies, DiamiR believes that over time, blood-based tests for AD will play a role in identifying the “right patient for the right drug”, and that DiamiR’s test may, upon completion of additional studies, become a useful tool for this use. Currently, few diagnostic tools are available for identifying these early-stage subjects, and those that are available maybe limited in their effectiveness. Historically, these tests have been based on imaging and cerebrospinal fluid analysis as well as more recently on the analysis or protein markers in the blood. DiamiR believes that its innovative platform technology may prove to have utility in identification of pre-symptomatic, MCI and early dementia patients, opening up a significant opportunity for DiamiR to