Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 274

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 274
---
ational
drugs for AD failed in clinical development. These drugs were intended to affect different aspects of AD pathology. A fundamental challenge
of AD is that at the point at which physicians can render a definitive diagnosis, the patient has already suffered massive neuronal loss
leading to overt cognitive dysfunction. Thus, clinical trials that are conducted in patients with advanced disease at the time of their
enrollment may 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.

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Currently, few