Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 297

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 297
---
 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 develop a pharma services business to support clinical
studies for Alzheimer’s therapies.

In October 2025, the FDA cleared
Roche’s Elecsys phosphorylated Tau (pTau) 181 blood test to be used in the initial assessment for Alzheimer’s disease and
other causes of cognitive decline in the primary care setting. The Elecsys pTau181 test measures pTau181in human plasma and is intended
to identify individuals who are unlikely to have Alzheimer’s-related amyloid pathology among patients ages 55 and older presenting
signs of cognitive decline.

In May 2025, the FDA granted 510(k) clearance for the Fujirebio’s Lumipulse ®G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being