Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 275

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 275
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 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 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 evaluated for Alzheimer’s disease and other causes of cognitive decline.
The test, intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms
of cognitive decline, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated
with AD.

Currently it is accepted that AD dementia is preceded
by 10-20 years of the disease development, initially without clinical symptoms (pre-symptomatic AD), and then eventually manifested as
MCI, followed by onset of dementia and clinical AD symptoms. Notably, detailed analyses of failed clinical trials suggest a therapeutic
benefit in the sub-groups of patients with mild and moderate AD, a thesis validated by the lecanemab approval. Thus, there is a significant
need for the development of new methods for early AD detection.

The urgent need to address AD epidemics has been
recognized by the US Congress. “National Alzheimer’s Project Act” (NAPA) has been signed into law in 2011. As the result
of the increased congressional funding, NIH spending on Alzheimer’s and related dementias research rose more than six-fold since
2015, reaching $3.87 billion requested for FY2024 ($321 million increase over previous year).

Current NIH budget proposal (nia.nih.gov/research/blog/2022/07/looking-forward-nihs-alzheimers-disease-and-related-dementias-fy-2024-bypass)
describes prospective research opportunities organized in six broad categories, including: Diagnosis, Assessment, & Disease Monitoring:
developing the next generation