Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 203

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 203
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 novel approaches to
address most neurodegenerative diseases, especially for progressive and severe conditions such as ALS.

Currently, there are no FDA approved-treatments
to stop the disease’s progression or prevent onset. There are two FDA-approved treatments which attempt to slow ALS progression;
Riluzole and Radicava. There are a number of ongoing trials examining potential treatments for ALS.

ALS is a multifactorial disease and therapeutic
approaches should consider the multiplicity of pathophysiological mechanisms that underlie motor neuron, or MN, degeneration in this disease.
Though MNs are the main affected cells in the disease, there is involvement of malfunctioning astrocytes in the pathogenesis and progression
of ALS. This notion supports the rationale that transplantation of healthy human astrocytes into the CNS of ALS patients may compensate
for the malfunctioning astrocytes and rescue remaining MNs by supply supportive factors, clues and functions. The product AstroRx®is composed of healthy human astrocytes derived from hESCs which allows ready scale-up of large numbers of donor cells. AstroRx®cells are manufactured in compliance with GMP guidelines. Once manufactured, the cells are resuspended in PlasmaLyte A (a physiological
solution) to formulate the AstroRx®product. The product is loaded into a syringe and delivered to the physician at point-of-care
for intrathecal injection, or IT injection, into the CSF of ALS patient following minimally invasive lumbar puncture, or LP.

Kadimastem’s Solution

The cell therapy
Kadimastem is developing to treat ALS, AstroRx®, is based on the transplantation of allogeneic glial cells (mainly
cells that support the CNS, or astrocytes) that have differentiated from pluripotent stem cells, thereby returning to the recipient
the motoneuron-supporting environment. It is assumed that this procedure will moderate the mortality rate of the neurons, and maybe
even stop it, so that the quality of life and life expectancy of the patients will improve. Astrocyte function in neuronal support
is also impaired in other neurodegenerative diseases such as multiple sclerosis, progressive multiple sclerosis, frontotemporal
dementia, or FTD, Alzheimer’s, Parkinson’s and glaucoma.

Mechanism of Action: AstroRx®was demonstrated to promote neuroprotection and to maintain homeostasis through several mechanisms including reuptake of excessive glutamate,
neutralizing oxidative stress, immunomodulation