Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 18

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 18
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 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 (FTD), Alzheimer’s, Parkinson’s and glaucoma.

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Mechanism of Action: AstroRx® were demonstrated to promote neuroprotection and to maintain homeostasis by several mechanism including reuptake of excessive glutamate, neutralizing oxidative stress, immunomodulation and secretion of a variety of potent neurotrophic factors. In addition, disruption of the astrocytic TNFR1–GDNF axis accelerates MN degeneration and disease progression, as the levels of the protective agents for MNs, glial-derived neurotrophic factor (GDNF), are reduced. As so, Kadimastem believes that it is more likely that AstroRx® astrocytes will be more effective in treating diseases than single-molecule based drugs, e.g. Riluzole (assumed to improve glutamate uptake and to reduce excitotoxicity), or Edaravone (an reactive oxygen species , reducing oxidative stress). AstroRx® astrocytes’ activity may include both drugs’ modes of action, in addition to secretion of multiple neurotrophic factors that act through multiple pathways. Importantly, this astroglial-based approach should be therapeutic regardless of the etiology of the ALS – familial (independent of genotype) as well as sporadic – because it attacks final common molecular pathways of MN demise; this contrasts with some present genetic approaches. Mode of Action:AstroRx® is based on differentiated clinical grade cells derived from embryonic stem cells it received under licensing agreements and technologies developed by it to expand pluripotent stem cells and differentiate them into cells supporting the central nervous system (astrocytes), and then transplant them into patients. In healthy individuals, the role of astrocytes is to support the health of neurons and their proper functioning by secreting growth inducers on them and monitoring, eliminating toxic substances and reducing environmental stress (such as free radicals and excessively high levels of glutamate and potassium). Strengths Kadimastem’s vision is to act to find cell therapy treatments for incurable diseases that impair patients’ life expectancy and quality of life, such as ALS. The strategy is to replace the functionality of malfunctioning cells