Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 410

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 410
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 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 -basedapproach 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, which 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, astrocytes support neuronal health and function by releasing growth factors, removing toxins and reducing environmental stressors such has free radicals and excess glutamate or 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 even within some distance from the original tissue/organ that is difficult or impossible to replace. The activity of malfunctioning astrocytes can be restored using “healthy” astrocytes cells that perform their physiological role upon their implantation. Kadimastem believes it has the potential to transform the lives of individuals living with devastating neurodegenerative diseases beginning with patients suffering from ALS. Kadimastem’s key competitive strengths include: •Kadimastem developed scalable manufacturing capabilities and industrialization capabilities for AstroRx ®. •Kadimastem has a well differentiated, solid, and diversified technology platform. •AstroRx ®can be utilized for other neurodegenerative indications. Some of the additional indications in the pipeline were already evaluated pre -clinically. 206 •Kadimastem has experienced leadership that will continue post -Merger. •Strong global IP position and differentiation. In the field of regenerative medicine, Kadimastem’s product candidate, AstroRx ®, is a cell therapy product that is manufactured from a frozen ampoule of immature astrocyte cells (production batches). The process of production of the AstroRx ®cells takes about one month, conducted by a manufacturing team in GMP suits. Utilizing a frozen, off -the-shelfproduct improved the streamlined production processes and allow Kadimastem to transport AstroRx ®frozen cell product from