Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 206

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 206
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 and function
by releasing growth factors, removing toxins, and reducing environmental stressors such as 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  

  Kadimastem has a well differentiated, solid, and diversified  

  AstroRx ® can be utilized for other neurodegenerative                                                   

  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-shelf product improved the streamlined production
processes and allow Kadimastem to transport AstroRx®frozen cell product from one (or more) production facility to
anywhere in the world, at any point in time, without Kadimastem having to synchronize the production process with the exact date of
injection of the product to any patient. Kadimastem conducted several trials that supported the stability of the frozen
AstroRx®product and that the freezing process did not change the characteristics of the product. In addition,
AstroRx®successfully passed toxicity studies. The final chemistry, manufacturing and controls data was submitted to
the FDA in the Investigational New Drug, or IND, application and the FDA approved the conduction of Phase IIa clinical trial in
March 2023. Kadimastem intends to initiate a Phase IIa multisite study in the United States shortly following the
closing of the Merger.

As described in more detail