Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 408

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 408
---
 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. 205 •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 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 below, in 2021 Kadimastem completed a Phase 1/2a clinical trial of AstroRx ®that began in April 2018, with the first patient treated in November 2018. The study was conducted at Hadassah Medical Center, Israel. Study protocols were approved by the Israeli Ministry of Health and the institutional review board of Hadassah Medical Center in Jerusalem, Israel. Eligible participants were aged between 18 and 70 years with a diagnosis of probable or definite ALS by revised El Escorial Criteria, within two years of diagnosis. The ALS Functional Rating Scale -Revised, or ALSFRS -Rscore was higher than 30, and slow vital capacity, or SVC, was 70% or more