Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 732

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 732
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, the company is continuously working to create additional strategic business and research collaborations, as well as professional ones, that will promote its activities, alongside raising the necessary financing to complete the development of the drugs mentioned above. AstroRx ® In developing the AstroRx ®product, the company assumes that implanting healthy astrocytes in ALS patients will improve the protection of neurons, slow their death, and consequently delay (even significantly) the progression of the disease. The company’s drug is based on pluripotent stem cells derived from embryonic stem cells, which, using the company’s technological platform, underwent a process of expansion and differentiation into supporting cells of the central nervous system (astrocytes). After multiplication and differentiation as described, the company freezes the cells (off -the-shelfproduct) for transportation to the required locations worldwide. After arriving at the destination and thawing, these cells will be implanted in patients by injection into the spinal cord, as detailed below: a. Multiplication and differentiation into glial cells (supporting cells in the brain and spinal cord containing, among other things, astrocytes) — production of large quantities of pluripotent stem cells at the drug level (under good manufacturing practices, GMP) so that they serve as a starting material for the cell product. Subsequently, these pluripotent cells undergo controlled differentiation under laboratory conditions into glial cells, which mainly contain astrocytes. b. Implantation in the patient’s body — implantation of the cells into the cerebrospinal fluid in the patient’s central nervous system, occasionally, so that the implanted cells support the external environment of motor neurons, produce and release neurotrophic factors essential for normal survival of motor neurons, and protect and prevent an increase in glutamate and free radical levels in the environment of nerve cells. Clinical and preclinical trials August 2020 — The company announced positive interim results in the clinical trial of the second treatment group (B Cohort). As mentioned, the trial’s primary objective was to assess the safety of the AstroRx ®product. Like the first treatment group (Group A), the second treatment group (Group B), which was given a higher dose of the drug, did not report serious adverse events related to the treatment, and no adverse events were found that limited the treatment dose. The secondary objective of the clinical trial included the assessment of treatment efficacy, which is based, among other things, on the ALS Functional Rating Scale -Revised(ALSFRS -R) to assess the rate of progression of