Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 721

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 721
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 held a pre -meetingwith the FDA in which the FDA was briefed on the company’s plans regarding the planned safety and efficacy trials.

| Moore Financial Consulting |

Annex E-7

The company’s business model is to complete the development of the products to a stage where, in the company’s estimation, it will be possible to commercialize the development results, among other things, for each of the products through a strategic partner (international pharmaceutical companies) who will complete the development and/or market and commercialize the product if the company completes development. Considering the above, in parallel to the research and development of the drugs mentioned above, 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