Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 682

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 682
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 led to the development of the drug Rebif for the treatment of multiple sclerosis. Rebif was sold to Serono Merck in 2006 and has generated annual sales of approximately one billion dollars since then. The company’s field of activity is the development of cell therapy in regenerative medicine. Regenerative medicine is an innovative field of medical research focused on the regeneration of damaged tissues or organs, whether due to disease, injury, or congenital defects, through (1) Creating new cells, tissue parts, or organs in laboratory conditions, or using cells, organs, or tissue parts from donors and implanting them in the patient to replace damaged cells or tissues; or (2) Finding and developing drugs that will help induce the spontaneous regeneration of the damaged tissue or organ by encouraging the adult stem cells permanently present in the tissue to divide, differentiate, and replace the damaged area. The company developed a technological platform for the development and production of target cells differentiated from embryonic stem cells and engineered pluripotent stem cells as off -the-shelfproducts aimed at repairing and replacing damaged cells, tissues, and organs. By using functional cells differentiated from embryonic stem cells, drugs can be developed to treat a wide range of diseases. The company’s unique technological platform enables the expansion of embryonic stem cells and engineered pluripotent stem cells and their differentiation into specific cells in the body according to choice and relevant needs. In addition, the company developed technological processes that allow, after differentiation and, if necessary, the selection of the relevant cells for therapeutic function created in differentiation and reassembling them. The company is also developing a delivery system that will encapsulate the cells before implantation into the patient, thus protecting them from the patient’s immune system if necessary. After conducting a thorough examination of a variety of medical indications in which the technological platform can be used as a basis for drug development, as of the date of the periodic report, the company decided to focus on developing cell therapies for the treatment of two diseases: amyotrophic lateral sclerosis (ALS) and insulin -dependentdiabetes, as detailed below: AstroRx ®— clinical development of groundbreaking cell therapy for treating amyotrophic lateral sclerosis, an incurable disease. The company completed a Phase I/IIa clinical trial at Hadassah Hospital, Israel, focusing on the implantation of healthy supporting cells of the nervous system (astrocytes) that support the survival of motor neurons and received orphan drug status from the FDA. As of the report’s publication, the company received approval from the FDA