Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 720

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 720
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 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 to initiate a Phase IIa multi -siteclinical trial in the US, following the IND application submitted by the company, per its work plan. IsletRx— development of insulin -secretingpancreatic cells to be implanted in diabetes patients as a treatment for insulin -dependentdiabetes (type 1 diabetes and type 2 diabetes requiring insulin). As of the report’s publication, the company has completed a pre -meetingwith the FDA in which the FDA was briefed on its plans regarding its planned safety and efficacy trials. If the company’s development is completed, the developed treatment has the potential to cure diabetes. As of the date of the report, the company has a collaboration with iTolerance Inc. for the joint development of an innovative treatment in the field of diabetes based on the company’s IsletRx product and iTolerance’s 100 -iTOLtechnology. During the reporting period, the joint venture received a grant of $1 million from the BIRD Foundation. After the reporting period, the parties