Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 724

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 724
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clinical trial in the USA Phase IIa Multi -Site(phase 2a) of the company’s AstroRx ®product for the treatment in the case of ALS, this follows the IND request submitted by the company in February. In addition, during the reporting period, the company began preparations for the clinical trial and, among other things, worked to preserve the existing knowledge in the company as part of the audit plan for 2023, which dealt with the transfer of Transfer -Techknowledge and began the process to locate a CRO. As part of the clinical trial, the company intends to examine the administration of repeated doses of AstroRx ®every three months to prolong the observed therapeutic effect. As detailed above, as part of the Phase I/IIa clinical trial carried out by the company in Israel between 2018 – 2020. At the same time as conducting the clinical trials, the company intends to continue developing closed and automated production processes that will answer the commercial production phase for thousands of patients once the clinical phases are successful. The company estimates that it will be ready to start the multi -siteclinical trial during the fourth quarter of 2025, subject to obtaining the required funding for the experiment. Like the support that AstroRx ®cells provide to the motor neurons survival in ALS disease, the astrocyte cells support the survival of nerve cells that are damaged in other neurodegenerative diseases. The company’s progress in the process of development, production, regulation, and clinical assessment of the AstroRx ®product in the use of these cells in the ALS disease may serve a rapid and efficient development of the product for additional indications,

| Moore Financial Consulting |

Annex E-9

thus shortening the arrival of the product to clinical stages in a relatively short period of time and raising the business potential of the company, the company intends to examine the possibilities for reviewing the effectiveness of the cellular product in supporting the survival of nerve cells in other neurodegenerative diseases such as the advanced stage of Multiple Sclerosis, Glaucoma, Parkinson and Alzheimer. IsletRx IsletRx’s cellular product is based on pluripotent stem cells expansion and differentiation. It received as part of non -exclusivelicense agreements and on its technological platform, which enables the proliferation of pluripotent stem cells and their differentiation into cells like the islets of Langerhans (which contain insulin -producingbeta cells and glucagon -producingalpha cells). These cells are intended for transplantation in diabetics whose beta cells are unable to