Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 734

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 734
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 ALS in the prestigious scientific journal Transitional Medicine, which underwent a successful independent peer review. The Year 2021 — In light of the company’s decision to act against the submission of an IND to the FDA to start the multi -siteclinical trial in the USA, during the year 2021, the company’s main clinical activity in relation to ALS focused on two primary levels: (1) completion of all the trials required for IND submission for the company’s AstroRx ®product for the multi -sitetrial (2) Completion of the development of the ability to freeze (off -the-shelf) and thaw the AstroRx ®cells as before the development of this ability, as mentioned, the AstroRx ®cells could be transplanted into the patient’s body within a limited period of 24 hours only. The company completed these objectives. The year 2022 — The company completed the experiments required to develop the ability to freeze and thaw the cells without harming their quality and completed the toxicology experiment to examine their safety. Developing an off -the-shelfproduct that can be thawed and injected at the patient’s bedside is very valuable since it will allow the company to transport the cells globally as required in the performance of a multi -siteclinical trial, as well as produce an off -the-shelfproduct on a commercial scale that will be available to the ALS patient’s community around the world. Also, during the year 2022, the company invested a lot of effort to complete the submission of an IND to the FDA, including the completion of a clinical protocol after consultation with key opinion leaders in the US and Europe and the completion of additional data regarding the product’s safety and quality assurance. The Year 2023 — In continuation of the company’s efforts to complete what is required for submitting the IND as detailed above, during the reporting period, the company received FDA approval to start a multi -siteclinical 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 Astro