Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 206

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 206
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; •retain and integrate key NLS and Kadimastem employees; •successfully address Kadimastem’s existing liabilities; •coordinate operations across time zones, continents and cultures; •manage the diversion of management’s attention from business matters to integration issues; •retain customers; and •combine Kadimastem’s business and management culture with the business and management culture of NLS. For more information, please see “ Summary of Risk Factors — Risks Related to the Merger” and “ Summary of Risk Factors — Risks Related to NLS After the Consummation of the Merger.” Risks Related to Product Development, Regulatory Approval and Commercialization Kadimastem depends substantially on the success of its proprietary product candidates. Kadimastem cannot give any assurance that any of its drug substances and product candidates will receive regulatory approval, which is necessary before they can be commercialized. Kadimastem has invested almost all of its efforts and financial resources in research and development of Kadimastem’s drug substances, as defined by the Harmonised Tripartite Guideline for Good Clinical Practice (ICH -GCPE6), and product candidates and general and administrative costs. Kadimastem’s portfolio comprises a clinical program, AstroRx ®, human astrocytes derived from pluripotent stem cells for the treatment of neurodegenerative diseases such as ALS, as well as a preclinical proof of concept program, IsletRx, human pancreatic islet like clusters for the treatment of insulin dependent diabetes. The process to develop, obtain regulatory approval for and commercialize pharmaceutical drug substances and product candidates is long, complex, costly, and inherently uncertain of outcome. Kadimastem is not permitted to market any of its drug substances and product candidates in the United States, the EU, or any other jurisdiction until Kadimastem receives the requisite regulatory approvals. Kadimastem cannot give any assurance that its current clinical development plan will proceed as planned, that its product candidates will receive regulatory approval, or that such regulatory approval, if received, will be within a timeframe that allows Kadimastem to effectively compete with its competitors or be successfully marketed and commercialized, which could harm its business, operating results, prospects or financial condition. All of Kadimastem’s drug substances and product candidates are in various stages of clinical and/or preclinical development. Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials of its drug substances and product candidates are prolonged, delayed or not commercially viable,