Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 177

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 177
---
, the failure to: •effectively coordinate efforts to communicate Kadimastem’s capabilities and products following closing; •compete effectively for additional opportunities expected to be available to Kadimastem following closing; •integrate and harmonize financial reporting and information technology systems of Kadimastem and NLS; 69 •retain Kadimastem’s relationships with its customers and successfully integrate NLS into these existing relationships; •integrate NLS and Kadimastem executive officers’ teams; •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