Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 99

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 99
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 “off -the-shelf”, allogenic, proprietary cell products, which may not be successful. •Following the Merger, NLS may be unable to integrate successfully and realize the anticipated benefits of the Merger. •Following the Merger, NLS’s business strategy will depend heavily on advancing and commercializing its pipeline products. However, NLS’s research and development efforts are subject to substantial risk, as drug development requires significant investment and faces inherent uncertainties. •Kadimastem has incurred significant operating losses since Kadimastem’s inception and anticipates that the combined company will incur continued losses for the foreseeable future. •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 not generated revenue from any product candidate and may never be profitable. •The results of Kadimastem’s clinical trials may not support its product candidates’ claims or any additional claims Kadimastem may seek for its drug substances and product candidates and its clinical trials may result in the discovery of adverse side effects. •Kadimastem will need to obtain FDA approval of any proposed names for its drug substances that gain marketing approval. •International expansion of Kadimastem’s business exposes it to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States, within Israel, the European Union, or the EU, and Japan. •Kadimastem’s market is subject to intense competition, which may result in others commercializing products before or more successfully. •The operations and commercialization of stem cell therapies is a new and integral part of the emerging regenerative medicine market, but the field remains in its infancy. 25 NLS Risk Factors NLS may fail to comply with data protection legislation or appropriate practices. NLS is subject to laws regarding the protection, privacy and security of personal information, such as the Swiss Federal Act on Data Protection (Bundesgesetz über den Datenschutz of 2020, as amended), or the Federal Data Protection Act, and Regulation (EU) 2016/679 (General Data Protection Regulation, or GDPR), and expects the regulatory landscape to continue to evolve. Data protection laws may impose restrictions on data practices which may necessitate changes to NLS’s operations, impact operational efficiency, prevent the application of certain marketing and sales initiatives and result in increased regulatory and compliance costs. Also, compliance with data