Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 2

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 2
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 share price and business could be adversely affected;                        
  Following the Merger, NLS may lose its foreign private issuer status and face increased U. S. reporting and compliance obligations;  

  The Merger with Kadimastem may result in dilution and reduced influence for current NLS shareholders.  
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  NLS may not be able to successfully integrate Kadimastem’s business or realize the expected benefits of the Merger;  
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  Following the Merger, NLS plans to shift its business to Kadimastem’s cell therapy platform, which may not succeed;  
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  Kadimastem has no revenue and a history of losses, and its drug candidates may never receive regulatory approval or be commercialized; and  
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  Legal or regulatory challenges, including lawsuits, could delay or prevent the completion of the Merger with Kadimastem.  

Risks Related to Our Current Business

We depend substantially on the success of
our two product candidates, Quilience and Nolazol. We cannot give any assurance that any of our product candidates will receive regulatory
approval, which is necessary before they can be commercialized.

We have invested
almost all of our efforts and financial resources to achieve and maintain phase 3 readiness in research and development and general and
administrative costs of our two product candidates, Quilience for the treatment of excessive daytime sleepiness, or EDS, and cataplexy
associated with narcolepsy and Nolazol, for the treatment of ADHD. The process to develop, obtain regulatory approval for and commercialize
pharmaceutical product candidates is long, complex, costly and inherently uncertain of outcome. We are not permitted to market any of
our product candidates in the United States, European Union, or the EU, or any other jurisdiction until we receive the requisite regulatory
approvals. We may be able to generate pre-approval revenues from compassionate use activities leveraging on an expanded access policy
in certain countries around the world. However, we cannot give any assurance that our current clinical development plan will proceed as
planned, or that our product candidates will receive regulatory approval, or that such