Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 96

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 96
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ensed
or used. Furthermore, if Kadimastem or others later identify undesirable side effects caused by AstroRx®and/or IsletRx,
several potentially significant negative consequences could result, including:

  regulatory authorities may suspend or withdraw approvals of  
  such a product candidate;                                    
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  regulatory authorities may require additional warnings on  
  the label;                                                 
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  regulatory authorities may issue negative publicity regarding  
  the affected product, including safety communications;         
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  Kadimastem may be required to change the way the product is                                                           
  manufactured, distributed, dispensed or administered, or conduct additional pre-clinical studies or clinical trials;  
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  Kadimastem may need to voluntarily recall its products; and  
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  Kadimastem could be sued and held liable for harm caused to  

Any of these events could
prevent it from achieving or maintaining market acceptance of the affected product candidate and could significantly harm its business,
prospects, financial condition and results of operations.

Changes in methods of product candidate
manufacturing or formulation may result in additional costs or delay.

As drug substances and product
candidates proceed through pre-clinical studies to late-stage clinical trials towards potential approval and commercialization, it is
common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an
effort to optimize processes and results and/or reduce cost of goods sold. Such changes carry the risk that they will not achieve these
intended objectives. Any of these changes could cause its drug substances and product candidates to perform differently and affect the
results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes.
Such changes may also require additional testing, FDA or EMA notification or FDA approval. This could delay completion of clinical trials,
require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay
approval of Kadimastem’s drug substances and product candidates and jeopardize its ability to commence sales and generate revenue.

Legislative or regulatory healthcare reforms
in the United States may make it more difficult and costly for the combined company to obtain regulatory clearance or approval of