Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 106

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 106
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 law could require it to expend significant time and resources in response and could generate negative publicity.
The occurrence of any event or penalty described above may inhibit Kadimastem’s ability to commercialize its product candidates
and adversely affect its business, financial condition, results of operations and prospects.

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 EU and Japan.

Other than Kadimastem’s
headquarters and other operations which are located in Israel, it currently have limited international operations, but Kadimastem’s
business strategy incorporates potentially significant international expansion, particularly in anticipation of approval of its product
candidates. Kadimastem plans to maintain research and development, manufacturing, development, and sales representatives and conduct physician
and patient association outreach activities, as well as clinical trials, within and outside of the United States, in Israel, Europe.
and Japan. If Kadimastem’s products are approved for commercialization outside the United States, Israel, or the EU, Kadimastem
will likely enter into agreements with third parties to market its drug substances in these additional global territories. Kadimastem
expects that it will be subject to additional risks related to entering into or maintaining international business relationships, including:

  different regulatory requirements for approvals of drug substances  

  differing United States and foreign drug import and export  

  reduced protection for intellectual property rights in foreign  

  failure by Kadimastem to obtain regulatory approvals for the  

  different reimbursement systems;  

  economic weakness, including inflation, or political instability  

  multiple, conflicting and changing laws and regulations such                                                                                  

  complexities associated with managing multiple payor reimbursement  

  financial risks, such as longer payment cycles, difficulty                                                                             

  workforce uncertainty in countries where labor unrest is more  

  production shortages resulting from any events affecting raw  

  regulatory and compliance risks that relate to maintaining                                                                          
  accurate information and control over sales and activities that may fall within the purview of the U. S. Foreign Corrupt Practices  
  Act, its books and records provisions or its anti-bribery provisions;                                                               
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  potential liability resulting from development work conducted  

  business interruptions resulting from a local or worldwide                                  

Any of these factors could
significantly harm its future international expansion and operations and, consequently, Kad