Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 14

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 14
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 adversely affect our financial condition. As a result of such lawsuits and their potential results, we may be required to
limit commercialization of our product candidates. Regardless of the merits or eventual outcome, liability claims may result in:

  decreased demand for our product candidates;                   
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  termination of clinical trial sites or entire trial programs;  
  injury to our reputation and negative media attention;         

  product recalls or increased warnings on product labels;  
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  withdrawal of clinical trial participants;  

  costs of to defend the related litigation;  

  diversion of management and our resources;                                                                             
  substantial monetary awards to, or costly settlements with, clinical trial participants, patients or other claimants;  
  higher insurance premiums;                                                                                             
  loss of initiation of investigations by regulators or other authorities; and                                           
  the inability to successfully commercialize our product candidates, if approved.                                       

Risks Related to the Regulatory Environment

Obtaining approval of an NDA or a MAA even
after clinical trials that are believed to be successful is an uncertain process.

We are not permitted to market
Quilience and/or Nolazol in the United States or the EU until we receive regulatory approval of an NDA from the FDA or MAA from the EMA,
or in any foreign countries until we receive the requisite approval from regulatory authorities in such countries. We have not received
regulatory clearance to conduct the additional clinical trials that are necessary to be able to submit an NDA to the FDA for Nolazol.
Similarly, we have not received regulatory clearance in the EU to conduct clinical trials that are necessary to receive approval of a
MAA for Quilience in Europe. As such, we have not submitted an MAA for any of our product candidates.

We may be able make our products
available on a named patient basis and generate pre-approval revenues from compassionate use activities leveraging on an expanded access
policy in certain countries around the world.

Even if we complete our planned
clinical trials and believe the results to be successful, all of which are uncertain, obtaining regulatory approval is an extensive, lengthy,
expensive and uncertain process, and the FDA and EMA, and other regulatory authorities may delay, limit or deny approval of Quilience
and/or Nolazol for many reasons, including, but not limited to:

  we may not be able to demonstrate to their satisfaction that the product candidate