Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 18

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 18
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 Quilience and/or Nolazol, or other product candidates that we may
seek to develop, have side effects or cause serious or life-threatening side effects, the development of the product candidate may fail
or be delayed, or, if the product candidate has received regulatory approval, such approval may be revoked or limited.

Additionally, if any of our
product candidates receives marketing approval, the FDA or EMA could require us to adopt a REMS to ensure that the benefits outweigh its
risks, which may include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication
plan to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used. Furthermore, if
we or others later identify undesirable side effects caused by Quilience and/or Nolazol, 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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  we may be required to change the way the product is distributed, dispensed or administered, or conduct additional pre-clinical studies or clinical trials;  
  we may need to voluntarily recall our products; and                                                                                                         
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  we could be sued and held liable for harm caused to patients.  

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

We will need to obtain FDA approval of any
proposed names for our product candidates that gain marketing approval, and any failure or delay associated with such naming approval
may adversely impact our business.

Any name we intend to
use for our product candidates will require approval from the FDA regardless of whether we have secured a formal trademark
registration from the U. S. Patent and Trademark Office, or the U. S. PTO. The FDA typically conducts a review of proposed product
names, including an evaluation of whether proposed names may be confused with the