Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
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Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
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ITEM 3. KEY INFORMATION

A. [Reserved.]

B. Capitalization and Indebtedness.

Not applicable.

C. Reasons for the Offer and Use of Proceeds.

Not applicable.

D. Risk Factors.

You should carefully consider
the risks described below, together with all of the other information in this annual report. The risks described below are not the only
risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially
and adversely affect our business operations. If any of these risks actually occurs, our business and financial condition could suffer
and the price of our common shares and our publicly listed warrants, or Warrants, could decline.

Summary of Risk Factors

Investing in our common shares
and Warrants involves substantial risks. Our ability to execute our strategy is also subject to certain risks. The risks described below
may cause us not to realize the full benefits of our strengths or may cause us to be unable to successfully execute all or part of our
strategy. In particular, our risks include, but are not limited to, the following summary of such risk factors:

  We may be unable to successfully use mazindol, on which we depend substantially, as the drug substance for each of our current clinical mid-stage product candidates, Quilience, for the treatmen...  
  We may not be able to initiate our Phase 3 clinical trials in Quilience without additional pre-clinical studies, chemistry, manufacturing, and controls, or CMC, work or early-stage clinical tri...  
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  Prior results of mazindol for the treatment of other indications may not be replicated in the clinical trials that we conduct for the treatment of narcolepsy or ADHD;                                
  If, and when, we seek to commercialize Quilience and/or Nolazol, we may be partially dependent upon prescriptions from physicians for the sale of both such product candidates, and therefore, th...  
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  We are dependent on a sole manufacturer for mazindol drug substance and product. Any delay, price increase, or unavailability could materially disrupt our clinical development or commercializat...  

  Failure to secure additional strategic partnerships could negatively