Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 174

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 174
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 early source of biopharma revenues and incentivize the increased availability of potentially
transformative treatments, especially for rare disorders and orphan diseases. Given the extensive therapeutic experience with mazindol,
including off-label in narcolepsy patients, we believe that there is ample precedence to justify a funded CUP in selected European countries
for a defined group of patients.

We intend to conduct either
or both a cohort program and a named patient program, or NPP, each of which is highlighted below in a variety of European countries. Although
we have yet to determine which countries, we will initiate CUPs in first, our current plan is to target the following countries in the
following priorities (priority in each wave has yet to be determined):

  First Wave: United Kingdom, Netherlands, Belgium, France, Italy and Switzerland;  

  Second Wave: Latin America, the Czech Republic, Denmark and Spain; and  

  Third Wave: China, Germany, Austria, Japan, Sweden and Taiwan.  

In addition to the potential
benefit of generating revenues before Quilience market authorization from the regulatory agencies, the collection of data within the CUP
is a key potential benefit for the overall Quilience evidence generation strategy, as we believe that a CUP program for Quilience would:

  complement                                             

  support                                                                                                                       

  support                                                                                                                   

  potentially                                                                                    

  enhance                                                                

  provide                                                                                                                                  
  qualitative live-experience data and information on the unmet needs from the patient (and caregiver) perspective that may contextualize  
  the net therapeutic benefits offered by Quilience within the narcolepsy management paradigm;                                             
 ───────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

  bridge                                                                                                          

  allow                                                                                                    

  allow                                                                                                                 

  allow                                                                                               

  [1]      Central Disorders of Hypersomnolence (including but not limited to narcolepsy type 1 / type 2, IH, etc.)  
 ─────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

In addition to these potential
benefits of a CUP program for Quilience, commercial objectives of such a program would include the ability to (i) generate pre-licensing
revenues in selected countries, (ii) receive post-authorization revenues in non-priority countries for commercial use, (iii) potentially
establish an early market presence with a key opinion lead, and center of excellence strategy