Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 154

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 154
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-clinical, non-clinical and clinical data and to Sanorex (mazindol) NDA
in the U. S., and non-exclusive rights of mazindol in the rest of the world, except Japan and intend to use the toxicology, clinical safety
and tolerability, and CMC intellectual property from the Sanorex (mazindol) NDA to support a marketing application for Mazindol ER for
the treatment of narcolepsy.

We believe that our lead product
candidate, Quilience, offers a meaningfully differentiated product profile over current treatment options for the following reasons:

  Mechanism                                                                                                                                         
  of action. If approved today, Quilience would be the only partial orexin 2 receptor agonist approved by the FDA, as well as the                   
  only triple monoamine reuptake inhibitor approved by the FDA for the treatment of narcolepsy. Narcolepsy is caused by a profound loss             
  of orexin producing neurons and a partial orexin 2 receptor agonist may help to replace the missing endogenous orexin peptide, addressing         
  the underlying orexin deficiency and reduce disease specific symptoms. In addition, its unique dual mechanism of action as also a monoamine       
  triple reuptake inhibitor further acts to reduce disease specific symptoms, offering patients a treatment option that may address simultaneously  
  and in concert the two primary symptoms of narcolepsy.                                                                                            
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  Low                                                                                                                                     

  Quilience                                                                                                                                      
  is expected to be administered as a monotherapy. Narcolepsy is a complex spectrum disorder to manage and even with available                   
  approved medications, the majority of narcolepsy patients often require multiple medications to treat their symptoms. According to the         
  current treatment guidelines (initially published in 2007) of the AASM, approved medications for narcolepsy, at best, provide only moderate    
  improvement in narcolepsy symptoms and their respective side effects may limit their use. The AASM specifically highlights that future         
  investigations should be directed toward development of more effective and better tolerated therapies and primary prevention. The Voice        
  of the Patient report from the FDA’s patient-focused drug development initiative, published in 2014, concluded that, based on the              
  overall benefit-risk assessment of currently approved medications, there is a continued need for additional effective and tolerable treatment  
  options for patients