Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 197

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 197
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 future.

Many of our competitors have
far greater marketing and research capabilities than us. All of these companies and institutions may have product candidates in development
that are or may become superior to Quilience and Nolazol. Our commercial opportunity would be reduced significantly if our competitors
develop and commercialize products that are safer, more effective, more convenient, have fewer side effects or are less expensive than
either or both of Quilience or Nolazol. Public announcements regarding the development of competing drugs could adversely affect the commercial
potential of either or both of Quilience and Nolazol.

Narcolepsy

We face competition from established
pharmaceutical and biotechnology companies that currently market products for the treatment of symptoms in narcolepsy. There is no cure
and many patients report that their medicines do not improve their complete range of symptoms. For the treatment of both EDS and cataplexy,
we believe that currently our only competitors are Jazz Pharmaceuticals (Xyrem/Xywav®, sodium oxybate) and Harmony Biosciences
(Wakix®, pitolisant). Although only indicated for EDS, our competitors also include Novartis (Ritalin®),
Teva (Provigil®/Nuvigil®, Modafinil/Armodafinil, Axsome (Sunosi®, solriamfetol), Avadel (Lumryz®,
once nightly sodium oxybate), as well as amphetamines, such as Adderall®and Dexedrine®. Other development
stage compounds currently under development include TAK-861 (Takeda’s selective OXR2-agonist), AXS-12 (Axsome, reboxetine) and other
early-stage OX2R agonist (Orexia, Alkermes, Jazz/Sumitomo, Harmony).

The below table highlights
the limitations of certain drug products approved for use in the United States by the FDA for treatment of EDS or cataplexy.

  Product                     Cataplexy Approval      Risk of                                     Limitations                                                                                                                                                                                                                                                                                                                                                       
                                                      Abuse                                                                                                                                                                                                                                                                                                                                                                                                         
                                                      Diversion                                                                                                                                                                                                                                                                                                                                                                                                     
  Amphetamines                No                      High: CII                                   “ Grandfathered” approval only (pre-1938 indication) for Immediate Release (IR)                                                                             Tolerance and rebound hypersomnolence                                                                                                                                                                 
  (Adderall, Dexedrine)                                                                                                                                                                                                                                                                                                                                                                                                                                             
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