Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 396

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 396
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 major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions, which may in the future develop products to treat those diseases that NLS currently or, in the future, seeks to treat. Any product candidates that NLS successfully develops and commercializes may compete with existing therapies and new therapies that may become available in the future. Many of NLS’s competitors have far greater marketing and research capabilities than NLS. All of these companies and institutions may have product candidates in development that are or may become superior to Quilience and Nolazol. NLS’s commercial opportunity would be reduced significantly if NLS’s 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 NLS faces 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, NLS believes that currently NLS’s only competitors are Jazz Pharmaceuticals (Xyrem/Xywav ®, sodium oxybate) and Harmony Biosciences (Wakix ®, pitolisant). Although only indicated for EDS, NLS’s competitors also include Novartis (Ritalin ®), Teva (Provigil ®/Nuvigil ®, Modafinil/Armodafinil, Axsome (Sunosi ®, solriamfetol), Avadel (Lumryz ®, once nightly sodium

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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 -stageOX2R 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 Abuse