Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 399

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 399
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, 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                          
 Diversion                              |     | Limitations                                                                                                               |     |                                                                                                                                |
| Amphetamines (Adderall, Dexedrine)       |     | No        |     | High: CII                              |     | •   “Grandfathered” approval only (pre-1938 indication) for Immediate Release (IR)                                        |     | •   Tolerance and rebound hypersomnolence                                                                                      |
|                                          |     |           |     |                                        |     |                                                                                                                           |     | •   Short-acting                                                                                                               |
| Methylphenidate (Ritalin)                |     | No        |     | High: CII                              |     | •   “Grandfathered” approval only (pre-1938 drug) for IR                                                                  |     | •   Tolerance and rebound hypersomnolence                                                                                      |
|                                          |     |           |     |                                        |     |                                                                                                                           |     | •   Short-acting                                                                                                               |
| Solriamfetol                             
 (Sunosi)                                 |     | No        |     | Low: CIV                               |     | •   Efficacy for controlling cataplexy not available                                                                      |     | •   Risk for drug induced high-blood pressure that can go undetected                                                           |
| Modafinil/Armodafinil (Provig