Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 360

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 360
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agnosed and/or because of inadequate treatments. One FDA approved medication for both EDS and cataplexy associated with narcolepsy, sodium oxybate franchise (Xyrem/Xywav), although marketed with significant limitations impeding its use, generated revenues of over $2.0 billion in 2022 according to Jazz Pharmaceuticals’ 2022 full year financial results issued on March 1, 2023. On October 15, 2024, CoherentMI published a report titled “Narcolepsy Market Outlook 2024 – 2031,” which estimated that the global narcolepsy market would be valued at approximately $ 2.53 billion in 2024, and projected it would grow to $ 4.68 billion by 2031, reflecting a CAGR of 9.3% over the forecast period. As partial agonist of the OX2R and a triple monoamine reuptake inhibitor, NLS believes that Quilience reflects a unique mechanism of action to address the shortcomings of the approved medications and the unmet needs of patients. Quilience is being designed as an oral, once -dailytreatment, intended for long -termuse. Through the use of mazindol in Quilience and the expected benefits of NLS’s proprietary controlled -releaseformulation, NLS hopes that regulatory agencies will conclude that Quilience has a desirable balance of efficacy, safety and tolerability to support marketing authorization. NLS also anticipates developing additional mazindol based ER product(s) for broader hypersomnia indications, such as IH, where there is a critical unmet need and no currently approved treatments available, in addition to other disorders, such as neurocognitive disorders implicated by EDS. 170 Quilience has been granted orphan drug designation by both the FDA and European Commission for the treatment of narcolepsy, and if approved for marketing in adults, this designation is expected to provide 7 years and 10 years of market exclusivity in the United States and Europe, respectively, and with the potential for additional market exclusivity, if and when further developed and approved in pediatrics (extended for an aggregate of 7.5 years and 12 years in the United States and Europe, respectively). Additionally, NLS has been granted formulation patents in several countries including the U.S., Europe, Canada and South Korea for its proprietary ER formulation, which provide patent protection through 2037. After obtaining an IND approval mid -2021, NLS