Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 597

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 597
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 critical unmet needs in rare and complex CNS and neurodevelopmental disorders, such as Central Disorders of Hypersomnolence (which include narcolepsy as well as IH) and ADHD. NLS also intend to continually seek out -licensingand asset sale transactions that they believe will allow them to drive greater value for the shareholders. The key elements of the business strategy are to: •globally develop Quilience for narcolepsy in adults (lead project); •pursue new indications beyond narcolepsy (e.g., Quilience in IH) (follow -onprojects); •explore expansion of their growing product pipeline either through in -houseinnovation or in -licensing. Quilience 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 have been granted formulation patents in several countries including the U.S., Europe, Canada and South Korea for our proprietary ER formulation, which provide patent protection through 2037. Quilience has a mechanism of action that is distinct from existing and emerging therapies. If approved, Quilience may represent a substantial improvement to existing treatments. Mazindol’s mechanism of action, which may restore orexin signaling in the brain and further enhance monoamine availability in promoting wakefulness and reducing cataplexy has the potential to be a breakthrough treatment and thereby offering a significant treatment advancement. After obtaining an IND approval mid -2021, the Company initiated a Phase 2 clinical trial in the third quarter of 2021 to evaluate Quilience as a once -dailymonotherapy for the treatment of EDS and cataplexy, the primary symptoms of narcolepsy. This proof -of-concept, or PoC, trial was conducted in approximately 20 -25specialized centers across the U.S. and positive top -lineresults were announced on September 27, 2022. On January 30, 2023, NLS announced the completion of an open label extension study with Quilience(R) (Mazindol ER) for the treatment