Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 748

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 748
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.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 of narcolepsy. On March 27, 2023, they announced open label extension study six -monthdata for Quilience(R) (Mazindol ER) in the treatment of narcolepsy Type 1 and Type 2. Quilience Label Expansion — following the current focus on the development of Quilience for narcolepsy in adults, and if approved for marketing, NLS intends to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional nonclinical and