Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 361

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 361
---
 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 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, NLS announced open label extension study six -monthdata for Quilience(R) (Mazindol ER) in the treatment of narcolepsy Type 1 and Type 2. As a result of the subsequent open label extension, or OLE, interim data results discussed more fully below, NLS intends to pursue an expedited development program with the FDA under the Breakthrough Therapy and Fast Track designation programs, as well as potentially a similar program, PRIME, with the EMA. Collectively, these programs are designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need. NLS believes Quilience may qualify for these programs based on (i) positive real -worldevidence, namely, previous off -labeluse of Quilience’s active molecule, mazindol, in treating narcolepsy, which was prescribed under France’s Authorization Treatment Use program for 17 years in patients who failed to respond or could not tolerate the available approved treatments, (ii) its dual mechanism of action as a serotonin -norepinephrine-dopaminereuptake inhibitors, or SNDRI, and partial OX2R agonist, which NLS believes are crucial in addressing the underlying symptoms of both EDS and cataplexy, providing a pharmacological profile targeting multiple CNS pathways, and (iii) the limited availability of treatments