Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 360

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 360
---
 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 that successfully treat both cataplexy and EDS in narcolepsy. Additionally, NLS is planning to leverage the demonstrated biological activity of the active molecule in Quilience to further expedite the clinical development, as well as drawing on the data from its ADHD program to support its clinical development efforts of Quilience and the FDA’s previous approval of mazindol (in its immediate release form in the pharmaceutical product “Sanorex ®,” as manufactured and distributed by Novartis (through its Sandoz division) as safe in the management of exogenous obesity through the 505(b)(2) regulatory pathway. In March 2021, NLS entered into a license agreement with Novartis Pharma AG, whereby NLS obtained, on an exclusive basis in the U.S., all of the available data referred to and included in the original NDA for Sanorex ®(mazindol) submitted to the FDA in February 1972. The agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know -howfor all products containing mazindol as an active substance, and all post -marketingclinical studies and periodic safety reports from 1973 onwards. Under the agreement, NLS has obtained the same rights on a non -exclusivebasis in all territories outside of the U.S. except for Japan, with the right to cross -referencethe Sanorex ®NDA with non -U.S. regulatory agencies in the