Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 354

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 354
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ized 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 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