Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 159

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 159
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20-25 specialized centers across the U. S. and positive top-line results were announced on September 27, 2022. On January 30, 2023, we
announced the completion of an open label extension study with Quilience(R) (Mazindol ER) for the treatment of narcolepsy. On March 27,
2023, we announced open label extension study six-month data 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, we intend 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. We believe Quilience may qualify for these programs based on (i) positive real-world evidence, namely, previous
off-label use 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-dopamine reuptake inhibitors, or SNDRI, and partial OX2R agonist, which we believe
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, we are 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 our ADHD program to support our 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, we entered into a license agreement with