Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 153

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 153
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 treatment of ADHD. We initiated our clinical development with a Phase 2 clinical trial in the third quarter of 2021,
in adult patients with narcolepsy. We published positive interim top-line results from our Phase 2 clinical trial in March 2022. As a
result, we intend to apply for expedited development program(s) facilitated by the FDA, such as Breakthrough Therapy and/or Fast Track
designations and by the European Medicines Agency, or EMA, such as PRIME. We have completed a Phase 2 clinical trial evaluating the safety
and efficacy of Nolazol in adults with ADHD in the U. S. Although further clinical development of Nolazol in ADHD is on hold, given the
positive outcome of this trial, we may initiate Phase 3 clinical trials after we receive approval to commercialize Quilience. We also
intend to seek FDA and other regulatory approval for Nolazol for use in children with ADHD, which requires additional nonclinical work,
as well as staged clinical work in determining safe dosing and monitoring. In addition, following our current focus on the development
of Quilience for narcolepsy in adults, and if approved for marketing, we intend to seek a label expansion for the treatment of narcolepsy
in pediatric patients, which may require additional pre-clinical and clinical studies.

Quilience and Nolazol both
contain mazindol as the active ingredient in a proprietary controlled release, or CR, formulation developed for a once-a-day dosing. Mazindol
has a well-established safety record from its extended history of clinical use across the United States and several countries in Europe,
where mazindol was previously approved in an immediate release formulation for the short-term management of exogenous obesity. It was
marketed for nearly 30 years, into the early 2000’s, before being voluntarily withdrawn from the market not for safety nor for efficacy
reasons (Docket n° FDA-2007-P-0326) but for commercial. In addition to the 30-year period in which it was marketed, mazindol was also
widely used off-label and prescribed under compassionate use for the treatment of narcolepsy for approximately four decades, during which
time it demonstrated a well-tolerated safety profile in patients over long-term, chronic use of the drug. We have entered into an agreement
with Novartis Pharma AG for the exclusive rights to mazindol pre