Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 713

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 713
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 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 its current focus on the development of Quilience for narcolepsy in adults, and if approved for marketing, they intend to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional pre -clinicaland clinical studies.

| Moore Financial Consulting |

Annex E-36

Quilience and Nolazol both contain mazindol as the active ingredient in a proprietary controlled release, or CR, formulation developed for a once -a-daydosing. Mazindol has a well -establishedsafety 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 -termmanagement 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 It was marketed for nearly 30 years, into the early 2000’s, before being voluntarily withdrawn from the market not for safety nor for efficacy reasons but for commercial. In addition to the 30 -yearperiod in which it was marketed, mazindol was also widely used off -labeland prescribed under compassionate use for the treatment of narcolepsy for approximately four decades, during which time it demonstrated a well -toleratedsafety profile in patients over long -term, chronic use of the drug. NLS entered into an agreement with Novartis Pharma AG for the exclusive rights to mazindol pre -clinical, non -clinicaland clinical data and to Sanorex (mazindol) NDA in the U.S., and non -exclusiverights of mazindol in the rest of the world, except Japan and intend to use the toxicology, clinical safety and tolerability, and CMC intellectual property from the Sanorex (mazindol) NDA to support a marketing application for Mazindol ER for the treatment of narcolepsy. The Company’s business strategy is to continue building a differentiated, global biopharmaceutical company that is patient -focusedon the development of transformative therapies that address critical unmet needs in rare and complex CNS and neurodevelopmental disorders, such as Central Disorders of Hypersomnolence (which include narcolepsy as well as IH) and ADHD. NLS also intend to continually seek out -licensingand asset sale transactions that they believe will allow them to drive