Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 355

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 355
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 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, NLS intends to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional pre -clinicaland 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-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 It was marketed for nearly 30 years, into the early 2000’s, before being voluntarily withdrawn from the market not for safety nor for efficacy reasons (Docket n° FDA -2007-P-0326) but for commercial.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 has 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 intends 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. 167 NLS believes that its lead product candidate, Quilience, offers a meaningfully differentiated product profile over current treatment options for the following reasons: • Mechanism of action. If approved today, Quilience would be the only partial orexin 2 receptor agonist approved by the FDA, as well as the only triple monoamine reuptake inhibitor approved by the FDA for the treatment of narcolepsy. Narcolepsy is caused by a profound loss of orexin producing neurons and a partial orexin 2 receptor agonist may help to replace the