Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 760

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 760
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 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 It was marketed for nearly 30 years, into the early 2000’s, before being voluntarily withdrawn from the market not for safety nor for efficacy reasons but for commercial.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 greater value for the shareholders. The key elements of the business strategy are to: •globally develop Quilience for narcolepsy in adults (lead project); •pursue new indications beyond narcolepsy (e.g., Quilience in IH) (follow -onprojects); •explore expansion of their growing product pipeline either through in -houseinnovation or in -licensing. Quilience Quilience has been granted orphan drug designation by both the FDA and European Commission for the treatment of narcolepsy, and if approved for marketing in adults, this designation is expected to provide 7 years and 10 years of market exclusivity in the United States and Europe, respectively, and with the potential for additional market exclusivity, if and when further developed and approved in pediatrics (extended for an aggregate of 7.5 years and