Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 353

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 353
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 -stagebiopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex CNS disorders with unmet medical needs. NLS’s lead compound mazindol, a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, in a proprietary extended -release, or ER formulation, is being developed for the treatment of narcolepsy (lead indication) and ADHD (follow -onindication). NLS believes that this dual mechanism of action will also enable mazindol ER to provide potential therapeutic benefit in other rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders. According to the World Health Organization and based on data from the Global Burden of Disease Report, CNS disorders result in a socio -economicburden of more than $317billion annually in the United States alone. Additionally, CNS disorders were expected to account for approximately 15% of the global disease burden in 2020, the largest of any disease area. However, treatment options for these conditions are often limited, inadequate or nonexistent, and the development of new CNS treatments generally trails behind 166 other therapeutic areas. NLS is pursuing the development of the next generation of CNS therapies with high medical impact to address this critical and growing unmet need. NLS’s dual development strategy is designed to optimize the outcome of its clinical programs by developing new chemical entities from known molecules with strong scientific rationale, and also by re -definingpreviously approved molecules with well -establishedtolerability and safety profiles, as determined by applicable regulatory agencies. NLS believes that its streamlined clinical development approach has the potential to advance its product candidates rapidly through early -stageclinical trials, while carrying an overall lower development risk. A lower development risk, NLS believes, exists with respect to the development of its lead product candidate, Quilience, and follow -onproduct candidate, Nolazol, due to their use of mazindol as the active ingredient, which was previously approved and marketed in the United States, Japan and Europe to manage exogenous obesity (obesity caused by overeating). The Merger Agreement provides that, upon the terms and subject to the conditions thereof, following and subject to the Closing, NLS shall work diligently to dispose of any Legacy Assets, including, Quilience, Nolazol and all other product candidates, but excluding the DOXA platform. The DOXA platform includes AEX -041. It