Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 388

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 388
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 Phase 3 Development Strategy Having successfully met both the primary and secondary endpoints in NLS’s initial Phase 2 trial, NLS may plan to further the development of Nolazol as a follow -onor back -upcandidate to support filing for marketing and commercialization approval initially in adults in the United States, followed by children and adolescents. NLS’s first Phase 3 clinical trial may aim to evaluate doses of Nolazol in approximately 260 adults with ADHD, with subjects randomized to receive Nolazol or placebo for 6 weeks. The primary endpoint being the change from baseline in the ADHD -RS-5score, which was the primary endpoint in NLS’s Phase 2 trial. NLS’s second Phase 3 clinical trial may target to evaluate doses of Nolazol in children and adolescents, with an embedded placebo -controlledsub -studyin a laboratory classroom setting for the children age group. A laboratory classroom study provides a simulation of a real academic environment, including the potential for interaction and distraction among children, and allows for assessment by trained observers over the course of a typical extended school day. 189 NLS’s Research Pipeline In addition to NLS’s product candidates, Quilience and Nolazol, NLS has early and mid -stagecompounds that it may seek to further develop in the future. NLS may seek to develop these other compounds, comprising of NCEs, as well as repurposed compounds, in order to build a pipeline of product candidates at various stages of development that further complement NLS’s rare hypersomnia and complex neurodevelopmental disorder franchises. Additionally, NLS intends to continue to invest in its discovery research and development programs, with the goal of adding what NLS believes to be promising new compounds and indications to its product candidate development pipeline. NLS-4 NLS -4is a next -generationselective dopamine reuptake inhibitor. NLS believes that NLS -4is the only wake -promotingcompound without any rebound hypersomnia. This “hypnolytic effect” of NLS -4is thought to be due to the compound’s ability to prevent increased sleep need following sleep loss as supported by the recently published pre -clinicalresults. With the promising results from the cutting -edgepreclinical fatigue study in animals, and the apparent absence of CYP450 enzyme induction, NLS -4appears to have a superior profile compared to the widely used drug modafinil, and potentially represents an important milestone in the development of