Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 706

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 706
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, with >90% improvement in ADHD symptoms from baseline (p<0.0001), pointing to a viable long -actingtreatment option, assuming it is shown to be safe, as determined by applicable regulatory agencies. Additionally, the mean change in the parent rated and clinician rated ADHD -RS-IVtotal score from end of treatment (Week 1) to the final observation visit (Week 4) demonstrated statistical significance (p<0.0001), indicating significant alteration in the level of symptomology of ADHD after mazindol withdrawal. The figure below summarizes the results of the primary endpoint. Annex F-62 Mazindol was well tolerated in children with ADHD. Adverse events included decreased appetite, headache and abdominal pain and there were no clinically significant changes in laboratory values, ECG, blood pressure, heart rate, or body weight. This clinical trial provided proof -ofconcept data, potential benefit, and supported the advancement into a more expansive Phase 2 trial. Phase 3 Development Strategy Having successfully met both the primary and secondary endpoints in our initial Phase 2 trial, we 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. Our 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 our Phase 2 trial. Our 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. Annex F-63 Our Research Pipeline In addition to our product candidates, Quilience and Nolazol, we have early and mid -stagecompounds that we may seek to further develop in the future. We 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 our rare hypersomnia and complex neurodevelopmental disorder franchises