Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 389

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 389
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 observation period. The mean change from baseline in the parent rated and clinician rated ADHD -RS-IVtotal score after 7 days of treatment was -24.1, with >90% improvement in ADHD symptoms from baseline (p<0.0001), pointing to a viable long -actingtreatment 189 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. 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 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. 190 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