Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 354

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 354
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treatedsubjects and included dizziness and somnolence and there were no clinically significant changes in laboratory values, ECG, blood pressure, or heart rate. Phase 2 Pediatric Clinical Trial A Phase 2 open -labelpilot study in France was conducted in 2015 by Eric Konofal, one of NLS’s founders and Chief Scientific Officer, and others while at AP -HP. This study evaluated the efficacy, safety, and tolerability of mazindol in 24 children, aged 9 – 12 years, and diagnosed with ADHD. All enrolled patents had a low rate of response to methylphenidate, which is a first -linetreatment in children with ADHD. All patients received the same fixed dose of mazindol daily for seven days, followed by a three -weekdrug -freesafety 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 185 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