Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 387

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 387
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 administration, which is an important feature for increased compliance in ADHD patients. A definitive food -effectstudy with the final formulation of Nolazol will be conducted during the Phase 3 program. The figure below shows the pharmacokinetic curve of Nolazol under the fed and fasted conditions utilized in this clinical trial. Nolazol was well -toleratedand there were no deaths, serious adverse events or withdrawals due to adverse events. Adverse events were reported in 30% of the Nolazol -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 188 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.