Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 702

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 702
---
 and agreement that Nolazol has a lower risk of abuse than CII stimulants. In addition, based on the current DEA classification of mazindol as a CIV stimulant, we expect that Nolazol will continue to be without a Black Box warning in the U.S., which is another important differentiator relative to both CII stimulants and the current non -stimulantsin use today to treat ADHD. Annex F-58 Our Phase 2 trial showed significant improvement in ADHD symptoms, met all primary and secondary study endpoints and was well -toleratedand with no clinically significant adverse effects over placebo. In light of its innovative mechanism of action and low potential for abuse, we believe Nolazol, if approved for marketing, could represent a highly differentiated alternative to the CII treatments in use today to treat ADHD. Nolazol Clinical Trial Results Phase 2 Clinical Trial We completed a Phase 2 clinical trial in 2017 in the United States, in which Nolazol was well -toleratedand demonstrated statistically significant improvement over placebo. The clinical trial met the primary and all secondary endpoints and had a robust effect on ADHD symptoms with a large placebo -adjustedeffect size of 1.09 in the investigator -ratedADHD symptom scores. We believe that the magnitude of this effect is comparable to currently leading CII stimulants and considerably larger than the available non -stimulanttreatment options. The table below summarizes the results of our Phase 2 clinical trial in adults in terms of adverse events. Our Phase 2 clinical trial evaluated the efficacy, safety and tolerability of Nolazol in a randomized, double -blind, placebo -controlled, multi -center, parallel trial in 85 adults with a diagnosis of ADHD. Subjects were administered Nolazol or matching placebo once a day for six weeks, dosed flexibly (between 1mg/day and 3mg/day) during a three -weekdouble -blindoptimization period, followed by a three -weekdouble -blindfixed dosing period. Efficacy Results The primary efficacy endpoint was the change from baseline in the total ADHD -RSscore at Week6, as compared to placebo, and measured by the clinician -administeredADHD Rating Scale with DSM -5symptoms, or the ADHD -RS-5. ADHD -RS-5is a standardized, “gold standard endpoint” validated test for measuring severity of ADHD symptoms and assessing response to treatment. The