Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 385

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 385
---
, which NLS believes is an important, unique and differentiating factor relative to other ADHD treatments. In NLS’s clinical studies conducted to date, Nolazol has been well -toleratedand there were no treatment -relatedserious adverse effects or discontinuations. In terms of abuse potential, Nolazol has an already established low risk of abuse, as previously determined by the DEA when mazindol, its active ingredient, was scheduled as a CIV substance, underscoring the awareness and agreement that Nolazol has 185 a lower risk of abuse than CII stimulants. In addition, based on the current DEA classification of mazindol as a CIV stimulant, NLS expects 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. NLS’s 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, NLS believes 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 NLS 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. NLS believes 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 NLS’s Phase 2 clinical trial in adults in terms of adverse events. NLS’s 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