Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 383

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 383
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a, have unacceptable side effects with stimulants or Strattera, or have significant comorbid conditions limiting the treatment options to these products. These two drugs have not had significant commercial success, with a combined peak market share of about 5%. NLS’s Solution: Nolazol — Next-Generation ADHD Therapeutic NLS believes a large market opportunity exists for a non -CIIstimulant, such as Nolazol, that uses mazindol controlled release as its active ingredient; mazindol has been classified as a CIV stimulant, due to its low risk of abuse and tolerance. Given its unique binding profile (specifically, as a partial OX2R agonist), in addition to its classification as a CIV stimulant, NLS believes Nolazol could be transformative for the ADHD treatment landscape. Nolazol is a triple monoamine reuptake inhibitor and also a partial agonist of the OX2R, 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 184 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