Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 377

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 377
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 onset of action of the compound. Today, Strattera (branded and generic version) has about 3.6% market share, despite initially climbing to nearly 20% following launch on the basis of being an alternative to CII stimulants. Clonidine and Guanfacine are also non -stimulantsthat are alpha -2adrenergic receptor agonists and were both initially approved for managing blood pressure. They have been approved for use in children and adolescents, generally in conjunction with CII stimulants as an add -ontherapy. While they are used in children and adolescents, there is little study of their efficacy and safety in adults. As a monotherapy, they are usually reserved for children and adolescents who respond poorly after several trials of stimulants and Strattera, 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 185 a lower risk of abuse than CII stimulants. In addition, based on the current DEA classification of mazindol as a CIV stimulant, NLS