Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 182

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 182
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ulants. It is now considered a second-line treatment and is typically used as an alternative to CII stimulants for patients
who have a substance abuse problem, a family member(s) with a substance abuse problem, tics, or intolerable side effects with CII stimulants.
Strattera carries a Black Box warning for increased risk of suicidal thoughts in children and adolescents and additional warning statements
for liver damage. Moreover, Strattera takes four weeks to reach initial onset of action and six to ten weeks to achieve full clinical
effectiveness, related both to the prolonged titration needed and the delay in the 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-stimulants that are alpha-2 adrenergic 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-on therapy. 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%.

Our Solution: Nolazol - Next-Generation ADHD Therapeutic

We believe a large market
opportunity exists for a non-CII stimulant, 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, we believe 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 we believe
is an important, unique and differentiating factor