Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 179

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 179
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 is well tolerated with lower potential for abuse represents what we believe
is an important unmet need to persons with ADHD. The magnitude of the treatment effect demonstrated in our Phase 2 study is comparable
to what is typically seen with the leading CII stimulants, and, mazindol, the active molecule in Nolazol, is currently a CIV controlled
substance under the CSA, meaning it has an already established low risk of abuse. We believe Nolazol, whose active ingredient is mazindol,
a CIV stimulant, may be the transformative treatment for ADHD that physicians and patients have been waiting for, by providing a treatment
with what we believe will be similar efficacy as CII stimulants, but with a low potential for abuse.

We have a robust method of
use patent for Nolazol for the treatment of ADHD expiring in August 2028 in the United States and in December 2027 in Europe. Additionally,
we have filed an international patent application under the PCT, for a proprietary controlled release formulation, and, if granted, may
provide patent protection through 2037 in the United States.

Diagnostics and Patient Sub-Types

Healthcare providers use the
guidelines in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, or DSM-5,
to help diagnose ADHD and this diagnostic standard helps ensure that people are appropriately diagnosed and treated for ADHD. The DSM-5
identifies three sub-types and each presentation is distinguished by a distinct set of symptoms that physicians use to diagnose the condition.
The three presentations are: (1) Predominantly Inattentive; (2) Predominantly Hyperactive-Impulsive; and (3) Combined Presentation.

The diagnostic evaluation
for ADHD includes a comprehensive medical, developmental, educational, and psychosocial evaluation. This comprehensive evaluation is necessary
to confirm the presence, persistence, pervasiveness, and functional complications of core symptoms, exclude other explanations for core
symptoms and identify coexisting emotional, behavioral, and medical disorders. In order to meet criteria for ADHD, core symptoms must
also impair function in academic, social, or occupational activities.

Two-thirds of individuals
with ADHD have at least one other neurodevelopmental, psychiatric, or other CNS disorder, including anxiety, depression, autism, and sleep
disorders. Substance use disorder is a common comorbidity associated with ADHD and may have a direct underpinning in the pathophysiology