Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 175

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 175
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 and (iv) more rapid revenue uptake (than
a non-CUP program) upon commercial availability (patients already on product and treated).

Nolazol for the Treatment of ADHD (Back-up
Program Product Candidate)

Nolazol is a triple monoamine
reuptake inhibitor and orexin receptor-2 partial agonist and its unique pharmacological profile is expected to yield important benefits
compared to existing treatments of ADHD. Enhancing the function of the three neurotransmitters well-known to be implicated in ADHD, norepinephrine,
dopamine and serotonin, along with its activity on the orexin-2 receptor, Nolazol may produce an optimal reduction in ADHD symptoms over
available treatments.

Nolazol is supported by a
positive pilot clinical trial with mazindol in 24 children with ADHD and a positive Phase 2 clinical trial in 85 adults with ADHD. The
Phase 2 clinical trial in adults met all primary and secondary study endpoints and was well-tolerated. A robust effect on ADHD symptoms
was demonstrated with a large placebo-adjusted effect size of 1.09 in the investigator-rated ADHD symptom scores.

Although more than 25 different
products have been approved by the FDA since 1937 for the treatment of ADHD, many of which are no longer available, there still continues
to be a large treatment gap with no optimal treatment currently available. Physicians, patients and their caregivers press for improved
treatment options to address key shortcomings with currently available treatments, including the need for a more tolerable safety profile,
more consistent efficacy with no rebound effect, and the need for lower risk of abuse, dependence, and misuse. Currently, doctors, patients,
and caregivers must choose between treatments that may be effective, but come with significant safety liabilities, such as high potential
for abuse and risk of diversion coupled with tight restrictions on writing and filling prescriptions; or treatments that are unscheduled,
but are also typically less effective. We are seeking to develop Nolazol such that, if approved for marketing, it could be the drug product
to close this treatment gap and address this unmet medical need.

Given the positive outcome
of our Phase 2 trial in ADHD, we may initiate Phase 3 clinical trials if we receive FDA’s green light to proceed at a later stage.

ADHD Overview and Market Opportunity

ADHD is a chronic neurodevelopmental
disorder affecting children, adolescents and adults and is characterized by an ongoing pattern of inattention and/or hyper