Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 370

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 370
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olazol is a triple monoamine reuptake inhibitor and orexin receptor -2partial 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 -knownto be implicated in ADHD, norepinephrine, dopamine and serotonin, along with its activity on the orexin -2receptor, 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 -adjustedeffect size of 1.09 in the investigator -ratedADHD 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. NLS is 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 NLS’s Phase 2 trial in ADHD, NLS may initiate Phase 3 clinical trials if it receives 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 hyperactivity -impulsivityand is associated with clinically significant impairments in executive functioning. In addition, ADHD is one of the most commonly diagnosed neurodevelopmental disorders in school -agechildren and it often persists into adulthood. It is characterized by symptoms of inattention and/or hyperactivity