Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 343

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 343
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 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 -impulsivity, and affects cognitive, academic, behavioral, emotional, and social functioning. An estimated 8.4% of children and 5% of adults in the United States have a current diagnosis of ADHD, and if left untreated can lead to poor occupational and psychosocial outcomes. According to a report published by Global Market Insights on December 17, 2024, the global ADHD market was valued at $15.8 billion in 2023 and is projected to grow at a CAGR of over 5.1 %from 2024 to 2032. Furthermore, based on a report by Grand View Research, Inc., ADHD is