Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 178

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 178
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Data reported that since 2015, the adult ADHD market has become larger and begun growing at a faster rate than
the pediatric ADHD market. Adult ADHD is often characterized by recurrent problems with restlessness, impulsivity, problems with time
management and finances, as well as problems regulating emotions. Rather than being hyperactive like children, adults with ADHD report
experiencing an internal sense of fidgetiness and restlessness and with signs of inattention more apparent through problems communicating
with others. Upon entering the job market, many adults also experience obstacles in employment, and are at increased risk to be terminated
due to repeated tardiness or absenteeism. Such difficulties contribute to poorer employment outcomes and a lower likelihood of being employed
in professional environments. Adults with ADHD often find it difficult to generate effective solutions to social problems and these deficits
in social cognition can increase the likelihood of peer rejection, and social isolation, adding to struggles with depression and social
anxiety.

Throughout an individual’s
lifetime, untreated ADHD can increase the risk of psychiatric disorders, educational and occupational failure, accidents, criminality,
social disability and addictions and ADHD treatment is usually initiated with stimulants, such as amphetamine and methylphenidate-based
products. While these drugs may provide a generally effective treatment option for patients, they also have serious safety concerns and
are misused recreationally with both diversion and abuse being a common and significant risk. As a result, they are controlled substances
and classified under the CSA as CII stimulants. Consequently, they all carry an FDA imposed Black Box warning on the drug label to call
attention to these serious or life-threating risks. Further, not all individuals respond optimally to or can tolerate CII stimulants and
their use is contraindicated in numerous patients, including those with tics, anxiety and other certain psychiatric disorders, cardiovascular
concerns, substance use disorder, or stimulant refusal. A few non-stimulant treatment options are available; however, their efficacy is
not as robust, and their tolerability profile is not necessarily improved when compared to CII stimulants. In addition, the few non-stimulant
treatments available are generally considered as second-line treatments and are often used in conjunction with schedule II (CII) simulants
rather than as a therapy that uses one type of treatment, commonly referred to as a monotherapy.

The availability of a treatment
that has robust efficacy on par with CII stimulants and that