Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 180

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 180
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of the disease, amplifying the need for treatment options with a lower risk of abuse.

Adults with ADHD, with a delayed
diagnosis in adulthood, are often diagnosed after several attempts to find treatment for comorbid disorders, such as depression, substance
abuse, sleep disturbances, or anxiety. The presentation in adults is typically related to problems with work, disorganization, and tendency
to procrastinate, as well as anxiety, sleep disorders, and impulsivity.

We believe Nolazol could provide
a transformative treatment option for all individuals with ADHD and further could draw substantial market share from patients who have
failed or couldn’t tolerate stimulants; current patients, or their parents, with concerns with stimulant use; current patients seeking
the convenience of a CIV product compared to a CII product, allowing for generally no limitations on quantity, the ability to refill,
phone-in prescriptions, and less frequent office visits; individuals where abuse and/or diversion is a prominent concern; and individuals
or parents of individuals diagnosed with ADHD who have avoided treatment due to stimulant concerns and the associated stigma.

Current Treatment Landscape and Treatment Limitations

Although there is no cure
for ADHD, medications may help to reduce symptoms and improve functioning. The current treatment options for ADHD can be broadly classified
as either amphetamine or methylphenidate-based stimulants or as non-stimulants. Based on data
that we have collected, we believe that stimulants represent a majority of the ADHD drug market in the United States, with a market share
of approximately 90%.

Amphetamine and methylphenidate-based
products are all classified under the CSA as CII stimulants, due to their high potential for abuse and the risk of severe psychological
or physical dependence. These drugs are heavily controlled under U. S. federal and state laws, and are subject to criminal sanctions for
abuse, diversion and misuse and require a CII level prescription, and despite being a chronic disorder and need for daily medication,
this limits the quantity to a 30-day supply and is also not refillable. Consequently, all CII stimulants contain Black Box warnings, similar
to narcotics such as fentanyl and oxycodone, which are also CII substances. In addition, CII stimulants have the potential for numerous
adverse effects, as indicated by their warnings of serious cardiovascular reactions such as sudden death, stroke, and heart attack, psychotic
or manic symptoms in patients with no prior