Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 165

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 165
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. Patent No. 11207271), from the U. S. Patent and Trademark Office which covers oral formulations containing immediate-release
and sustained-release layers of mazindol and their use in the treatment of attention deficit disorders (ADD or ADHD), related deficit
of alertness or decline in vigilance, or EDS (e. g., narcolepsy, IH).

The patent has a term that
expires no earlier than April 2037. Based on its current clinical development plans to obtain regulatory approval, we intend to list the
patent in FDA Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, if it receives market approval.

In January 2023, we announced
the new in vitro study results demonstrating the agonist effect of Mazindol ER at the Orexin-2 Receptor (OX2R). Two identical studies
measuring differing concentrations of Mazindol ER confirmed significant OX2R partial agonist activity at 30μ M or higher. Notably,
findings show that Mazindol ER showed strong OX2R partial agonist activity by cellular and nuclear receptor functional assays. Results
showed pEC50 (a logarithm measure of drug potency expressing a concentration that is effective in producing 50% of the maximal response)
values of 4.7 to 5 for mazindol on the OX2R, indicating a strong OX2R partial agonist. Additional pre-clinical in vivo studies are currently
underway to confirm OX2R activity. A pilot study in OXR2 KO mice animal model compared favorably with investigational drug, TAK-925, an
orexin 2 receptor agonist.

Prevalence

According to the European
Narcolepsy Network, narcolepsy affects only 20 to 40 out of every 100,000 people; however, it is estimated that only one out of four people
living with narcolepsy have been properly diagnosed. Although it usually has an early age of onset during the adolescent years, a diagnostic
delay that often exceeds 10 years from the time of symptom onset suggests that narcolepsy is both under diagnosed and under treated. This
delay may result from several factors, including lack of clinician and patient recognition of the signs and symptoms of narcolepsy and
leading to multiple physician visits before receiving a diagnosis, as well as misdiagnosis of narcolepsy as another condition, such as
epilepsy,