Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 377

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 377
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 satisfaction); and •allow NLS to professionally address patient and physician requests (formal published policy and process). In addition to these potential benefits of a CUP program for Quilience, commercial objectives of such a program would include the ability to (i) generate pre -licensingrevenues in selected countries, (ii) receive post -authorizationrevenues in non -prioritycountries for commercial use, (iii) potentially establish an early market presence with a key opinion lead, and center of excellence strategy and (iv) more rapid revenue uptake (than a non -CUPprogram) upon commercial availability (patients already on product and treated). 181 Nolazol for the Treatment of ADHD (Back-up Program Product Candidate) Nolazol 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