Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 702

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 702
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 state trials (e.g., in juvenile narcolepsy); •potentially accelerate regulatory approval in China if we were to seek regulatory approval for Quilience; •enhance the evidence package for market access and pricing and reimbursement; •provide qualitative live -experiencedata and information on the unmet needs from the patient (and caregiver) perspective that may contextualize the net therapeutic benefits offered by Quilience within the narcolepsy management paradigm; ____________ 1Central Disorders of Hypersomnolence (including but not limited to narcolepsy type 1/type 2, IH, etc.) Annex F-54 •bridge patients from the end of Phase 2 and 3 clinical trials to commercialization (assure continued patient access); •allow us to generate hypotheses for label expansions in broader populations (as compared to clinical trials); •allow us to leverage real -worldand patient -centricdata collected (board populations, quality of life, satisfaction); and •allow us 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). 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 -