Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 369

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 369
---
 the following priorities (priority in each wave has yet to be determined): •First Wave: United Kingdom, Netherlands, Belgium, France, Italy and Switzerland; •Second Wave: Latin America, the Czech Republic, Denmark and Spain; and ____________ 1Central Disorders of Hypersomnolence (including but not limited to narcolepsy type 1/type 2, IH, etc.) 180 •Third Wave: China, Germany, Austria, Japan, Sweden and Taiwan. In addition to the potential benefit of generating revenues before Quilience market authorization from the regulatory agencies, the collection of data within the CUP is a key potential benefit for the overall Quilience evidence generation strategy, as NLS believes that a CUP program for Quilience would: •complement the clinical data package for regulatory submissions; •support primary regulatory approvals with longer -termfollow up effectiveness and safety data and patient lived experience evidence; •support label expansions in broader populations than included in the Quilience late state trials (e.g., in juvenile narcolepsy); •potentially accelerate regulatory approval in China if NLS was 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; •bridge patients from the end of Phase 2 and 3 clinical trials to commercialization (assure continued patient access); •allow NLS to generate hypotheses for label expansions in broader populations (as compared to clinical trials); •allow NLS to leverage real -worldand patient -centricdata collected (board populations, quality of life, 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) N