Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 376

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 376
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 patients. NLS intends to conduct either or both a cohort program and a named patient program, or NPP, each of which is highlighted below in a variety of European countries. Although NLS has yet to determine which countries, NLS will initiate CUPs in first, NLS’s current plan is to target the following countries in 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