Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 701

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 701
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 for lack of performance of Calcog (Caligor Coghlan Ltd.), the service provider in charge of the development and execution of this program in Europe. We partnered with a third -partypharmaceutical company to expand access, early access and compassionate use programs to provide treatment of IH with Mazindol ER where it would otherwise not be available. In January 2023, we announced a technology patent grant covering Mazindol ER for treatment of ADHD and IH in Hong Kong. This further supports our global strategy with key patents granted the following major markets: Hong Kong, Japan, South Korea, the U.S., Europe & Canada. Annex F-53 Compassionate Use Objectives in CDH 1 in Europe While “compassionate use” originally was understood to imply that the drug product is supplied for free, there is a growing understanding with policymakers, payers and patient organizations, that paid -forCUPs are justifiable. In Europe and other regions of the world (excluding the United States), it is recognized that CUP funding can provide an early source of biopharma revenues and incentivize the increased availability of potentially transformative treatments, especially for rare disorders and orphan diseases. Given the extensive therapeutic experience with mazindol, including off -labelin narcolepsy patients, we believe that there is ample precedence to justify a funded CUP in selected European countries for a defined group of patients. We intend 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 we have yet to determine which countries, we will initiate CUPs in first, our 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 •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 we believe 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