Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 368

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 368
---
 previous findings of safety studies published in the scientific literature, and the extent to which licensed innovator data may be utilized will depend on NLS’s ability to demonstrate a scientific bridge to Mazindol ER from the previous formulation. In November 2022, NLS launched an individual Paid -forNamed Patient Program, or NPP, to provide access to Mazindol ER for the treatment of IH in Europe where this medication would not otherwise be available for this indication in certain countries. The NPP for IH was launched in the United Kingdom and NLS was expected to expand to other countries including France, Italy and Switzerland. This NPP was terminated in May 2023 for lack of performance of Calcog (Caligor Coghlan Ltd.), the service provider in charge of the development and execution of this program in Europe. NLS 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, NLS announced a technology patent grant covering Mazindol ER for treatment of ADHD and IH in Hong Kong. In October 2024, NLS announced its patent grant covering Mazindol ER for the treatment of heroin dependence in Japan. This further supports NLS’s global strategy with key patents granted the following major markets: Hong Kong, Japan, South Korea, the U.S., Europe & Canada. 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, NLS believes that there is ample precedence to justify a funded CUP in selected European countries for a defined group of 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