Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 717

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 717
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 biotechnology companies that currently market a range of CII stimulants to treat ADHD. Our primary competitors include Takeda Pharmaceutical Company Ltd. (Vyvanse ®, Adderall ®and Mydayis ®), Neos Therapeutics Ltd. (Adzenys ®XR -ODTand Contempla ®XR -ODT), Eli Lilly & Co. (Strattera ®), Novartis AG (Focalin ®) and Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson (Concerta ®). The below table provides a more in -depthbreakdown of Nolazol against certain competing pharmaceutical products, based on the current scheduling of mazindol by the DEA. Research and Development Strategy Subject to obtaining sufficient funding, we aim to continue conducting research and development activities to expand the commercial potential of both Quilience and Nolazol, while continuing to examine the development of compounds that could serve as effective treatments for other CNS disorders. We sponsor and conduct clinical research activities with investigators and institutions to measure key clinical outcomes that are necessary in order for us to be able to file an NDA with the FDA and equivalent filings with other regulatory authorities. Our research and development efforts are focused primarily in the following areas and serve as a basis for future development, if any, of a more diverse product pipeline, of which certain product candidate leads, such as NLS -4are in preclinical development stages. As we navigate the competitive landscape of our industry, while focusing on development of our product candidates, we also intend to continually pursue out -licensingagreements and asset sale transactions that we believe will allow us to drive greater value for our shareholders. Key elements of our research and development strategy include the following: • Efficiently advance our lead product candidate, Quilience, and follow -on product candidate, Nolazol, through marketing approval.We plan to first advance the development of Quilience, followed by the development of NLS -4(follow on). If successful, we plan to initially file for marketing approval in the United States and potentially also in the EU for Quilience and subsequently develop NLS -4(NCE) for post -COVIDchronic fatigue syndrome for global markets. Annex F-72 • Find partners for out -licensing and asset sale agreements.While we continue with our goal of progressing our product candidates, Quilience and Nolazol, on our own into further clinical development in order to initiate commercialization of such product candidates,