Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 391

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 391
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 (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.

198 Research and Development Strategy Subject to obtaining sufficient funding, NLS aims 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. NLS sponsors and conducts clinical research activities with investigators and institutions to measure key clinical outcomes that are necessary in order for it to be able to file an NDA with the FDA and equivalent filings with other regulatory authorities. NLS’s 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 NLS navigates the competitive landscape of its industry, while focusing on development of its product candidates, NLS also intends to continually pursue out -licensingagreements and asset sale transactions that it believes will allow us to drive greater value for its shareholders. Key elements of NLS’s research and development strategy include the following: • Efficiently advance NLS’s lead product candidate, Quilience, and follow -on product candidate, Nolazol, through marketing approval.NLS plans to first advance the development of Quilience, followed by the development of NLS -4(follow on). If successful, NLS plans 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. • Find partners for out -licensing and asset sale agreements.While NLS continues with its goal of progressing its product candidates, Quilience and Nolazol, on its own into further clinical development in order to initiate commercialization of such product candidates, NLS may seek to enter into transactions to sell or out -licenseQuilience, Nolazol or certain other product candidates or intellectual property that it develops. This strategy allows NLS to potentially create value for its shareholders ahead of its approval timelines. • Reduce clinical and regulatory risk, limit development costs, and accelerate time to market.NLS’s product candidates,