Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 399

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 399
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 hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse or misuse of illicit GHB is associated with CNS adverse reactions (acting as a CNS depressant), including seizures, respiratory depression, decreased consciousness, coma, and death |

ADHD NLS faces competition from established pharmaceutical and biotechnology companies that currently market a range of CII stimulants to treat ADHD. NLS’s 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.

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