Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 352

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 352
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tolerability and safety profiles, as determined by applicable regulatory agencies. NLS believes that its streamlined clinical development approach has the potential to advance its product candidates rapidly through early -stageclinical trials, while carrying an overall lower development risk. A lower development risk, NLS believes, exists with respect to the development of its lead product candidate, Quilience, and follow -onproduct candidate, Nolazol, due to their use of mazindol as the active ingredient, which was previously approved and marketed in the United States, Japan and Europe to manage exogenous obesity (obesity caused by overeating). The Merger Agreement provides that, upon the terms and subject to the conditions thereof, following and subject to the Closing, NLS shall work diligently to dispose of any Legacy Assets, including, Quilience, Nolazol and all other product candidates, but excluding the DOXA platform. The DOXA platform includes AEX -041. It is important to note that AEX -041is currently in the preclinical stage of development. This means that the candidate is undergoing early laboratory studies to evaluate its safety profile and pharmacological properties, and it has not yet been tested in human clinical trials. Consequently, its efficacy, safety, and potential for regulatory approval remain subject to further research and development. It is expected that the proceeds from any such disposition will be distributed to the shareholders and warrant holders of NLS as of immediately prior to the Effective Time pursuant to the terms and conditions of the CVR Agreement, subject to the adjustments set forth therein. NLS’s discovery platform currently focuses on single molecules that operate through multiple mechanisms designed to target the complexity of the CNS disease state, and, it believes these may potentially offer new treatment options for patients, including for those patients who are refractory to currently available treatments. NLS recently announced pre -clinicalresults of NLS -4, NLS’s next -generationwake -promotingdrug candidate, for the chronic fatigue syndrome, or CFS, associated with the symptoms of Long -COVID, also known as Chronic Fatigue caused by COVID -19infection. NLS’s current focus is in the therapeutic areas of rare hypersomnia disorders (conditions highlighted by EDS) and complex neurodevelopmental disorders, and includes its lead product candidate: Quilience, for the treatment of EDS and cataplexy associated with narcolepsy, and its follow -oncandidate Nolazol, for the treatment of ADHD. NLS initiated its clinical development with a Phase