Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 346

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 346
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 Global Burden of Disease Report, CNS disorders result in a socio -economicburden of more than $317billion annually in the United States alone. Additionally, CNS disorders were expected to account for approximately 15% of the global disease burden in 2020, the largest of any disease area. However, treatment options for these conditions are often limited, inadequate or nonexistent, and the development of new CNS treatments generally trails behind 166 other therapeutic areas. NLS is pursuing the development of the next generation of CNS therapies with high medical impact to address this critical and growing unmet need. NLS’s dual development strategy is designed to optimize the outcome of its clinical programs by developing new chemical entities from known molecules with strong scientific rationale, and also by re -definingpreviously approved molecules with well -establishedtolerability 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 Holders 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