Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 757

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 757
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azol, NLS have early and mid -stagecompounds that it may seek to further develop in the future. NLS may seek to develop these other compounds, comprising of NCEs, as well as repurposed compounds, to build a pipeline of product candidates at various stages of development that further complement the rare hypersomnia and complex neurodevelopmental disorder franchises. Additionally, the Company intends to continue to invest in the discovery research and development programs, with the goal of adding new compounds and indications to the product candidate development pipeline. Aexon Labs Inc. On March 20, 2024, NLS announced that it entered into an exclusive worldwide license agreement with Aexon Labs, Inc (“the Aexon Agreement”), a privately held U.S. company, under which the Company acquired full global development and commercialization rights to Aexon’s Dual Orexin Receptor Agonists (DOXA) platform, new molecular entities, highly selective dual oral orexin -1and orexin -2receptor agonists (OX1R and OX2R) with potential applications in the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro -degenerativedisorders such as Parkinson’s and Alzheimer’s disease. This license agreement represents a potentially leading next -generation, first -in-class, oral, dual orexin receptor agonist platform that is expected to address high unmet medical needs and has shown promising results in pre -clinicalin vitro assays. NLS has plans to initiate proof -of-conceptpreclinical development in the second half of 2024, subject to sufficient funding. The DOXA platform, consisting of over 300 compounds, bridges the present to the future treatment of sleep disorders as well as other neuro -degenerativedisorders. Orexin receptor pathways play vital regulatory roles in many physiological processes and studies have shown that orexin receptor pathways are involved in pathological processes of neurological diseases such as obesity, narcolepsy, depression, ischemic stroke, drug addiction and Alzheimer’s disease. These new compounds, in addition to the Company’s current pipeline, including Mazindol ER for the treatment of narcolepsy, NLS -4focused on idiopathic hypersomnia, long -COVIDand chronic fatigue syndrome, and NLS -11, addressing Kleine -LevinSyndrome and neurodegenerative diseases, will further complement and strengthen our sleep franchise. NLS will be uniquely positioned to hold the key to unlock the challenges associated with rare sleep disorders now