Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 98

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 98
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 statement/prospectus. NLS Risk Factors NLS Risks Related to its Current Business NLS depends substantially on the success of its two product candidates, Quilience and Nolazol. NLS cannot give any assurance that any of its product candidates will receive regulatory approval, which is necessary before they can be commercialized. NLS has invested almost all of its efforts and financial resources to achieve and maintain phase 3 readiness in research and development and general and administrative costs of its two product candidates, Quilience for the treatment of excessive daytime sleepiness, or EDS, and cataplexy associated with narcolepsy and Nolazol, for the treatment of ADHD. The process to develop, obtain regulatory approval for and commercialize pharmaceutical product candidates is long, complex, costly and inherently uncertain of outcome. NLS is not permitted to market any of its product candidates in the United States, European Union, or the EU, or any other jurisdiction until NLS receive the requisite regulatory approvals. NLS may be able to generate pre -approvalrevenues from compassionate use activities leveraging on an expanded access policy in certain countries around the world. However, NLS cannot give any assurance that its current clinical development plan will proceed as planned, or that its product candidates will receive regulatory approval, or that such regulatory approval, if received, will be within a timeframe that allows it to effectively compete with its competitors, or be successfully marketed and commercialized. NLS’s initiation of clinical trials for Quilience is dependent upon the review and approval of the relevant regulatory agencies and authorities and if NLS is required to conduct pre-clinical trials, approval of an NDA or MAA, if any, for Quilience would be delayed and NLS may require additional capital as a result thereof. Based in part on the prior use and FDA approval of mazindol to manage exogenous obesity, NLS has been able to commence its Phase 2 clinical trials for Quilience without having to do prior pre -clinicaland/or early -stageclinical trials, such as Phase 1 trials. No assurance can be given that the EMA or FDA will agree to allow it to initiate Phase 3 clinical trials for Quilience without conducting such pre -clinicaltrials. If the FDA or EMA, or any other applicable regulatory agency, were to require it to conduct additional pre -clinicaltrials, its planned development strategy for Quilience would be materially impacted and approval of an NDA or MAA, if any