Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 127

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 127
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 Merger, which may be affected by, among other things, competition and the ability of NLS to grow and manage growth profitably; •costs related to the Merger; •changes in applicable laws or regulations; •the occurrence of one or more high profile accidents by autonomous driving vehicles that result in lower customer demand or more stringent regulations in one or more jurisdictions in which NLS intends to operate; •NLS’s ability to raise capital; •the possibility that NLS or Kadimastem may be adversely affected by other economic, business and/or competitive factors; •other risks and uncertainties described in this proxy statement/prospectus, including those under the section entitled “Risk Factors”; and •other factors beyond the control of NLS and Kadimastem and their respective management teams. 24 RISK FACTORS The following risk factors will apply to business and operations of NLS following the Closing. NLS will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. You should carefully consider the following risk factors in addition to the other information included in this proxy statement/prospectus before deciding how to vote your NLS Common Shares. You should also read and consider the risks associated with the business of NLS because these risks may also affect the combined company. Please see the section entitled “Where You Can Find More Information” in this proxy 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 receives the requisite regulatory approvals. NLS may be able to generate pre -approvalrevenues from compassionate use activities leveraging on an expanded access policy