Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 89

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 89
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 if at all. Even if we succeed in developing and commercializing our product candidates, we may never generate sufficient revenue to sustain profitability. As of December31, 2023, we had an accumulated deficit of approximately $70.4 million. •To date, we have not generated any revenues, have a history of losses and expect to incur losses in the foreseeable future and will need to raise substantial additional capital to successfully complete development, achieve and maintain phase 3 readiness, and seek to commercialize Quilience and/or Nolazol or other product candidates including NLS4, NLS -8, NLS -11, and NLS -12and the Aexon Labs Inc., or Aexon, platform, recently in -licensed, that we may seek to develop in the future, and such capital may not be available to us or available to us only on unfavorable terms. •As a public company, we are required to comply with extensive securities rules and regulations and Swiss governmental and Nasdaq Capital Market regulations, which are expensive, and which require significant management attention. We may voluntarily choose, or be forced to delist, from the Nasdaq Capital Market in case of non -complianceand or due to financial purposes. Risks Related to the Regulatory Environment •We require regulatory approvals prior to any attempt to commercialize our product candidates from the FDA and European Medicines Agency, or the EMA; and •Our data from clinical trials may not satisfy the FDA or other comparable regulatory agencies, or the FDA or other regulatory agencies may require additional time or studies to assess the safety and efficacy of Quilience and/or Nolazol or other product candidates that we may seek to develop in the future. Risks Related to the Ownership of Our Securities •Our failure to meet the continued listing requirements Nasdaq could result in a delisting of our securities or us seeking to transfer our listed securities to a different exchange; •The Jumpstart Our Business Startups Act of 2012, or the JOBS Act, allows us to postpone the date by which we must comply with some of the laws and regulations intended to protect investors and to reduce the amount of information we provide in our reports filed with the SEC, which could undermine investor confidence in our Company and adversely affect the market price of our common shares and Warrants; •As a “foreign private issuer” we follow certain home country corporate governance practices instead of otherwise applicable SEC and Nasdaq requirements, which may result in less protection than is accorded to investors under rules applicable