Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 91

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 91
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 -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 to domestic U.S. issuers; •For as long as we remain an emerging growth company, or EGC, we will be exempt from certain securities laws requirements, including the fact that our auditors are not required to conduct an audit of our internal control over financial reporting; however, once we cease to qualify as an EGC, we will no longer be permitted to rely on such exemptions and as a result we will incur additional legal, accounting and other expenses; and •We have identified material weaknesses in our internal control over financial reporting and instituted ongoing remediation efforts. If our ongoing remediation efforts are not effective, we may not be able to accurately or timely report our financial results, or prevent fraud, and investor confidence in our Company and the market price of our common shares and Warrants may be adversely affected. 19 See the section entitled “ Where You Can Find More Information” beginning on page 243 of this proxy statement/prospectus for more information about the SEC filings incorporated by reference into this proxy statement/prospectus. Nasdaq Capital Market Listing (see page 127) NLS has filed a listing of additional securities application with Nasdaq, as required by Nasdaq to effect