Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 110

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 110
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 and result in increased regulatory and compliance costs. Also, compliance with data privacy laws has become more complex and compliance costs have increased significantly and may continue to do so. NLS may not be fully compliant with the Federal Data Protection Act or other applicable data protection legislation at all times. Failure to comply with data protection laws or laws related to use of personal data in marketing (such as laws concerning use of cookies and similar techniques) could subject NLS to potentially significant liability, including litigation, investigation, regulatory actions or other actions by local, cantonal or federal authorities, and may result in, among other consequences, penalties and fines (which may not be covered by NLS’s insurance policies or contractual protections and which may be significant, particularly if imposed under the GDPR), required remedial actions, as well as reputational harm, negative publicity and increased customer churn, any of which could have a material adverse effect on NLS’s business, revenues, earnings and cash flows. NLS Risks Related to the Regulatory Environment Obtaining approval of an NDA or a MAA even after clinical trials that are believed to be successful is an uncertain process. NLS is not permitted to market Quilience and/or Nolazol in the United States or the EU until NLS receive regulatory approval of an NDA from the FDA or MAA from the EMA, or in any foreign countries until NLS receive the requisite approval from regulatory authorities in such countries. NLS has not received regulatory clearance to conduct the additional clinical trials that are necessary to be able to submit an NDA to the FDA for Nolazol. Similarly, NLS has not received regulatory clearance in the EU to conduct clinical trials that are necessary to receive approval of a MAA for Quilience in Europe. As such, NLS has not submitted an MAA for any of its product candidates. NLS may be able make its products available on a named patient basis and generate pre -approvalrevenues from compassionate use activities leveraging on an expanded access policy in certain countries around the world. 31 Even if NLS complete its planned clinical trials and believe the results to be successful, all of which are uncertain, obtaining regulatory approval is an extensive, lengthy, expensive and uncertain process, and the FDA and EMA, and other regulatory authorities may delay, limit or deny approval of Quilience and/or Nolazol for many reasons, including, but not limited to: •NLS may not be able to demonstrate to their satisfaction that the product candidate is a safe or