Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 132

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 132
---
 patients or other claimants; •higher insurance premiums; •loss of initiation of investigations by regulators or other authorities; and •the inability to successfully commercialize our product candidates, if approved. NLS may fail to comply with data protection legislation or appropriate practices. NLS is subject to laws regarding the protection, privacy and security of personal information, such as the Swiss Federal Act on Data Protection (Bundesgesetz über den Datenschutz of 2020, as amended), or the Federal Data Protection Act, and Regulation (EU) 2016/679 (General Data Protection Regulation, or GDPR), and expects the regulatory landscape to continue to evolve. Data protection laws may impose restrictions on data practices which may necessitate changes to NLS’s operations, impact operational efficiency, prevent the application of certain marketing and sales initiatives 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 an 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 receives regulatory approval of an NDA from the FDA or MAA from the EMA, or in any foreign countries until NLS receives 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