Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 102

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 102
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 potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause its product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes. Such changes may also require additional testing, FDA or EMA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of its product candidates and jeopardize its ability to commence sales and generate revenues. International expansion of its business exposes it to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States, Switzerland or the EU. Other than its headquarters and other operations which are located in Switzerland and its wholly owned U.S. subsidiary, NLS Pharmaceutics Inc., a Delaware corporation (as further described below), NLS currently has limited international operations, but its business strategy incorporates potentially significant international expansion, particularly in anticipation of approval of its product candidates. NLS may plan to maintain sales representatives and conduct physician and patient association outreach activities, as well as clinical trials, outside of the United States, Switzerland and Europe. If Quilience and/or Nolazol or any of its other product candidates are approved for commercialization outside the United States, Switzerland, or the EU, NLS will likely enter into agreements with third parties to market the drugs in these additional global territories. NLS expects that NLS will be subject to additional risks related to entering into or maintaining international business relationships, including: •different regulatory requirements for drug approvals in foreign countries; •differing United States and foreign drug import and export rules, tariffs and other trade barriers; •reduced protection for intellectual property rights in foreign countries; 26 •NLS’s failure to obtain regulatory approvals for the use of its products in various countries; •different reimbursement systems; •economic weakness, including inflation, or political instability in particular foreign economies and markets; •multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; •complexities associated with managing multiple payor reimbursement regimes, government payors or patient self -paysystems; •financial risks, such