Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 130

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 130
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 position before NLS is able to enter the applicable market. Many of its potential competitors, alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, pre -clinicaltesting, conducting clinical trials, obtaining marketing approvals and commercializing approved products than NLS does. There is a trend toward consolidation in the pharmaceutical and biotechnology industry, and additional mergers and acquisitions in these industries may result in even more resources being concentrated among a smaller number of its competitors, which may adversely affect us. Smaller or early -stagecompanies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies also compete with it in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials. In addition, if NLS enters the markets of its product candidates, with such entrance remaining subject to various additional regulatory approvals, too late in the cycle, NLS may not achieve commercial success, or NLS may have to reduce its price in order to effectively compete, which would impact its ability to generate revenues, obtain profitability and adversely affect its operating results. While orphan drug product candidates are typically sold at a high price relative to other medications, the market may not be receptive to high pricing of its product candidates. NLS is developing certain product candidates to treat rare central nervous system, or CNS, disorders with high unmet medical needs, a space where medications are usually sold at high prices compared with other medications. Accordingly, even if regulatory authorities approve its product candidates, the market may not be receptive to, and it may be difficult for it to achieve, a per -patientper -yearprice high enough to allow it to realize a return on its investment. Unfavorable global economic conditions, including as a result of the ongoing war between Russia and Ukraine as well as Israel’s multi-front war, could have a negative impact on its operations, which could materially and adversely affect its business, financial condition, results of operations, prospects and market price of its NLS Common Shares. Global economic instability and unfavorable conditions could materially and adversely affect its business. The war between Russia and Ukraine is ongoing. The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the European Union, the United States and other countries against officials, individuals, regions, and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and responses of countries and political bodies to such sanctions, tensions,