Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 136

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 136
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 regulation on distribution of these products. NLS’s market is subject to intense competition, which may result in others commercializing products before or more successfully than us. If NLS is unable to compete effectively, Quilience and/or Nolazol may be rendered non-competitive or obsolete, which may adversely affect its operating results. The development and commercialization of new products is highly competitive. Its potential competitors include major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to Quilience and/or Nolazol or any future product candidate that NLS may seek to develop or commercialize. Its competitors may succeed in developing, acquiring or licensing technologies and products that are more effective, have fewer or more tolerable side effects or are more convenient or less costly than Quilience and/or Nolazol or any future product candidate NLS may develop, which could render any product candidates obsolete and non -competitive. 30 Its competitors also may obtain FDA or other marketing approvals for their products before NLS is able to obtain approval for ours, which could result in competitors establishing a strong market 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