Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 107

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 107
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 CII or CIII, they could still limit its ability to market and commercialize Quilience and Nolazol, if approved for marketing. In addition, failure to maintain compliance with applicable requirements under the CSA, particularly as manifested in loss or diversion of regulated substances, can result in enforcement action that could include civil penalties, refusal to renew registrations or quotas, revocation of registrations or quotas or criminal proceedings, any of which could have a material adverse effect on its business, results of operations and financial condition. Individual states also regulate controlled substances, and NLS along with its contract manufacturers will be subject to state 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. 29 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 enter