Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 136

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 136
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 a change in the drug enforcement agency, or the DEA, scheduling (e.g., from IV to III) post approval or other applicable federal or state regulations could have an adverse effect on its operations and business. Controlled substances are classified by the DEA as Schedule I, II, III, IV or V, or CI, CII, CIII, CIV, and CV, substances, with CI substances considered to present the highest risk of substance abuse and Schedule V substances the lowest risk. The active ingredient of its lead and follow -onproduct candidates is mazindol, which is classified as a Schedule IV controlled substance under the CSA and regulations of the DEA. Under the CSA, subject to certain exemptions, every person who manufactures, distributes, dispenses, imports or exports any controlled substance must register with the DEA. Although the CSA’s restrictions governing substances in CIV are not as stringent as those for substances in CI, 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. 30 Its competitors also may obtain FDA or other marketing approvals for their