Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 131

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 131
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 conducted with product candidates which are produced under cGMP regulations. Its failure to comply with these regulations may require it to repeat clinical studies, which would delay the regulatory approval process. NLS has no manufacturing capacity and anticipates reliance on third-party manufacturers for its products. NLS does not currently operate manufacturing facilities for clinical production of Quilience and/or Nolazol. NLS does not intend to develop facilities for the manufacture of products for clinical trials or commercial purposes in the foreseeable future. NLS will rely on third -partymanufacturers to produce bulk drug products required for its clinical trials and commercial sales, if any. NLS plan to continue to rely upon contract manufacturers and, potentially, collaboration partners to manufacture commercial quantities of its drug product candidates if and when approved for marketing by the applicable regulatory authorities. Its contract manufacturers have not completed process validation for the drug substance manufacturing process. Process validation involves a series of activities taking place over the lifecycle of the product and process. If its contract manufacturers are not approved by the FDA, or other regulatory bodies, its commercial supply of drug substance will be significantly delayed and may result in significant additional costs. If the FDA does not consider the result of the process validation or required testing to be satisfactory, regulatory approval and/or commercial supply after launch may be delayed. The FDA and similar foreign regulatory bodies may also implement new requirements, or change their interpretation and enforcement of existing requirements, for manufacturers, packaging or testing of products at any time. If we, or its contract manufacturers are unable to comply with such process validation or other requirements, NLS may be subject to regulatory, civil actions or penalties which could harm its business. NLS purchases finished mazindol, the molecule in both of Quilience and Nolazol, from a single third party, currently under a development agreement with us. In addition, NLS does not have an agreement in place for, but NLS has identified, a secondary fill/finish supplier. There can be no guarantee that NLS will enter into an agreement with such fill/finish supplier or that an effort to enter into such an agreement will be on favorable terms. If NLS need to identify an additional fill/finish manufacturer, NLS would not be able to do so without delay and likely significant additional cost. 43 Its existing manufacturer and any future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business. In the event of a natural disaster, business failure, strike or other difficulty, such as difficulties involving production yields, quality