Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 134

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 134
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 in adults), or vice versa. Before NLS can submit an NDA to the FDA, NLS must conduct pivotal trials, in addition to human pharmacokinetic and bioavailability studies, that will be substantially broader than its Phase 2 trial for Nolazol and or Quilience. An NDA must be supported by extensive clinical and pre -clinicaldata, as well as extensive information regarding chemistry, manufacturing and controls to demonstrate the safety and effectiveness of the applicable product candidate. The number and types of pre -clinicalstudies and clinical trials that will be required varies depending on the product candidate, the disease or condition that the product candidate is designed to target and the regulations applicable to any particular product candidate. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and NLS may not be successful in obtaining approval. The FDA review processes can take years to complete and approval is never guaranteed. In this respect, NLS will also need to agree on a protocol with the FDA for the pivotal trials before commencing those trials. Pivotal trials frequently produce unsatisfactory results even though prior clinical trials were successful. Therefore, the results of the additional trials that NLS conduct may or may not be successful. The FDA may suspend all clinical trials or require that NLS conduct additional clinical, nonclinical, manufacturing validation or drug product quality studies and submit those data before it will consider or reconsider the NDA. Depending on the extent of these or any other studies, approval of any applications that NLS submits may be delayed by several years, or may require it to expend more resources than NLS has available. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve the NDA. If any of these outcomes occur, NLS would not receive approval for Quilience or Nolazol at such time, if any, when NLS seeks FDA approval. NLS may face similar risks with respect to obtaining regulatory approval from the EMA for Quilience, and for Nolazol, at such 33 time, if any, when NLS seeks EMA approval. The risks that NLS faces in obtaining applicable approvals from the FDA and EMA for Quilience and/or Nolazol or any other product candidate that NLS may seek to develop, may also exist with other regulatory authorities, such as those in Latin America. Even if NLS obtains FDA, EMA or other regulatory approval for Quilience and/or N