Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 137

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 137
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 of any proposed names for its product candidates that gain marketing approval, and any failure or delay associated with such naming approval may adversely impact its business. Any name NLS intends to use for its product candidates will require approval from the FDA regardless of whether NLS has secured a formal trademark registration from the U.S. Patent and Trademark Office, or the U.S. PTO. The FDA typically conducts a review of proposed product names, including an evaluation of whether proposed names may be confused with the names of other drug products. The FDA may object to any product name NLS submits if it believes the name inappropriately implies medical claims. If the FDA objects to any of its proposed product names, NLS may be required to adopt an alternative name for its product candidates, which could result in further evaluation of proposed names with the potential for additional delays and costs. Obtaining regulatory approval for clinical trials of Nolazol in children will be more difficult than obtaining such approvals for adult clinical trials since the requirements for regulatory approval to conduct pediatric clinical trials are more stringent. Pediatric drug development requires additional nonclinical work (such as animal studies in juvenile animals and additional reproductive toxicity work), as well as staged clinical work in determining safe dosing and monitoring. These additional tasks involve investment of significant additional resources beyond those needed for approval of the drug for adults. Approval of Nolazol for use in children may be significantly delayed due to these additional requirements and this may have an adverse effect on the commercial prospects for Nolazol and its ability to generate product revenues would be delayed, possibly materially. NLS cannot guarantee that NLS will receive any regulatory approvals to commercialize its product candidates in children. Changes in regulatory requirements and guidance or unanticipated events during its clinical trials may occur, which may result in necessary changes to clinical trial protocols, which could result in increased costs to us, delay its development timeline or reduce the likelihood of successful completion of its clinical trials. Changes in regulatory requirements and guidance or unanticipated events during its clinical trials may occur, as a result of which NLS may need to amend clinical trial protocols. Amendments may require it to resubmit its clinical trial protocols to IRBs for review and approval, which may impact the cost, timing or successful completion of a clinical trial. If NLS experiences delays in completion of, or if NLS terminates, any of its clinical trials, the commercial prospects for Quilience and Nolazol would be harmed and its ability to generate product revenues would be delayed, possibly materially. NLS