Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 604

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 604
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 needs and expenses, statements relating to the research, development, completion and use of our product candidates, and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future. Forward -lookingstatements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward -lookingstatements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward -lookingstatements include, among other things: •the regulatory pathways that we may elect to utilize in seeking European Medicines Agency, or EMA, the U.S. Food and Drug Administration, or FDA, and other regulatory approvals; •that our financial position raises substantial doubt about our ability to continue as a going concern; •our ability to maintain listing and effectively comply with the listing requirements of The Nasdaq Stock Market LLC, or Nasdaq; •the re -schedulingof Mazindol ER in the U.S. by the DEA following approval by the FDA; •the launch of a different formulation or different dosage of Mazindol by another company; •the use of Quilience (Mazindol ER) in a compassionate use program, or CUP, and the results thereof; •obtaining EMA and FDAFDA approval of, or other regulatory action in Europe or the United States and elsewhere with respect to, Quilience, Nolazol NLS -4, or other product candidates that we may seek to develop; •the commercial launch and future sales of Quilience and/or Nolazol, or any other future product candidates; •the dosage of Quilience, Nolazol, and or any of our pipeline drugs; •our ability to move NLS -8, NLS -11, NLS -12and any of our Aexon Labs (Dual) Orexin compounds (recently secured through an in -license) into investigational new drug, or IND -enablingstudies; •our expectations regarding the timing of commencing further clinical trials, the process entailed in conducting each such trial, including dosages, and the order of such trials with each of our product candidates or whether such trials will be conducted at all; •improved convenience relating to the