Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 112

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 112
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-looking statements
may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections
of results of operations or of financial condition, expected capital 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-looking statements
are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements 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-looking statements
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 completion and timing of the transaction contemplated by our Merger Agreement with Kadimastem are uncertain, and the risk that the transaction may not close as expected or at all; |

| ● | our ability to drive revenue growth, enhance research and development capabilities, and improve financial performance as a result of the potential merger with Kadimastem is subject to uncertainties, including unforeseen costs and integration issues; |

| ● | the re-scheduling of Mazindol ER in the United States by the U.S. Drug Enforcement Agency 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 FDA 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 Qu