Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 65

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 65
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 the U.S.
population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful.
Generally, the subject population for any clinical trials conducted outside of the United States must be representative of the U.S. population.
In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its
determination that the trials were conducted consistent with all applicable U.S. laws and regulations. There can be no assurance the FDA
or international regulatory authorities will accept data from trials conducted outside of the United States or inside the United States,
as the case may be, as adequate support of a marketing application. If the FDA does not accept the data from sites in its globally conducted
clinical trials, or if international regulatory authorities do not accept the data from its U.S. clinical trials, it would likely result
in the need for additional trials, which would be costly and time-consuming and could delay or permanently halt the development of one
or more of its product candidates.

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The results of Kadimastem’s clinical trials may not support its product candidates’ claims or any additional claims Kadimastem may seek for its drug substances and product candidates and its clinical trials may result in the discovery of adverse side effects.

Even if any clinical trial
that Kadimastem needs to undertake is completed as planned, or if interim results from existing clinical trials are released, Kadimastem
cannot be certain that such results will support its drug substances and product candidates claims or any new indications that Kadimastem
may seek for its products or that the FDA or foreign authorities will agree with its conclusions regarding the results of those trials.
The clinical trial process may fail to demonstrate that its products or a product candidate is safe and effective for the proposed indicated
use, which could cause it to stop seeking additional clearances or approvals for its product candidates. Any delay or termination of Kadimastem’s
clinical trials will delay the filing of its regulatory submissions and, ultimately, Kadimastem’s ability to commercialize a product
candidate. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part
of the product candidate’s profile.

Kadimastem’s drug substances and product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following regulatory