Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 94

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 94
---
 accepted by the FDA and the results of clinical trials conducted at clinical
sites in the United States may not be accepted by international regulatory authorities.

Kadimastem plans to conduct
some of its clinical trials outside the United States. Such trials would be guided under FDA or EMA guidelines and inspections. It
is planning to globally develop AstroRx®and/or IsletRx in the United States and the EU. Although the FDA may
accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed
by the FDA. For example, the clinical trial must be well-designed and conducted and performed by qualified investigators in accordance
with ethical principles such as IRB or ethics committee approval and informed consent. The study population must also adequately represent
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.

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