Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 92

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 92
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 studies, approval of any applications that Kadimastem submit may be delayed by several years, or may require
it to expend more resources than it has available. It is also possible that additional studies, if performed and completed, may not
be considered sufficient by the FDA to approve the BLA. If any of these outcomes occur, Kadimastem would not receive approval
at such time, if any, that it seeks FDA approval. Kadimastem may face similar risks with respect to obtaining regulatory approval
from the EMA at such time, if any, that it seeks EMA approval. The risks that it faces in obtaining applicable approvals from the
FDA and EMA for AstroRx®and/or IsletRx, or any other product candidate that it may seek to develop, may also exist
with other regulatory authorities, such as those in Latin America or other regions.

Even if Kadimastem obtain
FDA, EMA or other regulatory approval for AstroRx®and/or IsletRx, the approval might contain significant limitations related
to use restrictions, warnings, precautions or contraindications, or may be subject to significant post-marketing studies or risk mitigation
requirements. If Kadimastem is unable to successfully commercialize AstroRx®and/or IsletRx, it may be forced to cease
operations.

Preliminary data that Kadimastem or others
announce or publish from time to time with respect to its products may change as more data become available and are subject to audit and
verification procedures that could result in material changes in the final data.

From time to time, Kadimastem,
or its partners, may publish or seek to publish preliminary data from ongoing clinical trials, which are based on a preliminary analysis
of then-available data. Positive preliminary data may not be predictive of such trial’s subsequent or overall results. Preliminary
data are subject to the risk that one or more of the results and related findings and conclusions may materially change following a more
comprehensive review of the data or as more data become available. Therefore, positive preliminary results in any ongoing clinical trial
may not be predictive of such results in the completed trial. Kadimastem also make assumptions, estimations, calculations and conclusions
as part of its analyses of data, and it may not have received or had the opportunity to fully evaluate all data. As a result, preliminary
data that it reports may differ from future results from the same clinical trials, or different conclusions or considerations may qualify
such