Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 63

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 63
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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.

<div align='center'>46</div>

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 results, once additional data have been received and fully evaluated. Preliminary data also remain subject to audit and verification
procedures that may result in the final data being materially different from the preliminary data it previously published. As a result,
preliminary data should be viewed with caution until the final data are available. Material adverse changes in the final data compared
to preliminary data could significantly harm its business prospects.

Further, others, including
regulatory agencies, may not accept or agree with its assumptions, estimates, calculations, conclusions or analyses or may interpret or
weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization
of the particular product candidate or product and its company in general. In addition, the information it chose to publicly disclose