Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 93

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 93
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 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
regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with
what Kadimastem determines is material or otherwise appropriate information to include in its disclosure. If the interim, top-line or
preliminary data that Kadimastem reports differ from actual results, or if others, including regulatory authorities, disagree with the
conclusions reached, its ability to obtain approval for, and commercialize, in scale, its drug substances and product candidates may be
harmed, which could harm its business, operating results, prospects or financial condition.

The results of preclinical studies and early-stage
clinical trials of Kadimastem’s drug substances and product candidates may not be predictive of the results of later-stage clinical
trials. Initial success in Kadimastem’s ongoing clinical trials may not be indicative of results obtained when these trials are
completed or in later stage trials.

Drug substances and product
candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through
preclinical studies and initial clinical trials. Furthermore, there can be no assurance that any of Kadimastem’s clinical trials
will ultimately be successful or support further clinical development of any of Kadimastem’s product candidates. There is a high
failure rate for drugs and biologics proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology
industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies, and any
such setbacks in Kadimastem’s clinical development could harm its business and operating results.

The results of clinical trials conducted
at clinical sites outside the United States may not be