Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 64

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 64
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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 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 IsletRxAstroRx 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 or IRB or ethics committee approval and informed consent. The study population must also adequately represent