Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 58

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 58
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 its competitors or be successfully marketed and commercialized,
which could harm its business, operating results, prospects or financial condition.

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All of Kadimastem’s drug substances and product candidates are in various stages of clinical and/or preclinical development. Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials of its drug substances and product candidates are prolonged, delayed or not commercially viable, Kadimastem or its collaborators may be unable to obtain required regulatory approvals, and therefore may be unable to commercialize its drug substances and product candidates on a timely basis or at all, which will adversely affect its business.

To obtain the requisite regulatory
approvals to market and sell any of Kadimastem’s product candidates, Kadimastem or its collaborators for such candidates must demonstrate
through extensive preclinical studies and clinical trials that its products are safe, pure and potent or effective in humans. Further,
the process of obtaining regulatory approval is expensive, often takes many years following the commencement of clinical trials and can
vary substantially based upon the type, complexity and novelty of the drug substances and product candidates involved, as well as the
target indications and patient population. Prior to obtaining approval to commercialize a product candidate in the United States or abroad,
Kadimastem or its potential future collaborators must demonstrate with substantial evidence from adequate and well-controlled clinical
trials, and to the satisfaction of the United States Food and Drug Administration, or FDA, or comparable foreign regulatory authorities,
that such drug substances and product candidates are safe and effective for their intended uses. Additionally, clinical testing is expensive
and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial
process and its future clinical trial results may not be successful.

Kadimastem may not be able
to commence or complete the clinical trials that would support its submission of a BLA to the FDA or a Marketing Authorization Application,
or MAA, to the EMA, and other regulatory approvals from the Israeli Mistry of Health, or MOH. Drug development is a long, expensive and
uncertain process, and delay or failure can occur at any stage of any of its clinical trials. Clinical trials can be delayed or prevented
for a number of reasons, including:

| ● | difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial;