Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 88

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 88
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 at a commercial level. There
can be no guarantee that it will be able to successfully develop and manufacture its product candidates in a manner that is cost-effective
or commercially viable, or that its development and manufacturing capabilities might not take much longer than currently anticipated to
be ready for the market. In addition, if Kadimastem fails to maintain regulatory approvals for its manufacturing facilities, it may suffer
delays in its ability to manufacture it product candidates. This may result in a material adverse effect on its business.

If Kadimastem encounters problems or delays in the research and development of its potential cell therapy products, it may not be able to raise sufficient capital to finance its operations during the period required to resolve such problems or delays.

Kadimastem’s cell therapy
products are currently in the development stage and it anticipate that it will continue to incur substantial operating expenses and incur
net losses until it has successfully completed all necessary research and clinical trials. Kadimastem, and any of its potential collaborators,
may encounter problems and delays relating to research and development, regulatory approval and intellectual property rights of its technology.
Kadimastem’s research and development programs may not be successful, and its cell culture technology may not facilitate the production
of cells outside the human body with the expected result. Kadimastem’s cell therapy products may not prove to be safe and efficacious
in clinical trials. If any of these events occur, Kadimastem may not have adequate resources to continue operations for the period required
to resolve the issue delaying commercialization and it may not be able to raise capital to finance its continued operation during the
period required for resolution of that issue. Accordingly, Kadimastem may be forced to discontinue or suspend its operations.

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Any cell-based products that receive regulatory approval may be difficult and expensive to manufacture profitably.

Cell-based products are among
the more expensive biologic products to manufacture. Kadimastem does not yet have sufficient information to reliably estimate the cost
of commercially manufacturing any of its product candidates. Excessive manufacturing costs could make its product candidates too expensive
to compete in the medical marketplace with alternative products manufactured by its competitors or might result in third party payors
such as health insurers and Medicare, declining to cover its products or setting reimbursement levels too low for Kadimastem to earn a
profit from the commercialization of one or more of its products.

Kadimastem’s future success depends on its ability