Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 121

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 121
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. This may result in a material adverse effect on
its business.

If the combined company 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.

The combined
company’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.
The combined company, 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. The combined company’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. The combined company’s cell therapy products may not prove to be safe and efficacious in
clinical trials. If any of these events occur, the combined company 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, the combined company may be forced to discontinue or
suspend its operations.

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. The combined company 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 the combined
company to earn a profit from the commercialization of one or more of its products.

The combined company’s future success
depends on its ability to retain key executives and to attract, retain and motivate qualified personnel.

The combined company’s
future success depends to a large extent on the continued services of members of Kadimastem’s current management including, in particular,
Professor Michel Ravel, Chief Scientific Officer, and Dr. Kfir Molekandov, Kadimastem’s Vice President of Research and Development,
Dr. Ariel Revel, Director of Medical Affairs, and Ronen Twito, Kadimastem’s Executive Chairman and CEO. Any