Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 104

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 104
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 were to be damaged or destroyed, the loss of some or all
of the stored units of its cell therapy drug substances would force Kadimastem to delay or halt its clinical trial processes. Kadimastem
has a clinical research and development facility located in Ness-Ziona, Israel, and also collaborates with medical hubs in California
and other locations in the United States. If these facilities or the equipment in them are significantly damaged or destroyed, Kadimastem
may not be able to quickly or inexpensively replace its manufacturing research and development and operational capacity.

Kadimastem’s product development is
based on novel technologies and are inherently risky.

Kadimastem is subject to the risks of failure
inherent in the development of products based on new technologies. The novel nature of its therapeutics creates significant challenges
in regard to product development and optimization, manufacturing, government regulation, third party reimbursement and market acceptance.
For example, the FDA, the EMA and other countries’ regulatory authorities have relatively limited experience with cell therapies.
Very few cell therapy products have been approved by regulatory authorities to date for commercial sale, and the pathway to regulatory
approval for its cell therapy drug substances and product candidates may accordingly be more complex and lengthier. As a result, the development
and commercialization pathway for its therapies may be subject to increased uncertainty, as compared to the pathway for new conventional
drugs.

Kadimastem’s cell therapy drug candidates
represent new classes of therapy that the marketplace may not understand or accept.

Even if Kadimastem successfully
develops and obtain regulatory approval for Kadimastem’s cell therapy candidates, the market may not understand or accept them.
Kadimastem is developing cell therapy drug substances and product candidates that represent novel treatments and will compete with a number
of more conventional products and therapies manufactured and marketed by others, including major pharmaceutical companies. The degree
of market acceptance of any of its developed and potential products will depend on a number of factors, including:

  the clinical safety and effectiveness of Kadimastem’s                                                   

  adverse events involving Kadimastem’s cell therapy product                           

  the cost of Kadimastem’s products and the reimbursement  

If the health care community
does not accept Kadimastem’s potential products for any of the foregoing reasons, or for any other reason, it could affect its sales,
having a material adverse effect on Kadimastem’s business, financial condition and results of operations.

Even if Kad