Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 107

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 107
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imastem’s results of operations.

Even if any of Kadimastem’s product
candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors
and others in the medical community necessary for commercial success.

The commercial success of
Kadimastem’s products will depend upon the acceptance of each product by the medical community, including physicians, patients and
third-party payors. The degree of market acceptance of any approved product will depend on a number of factors, including:

  the efficacy and safety of the product;  

  the potential advantages of the product compared to available  

  the convenience and ease of administration compared to alternative  

  limitations or warnings, including use restrictions contained  

  distribution and use restrictions imposed by the EMA, FDA                                                           

  pricing and cost effectiveness in relation to alternative  

  if the product is included under physician treatment guidelines  

  the strength of sales, marketing and distribution support;  

  the availability of third-party coverage and adequate reimbursement                                     

  the strength of sales, marketing and distribution support;  

  the willingness of patients to pay for drugs out of pocket  

  the willingness of the target patient population to try new  

If Kadimastem’s products
are approved but do not achieve an adequate level of acceptance by physicians, third party payors and patients, Kadimastem may not generate
sufficient revenue from the product, and Kadimastem may not become or remain profitable. In addition, its efforts to educate the medical
community and third-party payors on the benefits of the product may require significant resources and may never be successful.

In addition, Kadimastem
may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment
its own sales force and distribution systems or in lieu of its own sales force and distribution systems. If Kadimastem enters into
arrangements with third parties to perform sales, marketing and distribution services for its products, the resulting revenues or
the profitability from these revenues to it are likely to be lower than if Kadimastem had sold, marketed and distributed its
products itself. If Kadimastem is unable to enter into such arrangements on acceptable terms or at all, Kadimastem may not be able
to successfully commercialize any of Kadimastem’s product candidates that receive regulatory approval. Depending on the nature
of the third-party relationship, Kadimastem may have little control over such third