Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 87

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 87
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Kadimastem’s
experience and others have shown that physicians are historically slow to adopt new treatment methods based on new technologies, like
Kadimastem’s, when existing and trusted methods continue to be supported by established practitioners. Overcoming these obstacles
often requires significant marketing expenditures, product performance, cost cutting and/or decreased pricing. It believes the skepticism
to be a significant barrier as Kadimastem’s attempts to gain market penetration with its products and services. Failure to achieve
market acceptance of its products and services would have a material adverse effect on Kadimastem’s financial condition.

Additionally,
part of Kadimastem’s success will depend on continuing to establish and maintain effective strategic partnerships and collaborations
with its international partners, which may impose challenges, restrictions, and or financial impacts to its business.

As
Kadimastem applies its business strategy of establishing and maintaining strategic relationships, it believes this will allow Kadimastem
to expand and complement its products, training, support and commercialization capabilities. Kadimastem believes will allow it to reduce
costs with greater economies of scale, and leverage a greater source of market intelligence, with crucial meta data gathered of stem cell
therapies applied to a full spectrum across global applications. Notwithstanding, there can be no assurances that Kadimastem will favorably
maintain all current or successfully add new relationships to successfully advance its business.

Kadimastem’s likelihood of profitability depends on its ability to license and/or develop and commercialize its products based on its cell production technology, which is currently in the development stage. If Kadimastem is unable to complete the development and commercialization of its cell therapy products successfully, its likelihood of profitability will be limited severely.

Kadimastem is engaged in the
business of developing cell therapy products. It has not realized a profit from its operations to date and there is little likelihood
that Kadimastem will realize any profits in the short or medium term. Any profitability in the future from its business will be dependent
upon successful commercialization of its potential cell therapy products and/or licensing of its products, which will require additional
research and development.

The clinical manufacturing process for cell therapy products is complex and requires meeting high regulatory standards. Any delay or problem in the clinical manufacturing of its products may result in a material adverse effect on its business.

The clinical manufacturing
process is complex, and Kadimastem has no experience in manufacturing Kadimastem’s product candidates