Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 120

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 120
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 be a significant barrier as the combined company’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 the combined company’s
financial condition.

Additionally, part of the
combined company’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 the combined company applies
its business strategy of establishing and maintaining strategic relationships, it believes this will allow the combined company to expand
and complement its products, training, support and commercialization capabilities. This the combined company 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 the combined
company will favorably maintain all current or successfully add new relationships to successfully advance its business.

The combined company’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 the combined company is unable to complete the development and commercialization
of its cell therapy products successfully, its likelihood of profitability will be limited severely.

The combined company 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 the combined company 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 the combined company has no experience in manufacturing the combined company’s product candidates 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 the combined company fails to maintain regulatory approvals for its manufacturing
facilities, it may suffer delays in its ability to manufacture it product candidates