Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 82

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 82
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 loss of market
share, and additional working capital requirements. To succeed, Kadimastem must, among other critical matters, gain consumer acceptance
for its products, as compared to other solutions currently available in the market. For example, since the currently accepted treatment
for ALS is not substantially effective for its patients and for diabetes is lacking in effectiveness and does not cure the disease itself
nor does it prevent long term complications, respectively, Kadimastem will need to invest resources in educating the medical community
and consumers, and establish strategic collaborations before Kadimastem will be able to gain market acceptance for Kadimastem’s
AstroRx and/or IsletRx as a treatment in severe acute emergency situations. If Kadimastem’s competitors offer significant discounts
on certain products and solutions, Kadimastem may need to lower its prices or offer other favorable terms in order to compete successfully.
Moreover, any broad-based changes to Kadimastem’s prices and pricing policies could make it difficult to generate revenues or cause
Kadimastem’s revenues to decline. Moreover, if Kadimastem’s competitors develop and commercialize products and solutions that
are more effective or desirable than products and solutions that it may develop, Kadimastem may not convince its customers to use its
products and solutions. Any such changes would likely reduce Kadimastem’s commercial opportunity and revenues potential and could
materially adversely impact Kadimastem’s operating results.

Although Kadimastem has obtained orphan drug designation from the EMA for its product AstroRx ®, it may not be able to realize the benefits of such designation, including potential marketing exclusivity of its product candidates, if approved.

Kadimastem applied for and
received designation from the FDA for AstroRx for cell therapy for ALS treatment. Regulatory authorities in some jurisdictions, including
the EU and United States, may designate drugs for relatively small patient populations as “orphan drugs.” In the EU, the European
Commission grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment
of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the EU community. Additionally,
designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating
or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the EU would be sufficient to
justify the necessary investment in developing the drug.