Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 119

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 119
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  substantial monetary awards to, or costly settlements with,  

  higher insurance premiums;  

  loss of initiation of investigations by regulators or other  

  the inability to successfully commercialize its drug substances  

Kadimastem’s inability
to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims
could prevent or inhibit the commercialization of products it develops or acquires. Kadimastem intends to obtain product liability insurance
covering its clinical trials. Although Kadimastem will maintain such insurance, any claim that may be brought against Kadimastem could
result in a court judgment or settlement in an amount that is not covered, in whole or in part, by its insurance or that is in excess
of the limits of Kadimastem’s insurance coverage. Kadimastem’s insurance policies also have various exclusions, and it may
be subject to a product liability claim for which Kadimastem has no coverage. Kadimastem may have to pay any amounts awarded by a court
or negotiated in a settlement that exceed its coverage limitations or that are not covered by its insurance, and Kadimastem may not have,
or be able to obtain, sufficient capital to pay such amounts.

Risks Related to the Combined Company’s
Business and Industry

The operations and commercialization of
stem cell therapies is a new and integral part of the emerging regenerative medicine market, but the field remains in its infancy.

As with all new technologies,
products, practices and solutions, there are inherit risks related to combined company’s industry and business.

The field of stem cell therapy
is relatively new, and not yet widely adopted by the medical community, and because of that infancy, it may have an adverse effect on
its ability to reach potential physicians that are skeptical of the benefits or have questions about the risks, and thus, the combined
company may run into resistance in the marketing of its products and services. Stem cell therapies may be susceptible to various risks,
including side effects, unintended immune system responses, inadequate therapeutic efficacy, and lack of acceptance by physicians, hospital,
and the patients themselves.

The combined company’s
experience and others have shown that physicians are historically slow to adopt new treatment methods based on new technologies, like
the combined company’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