Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 158

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 158
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 outcome, liability claims may result in: •decreased demand for its drug substances and product candidates; •termination of clinical trial sites or entire trial programs; •injury to its reputation and negative media attention; •product recalls or increased warnings on product labels; •withdrawal of clinical trial participants; •costs of to defend the related litigation; •diversion of management and its resources; •substantial monetary awards to, or costly settlements with, clinical trial participants, patients or other claimants; •higher insurance premiums; •loss of initiation of investigations by regulators or other authorities; and •the inability to successfully commercialize its drug substances and product candidates, if approved. 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