Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 133

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 133
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 third party payors and patients, NLS may not generate sufficient revenue from the product, and NLS may not become or remain profitable. In addition, its efforts to educate the medical community and third -partypayors on the benefits of the product may require significant resources and may never be successful. In addition, NLS may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment its own sales force and distribution systems or in lieu of its own sales force and distribution systems. If NLS enters into arrangements with third parties to perform sales, marketing and distribution services for its products, the resulting revenues or the profitability from these revenues to it are likely to be lower than if NLS had sold, marketed and distributed its products itself. If NLS is unable to enter into such arrangements on acceptable terms or at all, NLS may not be able to successfully commercialize any of its product candidates that receive regulatory approval. Depending on the nature of the third -partyrelationship, NLS may have little control over such third parties, and any of these third parties may fail to devote the necessary resources and attention to sell, market and distribute its products effectively. If NLS is not successful in commercializing its product candidates, either on its own or through collaborations with one or more third parties, its future product revenue will suffer and NLS may incur significant additional losses. Even if NLS is able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, any of which could harm its business. Its ability to commercialize any product candidates successfully will depend, in part, on the extent to which coverage and reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third -partypayors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and impact reimbursement levels. Obtaining and maintaining adequate reimbursement for its products may be difficult. NLS cannot be certain if and when NLS will obtain an adequate level of reimbursement for its products by third party payors. Even if NLS does obtain adequate levels of reimbursement, third -partypayors, such as government or private healthcare insurers, may carefully review and increasingly question the coverage of, and challenge the prices charged for, its drugs. Reimbursement rates from private health insurance companies vary depending on the company, the insurance plan and other factors. A primary trend in the U.S.