Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 9

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 9
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 we had sold, marketed and distributed our products ourselves. If we are unable to enter into such
arrangements on acceptable terms or at all, we may not be able to successfully commercialize any of our product candidates that receive
regulatory approval. Depending on the nature of the third-party relationship, we 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 our products effectively.
If we are not successful in commercializing our product candidates, either on our own or through collaborations with one or more third
parties, our future product revenue will suffer and we may incur significant additional losses.

Even if we are 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 our business.

Our 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-party payors, 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 our products may be difficult. We cannot be certain if and when we will obtain an adequate level of reimbursement
for our products by third party payors. Even if we do obtain adequate levels of reimbursement, third-party payors, such as government
or private healthcare insurers, may carefully review and increasingly question the coverage of, and challenge the prices charged for,
our 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. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have
attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party
payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged
for drugs. We may also be required to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the level of
reimbursement relative to other therapies. If coverage and reimbursement are not available or reimbursement is available only to limited
levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval, and the royalties
resulting