Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 75

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 75
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 with one or more third parties, its future product revenue will suffer and Kadimastem
may incur significant additional losses.

Even if Kadimastem 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.

Kadimastem’s 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 Kadimastem’s products may be difficult. Kadimastem cannot be certain if and when Kadimastem will obtain
an adequate level of reimbursement for its products by third party payors. Even if it does obtain adequate levels of reimbursement, third-party
payors, such as government or private healthcare insurers, carefully review and increasingly question the coverage of, and challenge the
prices charged for, 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. Kadimastem 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, Kadimastem may not be able to successfully commercialize any product candidate for which Kadimastem obtain marketing
approval, and the royalties resulting from the sales of those products may also be adversely impacted.

There may be significant delays
in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved
by the FDA or similar regulatory authorities outside the United States. Moreover, eligibility for reimbursement does not imply that a
drug will be paid for in all cases or at a rate that covers Kadimastem’s costs, including research, development, manufacture, sale
and distribution