Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 10

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 10
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 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 our costs, including research, development, manufacture, sale and distribution.
Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.
Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement
levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be
reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of
laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Our inability
to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved products
that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products
and our overall financial condition.

The regulations that govern
marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country. Current and future
legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining
approvals. Some countries require approval of the sale price of a drug before it can be reimbursed. In many countries, the pricing review
period begins after marketing or product licensing approval is granted. In some foreign markets, prescription drug pricing remains subject
to continuing governmental control, including possible price reductions, even after initial approval is granted. As a result, we might
obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch
of the product, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product
in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if
our product candidates obtain marketing approval. There can be no assurance that our product candidates, if they are approved for sale
in the United States or in other countries,