Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 48

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 48
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 and the pricing and reimbursement of
medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers
have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context.
In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement
of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to
develop and market products, this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval
activities and affect our ability to commercialize any products for which we obtain marketing approval.

We are currently unable to
predict what additional legislation or regulation, if any, relating to the healthcare industry may be enacted in the future or what effect
recently enacted federal legislation or any such additional legislation or regulation would have on our business. The pendency or approval
of such proposals or reforms could result in a decrease in the price of our common shares or Warrants or limit our ability to raise capital
or to enter into collaboration agreements for the further development and potential commercialization of our products.

The use of any of our product candidates
could result in product liability or similar claims that could be expensive, damage our reputation and harm our business.

Our business exposes us to
an inherent risk of potential product liability or similar claims. The pharmaceutical industry has historically been litigious, and we
face financial exposure to product liability or similar claims if the use of any of our products were to cause or contribute to injury
or death. There is also the possibility that defects in the design or manufacture of any of our products might necessitate a product recall.
Although we plan to maintain product liability insurance, the coverage limits of these policies may not be adequate to cover future claims.
In the future, we may be unable to maintain product liability insurance on acceptable terms or at reasonable costs and such insurance
may not provide us with adequate coverage against potential liabilities. A product liability claim, regardless of merit or ultimate outcome,
or any product recall could result in substantial costs to us, damage to our reputation, customer dissatisfaction and frustration and
a substantial diversion of management attention. A successful claim brought against us in excess of, or outside of, our insurance coverage
could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to the Ownership of Our Securities

The market price of our common shares and