Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 13

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 13
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on our operations, which could materially and adversely affect our business, financial condition, results of operations, prospects and
market price of our common shares.

Global economic instability
and unfavorable conditions could materially and adversely affect our business. The war between Russia and Ukraine is ongoing. The impact
to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the
European Union, the United States and other countries against officials, individuals, regions, and industries in Russia and Ukraine, and
actions taken by Russia in response to such sanctions, and responses of countries and political bodies to such sanctions, tensions, and
military actions and the potential for more widespread conflict, have resulted in supply chain disruptions, increases in inflation, financial
market volatility and capital markets disruption. In addition, the war between Israel and Hamas is ongoing and has opened additional fronts.
Any resulting instability and unfavorable economic conditions from the wars could disrupt our and our collaborators’ supply chains
and adversely affect our and our collaborators’ ability to conduct ongoing and future clinical trials of our product candidates.
The extent and duration of the wars, sanctions and resulting economic, market and other disruptions are impossible to predict, but could
be substantial. Any such disruptions may heighten the impact of the other risks described in this annual report.

If product liability lawsuits are brought
against us, we may incur substantial liabilities, even if we have appropriate insurance policies, and we may be required to limit commercialization
of our product candidates.

We are exposed to potential
product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of
pharmaceutical products. Currently, we have no products that have been approved for marketing or commercialization; however, the use of
our product candidates in clinical trials, and the sale of these product candidates, if approved, in the future, may expose us to liability
claims. Product liability claims may be brought against us or our partners by participants enrolled in our clinical trials, patients,
health care providers, pharmaceutical companies, our collaborators or others using, administering or selling any of our future approved
products. If we cannot successfully defend ourselves against any such claims, we may incur substantial liabilities, even if we have product
liability or such other applicable insurance policies in effect. We may not be able to maintain adequate levels of insurance for these
liabilities at reasonable cost and/or reasonable terms. Excessive insurance costs or uninsured claims would add to our future operating
expenses and