Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 137

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 137
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 medications are usually sold at high prices compared with other medications. Accordingly, even if regulatory authorities approve its product candidates, the market may not be receptive to, and it may be difficult for it to achieve, a per -patientper -yearprice high enough to allow it to realize a return on its investment. Unfavorable global economic conditions, including as a result of the ongoing war between Russia and Ukraine as well as Israel’s multi-front war, could have a negative impact on its operations, which could materially and adversely affect its business, financial condition, results of operations, prospects and market price of its NLS Common Shares. Global economic instability and unfavorable conditions could materially and adversely affect its 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 its and its collaborators’ supply chains and adversely affect its and its collaborators’ ability to conduct ongoing and future clinical trials of its 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 proxy statement/prospectus. If product liability lawsuits are brought against NLS, NLS may incur substantial liabilities, even if NLS has appropriate insurance policies, and NLS may be required to limit commercialization of its product candidates. NLS is exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of pharmaceutical products. Currently, NLS has no products that have been approved for marketing or commercialization; however, the use of its product candidates in clinical trials, and the sale of these product candidates, if approved, in the future, may expose it to liability claims. Product liability claims may be brought against it or its partners by participants enrolled in its clinical trials, patients, health care providers, pharmaceutical companies, its collaborators or