Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 138

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 138
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 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 others using, administering or selling any of its future approved products. If NLS cannot successfully defend itself against any such claims, NLS may incur substantial liabilities, even if NLS has product liability or such other applicable insurance policies in effect. NLS may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms. Excessive insurance costs 31 or uninsured claims would add to its future operating expenses and adversely affect its financial condition. As a result of such lawsuits and their potential results, NLS may be required to limit commercialization of its product candidates. Regardless of the merits or eventual outcome, liability claims may result in: •decreased demand for NLS’s product candidates; •termination of clinical trial sites or entire trial programs; •injury to NLS’s reputation and negative media attention; •product recalls or increased warnings on product labels; •withdrawal of clinical trial participants; •costs to defend the related litigation; •diversion of NLS