Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 626

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 626
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 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 adversely affect our financial condition. As a result of such lawsuits and their potential results, we may be required to limit commercialization of our product candidates. Regardless of the merits or eventual outcome, liability claims may result in: •decreased demand for our product candidates; •termination of clinical trial sites or entire trial programs; •injury to our reputation and negative media attention; •product recalls or increased warnings on product labels; •withdrawal of clinical trial participants; •costs of to defend the related litigation; •diversion of management and our resources; •substantial monetary awards to, or costly settlements with, clinical trial participants, patients or other claimants; Annex F-8 •higher insurance premiums; •loss of initiation of investigations by regulators or other authorities; and •the inability to successfully commercialize our product candidates, if approved. Risks Related to the Regulatory Environment Obtaining approval of an NDA or a MAA even after clinical trials that are believed to be successful is an uncertain process. We are not permitted to market Quilience and/or Nolazol in the United States or the EU until we receive regulatory approval of an NDA from the FDA or MAA from the EMA, or in any foreign countries until we receive the requisite approval from regulatory authorities in such countries. We have not received regulatory clearance to conduct the additional clinical trials that are necessary to be able to submit an NDA to the FDA for Nolazol. Similarly, we have not received regulatory clearance in the EU to conduct clinical trials that are necessary to receive approval of a MAA for Quilience in Europe. As such, we have not submitted an MAA for any of our product candidates. We may be able make our products available on a named patient basis and generate pre -approvalrevenues from compassionate use activities leveraging on an expanded access policy in certain countries around the world. Even if we complete our planned clinical trials and believe the results to be successful, all of which are uncertain, obtaining regulatory approval is an extensive