Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 652

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 652
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 claims. In the future, we Annex F-28 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 Warrants may be highly volatile, and you may not be able to resell your shares or Warrants at or above the initial public offering price. The trading price of each of our common shares and Warrants is likely to be volatile. The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of such securities: •unsatisfactory results of clinical trials; •announcements of regulatory approval or the failure to obtain it, or specific label indications or patient populations for its use, or changes or delays in the regulatory review process; •announcements of therapeutic innovations or new products by us or our competitors; •adverse actions taken by regulatory authorities with respect to our clinical trials, manufacturing supply chain or sales and marketing activities; •changes or developments in laws or regulations applicable to the treatment of the symptoms of narcolepsy, ADHD, or any other indication that we may seek to develop, or the use of mazindol to treat any such indications; •any adverse changes to our relationship with manufacturers or suppliers; •any intellectual property infringement actions in which we may become involved; •announcements concerning our competitors or the pharmaceutical industry in general; •achievement of expected product sales and profitability or our failure to meet expectations; •our commencement of, or involvement in, litigation; •any major changes in our board of directors or management; •our ability to recruit and retain qualified regulatory, research and development personnel; •legislation in the United States relating to the sale or pricing of pharmaceuticals; •the depth of the trading market in our common shares and Warrants; •economic weakness, including rising or sustained high interest rates and high inflation, or political instability in particular foreign economies and markets; •business interruptions resulting from a local or worldwide pandemic, pandemics (such as the COVID -19pandemic), geopolitical instability (