Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 120

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 120
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 may not be replicated in the clinical trials that we conduct for the treatment of narcolepsy or ADHD;

18 •We may rely on physician prescriptions to commercialize Quilience and/or Nolazol, and a loss of referrals could adversely impact our future revenues and business; •We may fail to comply with data protection laws or appropriate privacy practices; •Following the Merger, we intend to shift our business focus to developing and manufacturing “off -the-shelf,” allogenic, proprietary cell products, a strategy that may not be successful; •We may be unable to successfully integrate Kadimastem’s operations or realize the anticipated benefits of the Merger; •Following the Merger, our business strategy will depend heavily on advancing and commercializing our pipeline products. However, our research and development efforts are subject to substantial risk, as drug development requires significant investment and faces inherent uncertainty; •Our future business strategy will rely heavily on the advancement and potential commercialization of our combined pipeline products, which are in early development and face substantial clinical, regulatory and financial risks; •The operations and commercialization of stem cell therapies is a new and emerging area within the regenerative medicine market, and the field remains in its infancy, presenting significant scientific, regulatory and commercial risks; •We depend on a sole manufacturer for mazindol, and any supply issues could disrupt clinical trials; •Failure to secure strategic alliances for our product candidates may adversely affect our business and commercialization prospects; •Our ability to compete may be compromised if we can’t secure effective patent protection, safeguard trade secrets, or defend against claims of misappropriating third -partyconfidential information; •Our financial statements for the year ended December31, 2024, contained a going concern disclosure in Note 1 regarding substantial doubt about our ability to continue as a going concern. This going concern disclosure in Note 1 of financial statements could prevent us from obtaining new financing on reasonable terms or at all and risk our ability to continue operating as a going concern; •To date, we have not generated any revenue, and may never achieve profitability even if/we obtain marketing approval for Quilience and/or Nolazol. As of December31, 2024, we had an accumulated deficit of approximately $74.4million; •We have a history of losses and expect to need additional capital to advance Quilience, Nolazol, and other product candidates, which may not be available on favorable terms; •As a public company, we face significant regulatory burdens,