Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 113

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 113
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imastem’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, and failure to comply with Swiss or Nasdaq requirements could lead to delisting; •Even if the Merger is completed, there is no guarantee that any proceeds will be paid to our shareholders under the CVR Agreement; •The unaudited pro forma condensed consolidated financial information included in this proxy statement/prospectus is presented for illustrative purposes only and may not reflect our actual operating results or financial condition following the Merger; •We must obtain regulatory approvals before commercializing our products, and clinical trial data may not meet FDA or European Medicines Agency, or the EMA requirements, potentially causing