Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 91

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 91
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 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; 18 •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 delays or additional study obligations; •Our failure to meet the continued listing requirements Nasdaq could result in a delisting of our securities or us seeking to transfer our listed securities to a different exchange; •As a “foreign private issuer” and emerging growth company, or EGC, we benefit from reduced SEC and Nasdaq requirements, which may offer less investor protection and impact market confidence; •We have identified material weaknesses in our internal control, and ineffective remediation could impair financial reporting and investor confidence; •As a Swiss stock corporation, we are governed by Swiss law, which may limit shareholder rights, pre -emptiveparticipation