Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 151

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 151
---
 drug is not the same drug or is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the EU, marketing authorization may be granted to a similar medicinal product for the same orphan indication if: •the second applicant can establish in its application that its medicinal product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clinically superior; •the holder of the marketing authorization for the original orphan medicinal product consents to a second orphan medicinal product application; or •the holder of the marketing authorization for the original orphan medicinal product cannot supply sufficient quantities of orphan medicinal product. Risks Related to NLS’s Financial Condition and Capital Requirements NLS’s financial statements for the year ended December 31, 2024, contained a disclosure in Note 1 regarding substantial doubt about its ability to continue as a going concern. This going concern disclosure in Note 1 of financial statements could prevent it from obtaining new financing on reasonable terms or at all and risks its ability to continue operating as a going concern. To date, NLS has not generated significant revenues from its activities and has incurred substantial operating losses. In part because NLS has incurred losses in each year since its inception, its audited financial statements for the period ended December 31, 2024 contain a disclosure in Note 1 regarding substantial doubt about its ability to continue as a going concern. These events and conditions, along with other matters, indicated that a material uncertainty existed as of December 31, 2024, that raises substantial doubt on its ability to continue as a going concern. The financial statements for the year ended December 31, 2024 have been prepared assuming that NLS will continue as a going concern. Management expects the Company to continue to generate substantial operating losses and to continue to fund its operations primarily through the utilization of its current financial resources, sales of its products, and through additional raises of capital. As of December 31, 2024, NLS incurred accumulated losses of approximately $74.4 million. The disclosure regarding substantial doubt about its ability to continue as a going concern could materially limit its ability to raise additional funds through the issuance of equity or debt securities or otherwise in 39 the future. Further financial statements may also include a similar disclosure with respect to its ability to continue as a going concern. Until NLS can generate significant recurring revenues, NLS expects to satisfy its future cash needs through existing cash, debt or equity financing. NLS expects to require additional financing