Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 644

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 644
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 to delay, limit or terminate our product candidate development efforts or other operations. As of December 31, 2023, our cash and cash equivalents were approximately $0.9 million, and we had a negative working capital of $6.07 million and an accumulated deficit of $70.4 million. Based upon our currently expected level of operating expenditures, we believe that our current cash on hand and access to existing financial arrangements will not be sufficient to fund our projected operating requirements for a period of one year from the issuance of these financial statements included elsewhere in this annual report. This raises substantial doubt about our ability to continue as a going concern. We expect that we will require substantial additional capital to commercialize our product candidates and put in place multiple options to raise the funds necessary to support our operations. However, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned. Our future funding requirements will depend on many factors, including but not limited to: •our clinical trial results and the costs for conducting pivotal trials; •the cost, timing and outcomes of seeking marketing approval of Quilience and/or Nolazol; •the cost of filing and prosecuting patent applications and the cost of defending our patents; •the cost of prosecuting patent infringement actions against third parties; •development of other early -stagedevelopment product candidates; •the costs associated with commercializing Quilience and/or Nolazol if we receive marketing approval, including the cost and timing of establishing sales and marketing capabilities to market and sell Quilience and/or Nolazol; •subject to receipt of marketing approval, revenue received from sales of approved products, if any, in the future; Annex F-19 •any product liability or other lawsuits related to our products; •the expenses needed to attract and retain skilled personnel; and •the costs associated with being a public company. Any additional fundraising efforts may divert our management from their day -to-dayactivities, which may adversely affect our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all, during or after the COVID -19pandemic. Moreover, the terms of any financing may adversely affect the holdings or the rights of holders of our securities and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our