Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 154

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 154
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, and drawdowns from a standby equity distribution agreement. NLS has only a limited operating history upon which you can evaluate its business and prospects. In addition, NLS has limited experience and has not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the pharmaceutical industry. To date, although NLS received an upfront payment of approximately $2.5 million pursuant to the EF License Agreement (defined below) in 2019, NLS has not generated revenue from the sale of its product candidates (see “ Item 5. Operating and Financial Review and Prospects — Components of Operating Results — Licensing Agreement” for additional information). NLS has incurred losses in each year since its inception. Its net loss attributable to holders of its NLS Common Shares for the year ended December 31, 2024, was approximately $4.1 million and for the year ended December 31, 2023, was approximately $12.2 million. As of December 31, 2024, NLS had an accumulated deficit of approximately $74.4 million. Substantially all of its operating losses resulted from costs incurred in connection with its clinical development program and from general and administrative costs associated with its operations. NLS expects its research and development expenses to increase in connection with its planned expanded clinical trials. In addition, if NLS obtains marketing approval for Quilience and/or Nolazol, or any other current or future product candidate, NLS will likely incur significant sales, marketing and outsourced manufacturing expenses, as well as continued research and development expenses. Furthermore, NLS expects to incur additional costs associated with operating as a public company, which NLS estimate will be at least several hundred thousand dollars annually. As a result, NLS expects to continue to incur significant and increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, NLS is unable to predict the extent of any future losses or when NLS will become profitable, if at all. NLS expects to continue to incur significant losses until NLS is able to commercialize its product candidates, which NLS may not be successful in achieving. NLS anticipates that its expenses will increase substantially if and as it: •continues the research and development of our product candidates; •expands the scope of our current clinical studies for our product candidates; •seeks regulatory and marketing approvals for our product candidates that successfully complete clinical studies;