Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 125

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 125
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. 39 NLS has a limited operating history, has incurred significant operating losses since its inception, and anticipates that it will incur continued losses for the foreseeable future. NLS is an emerging biopharmaceutical company with a limited operating history. To date, NLS has focused almost exclusively on developing product candidates using the active ingredient mazindol in proprietary formulations. NLS has funded its operations to date primarily through proceeds from the private placement of NLS Common Shares, convertible instruments, related party credit facilities, shareholder loans, an initial public offering of NLS Common Shares and Warrants, 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