Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 155

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 155
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 •establishes a sales, marketing, and distribution infrastructure to commercialize our product candidates; •seeks to identify, assess, acquire, license, and/or develop other product candidates and subsequent generations of our current product candidates; •seeks to maintain, protect, and expand our intellectual property portfolio; •seeks to attract and retain skilled personnel; and •creates additional infrastructure to support our operations as a public company and our product candidate development and planned future commercialization efforts. NLS has not generated revenues from any product candidate and may never be profitable. NLS’s ability to become profitable depends upon its ability to generate revenues. To date, NLS has not generated any revenue from its pre -clinicaland clinical development stage product candidates, Quilience, Nolazol and NLS -4, and NLS does not know when, or if, NLS will generate any such revenue. NLS does not expect to generate significant revenues unless or until NLS obtains marketing approval of, and commercializes, Quilience and/or Nolazol and/or the Aexon platform that NLS may seek to develop in the future. Its ability to generate future revenues from product candidate sales depends heavily on its success in many areas, including but not limited to: •obtaining favorable results from and progress the pre -clinicaland clinical development of NLS’s product candidates, namely Quilience and/or Nolazol; 41 •developing and obtaining regulatory approval for registration studies protocols for NLS’s product candidates, namely Quilience and/or Nolazol; •subject to successful completion of registration and clinical trials of Quilience and/or Nolazol, applying for and obtaining marketing approval; •establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products, and at acceptable costs, to support market demand for our product candidates, if marketing approval is received; •identifying, assessing, acquiring and/or developing new product candidates; •accurately identifying demand for NLS’s product candidates; •continued consumer interest in treatments to the symptoms of narcolepsy, IH, ADHD and Long -COVID; •obtaining market acceptance of NLS’s product candidates, if approved for marketing, as viable treatment options; •negotiating favorable terms in any collaboration, licensing or other arrangements into which NLS may enter; •obtaining and maintaining CIV labeling (no FDA imposed boxed warning, commonly referred to as a “Black Box” warning)