Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 149

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 149
---
 when, or if, NLS will generate any such revenue. NLS does not expect to generate significant 41 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; •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) of NLS’s lead product candidate Quilience and follow -onproduct candidates, Nolazol and NLS -4; •establishing and nurturing relationships with the leading prescribers of narcolepsy, ADHD and Long -COVIDprescriptions in the United States; and •attracting, hiring, and retaining qualified personnel. Alexander Zwyer, its Chief Executive Officer, and Eric Konofal, its Chief Scientific Officer, have interests that may be different from, or in addition to, the interests of its shareholders and the Company and Aexon may not have sufficient funds to continue or grow operations. Alexander Zwyer owns 35% of Aexon, and Eric Konofal owns 59% of Aexon. Mr. Konofal is the founder of Aexon, with which