Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 642

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 642
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 and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all. We expect to continue to incur significant losses until we are able to commercialize our product candidates, which we may not be successful in achieving. We anticipate that our expenses will increase substantially if and as we: •continue the research and development of our product candidates; •expand the scope of our current clinical studies for our product candidates; •seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies; •establish a sales, marketing, and distribution infrastructure to commercialize our product candidates; •seek to identify, assess, acquire, license, and/or develop other product candidates and subsequent generations of our current product candidates; •seek to maintain, protect, and expand our intellectual property portfolio; •seek to attract and retain skilled personnel; and •create additional infrastructure to support our operations as a public company and our product candidate development and planned future commercialization efforts. We have not generated revenues from any product candidate and may never be profitable. Our ability to become profitable depends upon our ability to generate revenues. To date, we have not generated any revenue from our pre -clinicaland clinical development stage product candidates, Quilience, Nolazol and NLS -4, and we do not know when, or if, we will generate any such revenue. We do not expect to generate significant revenues unless or until we obtain marketing approval of, and commercialize, Quilience and/or Nolazol and/or the Aexon platform that we may seek to develop in the future. Our ability to generate future revenues from product candidate sales depends heavily on our success in many areas, including but not limited to: •obtaining favorable results from and progress the pre -clinicaland clinical development of our product candidates, namely Quilience and/or Nolazol; •developing and obtaining regulatory approval for registration studies protocols for our 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 our product candidates; •continued