Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 30

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 30
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 million. As of December 31, 2024, we had an accumulated deficit of approximately
$74.4 million. Substantially all of our operating losses resulted from costs incurred in connection with our clinical development program
and from general and administrative costs associated with our operations.

We expect our research and
development expenses to increase in connection with our planned expanded clinical trials. In addition, if we obtain marketing approval
for Quilience and/or Nolazol, or any other current or future product candidate, we will likely incur significant sales, marketing and
outsourced manufacturing expenses, as well as continued research and development expenses. Furthermore, we expect to incur additional
costs associated with operating as a public company, which we estimate will be at least several hundred thousand dollars annually. As
a result, we expect 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, 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-clinical and 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