Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 12

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 12
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 and/or Nolazol or any future product candidate that we may seek to develop
or commercialize. Our competitors may succeed in developing, acquiring or licensing technologies and products that are more effective,
have fewer or more tolerable side effects or are more convenient or less costly than Quilience and/or Nolazol or any future product candidate
we may develop, which could render any product candidates obsolete and non-competitive. Our competitors also may obtain FDA or other marketing
approvals for their products before we are able to obtain approval for ours, which could result in competitors establishing a strong market
position before we are able to enter the applicable market.

Many of our potential competitors,
alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing,
pre-clinical testing, conducting clinical trials, obtaining marketing approvals and commercializing approved products than we do. There
is a trend toward consolidation in the pharmaceutical and biotechnology industry, and additional mergers and acquisitions in these industries
may result in even more resources being concentrated among a smaller number of our competitors, which may adversely affect us.

Smaller or early-stage companies
may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These
companies also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial
sites and patient registration for clinical trials.

In addition, if we enter the
markets of our product candidates, with such entrance remaining subject to various additional regulatory approvals, too late in the cycle,
we may not achieve commercial success, or we may have to reduce our price in order to effectively compete, which would impact our ability
to generate revenues, obtain profitability and adversely affect our operating results.

While orphan drug product candidates are
typically sold at a high price relative to other medications, the market may not be receptive to high pricing of our product candidates.

We are developing certain
product candidates to treat rare central nervous system, or CNS, disorders with high unmet medical needs, a space where medications are
usually sold at high prices compared with other medications. Accordingly, even if regulatory authorities approve our product candidates,
the market may not be receptive to, and it may be difficult for us to achieve, a per-patient per-year price high enough to allow us to
realize a return on our investment.

Unfavorable global economic conditions,
including as a result of the ongoing war between Russia and Ukraine as well as Israel’s multi-front war, could have a negative impact