Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 81

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 81
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imastem may seek
to develop or commercialize. Kadimastem’s 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 its products or any future
product candidate it may develop, which could render any product candidates obsolete and noncompetitive. Kadimastem’s competitors
also may obtain FDA or other marketing approval for their products before it is able to obtain approval for Kadimastem’s, which
could result in competitors establishing a strong market position before it is able to enter the applicable market.

Many of Kadimastem’s
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 it does. 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 Kadimastem’s
competitors, which may adversely affect it.

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 Kadimastem in recruiting and retaining qualified scientific and management personnel and establishing clinical
trial sites and patient registration for clinical trials.

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

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The major market players within
the ALS and diabetes drug markets and Kadimastem’s primary competitors in the United States and abroad include among others Biogen
and Mitsubishi Tanabe pharmaceuticals in the ALS domain and Vertex Therapeutics and Novo-Nordisk pharmaceuticals in the cell therapy for
diabetes domain. Some of these companies hold significant market share. Their dominant market position and significant control over the
market could significantly limit its ability to introduce or effectively market and generate sales and capture market share.

Competition in the pharmaceutical
industry is intense, and can lead to, among other things, price reductions, longer selling cycles, lower product margins,