Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 101

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 101
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 combined company’s
operations may rely is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and
other agencies may also increase the time necessary for new drugs to be reviewed and/or approved by necessary government agencies or to
otherwise respond to regulatory submissions, which would adversely affect its business. For example, the Trump Administration
has discussed several changes to the reach and oversight of the FDA, which could affect its relationship with the pharmaceutical industry,
transparency in decision making and ultimately the cost and availability of prescription drugs. Additionally, over the last several years,
the U. S. government has shut down multiple times and certain regulatory agencies, such as the FDA, have had to furlough critical
FDA and other government employees and stop critical activities. If funding for the FDA is reduced, FDA priorities change, or a prolonged
government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process combined company’s
regulatory submissions, which could have a material adverse effect on its business.

Kadimastem will need to obtain FDA approval
of any proposed names for its drug substances that gain marketing approval, and any failure or delay associated with such naming approval
may adversely impact its business.

Any name Kadimastem
intends to use for its drug substances and product candidates will require approval from the FDA regardless of whether Kadimastem
has secured a formal trademark registration from the U. S. Patent and Trademark Office, or the U. S. PTO. The FDA
typically conducts a review of proposed product names, including an evaluation of whether proposed names may be confused with the
names of other medical products and technology. The FDA may object to any product name it submits if it believes the name
inappropriately implies medical claims. If the FDA objects to any of its proposed product names, Kadimastem may be required to adopt
an alternative name for its product candidates, which could result in further evaluation of proposed names with the potential for
additional delays and costs.

Kadimastem may seek designations
for its drug substances and product candidates with the FDA and other comparable regulatory authorities that are intended to confer benefits
such as a faster development process or an accelerated regulatory pathway, but there can be no assurance that Kadimastem will successfully
obtain such designations. In addition, even if one or more of Kadimastem’s drug substances and product candidates are granted such
designations, Kadimastem may not