Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 112

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 112
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 it might operate, including  
  the GDPR.                                                                                                                                      
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The scope and enforcement
of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of
the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions
between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements
in the healthcare industry. It is possible that governmental authorities will conclude that Kadimastem’s business practices do not
comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If Kadimastem’s operations are found to be in violation of any of these laws or any other related governmental regulations that
may apply to it, Kadimastem may be subject to significant civil, criminal and administrative penalties, including, without limitation,
damages, fines, imprisonment, disgorgement, exclusion from participation in government funded healthcare programs, such as Medicare and
Medicaid, reputational harm, additional oversight and reporting obligations if Kadimastem becomes subject to a corporate integrity agreement
or similar settlement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of Kadimastem’s
operations. If any of the physicians or other healthcare providers or entities with whom Kadimastem expects to do business is found to
be not in compliance with applicable laws, they may be subject to similar actions, penalties and sanctions. Efforts to ensure that its
business arrangements comply with applicable healthcare laws and regulations, as well as responding to possible investigations by government
authorities, can be time- and resource-consuming and can divert a company’s attention from the business.

Obtaining and maintaining
regulatory approval of Kadimastem’s drug substances in one jurisdiction does not mean that it will be successful in obtaining regulatory
approval of Kadimastem’s drug substances in other jurisdictions. Kadimastem’s failure to obtain regulatory approval in foreign
jurisdictions would prevent its drug substances from being marketed abroad, and any approval it is granted for Kadimastem’s drug
substances in the United States would not assure approval of drug substances in foreign jurisdictions.

In order to market any
products outside of the United States, Kadimastem must establish and comply with numerous and varying regulatory requirements
of other countries regarding