Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 118

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 118
---
 with such foreign regulatory
requirements could result in significant delays, difficulties and costs for Kadimastem or its collaborators and could delay or prevent
the introduction of its current and any future products, in certain countries.

If Kadimastem or its collaborators
fail to receive applicable marketing approvals or comply with the regulatory requirements in international markets, its target market
will be reduced and its ability to realize the full market potential of its product candidates will be harmed and its business will be
adversely affected.

If product liability lawsuits are brought
against Kadimastem, it may incur substantial liabilities, even if Kadimastem has appropriate insurance policies, and it may be required
to limit commercialization of its product candidates.

Kadimastem is exposed to
potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing,
marketing and use of pharmaceutical products. Currently, it has no products that have been approved for marketing or
commercialization; however, the use of its product candidates in clinical trials, and the sale of these product candidates, if
approved, in the future, may expose it to liability claims. Product liability claims may be brought against Kadimastem or its
partners by participants enrolled in its clinical trials, patients, health care providers, pharmaceutical companies, its
collaborators or others using, administering or selling any of its future approved products. If Kadimastem cannot successfully
defend itself against any such claims, it may incur substantial liabilities, even if Kadimastem has product liability or such other
applicable insurance policies in effect. Kadimastem may not be able to maintain adequate levels of insurance for these liabilities
at reasonable cost and/or reasonable terms.

Excessive insurance costs
or uninsured claims would add to its future operating expenses and adversely affect its financial condition. As a result of such lawsuits
and their potential results, it may be required to limit commercialization of its product candidates. Regardless of the merits or eventual
outcome, liability claims may result in:

  decreased demand for its drug substances and product candidates;  
 ────────────────────────────────────────────────────────────────────

  termination of clinical trial sites or entire trial programs;  

  injury to its reputation and negative media attention;  

  product recalls or increased warnings on product labels;  
 ────────────────────────────────────────────────────────────

  withdrawal of clinical trial participants;  

  costs of to defend the related litigation;  

  diversion of management and its resources;