Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 100

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 100
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 Any reduction in reimbursement from Medicare
or other government programs may result in a similar reduction in payments from private payors. The combined company’s results of
operations could be adversely affected by the Affordable Care Act and by other health care reforms that may be enacted or adopted in the
future. In addition, the delivery of healthcare in the European Union, including the establishment and operation of health services, is
almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different
priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. Coupled with ever-increasing
EU and national regulatory burdens on those wishing to develop and market products, this could prevent or delay additional marketing approval
of product candidates or any initial marketing approval for combined company’s product candidates, restrict or regulate post-approval
activities and affect combined company’s ability to commercialize any products for which the combined company may obtain marketing
approval.

NLS and Kadimastem are currently
unable to predict what additional legislation or regulation, if any, relating to the health care industry may be enacted in the future
or what effect recently enacted federal legislation or any such additional legislation or regulation would have on combined company’s
business. The pendency or approval of such proposals or reforms could result in a decrease in the price of combined company’s capital
stock or limit the combined company’s ability to raise capital or to enter into collaboration agreements for the further development
and potential commercialization of combined company’s products.

Inadequate funding for the FDA and other
government agencies and/or potentially shifting priorities under the new administration could hinder the FDA’s and/or those other
government agencies’ ability to hire and retain key leadership and other personnel, prevent new products and services from being
developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which
the operation of the combined company’s business may rely, which could negatively impact its business.

The ability of the FDA to
review and approve new products, provide feedback on clinical trials and development programs, meet with sponsors and otherwise review
regulatory submissions can be affected by a variety of factors, including government budget and funding levels; ability to hire and retain
key personnel and accept the payment of user fees; and statutory, regulatory, and policy changes, among other factors. Average review
times at the agency may fluctuate as a result. In addition, government funding of other government agencies on which the