Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 234

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 234
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 maintained the existing six protected classes of drug categories, but stated that some of the proposals not included in the final
rule could still be finalized in the future, which would impact payor formulary and coverage decisions.

The American Recovery
and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different treatments
for the same illness. A plan for the research will be developed by the Department of Health and Human Services, the Agency for Healthcare
Research and Quality and the National Institutes for Health, and periodic reports on the status of the research and related expenditures
will be made to Congress. Although the results of the comparative effectiveness studies are not intended to mandate coverage policies
for public or private payors, it is not clear what effect, if any, the research will have on the sales of any product, if any such product
or the condition that it is intended to treat is the subject of a study. It is also possible that comparative effectiveness research
demonstrating benefits in a competitor’s product could adversely affect the sales of Kadimastem’s product candidates.

If third-party
payors do not consider Kadimastem’s product candidates to be cost-effective compared to other available therapies, they may not
cover Kadimastem’s product candidates as a benefit under their plans or, if they do, the level of payment may not be sufficient
to allow Kadimastem to sell Kadimastem’s product candidates on a profitable basis.

The Affordable
Care Act, enacted in March 2010, has had a significant impact on the health care industry. Some of the key changes made to date
pursuant to the ACA include an expansion of coverage for the uninsured, the creation of insurance marketplaces and increased protection
of insureds with new benefits, rights and protections. With regard to pharmaceutical products, among other things, the ACA made major
changes to the Medicare prescription drug program, which helped reduce drug costs for seniors and increased rebates and other costs for
the pharmaceutical industry. There have been judicial and congressional challenges to the ACA. In December 2017, Congress passed
and then the President Trump signed into law tax reform legislation that made significant changes to the ACA including the repeal of
the “individual mandate” that was in place to strongly encourage broad participation in the health insurance markets. On
December 14, 2018, a federal district court in Texas ruled that the ACA is unconstitutional as a result of the Tax Cuts and Jobs
Act,