Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 80

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 80
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 United States to fundamental changes. There
have been, and we expect there will continue to be, legislative and regulatory proposals to change the healthcare system in ways that
could significantly affect our future business.

Similar political, economic
and regulatory developments are occurring in the European Union and may affect the ability of pharmaceutical companies to profitably commercialize
their products. In addition to continuing pressure on prices and cost containment measures, legislative developments at the European Union
or member state level may result in significant additional requirements or obstacles. The delivery of healthcare in the European Union,
including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter
for national, rather than European Union, 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. In general, however, the
healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines
by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and
market products, this could restrict or regulate post-approval activities and affect the ability of pharmaceutical companies to commercialize
their products. In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries
have instituted price ceilings on specific products and therapies. In the future, there may continue to be additional proposals relating
to the reform of the healthcare system in the United States and international healthcare systems. Future legislation, or regulatory actions
implementing recent or future legislation may have a significant effect on our business. Our ability to successfully commercialize products
depends in part on the extent to which reimbursement for the costs of our drug candidates and related treatments will be available in
the United States and worldwide from government health administration authorities, private health insurers and other organizations. The
adoption of certain proposals could limit the prices we are able to charge for our drug candidates, the amounts of reimbursement available
for our drug candidates, and limit the acceptance and availability of our drug candidates. Therefore, substantial uncertainty exists as
to the reimbursement status of newly approved health care products by third party payors.

Inflation and Seasonality

Management believes inflation
has not had a material impact on our operations or financial condition. Management further believes that our operations are not currently
subject to seasonal influences due to our current lack of marketed products. Moreover, the targets of our drug candidates, are not seasonal
diseases.