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

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 25
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 the
uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The
Leahy-Smith Act made a number of significant changes to U. S. patent law. These include provisions that affect the filing and prosecution
strategies associated with patent applications, including a change from a “first-to-invent” to a “first-inventor-to-file”
patent system, and a change allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures
to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partesreview
and derivation proceedings. The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many
of the substantive changes to patent law associated with the Leahy-Smith Act and, in particular, the “first-inventor-to-file”
provisions, became effective in 2013. The Leahy-Smith Act and its implementation may increase the uncertainties and costs surrounding
the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have harm our business,
financial condition and results of operations.

Price controls may be imposed in non-U. S.
markets, which may negatively affect our future profitability.

In some countries, particularly
EU member states, Japan, Australia and Canada, the pricing of prescription drugs is subject to governmental control. In these countries,
pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a product. In addition,
there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost
containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations
may continue after reimbursement has been obtained. Reference pricing used by various EU member states and parallel distribution, or arbitrage
between low-priced and high-priced member states, can further reduce prices. In some countries, we or our collaborators may be required
to conduct a clinical trial or other studies that compare the cost-effectiveness of our drug candidates to other available therapies in
order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead
to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of our
drug candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business, revenues