Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 10

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 10
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. Further, Phase III clinical trials may not show sufficient safety or efficacy to obtain regulatory approval for marketing. In
addition, clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals.
Negative or inconclusive results or adverse medical events during a clinical trial could require that the clinical trial be redone or
terminated. The length of time necessary to complete clinical trials and to submit an application for marketing approval by applicable
regulatory authorities may also vary significantly based on the type, complexity and novelty of the drug candidate involved, as well as
other factors. If we suffer any significant delays, quality issues, setbacks or negative results in, or termination of, our clinical trials,
we may be unable to continue the development of our drug candidates or generate revenue and our business may be severely harmed.

If we do not obtain the necessary regulatory approvals, we will
be unable to commercialize our drug candidates

The clinical
development, manufacturing, sales and marketing of our drug candidates are subject to extensive regulation by regulatory authorities
in the United States, the United Kingdom, the European Union, Australia and elsewhere. Despite the substantial time and expense
invested in preparation and submission of a Biologic License Application or equivalents in other jurisdictions, regulatory approval
is never guaranteed. The number, size and design of preclinical studies and clinical trials that will be required will vary
depending on the product, the disease or condition for which the product is intended to be used and the regulations and guidance
documents applicable to any particular product. Additionally, during the review process and prior to approval, the FDA and/or other
regulatory bodies may require additional data, including with respect to whether our products have abuse potential, which may delay
approval. The FDA or other regulators can delay, limit or deny approval of a product for many reasons, including, but not limited
to, the fact that regulators may not approve our or a third party manufacturer’s processes or facilities or that new laws may
be enacted or regulators may change their approval policies or adopt new regulations requiring new or different evidence of safety
and efficacy for the intended use of a product.

Successful results in clinical
trials and in the subsequent application for marketing approval are not guaranteed. If we are unable to obtain regulatory approvals, we
will not be able to generate revenue from our drug candidates. Even if we receive regulatory approval for any of our drug candidates,
our profitability will depend on our ability to generate revenues from their sale or the licensing of our technology.

Even if our drug