Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 9

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 9
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  we may experience competition from existing products or new products that may emerge;  
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  we and our licensors may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect our drug candidates; and  
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  we may not be able to obtain and maintain coverage and adequate reimbursement from third party payors.  
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If any of these risks materialize,
we could experience significant delays or an inability to successfully develop and commercialize our drug candidates we or our partners
may develop, which would have a material adverse effect on our business, financial condition and results of operations.

Positive results from preclinical studies of our drug candidates
are not necessarily predictive of the results of our planned clinical trials of our drug candidates

Positive results in preclinical
proof of concept and animal studies of our drug candidates may not result in positive results in clinical trials in humans. Many companies
in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results
in preclinical development or early stage clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks
can be caused by preclinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials,
including adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. Many
companies that believed their drug candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to
obtain FDA or other regulatory authority approval. If we fail to produce positive results in our clinical trials of our drug candidates,
the development timeline and regulatory approval and commercialization prospects for our drug candidates, and, correspondingly, our business
and financial prospects, would be negatively impacted.

Ongoing and future clinical trials of drug candidates may not
show sufficient safety and efficacy to obtain requisite regulatory approvals for commercial sale

Phase I and Phase II clinical
trials are not primarily designed to test the efficacy of a drug candidate but rather to test safety and to understand the drug candidate’s
side effects at various doses and schedules. Furthermore, success in preclinical and early clinical trials does not ensure that later
large-scale trials will be successful nor does it predict final results. Acceptable results in early trials may not be repeated in later
trials