Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 17

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 17
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 exposure to claims by an even greater number of persons than were involved in the clinical
trials once marketing, distribution and sales of our drug candidates begin. Regardless of merit or eventual outcome, liability claims
may result in:

  decreased demand for our drug candidates;  
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  injury to our reputation;  

  withdrawal of clinical trial participants;  

  costs of related litigation;  

  substantial monetary awards to patients and others;  

  loss of revenues; and  

  the inability to commercialize drug candidates.  

With respect to product liability
claims, we could face additional liability beyond insurance limits if testing mistakes were to endanger any human subjects. In addition,
if a claim is made against us in conjunction with these research testing activities, the market price of our ADSs may be negatively affected.

The outbreak of a pandemic could adversely impact our business,
including our non-clinical studies and clinical trials.

Public health crises such
as pandemics or similar outbreaks might adversely impact our business. In December 2019, a novel strain of coronavirus (COVID-19) first
surfaced in China and subsequently spread to most countries in the world.

As a result of the COVID-19 outbreak,
or similar pandemics, we have and may in the future experience disruptions that could severely impact our business, preclinical studies
and clinical trials, including:

  delays or difficulties in enrolling patients in our clinical trials;  

  delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;  

  delays or disruptions in non-clinical experiments and investigational new drug application-enabling good laboratory practice standard toxicology studies due to unforeseen circumstances at contr...  

  increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting a contagious virus, being forced to quarantine, or not wanting  

  diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of...  

  interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by national, state or local governments, employer...  
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  interruption or delays in the operations of the U. S. Food and Drug Administration, the European Medicines Agency, the Australian Therapeutic Goods Administration or other foreign regulatory