Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 11

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 11
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 candidates receive regulatory approval, it may
still face development and regulatory difficulties that may delay or impair future sales of drug candidates

Even if we or our licensing
partners receive regulatory approval to sell any drug candidates, the relevant regulatory authorities may, nevertheless, impose significant
restrictions on their indicated uses, manufacturing, labelling, packaging, adverse event reporting, storage, advertising, promotion and
record keeping or impose ongoing requirements for post-approval studies. In addition, regulatory agencies subject a marketed product,
its manufacturer and the manufacturer’s facilities to continual review and periodic inspections. Previously unknown problems with
the drug candidate, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the
product, and could include withdrawal of the product from the market. In addition, new statutory requirements may be enacted or additional
regulations may be enacted that could prevent or delay regulatory approval of our drug candidates.

We have limited manufacturing experience with our drug candidates

We have no manufacturing capabilities
and are dependent on third parties for cost effective manufacture and manufacturing process development of the company’s drug candidates.
Problems with third party manufacturers or the manufacturing process, or the scaling up of manufacturing activities as such may delay
clinical trials and commercialization of our drug candidates.

To the extent we rely significantly on contractors, we will be
exposed to risks related to the business and operational conditions of our contractors

We are a small company, with
few internal staff and limited facilities. We are and will be required to rely on a variety of contractors to manufacture and transport
our drug candidates, to perform clinical testing and to prepare regulatory dossiers. Adverse events that affect one or more of our contractors
could adversely affect us, such as:

  a contractor is unable to retain key staff that have been working on our drug candidates;  

  a contractor is unable to sustain operations due to financial or other business issues;  

  a contractor loses their permits or licenses that may be required to manufacture our drug candidates; or  
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  errors, negligence or misconduct that occur within a contractor may adversely affect our business.  
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We depend on, and will continue to depend on, collaboration and
strategic alliances with third partners. To the extent we are able to enter into collaborative arrangements or strategic alliances, we
will be exposed to risks related to those collaborations and alliances

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