Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 45

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 45
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 light of the several regulatory steps needed to receive
such approvals, we are currently unable to determine what percentage of the addressable global market size we will be able to target with
our clinical products.

Nuclear Medicine and Theranostics

Nuclear medicine is a medical
specialty that uses radioactive tracers (radiopharmaceuticals) to assess bodily functions and to diagnose and treat diseases, including
tumors. Specially designed cameras allow doctors to track the path of these radioactive tracers. In particular, radiation methods are
used to provide images of tumors and thus localize them. X-ray, computerized tomography (“ CT”) and magnetic resonance imaging
(“ MRI”) are used to elucidate gross tumor characteristics, including size, shape, and position, and are often used to guide
surgery or external beam radiation therapy. To improve resolution of a scan, contrast media may be injected into the patient. More recent
developments employ intravenous administration of a radioisotopic tracer which localizes to specific areas or cells, such as tumors. The
radiation emanating from the tracers are collected by an external detector such as a gamma camera revealing areas of accumulation. For
example, a bone scan (using Technetium-99m, 99mTc) is used to identify bone metastases. However, the radioisotope is absorbed in areas
of high bone turnover and, as such, is not specific for metastases with dark spots also resulting from bone healing (e. g. fracture) or
infection (e. g. osteomyelitis). Similarly, some metastases may not be detected on a bone scan.

Positron emission tomography
(“ PET”) and single photon emission computed tomography (“ SPECT”) are functional imaging techniques that use radiotracers
to visualize and measure changes and staging for many cancers. A variety of different tracers are used but the most common used in PET
is fluorodeoxyglucose (“ FDG”) which incorporates isotopic fluorine,18F-FDG is a glucose analog and concentrates
in areas of high metabolic activity. Currently, more than 90% of clinical PET studies in cancer in the United States are performed with18F-FDG. However, FDG is physiologically absorbed in some parts of the human body, such as the brain, heart and urinary tract
(it is excreted renally). In addition, false positives may result from infection, inflammation or granulomat