Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 56

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 56
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 an expected start date. RAD102 targets brain tumors.

RAD201(Nano-mAb HER-2 Breast Diagnostic)
andRAD202(Nano-mAb Her-2 Breast Therapeutic)

The camelid derived single
domain antibody RAD201 is a novel antibody, engineered to bind to imaging isotope Tc-99m which targets a protein called human epidermal
growth factor receptor 2 (“ HER-2”) often associated with breast cancer. HER-2 overexpression in breast cancer is often associated
with aggressive disease and consequently, poor prognosis.

In December 2021, we announced
the completion of a Phase I study investigating the potential safety, dosimetry and efficacy of RAD201 in HER-2 positive breast cancer
subjects, in concert with its collaborators at Shanghai General Hospital in China and NanoMab in London, UK and Hong Kong, China. The
study, conducted at Shanghai General Hospital under the direction of Dr Jinhua Zhao, imaged 40 histopathologically-proven breast cancer
subjects. The procedure involved injecting the subject with RAD201, allowing time for the single domain antibody to localize at the HER-2
positive cancer and clear from non-target organs, then imaging the subject two hours post-injection using a Single Photon Emission Computed
Tomography (“ SPECT”) camera. This procedure yielded clear and easy to interpret images. The images provided outstanding target-to-background,
making quantification straightforward and RAD201 SPECT imaging a potentially fast and non-invasive way of gaining insight to HER-2 overexpression
in breast cancer primary and metastatic lesions. No concerning safety signal was observed, with only a minor grade 1 adverse event reported
as unrelated to RAD201.

RAD201 Phase I was performed
in China after having received approval from the Ethics Committee of the Shanghai hospital where the trial was conducted. The clinical
data gathered outside the United States in Phase I may not be accepted by the FDA or other comparable foreign regulatory authorities,
which could result in the need to conduct additional trials in the United States or elsewhere. Currently, we have postponed our plan to
further develop RAD201. The postponement was decided in late 2022, when we reassessed the prioritization of the development of our clinical
assets. In particular, we decided to prioritize the development of therapeutic clinical assets (such as RAD202) over diagnostic clinical
assets (such as RAD201).

The results of RAD201 Phase
I, however, supported our decision to start the RAD202 trial. RAD202