Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 57

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 57
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 will be composed of the same single domain antibody construct as
RAD201, but will incorporate the therapeutic, beta particle-emitting isotope, Lu177 that has the potential to kill cancer cells. RAD202
targets HER2 breast and gastric cancer. The Phase I of RAD 202 started in the second half of 2024 in Australia, to enroll 21 patients
and is anticipated to complete in the first half of 2026. We received Ethics Committee approval in Australia to start Phase I of RAD202
in the fourth quarter of 2024. The Phase II of RAD202 is expected to start in the United States in the second half of 2026, to enroll
50 patients and to complete by the beginning of 2028. We will seek IND approval from the FDA to start a Phase II trial with
RAD202 after completion of Phase I.

RAD203(Nano-mAb PDL1 Non-small Cell Lung
Diagnostic)and RAD204(Nano-mAb PDL1 Non-small Cell Lung Therapeutic)

The camelid derived single
domain antibody RAD203 is engineered to bind to imaging isotope Tc-99m which targets a protein called programmed cell death ligand (PDL1)
expressed in non-small cell lung cancer (NSCLC), the most common type of lung cancer and a high unmet medical need. NanoMab completed
a Phase I imaging study in 40 NSCLC patients in Shanghai and London. RAD 203 has been licensed to Lantheus Molecular Imaging (“ Lantheus”)
with worldwide rights (excluding China). Thus, Lantheus has been granted the rights to develop RAD203 and the rights to market it worldwide,
while we retained the rights to develop RAD203 and the rights to market it in China only. The technology is currently in Phase II imaging
trial in NSCLC.

In March 2022, Radiopharm
signed a Letter of Intent with global oncology provider GenesisCare to commence a Phase I therapeutic trial using RAD204, incorporating
the therapeutic, beta particle-emitting isotope, Lu177. It will be the first human clinical trial exposure to this compound and, if successful,
will set the stage for expanded development in lung cancer patients whose cancer is sensitive to treatment with this type of immunotherapy.
RAD204 will deliver increasing doses on Lu177 (beta emitter isotope) to the cancer cell, disrupting their tumor DNA and killing the tumor
cell as a result. Potentially, it could be used as a single agent