Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 54

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 54
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, pancreatic, colorectal, head and neck and breast tumors. The pre-clinical studies conducted
suggest the candidate antibody is effective in eliminating resistant colorectal cancers in lab models. Radiopharm Ventures received IND
approval in July 2025 and plans to initiate a Phase I clinical trial in the United States by the end of 2025.

In addition, Radiopharm Ventures
intends to develop three additional clinical assets that target multiple solid tumors. These additional assets are intended to be developed
as therapeutic assets. Radiopharm Ventures is currently developing the pre-clinical study protocols to determine the clinical targets
of these additional assets.

Our Drug Candidates

RAD101(Pivalate Brain
Metastasis Diagnostic) andRAD102(Pivalate Therapeutic)

We believe Pivalate will prove
useful for the detection of glioblastoma and brain metastases, with potential for characterizing the grade of the disease and for monitoring
progression and treatment related changes. The compound, fluoropivalate (FPIA) in which the fluorine moiety has been substituted by the
isotopic form,18F, as18F-fluoropivalate or18F-FPIA (or 3-18F-fluoro-2,2- dimethylpropionic acid),
can be used for the imaging of tumors which have a high fatty acid turnover and/or are hypoxic or for which the commonly used18F-FDG
imaging agent is sub-optimal. 18F-FPIA attempts to overcome the limitations of currently available technologies such as PET,
FDG and MRI, due to their necrotic, inflammatory and high sugar uptake confounding factors.

The ICL investigators believe
that FPIA uptake will be higher in high-grade or fast-growing gliomas compared to less serious lower grade gliomas, because high-grade
tumors have greater fatty acid oxidation as a result of biochemical processes aimed at overcoming oxidative stress.

The utility of18F-FPIA
as an imaging agent has been evidenced in animal models of disease and it has been well-tolerated with no off-target tissue absorption
in a human study. Low levels of accumulation in excretory organs are likely to be inconsequential, but may rule out use in liver, bladder
and kidney cancers and may confound attempts to image prostate cancer.

The primary endpoint of RAD101
Phase I was safety and biodistribution. There was no secondary endpoint. In the Phase I diagnostic trial of18