Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 60

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 60
---
,
choice of chelate and radionuclide having negligible impact on tumor targeting and organ kinetics of PSA-mAb. Treatment with 90Y-/225Ac-PSA-mAb
effectively reduced tumor burden and prolonged the animals’ survival. Effects of 90Y-PSA-mAb were more immediate than 225Ac-PSA-mAb
but less sustained. Complete responses were observed in seven of 18 225Ac-PSA-mAb and one of nine mice treated with 90Y- PSA-mAb. Pharmacokinetics
of 89Zr-PSA-mAb were consistent between NHPs and comparable with those in mice. The studies also provided information on the biodistribution
of the labelled agents. The authors concluded that their studies establish PSA-mAb as a new theranostic agent that allows highly specific
and effective downstream targeting of AR in PSA-expressing tissue and that the data supports the clinical translation of radiolabeled
PSA-mAb for treating prostate cancer.

A Phase I therapeutic trial
in Australia with RAD402, is anticipated to start after Ethics Committee approval that we expect to request in 2025. RAD402 target prostate
cancer. The clinical data that will be gathered outside the United States in Phase I for RAD402 and should form the basis for an IND submission
to FDA for Phase II in 2027.

RAD601(PTPµGlioblastoma Diagnostic)
and RAD602PTPµGlioblastoma Therapeutic)

PTPµ is a unique biomarker present only in
tumor cells but not healthy cells (see image below).

The technology has shown positive pre-clinical
data in human glioblastoma tumor models.

The radionuclide carrying
PTPµ-targeting agent holds the potential to be a therapy in a range of tumor types. The current standard of care is surgery followed
by nonspecific radiation and chemotherapy. There is an immediate need for targeted therapies with high sensitivity and specificity.

Our asset RAD601 combines
the PTPµ targeting agent with the isotope Gallium 68 (Ga86). RAD602 represents the following step in development. RAD601 combines
the PTPµ targeting agent with the isotope Lu177.

We do not expect to start
a clinical trial for RAD601 and RAD602 in the foreseeable future as these assets are still in the pre-clinical stage.

Intellectual Property

We have implemented a patent
filing strategy as we develop our