Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 50

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 50
---
 clinical assets (such as RAD201). RAD202 targets HER2 breast
and gastric cancer. The Phase I of RAD202 has 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 second half of 2027. We will seek Investigational New Drug (“ IND”) approval from the FDA to start a Phase II trial
with RAD202 after completion of Phase I.

In addition, in October 2023,
we received Ethics Committee approval in Australia to start a Phase I trial for RAD204. RAD204 targets non-small cell lung cancer. In
July 2024, the first patient in Phase I was dosed in Australia. We expect to recruit 27 patients for Phase I in Australia of RAD204 and
to complete it by the second half calendar 2026. We will seek IND approval from the FDA to start a Phase II trial with RAD204 after completion
of Phase I. We also expect to start Phase II for RAD204 by 2027 in the United States, to recruit 50 patients and to complete Phase II
by end of 2027.

Pivalate

Pivalate is a small molecule18F-FPIA radiotracer and is the invention of Professor Eric Aboagye of Imperial College London (“ ICL”). Pivalate
was developed for the detection, characterization and progression monitoring of glioblastoma and brain metastases using the novel agent,
Fluoropivalate (FPIA), tagged with the radioisotope Fluorine-18 (18F-FPIA) for imaging and potentially I-131 or At-211 for
therapeutic use.

The technology is based on
a short chain carbohydrate which utilizes the early steps of fatty acid oxidation and is very stable. Phase I diagnostic trial in high-
and low-grade glioma is complete. The clinical trials were performed at ICL, after the investigator received Ethics Committee approval.
Recent Phase IIa interim diagnostic results in Brain Metastases patients at ICL, showed high uptake regardless of origin of primary tumor.
This indicates that Pivalate has the potential to detect and monitor cerebral metastases. Patients without previous