Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 55

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 55
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F-FPIA (RAD101)
in high- and low-grade glioma, no adverse effects were recorded and tissue uptake, other than in the liver and kidneys, was low in 24
healthy volunteers.

In October 2022, the
interim data of RAD101 Phase IIa imaging trial in 17 brain metastases from different primary tumors, were presented at the 34th
Joint Meeting of the European Organization for Research and Treatment of Cancer (EORTC)/American Association for Cancer Research
(AACR) / US National Cancer Institute (NCI) symposium in Barcelona. The trial analyzed whether RAD101 uptake is higher over
background in cerebral metastases and whether Stereotactic Radiosurgery (SRS) impacts RAD101 uptake at early time points (4-8 weeks)
when changes in imaging outcome can influence future patient management. There were two cohorts of patients, 11 treatment naïve
and 6 SRS treated (4-8 weeks post treatment). The primary endpoint was biodistribution of18F-FPIA with different primary
tumors. Tumor-to-background ratio was lower in the cohort that received radiotherapy 2.92 ± 0.26 (p = 0.074) and
comparatively, dynamic contrast enhanced (DCE)-Kep - symmetric exchange rate of MRI contrast agent across the capillary wall - was
markedly lower in the same group. The results showed statistical significance due to a high uptake regardless of origin of primary
tumor, indicating RAD101 can be used to detect and monitor cerebral metastases, supporting therapeutic development. The results are
to be published in a peer-reviewed journal.

In July 2024, we received
the IND approval from the FDA to conduct a Phase IIb for RAD101 in the United States. RAD101 targets brain metastases. Phase IIb is expected
to enroll 30 patients and is expected to complete by Q1 2026. Phase III is planned to be conducted in the United States by enrolling 150
patients with a start date expected in in the second half of 2026 and is expected to complete in the beginning of 2028. The clinical data
gathered outside the United States in Phase I and II 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. While RAD102 Phase I is planned to be conducted
in United States, we cannot currently provide