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PIVALATE ACHIEVES POSITIVE PHASE 2 DATA IN BRAIN METS TRIAL

18 OCTOBER 2022

• F-18 Pivalate PET shows high uptake regardless of origin of primary tumour
• F-18 Pivalate can be used to monitor cerebral metastases
• Patients without previous external beam radiation show higher tumour uptake, while those previously treated show a trend towards lower uptake

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to announce that Imperial College London's F-18 Pivalate (RAD 101) has achieved successful Phase 2a data in patients with brain metastases, having shown significant tumour uptake that was consistent and independent from the tumour origin.

A full presentation of the results will take place at the 34th EORTC/AACR/NCI symposium in Barcelona (26-28 October 2022). The study was funded by the Medical Research Council and will also be published in a peer-reviewed journal in due course.

“We are very pleased to see a new molecule and an innovative mode of action showing significant results in brain cancer metastases,” said Radiopharm’s CEO & Managing Director Riccardo Canevari.

“The team at Imperial College London, led by Professor Eric Aboagye, did a tremendous job. F-18 Pivalate and its potential therapeutic variations, currently under development, represent a promising theranostic approach to target brain metastases and potentially other brain tumours.

“These positive and encouraging results will inform F-18 Pivalate accelerated future development and we are looking forward to starting conversations with medical experts and regulatory agencies.”

Professor Aboagye, from Imperial College London and the lead inventor of 18-F Pivalate, added:

“This technology, when compared to the current clinical standard in PET imaging, has showed superior imaging performance in several cancers. We’re very pleased to see this interim data further confirms its potential.”

Radiopharm acquired an exclusive worldwide licence for the Pivalate platform technology from Cancer Research Technology Limited and Imperial College London, and has a Sponsored Research Agreement on new analogues with Professor Aboagye.

The Company requests to remain in voluntary suspension until Thursday, 20 October 2022, pending an announcement regarding a capital raise.