Ann: FDA IND approval for Phase 2b trial in brain metastases, page-2

Radiopharm Theranostics receives FDA IND approval for Phase 2b
imaging trial in brain metastases
Sydney, Australia – 23 July 2024 – Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the
“Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology
radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that it has
received clearance for its Investigational New Drug (IND) application with the US Food and Drug
Administration (FDA), for F18-Pivalate (RAD 101).
Pivalate, labelled with the radioisotope F18, is a small molecule that selectively targets fatty acid
synthetase, which is overexpressed in brain tumours but not in normal cells. Pivalate is a novel
proprietary imaging agent under clinical investigation for the detection and characterisation of brain
metastases.
The IND approval is a clear recognition by the FDA of clinical data already generated for RAD 101 and
is a significant milestone towards starting a Phase 2b multi-center trial for the imaging of brain
metastases. Radiopharm anticipates having the first patient dosed during the fourth quarter of 2024.
Based on current enrolment expectations, the 30-patient Phase 2b read-out is expected by mid-2025
and will be followed by a Phase 3 registrational study.
Previously reported positive data from the Imperial College of London’s Phase 2a imaging trial of
Pivalate in 17 patients with brain metastases showed significant tumour uptake that was consistent
with and independent from the tumour of origin¹. This supports the potential use of pivalate to
monitor brain metastases.
“Pivalate represents a potential new target for radiopharmaceutical brain imaging agents, and its
unique mechanism of action may offer eligible patients and the medical community an alternative to
overcome the limitations of current standard of care for imaging brain metastasis.” said Riccardo
Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are very pleased by this FDA
approval as it allows us to commence late-stage clinical studies and address the high unmet medical
need in around 300,000 patients that are diagnosed with brain metastases in the U.S. every year.”
Radiopharm holds an exclusive global license for the pivalate platform technology and has a
collaboration in place with Imperial College of London to develop a therapeutic candidate leveraging
the same mechanism of action.

EV is about $10m, based on INDs and clinical trials. ALA approaching $200m based on just pre-clinicals. Totally undervalued.

GLTA