Ann: RAD Granted US FDA Fast Track for RAD101 Metastases Imaging, page-4

11 JUNE 2025
Radiopharm Theranostics Granted U.S. Food and Drug
Administration Fast Track Designation for RAD101 Imaging in Brain
Metastases
RAD101 in U.S. Phase 2 clinical trial to distinguish between recurrent disease and treatment effect of
brain metastases originating from solid tumors of different origin

Sydney, Australia – 11 June 2025 – 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, today announced that the U.S. Food
and Drug Administration (FDA) has granted Fast Track Designation for RAD101 to distinguish
between recurrent disease and treatment effect of brain metastases originating from solid tumors of
different origin including leptomeningeal disease.

RAD101 is the Company’s novel imaging small molecule that targets fatty acid synthase (FASN), a
multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors,
including cerebral metastases.

“The FDA’s Fast Track Designation for RAD101 highlights the seriousness of recurrent brain
metastases as a condition and the unmet medical need for innovative products that can differentiate
between tumor recurrence and radiation necrosis or pseudprogression,” said Riccardo Canevari, CEO
and Managing Director of Radiopharm Theranostics. “RAD101 represents a promising advancement
in improving diagnostic precision for brain metastases, offering hope for more effective clinical
decision-making in the over 300,000 patients diagnosed annually in the U.S. We are excited to
advance our Phase 2 clinical trial and anticipate sharing topline results in the second half of 2025.”
The FDA’s Fast Track designation is designed to facilitate the development and expedite the review
of drugs that are intended to treat serious or life-threatening conditions and demonstrate the
potential to address an unmet medical need. A Sponsor that receives Fast Track designation may be
eligible for more frequent meetings and communications with the FDA and rolling review of any
application for marketing approval. A Sponsor’s drug receiving Fast Track designation also may be
eligible for Priority Review if relevant criteria are met.

About the Phase 2 Clinical Trial of RAD101

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic
performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid
tumors of different origins. The primary objective of the study is concordance between 18F-RAD101
positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with
suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity
of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic
radiosurgery (SRS)-treated brain metastases.