On April 7, 2026 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, and Siemens Healthineers, reported the signing of a supply agreement in which Siemens Healthineers will radiolabel and distribute RAD101 with Fluorine-18 (18F). RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins.

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"This partnership marks a milestone for Radiopharm, as we bring RAD101 closer to improving diagnostic precision for brain metastases," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We have made considerable progress advancing RAD101 through the clinic, and the second interim analysis showed 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings. In addition, the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the secondary objectives). This partnership ensures our supply of 18F-labeled RAD101 in the U.S. for the initiation of the multi-center global Phase 3 registrational trial following our readout of topline data in the Phase 2b trial in the first half of 2026."

The company has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and the treatment effect of brain metastases originating from solid tumors of different origins, including leptomeningeal disease.

Under the terms of the agreement, Siemens Healthineers will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S.

"As the leader in PET imaging solutions, we are pleased to partner with Radiopharm Theranostics to provide our reliable and specialized manufacturing capabilities," said Barry Scott, Head of Radiopharma at Siemens Healthineers. "With our large national network of radiopharmacies in the U.S., we are uniquely qualified and well-equipped to deliver RAD101 as well as other novel PET biomarkers to assist in the fight against challenging diseases such as brain metastases, a condition that more than 300,000 people are diagnosed with in the U.S. each year."

(Press release, Radiopharm Theranostics, APR 7, 2026, View Source [SID1234664228])