RADX

Single, multicenter Phase 3 imaging trial of approximately 280 patients with brain metastases designed to demonstrate sensitivity and specificity above prespecified performance thresholds

Phase 3 imaging trial of RAD101 in recurrent brain metastases from solid tumors expected to initiate in 1Q27 following successful end-of-phase 2 meeting with U.S. Food and Drug Administration

Positive safety and favourable biodistribution seen in all subjects dosed Imaging data in all evaluable pancreatic cancer patients demonstrated significant tumor uptake Data support the targeting potential of RAD301 and continuation of its clinical development SYDNEY, Australia, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced positive data from the Phase 1 imaging trial designed to evaluate the safety, biodistribution and dosimetry of RAD 301 in healthy volunteers and subjects with Pancreatic Ductal Adenocarcinoma (PDAC).

Doses first patient at 70 mCi dose of RV-01, the first radiopharmaceutical therapeutic developed in Company's joint venture with MD Anderson Cancer Center Doses first patient at 70 mCi dose of RV-01, the first radiopharmaceutical therapeutic developed in Company's joint venture with MD Anderson Cancer Center

Advancing RAD202 Phase 1 trial to next dose level of 180mCi in patients with HER2+ advanced solid tumors Previous diagnostic study of RAD202 in ten HER2-positive breast cancer patients demonstrated clinical proof-of-concept with positive safety and biodistribution SYDNEY, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “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 it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 180mCi in the Phase 1 ‘HEAT' clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors1. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.

NEW YORK and SYDNEY, July 24, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics Limited (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announces that it has entered into a Securities Purchase Agreement (“SPA”) with certain U.S. accredited institutional investors to issue, in a registered direct offering, 1,281,646 American Depositary Shares (“ADSs”), representing 384,493,800 ordinary shares (with each ADS representing 300 ordinary shares) of the Company, at an offering price of US$3.16 per ADS, to raise aggregate gross proceeds of approximately US$4.1 million, before deducting the placement agent fees and other offering expenses payable by the Company.

First RECIST-confirmed durable Partial Response at current highest dose level #3 (90mCi) with the patient remaining progression free beyond seven months

RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint. 14 patients with available data from six-month follow-up and biopsy show preliminary 86% (12/14) Sensitivity (secondary objective).

Completed enrolment in Phase 2b clinical trial of imaging agent RAD 101 in patients with recurrent brain metastases following earlier announcement of interim data demonstrating concordance with MRI (the primary endpoint) in 90% of evaluable subjects (18/20)

Data from the interim analysis in Phase 2b trial of RAD101 showed significant and selective tumor uptake in brain metastases, with 90% concordance (Primary Endpoint) with MRI.