RAD202 (177Lu-RAD202) - (HEAT)

April 23, 2026: Radiopharm Theranostics (ASX: RAD; NASDAQ: RADX) provided a quarterly corporate update highlighting multiple clinical catalysts across its radiopharmaceutical pipeline.

18F-RAD101 (recurrent brain metastases imaging, Phase 2b): Completed enrollment/dosed the final patient in a single-arm U.S. Phase 2b study (30 patients planned). Previously reported interim data (18/20 evaluable) showed 90% concordance with MRI (primary endpoint). A Siemens Healthineers supply agreement was signed to radiolabel/distribute RAD101 with 18F. If interim findings are confirmed, the company expects to prepare a multi-center, multi-country Phase 3 registrational trial.

177Lu-RAD202 (HER2+ advanced solid tumors, ‘HEAT’ Phase 0/1): Presented AACR 2026 data showing meaningful tumor uptake, generally well tolerated with no dose-limiting toxicities, and organ absorbed doses within expected/acceptable ranges. DSMC recommended escalation to 130 mCi; cohort 2/3 data expected mid-2026.

177Lu-RAD204 (PD-L1-driven cancers, Phase 1): Completed cohort 2; DSMC-approved cohort 3 dosing at 90 mCi. Third-cohort data expected mid-2026.

Lu177-RV-01 (Betabart; B7H3, FIH Phase 1/2a): First patient dosed Feb 2026.

Tb161-RAD402 (KLK3, advanced prostate cancer, FIH Phase 1): First patient dosed March 2026.

Ga68-RAD301 (PDAC imaging, Phase 1): 8/9 patients dosed; last patient expected mid-2026; initial six patients showed safety and significant uptake in AvB6+ lesions.