177Lu-RAD204

Jan. 28, 2026: Radiopharm Theranostics (ASX: RAD; NASDAQ: RADX) reported 1H fiscal 2026 financial results (ended Dec. 31, 2025) and outlined 2026 clinical/regulatory milestones across its radiopharmaceutical pipeline.

18F-RAD101 (FASN-targeted imaging; recurrent brain metastases): Interim Phase 2b U.S. single-arm data (first 12 patients) showed 92% of evaluable patients met the primary endpoint (MRI concordance). Trial enrollment is ongoing, with enrollment completion expected in Q1 2026. RAD101 has FDA Fast Track Designation; if interim findings are confirmed, the company plans to prepare a multi-center, multi-country Phase 3 registrational study.

177Lu-RAD202 (HER2; Phase 1 HEAT in HER2+ advanced solid tumors): DSMC recommended escalation to the next dose level (75 mCi) after completion of 30 mCi dosing. First-cohort data (first three patients) showed significant tumor uptake; no drug-related adverse events reported. Company expects Cohort 2 enrollment completion and data from Cohorts 1–2 in 1H 2026.

177Lu-RAD204 (PD-L1; Phase 1 in PD-L1-driven cancers): Enrollment completed for Cohort 2; DSMC approved dosing Cohort 3 at 90 mCi. In the 30 mCi cohort, 2/3 metastatic NSCLC patients had stable disease for 5.5 months; no drug-related adverse events reported.

Lu177-RV01 (B7H3; Phase 1): FDA IND clearance received July 2025; first patient dosing expected in Q1 2026.

Tb161-RAD402 (KLK3; prostate cancer): Australian HREC approval granted Nov. 2025; Phase 1 initiation anticipated in Q1 2026.

Ga68-RAD301 (αvβ6 integrin; PDAC imaging): Phase 1 continues (8/9 dosed); last patient expected Q1 2026. Initial data from first six patients showed safety and significant uptake; company plans to move to Phase 2 imaging in loco-regional pancreatic cancer.

Financials: Cash and cash equivalents of ~$34.52M (runway into 2027); October 2025 private placement commitments of ~ $35M. Interim data from additional cohorts for RAD202/RAD204 are expected mid-2026.