Radiopharm Theranostics RAD101 Phase 3 Trial Set for 1Q27; RAD301 Data Positive
Radiopharm Theranostics announced significant progress across its pipeline, highlighted by a successful End-of-Phase 2 meeting with the FDA for RAD101, paving the way for a Phase 3 imaging trial in recurrent brain metastases in 1Q27. The company also reported positive Phase 1 imaging data for RAD301 in pancreatic cancer and advanced RAD202 in its Phase 1 HER2+ solid tumor study. A partnership with Siemens Healthineers was established for RAD101 manufacturing. Financially, Radiopharm received a substantial R&D tax refund and an advance on future refunds, strengthening its cash position to $7.5 million.
Key Highlights
- Phase 3 imaging trial of RAD101 in recurrent brain metastases expected to initiate in 1Q27 after successful FDA End-of-Phase 2 meeting.
- Positive Phase 1 imaging data reported for RAD301, supporting advancement to Phase 2 development in pancreatic ductal adenocarcinoma.
- Advanced RAD202 to the fourth dosing cohort in the ongoing Phase 1 ‘HEAT’ study for HER2+ solid tumors.
- RAD101 demonstrated 93% concordance with MRI in Phase 2b trial for brain metastases, meeting primary endpoint.
- Partnership with Siemens Healthineers to manufacture and distribute 18F-labeled RAD101 for Phase 3 trial.
- Received A$5.89 million R&D tax refund for FY25 and $8 million advance from Rockford Capital.
- Closing cash at quarter-end was $7.5 million, up from $4.1 million in the prior quarter.
Price Impact
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