Radiopharm Theranostics (RAD) Study Update summary

Study background and rationale

• Fatty acid synthase is crucial for brain cancer cell survival, enabling growth in a lipid-deprived environment and supporting resistance to therapies.

• Brain metastases mainly originate from lung, breast, and melanoma, accounting for 90% of cases, with poor overall survival.

• Differentiating between tumor recurrence and treatment effects post-stereotactic radiosurgery is challenging with MRI alone.

Study design and progress

• The first-in-class Phase IIb U.S. study is ongoing, enrolling patients with equivocal MRI findings after radiosurgery.

• The Phase 2b trial is a U.S. multi-center, open-label, single-arm study with 30 participants.

• Previous Phase IIa (22 patients) showed high tracer uptake in brain metastases, independent of tumor origin.

• The trial has reached 50% patient enrollment and received FDA Fast Track Designation.

• Phase IIb interim analysis is positive, with a final readout expected in the first half of 2026; Phase III (150 patients) is planned.

Interim analysis results and key findings

• 92% of evaluable patients in the Phase 2b trial achieved concordance with MRI, meeting the primary endpoint.

• Significant and selective tumor uptake was observed in suspected or recurrent brain metastases.

• PET imaging with RAD101 confirmed metabolic activity in brain metastases, even with equivocal MRI findings.

• High PET SUV (>2) correlates with shorter survival, while MRI contrast enhancement is less informative.

• PET imaging provides quantifiable data (SUV max) that can monitor tumor progression and guide early treatment decisions.