Quarterly Activities/Appendix 4C Cash Flow Report

Key points

• Ethics Approval received to start Phase 1 therapeutic trial of RAD202 for HER2-positive cancers
• Ethics Approval granted to expand RAD204 trial to five additional cancer types
• IND Approval for RAD 101 Phase 2b Imaging trial in Brain Mets & BAMF Health partnership

Full summary

Radiopharm Theranostics, a developer of a world-class platform of radiopharmaceutical products for diagnostic and therapeutic uses, has provided a summary of its activities for the quarter ended 31 December 2024. Key highlights include receiving ethics approval in Australia to initiate a Phase 1 trial of 177Lu-RAD202 for HER2-positive metastatic solid tumors, and expanding the scope of its ongoing Phase 1 trial of the radiotherapeutic 177Lu-RAD204 to include five additional PD-L1-positive solid tumors. The company also announced FDA IND approval for its 18F-RAD 101 Phase 2b imaging trial targeting brain metastases, and a strategic co-development partnership with Lantheus to advance clinical development of innovative radiopharmaceuticals in Australia. Additionally, Radiopharm completed preclinical studies for its KLK3-targeting radiotherapeutic, RAD 402, and partnered with AtomVie Global Radiopharma to develop and manufacture 177Lu-BetaBart, a radiopharmaceutical targeting B7-H3. The company also achieved a Nasdaq listing for its American Depositary Shares (ADSs) and appointed Noel Donnelly as a Non-Executive Director.

Guidance

The company's previous guidance of a cash runway to mid-2026 remains unchanged.