• Positive FDA feedback supports IND filing plans in Q4 2025
• Collaboration with Wayne State University to optimize MRI protocols
• $3.5M capital raise completed to fund IND submission and Phase 2 trial
• Manufacturing of MagSense® imaging agent completed

Imagion Biosystems (ASX: IBX) released its Appendix 4C and Quarterly Activities Report for Q3 FY2025, highlighting significant progress in advancing its MagSense® HER2 breast cancer imaging agent program. The company received positive feedback from the FDA regarding its plans to submit an IND application for a Phase 2 study of the MagSense® HER2 Imaging Agent. Imagion also entered into a collaboration with Wayne State University to develop optimized imaging protocols for the MagSense® agent, which will support the IND application. Additionally, the company completed a $3.5M capital raise to fund the IND submission and initiate the Phase 2 clinical trial. Subsequent to the quarter, Imagion announced the completion of manufacturing of the new clinical lot of the MagSense® HER2 Imaging Agent, an essential step in the IND application process. The company expects to submit the IND application to the FDA in Q4 2025 and commence the Phase 2 study upon IND approval. Imagion's cash balance at the end of the quarter was AU$3.2 million, providing a strong funding position to commence the planned clinical study.

Imagion expects to submit the IND application for the MagSense® HER2 Breast Cancer Imaging Agent to the FDA in Q4 2025. Commencement of the Phase 2 study is subject to approval of the IND by the FDA.

Following the anticipated approval of the IND application, Imagion will execute clinical site contracts for the planned multi-site open label Phase 2 study, with enrollment commencing after site initiation and training.