Imagion Biosystems HER2 Breast Cancer Program Update

• Manufacturing of MagSense® HER2 Breast Cancer Imaging Agent for Phase 2 trial completed
• Collaboration with Siemens and Wayne State University on AI imaging protocol optimization ongoing
• $3.5M capital raise completed to fund HER2 Phase 2 trial and other programs

Imagion Biosystems Limited (ASX: IBX) has provided an update on the progress of its HER2 Breast Cancer program. The company has completed the manufacturing of the MagSense® HER2 Breast Cancer Imaging Agent for the planned Phase 2 clinical trial, a major milestone. The required analytical testing is now underway ahead of the Investigational New Drug (IND) application submission to the U.S. Food and Drug Administration (FDA) in the second half of 2025. The company's collaboration with Siemens and Wayne State University (WSU) to develop optimized protocols for the MagSense® imaging agent is also progressing well, with results expected in the coming weeks to support the IND filing. Additionally, Imagion Biosystems has completed a AU$3.5 million capital raise, which will be used to commence the HER2 Breast Cancer Phase 2 clinical trial as well as preclinical studies for the prostate cancer and ovarian cancer programs. The company noted that the ongoing U.S. federal government shutdown is not expected to impact the planned IND submission for the HER2 Breast Cancer Phase 2 trial.

The company remains on track to submit its Investigational New Drug (IND) application to the U.S. FDA for the HER2 Breast Cancer Phase 2 clinical trial in the second half of 2025.