• Compelling results from Wayne State collaboration support Phase 2 trial design
• Strategic trial partners in place, preparing for Phase 2 trial in early 2026
• IND submission on track for December 2025

Imagion Biosystems has reached several important milestones towards commencing its MagSense® Phase 2 clinical trial for HER2 breast cancer in early 2026. The company has completed a strategic collaboration with researchers at Wayne State University, which has delivered highly encouraging results that strengthen the foundation of the planned Phase 2 trial. This has enabled Imagion to include a strong scientific rationale and justification for using a lower dose of the MagSense® HER2 Imaging Agent in the IND submission, addressing patient safety and trial efficiency. Additionally, the researchers were able to establish optimized MRI sequences for the reduced imaging agent dose while still achieving the expected detection sensitivity. The impact of the WSU program on the study design includes reducing the dose of the imaging agent, selecting optimized MRI sequences to improve clinical workflow and reduce scan times, and incorporating quantitative imaging techniques that could lead to AI-ready imaging data. Imagion is on track to submit the IND application to the FDA during December 2025, and pending FDA acceptance, the Phase 2 study is expected to commence in early 2026. To ensure the planned Phase 2 study can initiate as quickly as possible, the company has completed a vendor qualification process and selected all the required strategic trial partners in the US. These partners will play a crucial role in site identification, participant recruitment, and study logistics and data analysis.

The MagSense® Phase 2 Clinical Trial for HER2 Breast Cancer is expected to be completed in 18-24 months upon commencement of the program, following acceptance of the IND by the FDA.