• Investigational New Drug Application Submitted to FDA for Phase 2 clinical trials for HER2 Breast Cancer
• MagSense® imaging agent Phase 2 study in HER2 positive breast cancer patients planned initiation anticipated Q2 2026
• Clinical-study site engagement completed with four sites in the USA to commence upon FDA approval

Imagion Biosystems (ASX: IBX), a company dedicated to improving healthcare outcomes through the early detection of cancer using its proprietary MagSense® imaging technology, released its Appendix 4C and Quarterly Activities Report for the quarter ending 31 January 2026 (Q1 FY2026). The key highlights include the submission of the company's first Investigational New Drug (IND) application to the FDA, the planned initiation of the MagSense® Phase 2 study in HER2 positive breast cancer patients in Q2 2026 following anticipated IND approval, and the completion of clinical-study site engagement with four sites in the USA to commence upon FDA approval. The Phase 2 study will investigate the pharmacokinetics, dose, imaging schedule, and diagnostic performance of the MagSense® Imaging Agent in participants with HER2+ Breast Cancer. The company has also agreed to amend the terms of the Convertible Securities Agreement with Mercer Street Global Opportunity Fund, LLC to provide an additional $300,000 and extend the maturity date for the remaining existing notes. Imagion's cash balance at 31 March 2026 was AU$0.273 million, with an operating cash outflow of AU$1.279 million in the quarter. The company anticipates higher operating cash outflow over the next quarter as it incurs costs associated with initiating the Phase 2 clinical study.

All activities are focused on the company's readiness to commence the Phase 2 study while the IND application is under review by the FDA. Once approval of the IND application has been received, Imagion will initiate clinical site contracts and enrolment of patients into the study following ethics approval and site initiation.