• Returned to mission of developing world's first molecular MRI imaging technology
• Achieved milestone of filing first Investigational New Drug (IND) application with FDA
• Strengthened board and management team with new appointments

In 2025, Imagion Biosystems returned to its mission of developing the world's first molecular MRI imaging technology. The company successfully reestablished the development plan for its MagSense® HER2 imaging agent and achieved a significant milestone in filing its first application for an Investigational New Drug (IND) with the U.S. Food and Drug Administration. In the second half of the year, Imagion Biosystems strengthened its Board and management team with the addition of Nina Webster as a non-executive director and the appointment of Ward Detwiler as President of the US operational subsidiary. The company reestablished its foothold and, with the support of the capital markets, is prepared to move forward with a Phase 2 clinical investigation of its MagSense molecular MRI technology. The loss for the Consolidated Entity after providing for income tax amounted to $4,309,456, higher than the prior year due to the restart of Research and Development activities associated with the MagSense® HER2 imaging agent. Imagion Biosystems aims to begin the MagSense® HER2 Breast Cancer Phase 2 study in the first quarter of the 2026 calendar year, pending FDA review and approval.

The Consolidated Entity expects to maintain general and administration costs at a similar level as at the end of 2025 for the foreseeable future.

The Consolidated Entity aims to begin the MagSense® HER2 Breast Cancer Phase 2 study in the first quarter of the 2026 calendar year, depending on FDA review and approval. Key activities and objectives in the first half of calendar year 2026 include establishing and activating the initial clinical site(s), opening the study for enrolment, and dosing the first cohort of participants.