Imagion’s Cash Falls to AU$1.71M as R&D Spend Rises Ahead of IND Submission
Imagion Biosystems has progressed its MagSense HER2 breast cancer imaging agent towards a pivotal Investigational New Drug application with the FDA, backed by a solid funding runway exceeding 13 quarters.
- Progress on MagSense HER2 imaging agent manufacturing for Phase 2 study
- Planned IND application filing with FDA in Q3 2025
- Operating cash outflow increased to AU$0.959 million due to R&D ramp-up
- Cash balance at AU$1.71 million with AU$10.78 million undrawn convertible note facility
- Estimated funding runway of over 13 quarters at current burn rate
Progressing a Novel Cancer Imaging Technology
Imagion Biosystems Limited (ASX: IBX), a Melbourne-based biotech firm focused on early cancer detection, has reported steady progress in its MagSense HER2 breast cancer imaging agent program during the March quarter of 2025. The company is advancing towards a critical milestone: filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the third quarter of this year.
This IND filing is a gateway to initiating Phase 2 clinical trials in the second half of 2025, which aim to optimize testing parameters and evaluate the diagnostic performance of Imagion’s pioneering molecular MRI platform. The MagSense HER2 agent represents a first-of-its-kind non-radioactive imaging technology designed to improve specificity and early detection of breast cancer.
Manufacturing and Clinical Site Engagement
Manufacturing of the MagSense HER2 imaging agent is underway, aligning with the timeline to support the IND submission. Concurrently, Imagion has engaged with leading hospitals and cancer centers across the United States, securing preliminary support for the upcoming clinical studies. This proactive outreach is critical to ensuring robust trial enrollment and operational readiness once regulatory approvals are secured.
Financial Position and Cash Flow Dynamics
Financially, Imagion reported a cash balance of AU$1.71 million at quarter-end, down from AU$2.67 million in the previous quarter. The increased operating cash outflow of AU$0.959 million, up by AU$0.297 million, reflects intensified research and development activities associated with the MagSense HER2 program. Payments to related parties, primarily directors’ fees and reimbursable expenses, totaled approximately AU$116,000.
Importantly, the company holds an undrawn $10.78 million tranche of a $15 million convertible note facility with Mercer Street Global Opportunity Fund, LLC, providing a substantial liquidity buffer. Combining cash on hand and available financing, Imagion estimates it has funding to sustain operations for over 13 quarters at current expenditure levels, offering a comfortable runway to advance its clinical programs.
Looking Ahead: Regulatory and Clinical Milestones
Imagion’s near-term focus is on the IND filing with the FDA, anticipated in Q3 2025, which will enable the commencement of Phase 2 clinical trials later in the year. While the company is optimistic about regulatory approval and clinical site participation, the timeline remains contingent on FDA review and the availability of funds. The successful execution of these milestones could position Imagion as a frontrunner in molecular imaging diagnostics for cancer.
Beyond breast cancer, the company is also advancing R&D programs targeting prostate and ovarian cancers, signaling a broader pipeline of innovation leveraging its molecular imaging platform.
Bottom Line?
With a robust funding position and clear regulatory milestones ahead, Imagion Biosystems is poised to transform cancer diagnostics—pending FDA approval and clinical trial success.
Questions in the middle?
- What is the expected timeline for FDA IND approval and potential regulatory hurdles?
- How will manufacturing scale-up risks impact the Phase 2 study commencement?
- What partnerships or collaborations might Imagion pursue to accelerate clinical adoption?
