Cash Burn and FDA Timelines Pose Challenges for Imagion’s Next Phase
Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.
- MagSense® HER2 imaging agent manufacturing and testing completed
- IND submission to US FDA expected imminently
- Optimised MRI protocols developed with Wayne State University
- Ward Detwiler appointed President of US subsidiary
- Cash balance at AU$1.8 million with ongoing operating outflows
Manufacturing Milestone Achieved
Imagion Biosystems Limited (ASX, IBX) has reached a significant milestone by completing the manufacturing and analytical testing of its MagSense® HER2 Imaging Agent. This proprietary agent is central to the company’s mission to improve early cancer detection through molecular MRI technology. The high-quality manufacturing process, conducted via a preferred contract manufacturer, ensures the agent meets stringent standards required for human clinical trials.
The completion of these steps paves the way for the imminent submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), a critical regulatory hurdle before commencing the planned Phase 2 clinical trial.
Optimising Imaging Protocols with Academic Collaboration
Imagion’s collaboration with MRI specialists at Wayne State University has yielded optimised MRI protocols tailored for the MagSense® HER2 agent. Notably, the research demonstrated that the agent’s dosage could be reduced to one-third of that used in the Phase 1 trial without compromising image quality. This reduction not only enhances patient safety but also improves the agent’s clinical appeal.
Additionally, the team identified MRI sequences that enhance image clarity, a crucial factor since the Phase 2 trial aims to compare MagSense® imaging against standard ultrasound methods. These optimised protocols will be implemented across clinical sites, supported by an existing partnership with Siemens Healthineers.
Leadership Strengthened with US Appointment
In a strategic move to bolster its US operations, Imagion appointed Ward Detwiler as President of its US subsidiary effective December 2025. Detwiler brings extensive experience in commercialising MRI-based imaging technologies, having led SpinTech MRI through successful FDA approvals and market adoption. His leadership is expected to accelerate Imagion’s growth and help realise the potential of molecular MRI diagnostics.
Detwiler expressed enthusiasm about advancing the molecular MRI market and leveraging his expertise to bring diagnostic certainty to MRI, signalling a clear focus on commercialisation and strategic development.
Financial Position and Outlook
Imagion reported a cash balance of AU$1.8 million at the end of December 2025, down from AU$3.2 million the previous quarter, reflecting AU$1.4 million in operating cash outflows. These outflows were primarily driven by manufacturing and testing activities supporting the IND submission and upcoming clinical trial preparations.
The company also continued to reduce its convertible debt with Mercer Street Opportunities Fund LLC through partial conversions and repayments, improving its capital structure ahead of clinical milestones.
Looking ahead, the company expects the FDA to conduct a standard review of the IND application, after which clinical site contracts will be initiated and patient enrolment will begin under the leadership of Principal Investigator Dr. William Dooley at the University of Oklahoma.
Bottom Line?
With regulatory submission imminent and new leadership in place, Imagion is poised at a pivotal juncture in its clinical and commercial journey.
Questions in the middle?
- When exactly will the FDA complete its review and approve the IND application?
- How quickly can patient enrolment and Phase 2 trial initiation proceed post-approval?
- What are the company’s plans to extend its cash runway beyond the current 9-month estimate?
