Imagion Biosystems Doubles Loss as It Files FDA IND for MagSense® HER2
Imagion Biosystems reported a $4.31 million loss for 2025 amid resumed R&D and successfully filed an Investigational New Drug application with the FDA, setting the stage for a Phase 2 clinical trial.
- Net loss doubled to $4.31 million in 2025
- Raised $3.5 million in equity capital to fund clinical development
- Filed FDA IND application for MagSense® HER2 molecular MRI imaging agent
- Strengthened board and US management with key appointments
- Maintained $1.85 million cash balance amid ongoing convertible note financing
Financial Performance and Capital Raising
Imagion Biosystems Limited has reported a net loss of $4.31 million for the year ended 31 December 2025, more than doubling the prior year's loss of $2.07 million. This increase reflects the company's strategic decision to restart research and development activities, particularly in preparation for a Phase 2 clinical trial of its MagSense® HER2 molecular MRI imaging agent.
To support these efforts, Imagion successfully raised $3.5 million in equity capital through a two-tranche placement during the second half of 2025. The funds are earmarked for advancing clinical development and general working capital needs, underpinning the company’s commitment to its cancer diagnostic technology pipeline.
Clinical and Regulatory Milestones
A significant highlight for the year was the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in February 2026 for the MagSense® HER2 imaging agent. This milestone marks a critical regulatory step toward initiating a multisite Phase 2 clinical study in the United States, pending FDA approval. The company has also completed manufacturing and testing of the imaging agent to meet stringent regulatory standards, and collaborated with MRI experts at Wayne State University to optimise imaging protocols.
Leadership and Strategic Appointments
Imagion strengthened its leadership team during 2025 with the appointment of Dr Nina Webster, Managing Director and CEO of Dimerix Ltd, as a non-executive director, and Ward Detwiler as President of its U.S. subsidiary. Additionally, the company brought on Dr Leonardo Kayat-Bittencourt, a leading prostate cancer clinical advisor, to bolster its expertise in imaging for prostate cancer. These appointments reflect a strategic focus on both operational growth and scientific excellence.
Financial Position and Risks
At year-end, Imagion held $1.85 million in cash and cash equivalents, supported by a convertible note facility with Mercer Street Global Opportunity Fund, LLC, which remains a key financing source. The company’s net liabilities stood at $2.16 million, with auditors highlighting material uncertainty regarding the going concern due to ongoing losses and net liabilities. The company acknowledges typical biotech sector risks including funding requirements, regulatory approvals, intellectual property protection, and operational challenges.
Outlook
Looking ahead, the company aims to commence the MagSense® HER2 Phase 2 clinical trial in the first quarter of 2026, contingent on FDA approval. Key near-term objectives include activating clinical sites, enrolling patients, and dosing the first cohort. Progress on ovarian and prostate cancer imaging programs will depend on future funding availability. Investors will be watching closely for FDA feedback and the company’s ability to secure additional capital to sustain its development pipeline.
Bottom Line?
Imagion Biosystems’ 2025 results underscore the high-stakes nature of biotech innovation as it pushes forward with clinical milestones amid financial pressures.
Questions in the middle?
- When will the FDA complete its review of the MagSense® HER2 IND application?
- What is the company’s plan to secure additional funding beyond current cash and convertible notes?
- How will the upcoming Phase 2 trial results impact investor confidence and share price?
