Imagion Reports $1.66M Loss, Secures $3.5M Funding, Moves Toward FDA Phase 2 Trial
Imagion Biosystems reported a $1.66 million loss for the half-year ending June 2025 while progressing its MagSense® HER2 Imaging Agent towards a Phase 2 FDA trial and securing $3.5 million in new funding.
- Half-year loss increased slightly to $1.66 million
- Manufacturing of MagSense® HER2 Imaging Agent initiated for Phase 2 trial
- FDA pre-IND feedback received, IND submission planned for late 2025
- Key clinical advisors and principal investigator appointed
- Capital raising secured $3.5 million, with shareholder approval pending for second tranche
Financial Performance and Operational Focus
Imagion Biosystems Limited has reported a net loss of $1.66 million for the half-year ended 30 June 2025, a modest increase from the $1.53 million loss recorded in the same period last year. Despite the ongoing losses, the company remains focused on advancing its core biotechnology projects, particularly the MagSense® HER2 Imaging Agent, which is poised to enter a critical phase of clinical development.
Progress on MagSense® HER2 Clinical Development
In February 2025, Imagion commenced manufacturing of the MagSense® HER2 Imaging Agent, a key milestone ahead of its planned Phase 2 clinical study. The company engaged with the U.S. Food and Drug Administration (FDA) through a pre-Investigational New Drug (IND) meeting, receiving feedback that has allowed it to proceed with the IND submission. This submission is expected in the September quarter, with FDA approval anticipated by the December quarter of 2025.
To support the clinical trial, Imagion appointed Dr. William Dooley, a surgical oncologist with extensive credentials from Vanderbilt, Johns Hopkins, and Oxford, as Principal Investigator. Additionally, Dr. Leonardo Kayat-Bittencourt, a recognized expert in prostate cancer imaging, has been engaged as a clinical advisor to guide the company’s prostate cancer imaging program.
Capital Raising and Financial Position
Post-period, Imagion secured $3.5 million in firm commitments through a two-tranche capital raising. The first tranche, completed in August 2025, raised $675,000 through the issue of 45 million shares at $0.015 each. The second tranche, worth approximately $2.8 million, awaits shareholder approval at an Extraordinary General Meeting scheduled for September 2025. Investors in both tranches will receive free attaching listed options exercisable at $0.04, expiring in December 2027.
Despite the capital injection, the company faces material uncertainty regarding its ability to continue as a going concern, with net liabilities of $2.28 million and net current liabilities nearing $3.88 million as of June 30. However, directors remain confident that the capital raising and existing funding facilities, including a $10.78 million approved facility with Mercer Street Global Opportunity Fund, will support operations for the next 12 months.
Incentives and Governance
Imagion continues to incentivize its leadership and key personnel through share-based payments and options. During the half-year, options were granted to directors and the Chief Business Officer, linked to clinical milestones such as IND submission and Phase 2 study progress. These arrangements align management’s interests with the company’s clinical and commercial objectives.
Overall, Imagion Biosystems is navigating the challenging biotech development landscape with steady clinical progress and a bolstered financial position, setting the stage for upcoming regulatory milestones and shareholder engagement.
Bottom Line?
Imagion’s next 12 months hinge on FDA approval and successful capital raising completion to sustain its clinical ambitions.
Questions in the middle?
- Will the FDA approve the IND submission on schedule to enable the Phase 2 trial?
- Can the company secure shareholder approval for the second tranche of its capital raising?
- How will ongoing cash burn and net liabilities impact long-term sustainability beyond the next 12 months?
