Highlights

• Imagion Biosystems secured firm commitments to raise $3.75 million through a two-tranche placement.

• Funds will support commencement of the MagSense HER2 Phase 1b/2 clinical trial across multiple US sites.

• The capital raising follows the company's recent FDA clearance of its Investigational New Drug (IND) application.

• Directors and management intend to subscribe for up to $100,000, subject to shareholder approval.

• Patient recruitment is expected to begin during Q3 2026.

Imagion Biosystems Limited (ASX:IBX) has secured firm commitments to raise $3.75 million through a strongly supported capital raising, providing funding to commence its Phase 1b/2 clinical trial for the MagSense HER2 imaging agent across multiple clinical sites in the United States. The funding follows the company's recent achievement of obtaining clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, allowing the clinical program to proceed.

Imagion Biosystems shares closed 20.00% lower at AUD 0.012 on 25 June 2026. Despite the decline during the session, the stock remains 20.00% higher over the past year, reflecting longer-term investor interest in the company's molecular imaging technology and clinical development progress.

About Imagion Biosystems

Imagion Biosystems is a clinical-stage medical imaging company developing molecular magnetic resonance imaging (MRI) technology designed to improve the early detection of cancer. Its proprietary MagSense platform uses non-radioactive magnetic nanoparticles to assist clinicians in identifying cancer with greater precision.

The company is initially targeting HER2-positive breast cancer, while also pursuing future applications in prostate and ovarian cancers. By combining molecular imaging with MRI, Imagion aims to enhance diagnostic accuracy without relying on radioactive tracers.

Capital Raising Supports Clinical Trial Commencement

The company confirmed it has received firm commitments to raise $3.75 million before costs through a two-tranche placement managed by CPS Capital Group Pty Ltd.

The placement was conducted with Australian sophisticated investors and family offices and follows the recent FDA clearance that enables the MagSense HER2 imaging agent to enter clinical testing.

According to the company, investor demand exceeded expectations, providing additional support for advancing its clinical development strategy.

Funding to Advance Phase 1b/2 Clinical Trial

The primary purpose of the capital raising is to fund the commencement of the company's Phase 1b/2 HER2 breast cancer clinical trial in the United States.

Imagion has already begun trial activation activities, with patient recruitment expected to commence later in the third quarter of 2026.

The funding will also support completion of the first patient cohort, allowing the company to progress through the initial stages of clinical evaluation.

Additional Development Activities Supported

Beyond trial commencement, proceeds will also be directed towards continued manufacturing of the MagSense imaging agent required for clinical development.

The company will also invest in:

• further development of intellectual property related to molecular MRI;

• collaborations with leading MRI specialists;

• development of quantitative MRI techniques; and

• artificial intelligence-based modelling designed to optimise the MagSense imaging platform.

These activities are intended to support ongoing clinical development alongside the trial program.

Placement Structure

The placement will be completed in two stages.

Tranche One comprises approximately 49.3 million new shares, raising around $592,000 using the company's existing placement capacity under ASX Listing Rule 7.1.

Tranche Two, representing approximately $3.2 million, will require shareholder approval at an Extraordinary General Meeting expected to be held in August 2026.

Investors participating in the placement will receive one free attaching listed IBXO option for every two new shares acquired.

The options will carry an exercise price of $0.04 and expire on 13 December 2027.

Directors to Participate

Imagion also announced that directors and management intend to participate in the capital raising.

Subject to shareholder approval, they have agreed to subscribe for new shares valued at up to $100,000 under the same terms offered to placement participants.

The company noted that this participation remains conditional upon approval at the upcoming Extraordinary General Meeting.

Lead Manager Appointment

The capital raising was managed by CPS Capital, which acted as both broker and lead manager.

As part of the transaction, CPS Capital will receive:

• a 4% capital raising fee;

• a 2% management fee on gross proceeds; and

• 30 million IBXO listed options, subject to shareholder approval.

Clinical Development Milestones Ahead

Following FDA clearance, the company expects several near-term milestones over the coming months.

These include:

• commencement of patient enrolment;

• dosing of the first patient;

• completion of the initial patient cohort; and

• continued manufacturing activities supporting the clinical program.

These milestones represent the next phase of development for the MagSense HER2 imaging agent.

Management Commentary

Executive Chairman Robert Proulx said the company was pleased with the level of investor support following the FDA milestone.

He stated that the successful IND clearance represented a major technical and organisational achievement and that the capital raising enables Imagion to continue advancing its molecular imaging technology and broader cancer detection platform.

Management also acknowledged CPS Capital and participating investors for supporting the placement.

What This Means for Investors

Imagion Biosystems has secured $3.75 million in fresh funding to advance the next stage of clinical development for its MagSense HER2 imaging technology. The placement follows FDA clearance of the company's IND application and provides funding to commence the Phase 1b/2 clinical trial across multiple US sites.

With trial activation already underway and patient recruitment expected during Q3 2026, investors are likely to monitor upcoming clinical milestones, including enrolment, first patient dosing and completion of the initial study cohort.