Key Highlights:
- Positive Feedback from FDA Supports Company’s Plans to File an IND in Q4 2025
- Wayne State University Collaboration in MRI adds to existing Siemens Collaboration
- Dr Nina Webster joined IBX Board as Non-Executive Director
- $3.5M Capital Raising completed to fund IND Submission and initiate HER2 Breast Cancer Phase 2 Clinical Trial
- Major Milestone Achieved – Manufacturing of MagSense® Imaging Agent Completed
Imagion Biosystems (ASX: IBX) (Company or Imagion), a company dedicated to improving healthcare outcomes through the early detection of cancer utilising its proprietary MagSense® imaging technology, today released its Appendix 4C and Quarterly Activities Report for the quarter ending 30 September 2025 (Q3 FY2025).
Summary of September 2025 Quarter Activities
Significant progress related to advancing the Company’s MagSense® HER2 breast cancer imaging agent program towards the planned filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) was made in the third quarter.
“We made some pretty significant headway in the third quarter towards our next clinical milestone,” said Executive Chairman, Bob Proulx, “We’ve had positive interactions with the FDA that support our plans for the next phase of clinical investigation, and the various activities to support our IND application are coming together, including having the funding and resources to initiate the study, once approved. We’re now in the final stages of preparation for the next exciting chapter for Imagion.”
Positive FDA Feedback Received for HER2 Breast Cancer IND Application
In announcements released to the ASX on 10th and 15th July, the Company informed the markets that it had received positive feedback from the FDA regarding the Company’s plans to submit an IND application to seek authorisation to undertake a Phase 2 study of the MagSense® HER2 Imaging Agent. Through a combination of written responses and an online meeting, the Company and the Agency reviewed and clarified key points relating to the proposed IND and the Company’s planned HER2 Beast Cancer Phase 2 clinical trial. The Company reported that no issues were identified that could negatively impact the Company’s current plans and that the dialog included input regarding future clinical and commercial development considerations.
Wayne State University Collaboration for MRI Protocol Optimisation
In August 2025, the Company entered into a collaborative service agreement with MRI experts at Wayne State University (WSU) to develop optimised imaging protocols, for use with the MagSense® HER2 imaging agent. Objectives of the collaboration include:
- Determining the lowest concentration (dose) of the MagSense® imaging agent that could achieve detection sensitivity for clinical utility;
- Establishing Magnetic Resonance Imaging (MRI) sequences and protocols that are optimised for MagSense® molecular imaging agents; and
- Investigating the use of quantitative imaging techniques in combination with the MagSense® molecular imaging agents that could yield AI compatible image data and improve and democratise diagnostic accuracy.
The results of the WSU collaboration will be used to support the Company’s planned IND application, and the optimised protocols are expected to be implemented at each of the proposed Phase 2 study clinical sites under an existing collaboration agreement Imagion has with Siemens Healthineers.
Dr Nina Webster Appointed Non-Executive Director
Dr Nina Webster was appointed to the IBX Board of Directors on 1 September 2025. Dr Webster has a wealth of experience in the Australian ASX listed pharmaceutical industry and currently serves as Managing Director and Chief Executive Officer of Dimerix Ltd (ASX: DXB). Nina’s experience in investor relations, strategic planning, and scientific and operational execution is expected to further strengthen Imagion’s capabilities as the Company continues to execute on its strategic objectives to develop and gain regulatory approval for its pipeline of MagSense® molecular imaging technologies.
$3.5M Capital Raising Completed
On 4th August 2025, the Company announced it had secured firm commitments for $3.5m in new working capital (before costs) through a 2-tranche Placement of new fully paid ordinary shares in the capital of the Company. The placement to sophisticated professional investors was managed by CPS Capital Group Pty Ltd and included free attaching listed options. IBX Directors also subscribed for new shares as part of the capital raise.
On 11th August 2025, the company announced settlement of Tranche 1 of the Placement, receiving $0.675m and issuing 45.0 million new shares. On 24th September 2025 the Company held a general meeting where shareholders approved the issuance of 188,333,333 new shares for the receipt of the remaining $2.85m of funds for Tranche 2.
Manufacturing of MagSense® HER2 Imaging Agent Completed
Subsequent to the close of the quarter, the Company announced that manufacturing of the new clinical lot of the MagSense® HER2 Imaging Agent drug candidate had been completed. The contract manufacturer is completing the required analytical testing ahead of release of the drug product for use in the planned Phase 2 clinical study. Results of the testing ensure its quality, safety, and suitability for patient use, and are an essential part of the Company’s IND application to the U.S. Food and Drug Administration (FDA).
Near-Term Outlook
The Company expects to submit the IND application to the FDA in Q4 2025 and has been informed by the FDA that, despite the current U.S. government shutdown, the Agency is still receiving IND applications. Commencement of the Phase 2 study is subject to approval of the IND by the FDA.
Following the anticipated approval of the IND application, clinical site contracts will be executed for the planned multi-site open label study, with enrollment commencing after site initiation and training. Dr. William Dooley, a surgical oncologist at the University of Oklahoma Health Sciences College of Medicine, will serve as the study Principal Investigator.
Summary of IBX Cash Position
Please see attached Appendix 4C. Imagion’s cash balance at 30 September 2025 was AU$3.2 million, an increase of AU$2.4 million from the prior quarter, following the receipt of funds from the placement previously noted. The Company is in a strong funding position to commence the phase 2 clinical study. The Company reported an operating cash outflow of AU$0.9 million for the quarter which is anticipated to increase over the next quarter as the Company incurs costs associated with the planned clinical study.
The Company paid AU$137k to related parties and their associates during the September quarter, primarily for Director’s fees and reimbursable expenses.
Mercer Convertible Notes Summary
Immediately following the end of the quarter, the Company announced on 1st and 10th October that following instruction from Mercer under the Convertible Securities Agreement with Mercer Street Global Opportunity Fund, LLC (Mercer), the Company issued 12.3m and 17.1m fully paid ordinary shares, respectively, to Mercer, from the conversion of 898,061 Mercer Convertible Notes (Notes).
The table below sets out the details of the remaining Notes held by Mercer with the Company, for financing the Company’s corporate and financial restructuring in 2023 and 2024. The table sets out the current balance of notes outstanding as at the date of this report, 20 October 2025, and includes the conversion price and maturity dates of each remaining Note. Each Mercer Note holds the equivalent value in A$ terms of $1 ( 1 Note = A$1) to be converted at the election of Mercer, at the conversion price terms for ordinary shares in IBX as set out below, or can be repaid by the Company:
| Tranche | Issue Date | Maturity Date | No. of Convertible Notes | No. of Notes Converted | Balance of Notes Outstanding |
| Tranche 1 | 21-Mar-2023 | 21-Sep-2026 | 1,650,000 | 1,123,788 | 526,212 |
| Tranche 2 | 01-Jun-2023 | 01-Dec-2025 | 1,100,000 | 242,000 | 858,000 |
| Tranche 3 | 25-Aug-2023 | 25-Feb-2026 | 1,100,000 | – | 1,100,000 |
| Tranche 4 | 29-May-2024 | 29-Nov-2026 | 242,000 | – | 242,000 |
| Tranche 5 | 19-Sep-2024 | 19-Mar-2026 | 550,000 | – | 550,000 |
| Total Notes | 4,642,000 | 1,365,788 | 3,276,212 | ||
| A$ Value | $4,642,000 | $1,365,788 | $3,276,212 | ||
| Conversion Price: | |||||
| Tranche 1: Floor Price is $0.025 or 90% of the lowest daily VWAP of Shares for the 15 trading days on which Shares traded on the ASX ending on the date immediately prior to the relevant conversion notice. | |||||
| Tranches 2 to 5: Floor Price is $0.04 or 90% of the lowest daily VWAP of Shares for the 15 trading days on which Shares traded on the ASX ending on the date immediately prior to the relevant conversion notice. | |||||
Authorisation & Additional Information
This announcement was authorised by the Board of Imagion Biosystems Limited.
About Imagion Biosystems
Imagion Biosystems (ASX: IBX) is a clinical-stage, medical imaging company dedicated to transforming how cancer is diagnosed and treated. The company produced and is developing clinical applications for MagSense®, a first-of-its-class MRI imaging agent that enables clinicians to detect cancer earlier and with greater precision. Advancing molecular MRI, the company is using non-radioactive, bio-safe magnetic nanoparticles to improve diagnostic certainty for a broad range of applications, including HER2+ breast cancer, prostate cancers, and ovarian cancers. For more information, visit https://imagionbiosystems.com.
