Key Highlights:
- Manufacturing and Testing of MagSense® HER2 Imaging Agent Completed, Paving Way for IND Submission Q1 2026
- Wayne State University Collaboration for MRI Optimization Completed, Finalizing Optimum Trial Design for Proposed End Points
- Ward Detwiler Appointed President of Imagion’s US Subsidiary for Operations
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 31 December 2025 (Q4 FY2025).
“Completing manufacturing of the imaging agent in the fourth quarter was a significant achievement for IBX,” said Executive Chairman, Bob Proulx. “We have invested time in our manufacturing and analytical testing methods through our preferred vendor to ensure the high quality and suitability of the material for clinical use. As is appropriate, materials for use in human clinical studies must meet high quality release standards, which support the Investigational New Drug application. We are now finalizing the dossier for submission of the Investigational New Drug application to the US FDA.”
MagSense® HER2 Clinical Supply Manufacturing Completed
Early in the fourth quarter the Company reported that its contract manufacturer had completed production of the MagSense® HER2 Imaging Agent (MSH2IA) and was proceeding to undertake the required analytical testing ahead of release for use in the planned Phase 2 clinical trial.
Results of the independent testing of MSH2IA ensure its quality, safety, and suitability for patient use, and are an essential part of the Company’s Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The testing has since been completed and the quality documents needed for the Investigational New Drug (IND) application are being compiled and finalized for the IND submission to the FDA, which is expected to be completed shortly.
Wayne State University Collaboration Completed Establishing Optimized MRI Protocol
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. This project was undertaken and completed with WSU during the quarter and in December the Company reported that the results of the collaboration were very positive and strongly supported the objectives for the Phase 2 trial.
These important results from the Optimised MRI Imaging Protocol included:
- Reducing the dose of MagSense® HER2 Imaging Agent to one-third that used in the Phase 1 trial. Using a reduced dose would be better for the patient and could improve the safety profile of the agent, making the use of MSH2IA more attractive for clinical adoption.
- Selection of optimised MRI sequences that should improve the quality of the images obtained in the trial. Since a key endpoint of the Phase 2 trial is a comparison of MSH2IA to standard-of-care imaging by ultrasound, optimized imaging protocols yielding high quality images is important to the outcome of the trial.
The results of the collaboration were a very important part of the supporting documentation for the IND application, and the optimised protocols are expected to be implemented at each of the proposed the Phase 2 trial clinical sites under an existing collaboration agreement Imagion has with Siemens Healthineers.
Ward Detwiler Appointed President of Imagion’s US Subsidiary Operation
Effective 1 December 2025, Ward Detwiler was appointed as President of Imagion Biosystems, Inc. the Company’s U.S. subsidiary operation. Ward has been serving as Chief Business Officer for the US subsidiary since July of 2024. His experience in the development of MRI-based software solutions and his network in the medical imaging community have already made contributions to Imagion’s progress in establishing itself as an imaging company. Under the terms of his appointment, Ward will report to the Board of Directors of the listed Australian entity, Imagion Biosystems, Ltd., and have primary responsibility for driving growth and development for the consolidated Company. See further details about Ward below.
“I am extremely excited about the future of Imagion as we spearhead the development of the molecular MRI market and am honored by the opportunity to lead its growth,” said the newly appointed President Ward Detwiler. “Imagion’s MagSense® platform holds the potential to fulfill the long-held promise of bringing diagnostic certainty to MRI. I’m looking forward to leveraging my experience in developing and commercialising quantitative imaging solutions to drive the strategic direction of the company and make MRI-based molecular imaging a reality.”
Near-Term Outlook
The Company expects to submit the IND application to the FDA imminently and is compiling the final documents for inclusion. Following what is expected to be a standard review by the FDA, Imagion will begin initiation of clinical site contracts for the Phase 2 trial. Enrolment will commence 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 trial Principal Investigator.
Corporate Overview
Summary of IBX Cash Position
Imagion’s cash balance at 31 December 2025 was AU$1.8 million, a decrease of AU$1.4 million from the prior quarter. The Company reported an operating cash outflow of AU$1.4 million in the quarter. Operating cash outflows increased by AU$0.4 million from the prior quarter mainly due to the manufacturing and analytical testing required to support the Phase 2 clinical trial and IND submission documentation.
The Company paid AU$172k to related parties and their associates during the September quarter, primarily for Director’s fees and reimbursable expenses.
Mercer Street Convertible Debt Reduced During Quarter– Summary of Position
The table below sets out the details of the remaining convertible notes held by Mercer Street Opportunities Fund LLC (Mercer) with the Company as at the date of this report, following recent conversions of notes to IBX shares during the December quarter, per the terms of the Convertible Notes Agreement set out in ASX releases by the Company.
The table sets out a summary of the Mercer convertible notes on issue, including a further conversion and partial debt repayment in January, detailing the conversion price and maturity dates of each remaining Note held by the Company as at today.
| Remaining Tranches | Issue Date | Maturity Date | No. of Convertible Notes | No. of Notes Converted | Repayment | Current Balance |
| Tranche 2 | 01-Jun-2023 | 28-Feb-2026 | 1,100,000 | 242,000 | 300,000 | 558,000 |
| Tranche 3 | 25-Aug-2023 | 25-Feb-2026 | 1,100,000 | – | – | 1,100,000 |
| Tranche 4 | 29-May-2024 | 29-Nov-2026 | 242,000 | – | – | 242,000 |
| Tranche 5 | 19-Sep-2024 | 19-Mar-2026 | 550,000 | – | – | 550,000 |
| Total Notes | 2,992,000 | 242,000 | 300,000 | 2,450,000 | ||
| A$ Value | $2,992,000 | $242,000 | $300,000 | $2,450,000 | ||
| Conversion Price: | ||||||
| Tranche 1: Floor Price was $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. | ||||||
About Ward Detwiler
Ward Detwiler is an experienced entrepreneurial leader with a successful track record in the commercialization of advanced healthcare technology from concept to market. Ward was the co-founder and CEO of SpinTech MRI, a medical imaging software company focused on reducing MRI exam times and bringing advanced quantitative imaging tools into clinical practice. Under his leadership, SpinTech MRI successfully brought three products through the FDA 510(k) process, including the first clinically approved quantitative susceptibility mapping (QSM) software, new techniques for rapid MR image acquisition, and algorithms for improving signal to noise ratio (SNR) and image clarity. Additionally, as CEO he raised successive rounds of venture capital to fuel the company’s growth, built an IP portfolio of over 20 patents, and led sales and marketing efforts to achieve clinical adoption and revenue growth of the company’s novel product portfolio. Prior to SpinTech MRI, he served as Director of Digital Health Innovations at Henry Ford Health System. Ward received his BA in Economics from Northwestern University, and an MBA from the University of Michigan Ross School of Business.
