Imagion’s Funding and Siemens Collaboration Pave Way for Critical FDA Filings

Capital Raise Strengthens Financial Position

Imagion Biosystems Limited (ASX: IBX), a Melbourne-based biotech focused on early cancer detection, reported a successful completion of the second tranche of its AU$3 million capital raise during the December 2024 quarter. This funding round, led by CPS Capital and approved by shareholders in December, has bolstered the company's cash reserves to AU$2.67 million, a significant increase from the prior quarter's AU$0.386 million.

The fresh capital is earmarked primarily for advancing the clinical development of Imagion's proprietary MagSense® molecular MRI imaging technology, alongside general working capital needs. Despite an operating cash outflow of AU$0.662 million for the quarter, the company’s financial footing has been notably strengthened, providing a runway estimated to cover over 20 quarters of operations when combined with undrawn financing facilities.

Renewed Collaboration with Siemens Signals Confidence

Imagion has resumed its strategic collaboration with Siemens, a global leader in medical imaging technology. This partnership, reaffirmed during meetings at the Radiological Society of North America (RSNA) annual conference, will continue to support the Phase 2 clinical study of the MagSense® molecular MRI agents. Siemens’ MRI experts will assist in refining image reconstruction and analysis, aiming to enhance the sensitivity and specificity of cancer detection.

Ward Detwiler, Chief Business Officer, emphasized the importance of this collaboration, noting that while Phase 1 data was promising, there remains significant potential to improve image quality and interpretability through advanced post-processing techniques.

Focus on MagSense® HER2 Breast Cancer Program

The company has prioritized the IND (Investigational New Drug) filing with the U.S. Food and Drug Administration (FDA) to resume clinical trials for its MagSense® HER2 breast cancer imaging agent. A dedicated core team has been assembled to drive this initiative forward in early 2025.

Executive Chairman Robert Proulx expressed optimism about the company’s trajectory, highlighting that the capital raise enables immediate progress on manufacturing new lots of the imaging agent, identifying principal investigators and clinical sites, and finalizing the clinical study protocol. The goal is to commence the Phase 2 study in the latter half of 2025.

Outlook and Future Development

While the breast cancer program takes precedence, Imagion also plans to advance its R&D efforts in prostate and ovarian cancer imaging, contingent on available funding. The company maintains a $15 million convertible note facility with Mercer Street Global Opportunity Fund, of which approximately $10.78 million remains undrawn, providing additional financial flexibility.

Payments to related parties increased this quarter, reflecting the settlement of outstanding fees following the capital raise. The company continues to manage its operating costs prudently while investing strategically in clinical development and partnerships.

Imagion’s progress in molecular MRI technology, supported by renewed industry collaboration and a strengthened balance sheet, positions it well to deliver on its promise of improving early cancer detection and creating shareholder value.