Appendix 4C and Quarterly Activities Report - June 2026
| Stock | Imagion Biosystems Ltd (IBX.ASX) |
|---|---|
| Release Time | 31 Jul 2026, 9:13 a.m. |
| Price Sensitive | Yes |
Imagion Biosystems Receives FDA Approval for Clinical Trial
- FDA cleared IND for MagSense HER2 Imaging Agent
- Phase 2 clinical study notification received
- Extended collaboration with Siemens Healthineers
- Secured $3.75m in funding for clinical trial
- Cash balance at 30 June 2026 was AU$32K
Imagion Biosystems Limited (ASX: IBX) has announced significant progress in its clinical development program for the MagSense HER2 Imaging Agent, including receiving clearance from the US FDA for its Investigational New Drug (IND) application. The company also received notification from the FDA that its Phase 2 clinical study may proceed. Imagion extended its collaboration with Siemens Healthineers to support the MagSense Phase 1b/2 HER2 Breast Cancer clinical trial. Additionally, Imagion secured $3.75 million in funding commitments to commence the clinical trial. The company reported a cash balance of AU$32,000 at the end of June 2026, with an operating cash outflow of AU$507,000 for the quarter.
Imagion Biosystems expects higher operating cash outflows in the next quarter due to clinical study initiation costs.
Imagion Biosystems is focused on preparatory steps for the Phase 1b/2 trial, including clinical site contracts, ethics submissions, and regulatory approvals.