Imagion Biosystems Secures AU$3.75M in Capital Raise Following FDA Clearance of Phase 2 Clinical Trial

MELBOURNE, Australia–(BUSINESS WIRE)–$IBX #FDAImagion Biosystems, Ltd. (ASX: IBX) announced that it has secured firm commitments for AU$3.75M (US$2.59M) in new capital following the FDA’s clearance of the company’s IND application for a Phase 2 clinical trial. The raise will fund the commencement of the clinical trial of the MagSense® imaging agent in HER2+ breast cancer. The company has already begun trial activation activities and expects to begin patient recruitment later this year.

Imagion Biosystems Logo
Imagion Biosystems Logo

“We are very pleased with the strong demand we saw from investors following our milestone achievement of receiving clearance from the FDA for our MagSense® imaging to proceed with the clinical trial,” said Executive Chairman Robert Proulx. “The successful submission of the IND represents a major technical and organizational accomplishment for the company. With this kind of shareholder support we can continue to advance our MagSense® molecular imaging technology and change how cancer is detected.”

The raise was led by CPS Capital Group Pty Ltd in a two-tranche placement with support from investors “exceeding expectations.” Tranche 1 will be a placement of 49.3 million new shares at AU$0.012 for a total of AU$592,000 utilizing the company’s existing placement capacity. Tranche 2 will include the balance of shares, representing approximately AU$3.2 million, pending shareholder approval at an EGM.

About MagSense®

Conventional MRI can identify regions of interest using anatomical or morphological features, but without molecular specificity, cannot reliably differentiate benign from malignant tumors. MagSense® uses targeted nanoparticles to increase imaging specificity, making it easier for clinicians to make cancer diagnoses with certainty. The platform technology’s applications extend beyond breast cancer—Imagion has conducted pre-clinical studies of two additional imaging agents that target prostate and ovarian cancers.

About Imagion Biosystems

Imagion Biosystems (ASX: IBX) is a clinical-stage imaging company pioneering a new category of MRI technology that changes suspicion into certainty. The company has developed and is advancing 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 imagionbiosystems.com.

Contacts

Erich Boileau

[email protected]

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