First-in-human study update - First patient enrolled

MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to announce that the first patient has been enrolled in the MagSense® HER2 breast cancer Phase I first-in-human study. The study, which is expected to enroll approximately 15 patients, is the first clinical investigation of Imagion Biosystems’ MagSense® nanoparticle technology. This study investigates the use of a MagSense® imaging agent as a means of aiding in the staging of HER2 positive breast cancer by detecting if the patient’s tumor has spread to the lymph nodes. Current standard of care requires biopsy or surgical removal of lymph nodes to confirm metastases. With approximately half of HER2 breast cancer patients having no nodal disease, the MagSense® HER2 test achieved Breakthrough Device designation from the US FDA based on its potential to provide a non-invasive way to eliminate unnecessary surgical biopsy procedures and their resultant morbidities. “We are very pleased to report our first patient has been enrolled in this ground-breaking study,” said Bob Proulx, Executive Chairman of Imagion Biosystems. “Though recruiting newly diagnosed cancer patients into a research study can be challenging, we and our investigators remain confident we will reach our recruitment target. We are committed to explore all avenues to achieve our goal of completing this important study.” Each patient in the study receives an injection of the MagSense® nanoparticle imaging agent and undergoes imaging by MRI. Additionally, a sample of the lymph node is also assessed using Imagion’s proprietary MagSense® magnetic relaxometry technology. The primary endpoint of the study is to determine the safety and tolerability of the MagSense® imaging agent, but the study will also explore the effectiveness of the nanoparticles for in vivo detection which will inform further development and commercial considerations.

Imagion receives CSIRO Federal Government grant for prostate cancer project

Innovations Connections is a Federal Government funding program delivered by the CSIRO aimed to facilitate connecting industry with researchers to help fast-track R&D projects. The $50,000 grant will be used to help support a preclinical research project between Imagion and researchers at Monash University’s Biomedicine Discovery Institute with the aim of achieving an early proof of concept validation of a MagSense™ prostate cancer imaging agent.

“This collaboration with Monash, assisted by funding from CSIRO, helps jump start our prostate cancer project by leveraging the expertise at Monash University and provides a key opportunity to advance our MagSense technology for another important cancer indication,” said Bob Proulx, Executive Chairman of Imagion Biosystems. “We’re grateful for the support from the Australian Government through the Entrepreneurs’ Program

First-in-human study update: Study open for enrolment

MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to announce that Monash Health has been established as the first clinical site and is ready to commence enrolment of patients for the MagSense™ HER2 breast cancer Phase I first-in-human study.

Dr Jane Fox, the current Director of Breast Services at Monash Health, which encompasses breast surgery and the Monash BreastScreen program, has been named as the Principal Investigator of the MagSense™ study. Dr Fox is also a senior lecturer in the Monash University Department of Surgery and a senior leader of the multi-disciplinary team at the Monash Cancer Centre which includes medical imaging, medical oncology and radiation oncology.

Bob Proulx, Executive Chairman of Imagion Biosystems said, “We are delighted to be working with a leading healthcare organization and with Dr. Jane Fox, a highly regarded clinician who has dedicated her career to improving outcomes for patients with breast cancer and who is strongly supportive of the trial. After all the diligence and hard work, it is extremely exciting to be initiating our first clinical study.”

Imagion Biosystems appoints Geoff Hollis as CFO

MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare through the earlier detection of cancer, has appointed Geoff Hollis as Chief Financial Officer. The appointment strengthens the Company’s management and leadership team as the Company moves into its next phase of growth to develop and commercialize its medical device technology to non-invasively detect cancer. Geoff, based in Melbourne, takes up his position as Imagion CFO on 1 December 2020. Geoff has served as the Chief Financial Officer for multiple ASX listed companies, including Lifestyle Communities where he played a key role in cash management and financing to facilitate rapid growth, reaching the ASX300 and creating significant shareholder value. Geoff’s career in finance began with 10 years at Pitcher Partners a top ten national accounting and financial advisory firm. Imagion’s executive chairman and CEO, Bob Proulx, said Geoff is a welcome addition to Imagion’s executive management team. Being based in Australia, Geoff will be well positioned to assist with the Company’s developing business interests in Australia and will be closer to the Company’s investors and the capital markets to facilitate investor relations. “We look forward to having Geoff aboard as the Company moves through its next growth phase and as we plan to advance the business beyond our upcoming MagSense™ HER2 Phase I study for metastatic breast cancer,” Mr Proulx said. “Geoff has had great experience in corporate transformation, growth strategies, capital raising, capital management, attracting institutional investors and general investor relations. We expect that will be of significant benefit to Imagion as we enter an exciting phase of our business and work to maximise shareholder value.”

Imagion announces HREC approval for Phase I study

MELBOURNE — Imagion Biosystems (ASX: IBX), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to report that it has received approval from the Human Research Ethics Committee (HREC) for the MagSense™ HER2 Phase I study for metastatic breast cancer. With the study now approved the Company can proceed with finalising contracts with individual study sites.

Additionally, the Company reports that manufacturing of the MagSense™ HER2 nanoparticle formulation for the study remains on track, having successfully completed bulk batch production. The company expects to complete the final step of Good Manufacturing Practice (GMP) compliant packaging of the material on time to support the start of the study.

Imagion Biosystems Executive Chairman Bob Proulx said, “We are very pleased with our progress and will now be working diligently with our planned study sites to commence the study this calendar quarter as we have previously advised

Imagion Biosystems Limited - ASX Small & Mid Cap Conference

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Appendix 4D and Half Year Results H1 2020

Highlights • Significant advancements towards initiating first-in-human study, on track to commence in Q4

• Balance sheet strengthened by $2.5 million through an oversubscribed Rights Issue and shortfall placement

• $2.2 million R&D tax rebate received for 2019 fiscal year

• Subsequent to close of H1 $5 million in proceeds received from oversubscribed placement in July and $1.29 million received from options exercised

• Pro forma cash position improved to $10.2 million as of 18 August 2020

Ann: Chairman's Address to Shareholders at Annual General Meeting

Imagion announces plan to undertake first clinical study in Australia Live Webcast Scheduled

Imagion Nanoparticle Manufacturing Update

Saying we are pleased with the progress would be an understatement,” said Bob Proulx, Executive Chairman of Imagion Biosystems. “We took great care in our preparations before commencing manufacturing and that has paid off. The first step of the production process is the trickiest, so completing this step on schedule is encouraging.”