Imagion Biosystems : 2021 Annual Report to Shareholders

For personal use only

IMAGION BIOSYSTEMS

LIMITED

ANNUAL REPORT 2021

IBX ANNUAL REPORT 2021

ANNUAL REPORT CONTENTS
only	3
A Breakthrough in Magnetic Molecular Imaging
Letter from the Chairman	5
use	7
Directors' Report
Remuneration Report (audited)	14
Auditor's Independence Declaration	23
personal
Consolidated Statement of Profit and Loss and Other
Comprehensive Income	24
Consolidated Statement of Financial Position	25
Consolidated Statement of Changes in Equity	26
Consolidated Statement of Cash Flows	27
Notes to the Consolidated Financial Statements	28
Directors' Declaration	56
For	57
Independent Auditor's Report
Shareholder Information	60
Corporate Directory	63

IBX ANNUAL REPORT 2021

2021 HIGHLIGHTS

CLINICAL

• Multiple patients enrolled and completed the MagSense® HER2 Breast Cancer Phase I Study
• Four clinical sites in VIC, NSW, and QLD are participating in the Phase I Study

OPERATIONAL

• Secured new premises expanding R&D and manufacturing capabilities
• CSIRO funds support prostate cancer preclinical research at Monash University's Biomedicine Discovery Institute
• Collaboration with Patrys Limited looks towards a potential new imaging agent for brain cancer
• Joint Development Agreement with Global Cancer Technology aims to develop nanoparticle technology for treating breast cancer
• Revenue from sales of IBX's super-paramagnetic iron oxide nanoparticles to external parties remains steady

CORPORATE

• Imagion received $2.6 million in R&D tax incentives
• Cash balance of $13.4 million as of 31 December 2021
• Exercise of listed options delivering over $5.5 million to the Company
• Dr Yalia Jayalakshmi joins IBX as Chief Development
  Officer

1

2

IBX ANNUAL REPORT 2021

A BREAKTHROUGH IN

MAGNETIC MOLECULAR onlyIMAGING

ONE STEP CLOSER TO THE EARLY

DETECTION OF CANCER

use2021 was a very important year for Imagion as we became a clinical stage company with the commencement of our first-inhuman study of the MagSense® technology for HER2 breast cancer.

Imagion's MagSense® technology has the potential to provide

more specific and sensitive detection for cancer than current personalimaging technologies. By using tiny magnetic nanoparticles to

identify tumors, our MagSense® technology does not require use of radioactivity, making it a safer alternative for non-

i vasive detection.

With a safer, more specific, and more sensitive approach the Company hopes to enable a new standard of care in the detection of cancer and other diseases. One that will minimize the need for biopsies and thereby reducing costs while minimizing risks for patients.

The current Phase I study of the MagSense® HER2 breast cancer imaging agent is our first clinical investigation. it is an important and valuable step forward serving as a proof-of-

Forprinciple that our magnetic molecular imaging technology has potential to change clinical practices. But it's just the start. There are many types of cancer and other diseases that can benefit from earlier, better, and safer detection.

We're now one step closer to making a breakthrough in medical imaging.

IBX ANNUAL REPORT 2021

A WORLD OF

POSSIBILITY IN NANOPARTICLES

Nanoparticles are at the core of our business. We have developed a proprietary method for making magnetic nanoparticles while controlling for key attributes, such as size, dispersity, and magnetic properties. We plan to leverage this capability to supply tailor made nanoparticles to third parties for use in their biomedical applications.

Iron oxide nanoparticles are bio-safe with high magnetic susceptibility and can be used as an alternative to radiotracers for:

• Diagnostic imaging
• Cancer treatments
• Monitoring for recurrence
• Drug and vaccine delivery

Imagion sells PrecisionMRX® nanoparticles to third parties for research and use in their biomedical products.

PARTNERING WITH LEADING COMPANIES AND INSTITUTIONS

At Imagion, we believe collaborating with world-class researchers is the key to expanding our capabilities. We are currently working with several partners to explore the use of our nanoparticles for diagnosing and treating various forms of cancer.

3

4

IBX ANNUAL REPORT 2021

LETTER FROM
THE CHAIRMAN
only	DEAR SHAREHOLDERS,
	Firstly, I would like to thank all of our shareholders for their
use	ongoing support in 2021, with particular thanks to those
shareholders who demonstrated their commitment through the
exercise of their options, which added over $5.5 million to our
balance sheet throughout 2021. Combined with the $2.6 million
Research and Development tax rebate received earlier in the year,
we finished FY2021 with approximately the same amount of cash
on hand that we had at the end of FY2020 without requiring a
personal	capital raise.
FY2021 marked our transition to becoming a clinical stage
	company with the commencement of our MagSense® HER2
	breast cancer study - a first-in-human investigative study of our
	proprietary molecular magnetic nanoparticle-based imaging
	technology. This Phase 1 study is our initial clinical investigation
	into the safety and tolerability of the MagSense® HER2
	nanoparticles and their ability to reach tumour cells that may have
	metastasized to the lymph nodes. The study will also provide
	initial important information on the potential effectiveness of two
	imaging modalities to detect the MagSense® imaging agent,
	before we commit resources to larger studies for regulatory
	approval. While the pandemic significantly impacted us from
For	achieving our goal of completing the study in 2021, we made
significant progress securing four clinical sites across Victoria,

New South Wales, and Queensland in Australia and finishing the year with multiple patients having completed the study.

With our first imaging agent advancing into the clinic in

2021 we looked to expand our product pipeline and added several research collaborations for other diagnostic imaging applications. An Innovations Connections grant awarded under the Entrepreneurs' Programme of the Australian Government Department of Industry, Science, Energy and Resources and administrated through Commonwealth Scientific and Industrial Research Organisation, has been put towards a collaboration with Monash University's Biomedicine Discovery Institute to undertake

IBX ANNUAL REPORT 2021

preclinical research into a MagSense® as a prostate cancer imaging agent. Additionally, we established a collaboration with Patrys Limited, a therapeutic antibody company, to investigate use of a Patrys antibody with our MagSense® nanoparticles with the aim of improving brain tumour imaging and diagnosis. And a Joint Development Agreement with Global Cancer Technology (GCT) provides an opportunity to develop nanoparticle-based solutions for the treatment of breast cancer.

These relationships and ongoing projects are a testament to the unique and pioneering capabilities of our nanoparticle technology and lay the foundation for a strong future commercial pipeline of products addressing unmet clinical needs in the earlier diagnosis of cancer and other diseases to help enable improved therapeutic intervention and patient outcomes.

As our MagSense® HER2 clinical program began to advance in 2021, we also began to focus on building the organizational capabilities to support our future success. The appointment of Dr Yalia Jayalakshmi as Chief Development Officer with extensive experience in the clinical development of drugs and devices, adds significant depth to our leadership team. Additionally, we completed the fit-out out of our new R&D and manufacturing facility and moved in at the start of the new year. This new facility significantly expands our internal nanoparticle research

• development capabilities, provides additional manufacturing capacity to support our clinical programs and can be leveraged to generate revenue through third party commercial relationships.

Imagion starts 2022 in a strong financial position with our clinical study well underway and momentum in our research programs. We are looking forward to bringing our Phase I study to conclusion and executing our next phase of development. We are grateful to all our stakeholders - collaborators, patients that participate in the study, employees, and shareholders - for their ongoing commitment and support and we look forward to updating you with progress throughout the year.

Robert Proulx

Executive Chairman

Imagion Biosystems Limited

5

6

For personal use only

Imagion Biosystems Limited

Directors' Report

For the year ended 31 December 2021

Directors' Report

The directors present their report, together with the financial statements, on the consolidated entity (referred to hereafter as the 'consolidated entity') consisting of Imagion Biosystems Limited (referred to hereafter as the 'Company' or 'parent entity' or 'Imagion') and the entities it controlled at the end of, or during the year ended 31 December 2021.

Directors

The following persons were directors of Imagion Biosystems Limited during the whole of the financial year and up to the date of this report, unless otherwise stated:

Mr Robert Proulx

Executive Chair / President

Robert has been President of Imagion Biosystems since February 2015. Previous employment experience includes President / General Manager for Silicon Biosystems and a career in marketing and sales management with more than 25 years experience in the computer, life science and medical diagnostics industries. Some of Robert's other relevant experience include: Vice President Marketing and Sales for Nanogen Inc.; Senior Vice President of Marketing and Business Development at Gene Logic; and General Manager, Life Sciences at IGEN International Inc. Robert holds an M.A. and B.A. from The State University of New York at Albany and an Executive MBA from the Penn State Smeal College of Business.

Mr Michael Harsh

Non‐Executive Director

Michael is a co‐founder and Chief Product Officer of Terapede Systems, a digital X‐ray startup that focuses on developing an ultra‐high resolution medical flat panel X‐ray detector. Prior to co‐founding Terapede Systems in 2015, Mr. Harsh had a 36‐year long career with General Electric, including serving as Global Technology Leader - Imaging Technologies at the GE Global Research Center and culminating with him serving as Vice President and Chief Technology of GE Healthcare. Additionally, he serves on the boards of directors of Endra Life Sciences (NASDAQ: NDRA), EmOpti and Compute Health Acquisition Corp (NYSE:CPUH) as well as being a member the Radiological Society of North America ("RSNA"), Research & Education Foundation Board of Trustees. He had previously served as a director for FloDesign Sonics until its acquisition by MilliporeSigma, a division of the Merck Group. Mr. Harsh is a graduate of Marquette University, where he earned a bachelor's degree in Electrical Engineering. He holds numerous U.S. patents in the field of medical imaging and instrumentation. In 2008, Mr. Harsh was elected to the American Institute for Medical and Biological Engineering College of Fellows for his significant contributions to the medical and biological engineering field.

Mr David Ludvigson

Non‐Executive Director

David is currently President & CEO at Nanomix, a point‐of‐care diagnostic medical device company. David is a financial and operating executive with over 35 years of international experience in life sciences and technology companies including Biogen (formerly IDEC Pharmaceuticals), Matrix Pharmaceutical, Nanogen, and MIPS Computer Systems. His experience over 15 years in the diagnostics arena has led numerous new product efforts from concept to market launch. David has conducted many successful strategic transactions including multiple acquisitions, corporate partnerships, technology and intellectual property licensing agreements, and OEM relationships and his financing experience includes venture capital, corporate, mezzanine, lease, bank credit line, LBO, IPO and secondary public sources.

7