Announcement PDF Changing the way we look at cancer AGM Investor Presentation 25 May 2023 Imagion Biosystems Limited ImagionBiosystems.com ASX:IBX Disclaimers Imagionbiosystems.com This investor presentation (Presentation) has been prepared by Imagion Biosystems Limited (Imagion or the Company). This presentation does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of Imagion or any member of its group nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of Imagion or any member of its group, nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. This presentation is not a Prospectus and contains summary information about Imagion and its activities, which is current as at the date of this presentation. 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These forward-looking statements are subject to risks, uncertainties and assumptions and other factors, many of which are beyond the control of Imagion. Imagion cautions you that forward-looking statements are not guarantees of future performance and that its actual results of operations, financial condition, performance, prospects, growth or opportunities and the development of the industry in which Imagion operates may differ materially from those made in or suggested by the forward-looking statements contained in this presentation. In addition, Imagion does not guarantee any particular rate of return or the performance of Imagion nor does it guarantee the repayment or maintenance of capital or any particular tax treatment. Investors should note that past performance may not be indicative of results or developments in future periods and cannot be relied upon as an indicator of (and provides no guidance as to) Imagion's future performance. 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The distribution of this presentation in certain jurisdictions may be restricted by law and persons into whose possession this presentation comes should inform themselves about and observe any such restrictions. 2 Imagion Biosystems Overview We are a clinical stage medical imaging company developing next generation molecular imaging technologies Imagionbiosystems.com Imagion Biosystems ASX:IBX Market cap: ~$19 million Cash at 31 Mar 2023: $2.6 million Innovative medical imaging using bio-safe magnetic nanoparticles to detect cancer and other diseases Aug 2022 –MagSense® imaging agent for HER2 Breast Cancer reported for first patient cohort as safe and well tolerated Proprietary MagSense® technology is non-invasive and nonradioactive and provides more specific & sensitive detection for cancer than current imaging technologies Sep 2022 –Preclinical research for prostate cancer detection presented at World Molecular Imaging Conference Multiple commercial opportunities with magnetic nanoparticles: Imaging agents for use with mainstream clinical Magnetic Resonance Imaging (MRI) systems Doctor’s office testing with our proprietary Magnetic Relaxometry (MRX) system Therapy and/or drug delivery Dec 2022 -Clinical data from the first cohort of the MagSense® HER2 Breast Cancer Phase I study presented Feb 2023 -Company announces strategy to prioritize development and commercialization of the MagSense® nanoparticle technology w/ MRI Apr 2023 –Company announces intention to file an IND for HER2 phase 2 clinical study after positive FDA feedback 3 Investment Highlights Imagionbiosystems.com $ Key Initial Clinical Milestones Achieved Product Pipeline Addresses Large Markets & Unmet Needs MagSense® Technology Will Transform Cancer Diagnosis First product for HER2 breast cancer shown to be safe and well tolerated in Phase I study First 3 products address $4-5B markets for noninvasive detection of cancers Identifies molecular signature rather than identifying ”suspicious lesions” Reduces need to rely on invasive biopsies Works with conventional MRI and does not require radioactivity Clinical data support potential use with both proprietary detection technology and conventional MRI Earlier detection known to improve patient outcomes Multiple Revenue Opportunities 4 Strong Leadership and Advisory Boards To be sold as reimbursed single use consumable with high gross margins Experienced and skill diverse board of directors and management team Alignment with strategic partners to commercialise in global markets Clinical and Scientific Advisory Boards with collective expertise in oncology, medical imaging, nanotechnology and clinical trial design Utility extendable to therapeutic applications and delivering drugs 4 01 A Global Medical Need Each year cancer kills 9 million people globally $100 billion spent annually to diagnose or detect cancer, yet cancer continues to be a leading cause of mortality and morbidity. 5 A Growing Global Health Problem Imagionbiosystems.com 1 in 3 people are affected by cancer US$100 BILLION CANCER DIAGNOSTICS MARKET $30,000 $26.0b Millions (USD) $25,000 $20.1b $20,000 $15.5b $15,000 $10,000 $5,000 $- $7.2b $3.1b Blood $4.6b $8.9b $9.6b $5.9b Pancreatic Kidney Ovarian Liver Prostate Colorectal Breast Lung * Source: Transparency Market Research – Global Cancer Diagnostics Market 2014-2020 6 Clear Unmet Medical Need Imagionbiosystems.com Anatomical images can’t differentiate benign from malignant lesions 7 02 MagSense® Technology 8 Enabling Molecular Imaging Imagionbiosystems.com MagSense® Technology aims to transform how medical imaging can detect and diagnose cancer Non-invasive – a safe and non-surgical solution to detect cancer Conventional methods are not specific and can only identify a region of interest No radioactivity – uses bio-safe magnetic nanoparticles to “tag” cancer cells MagSense® nanoparticles produce a molecular signature indicating the presence of a tumor Specific – use of targeted imaging agent provides molecular confirmation of the presence of cancer not just a suspicion Platform technology – can be used for many cancers as well as other diseases 9 How It Works Imagionbiosystems.com Bio-safe magnetic nanoparticles are attracted to the tumor and detected Patients are given a low dose injection of the nanoparticle imaging agent Targeting molecules affixed to the nanoparticles, ensure high specificity for the cancer, and cause the nanoparticles to find and bind to tumor cells Once attached to the tumor the magnetic property of the particles is detectable by magnetic sensors and can be imaged by MRI The tiny nanoparticles are cleared by the body through the liver with the iron core being “repurposed” to produce ferritin used in hemoglobin production 10 MagSense® Molecular Imaging Imagionbiosystems.com 1 2 3 4 Clinical assessment identifies need for test MagSense® nanoparticle imaging agent given to patient MRI detects change in image contrast from imaging agent Physician sees molecular image signature if tumor present Works within current cancer diagnosis and staging protocols. 11 How It Works - Video Click play to watch video in browser Imagionbiosystems.com 12 Broad Commercial Applicability MagSense® imaging agents can be developed for many types of solid tumors and can be used at multiple stages of diagnosis including primary diagnosis, 1 Brain Cancer 2 Lung Cancer 3 Breast Cancer staging, and monitoring the effectiveness 4 Ovarian Cancer of therapy. 5 Prostate Cancer Imagionbiosystems.com Each type of cancer will have a unique and specific formulation for the cancer of interest creating a portfolio of imaging agents and a recurring revenue stream for each indication of use. 13 The Phase I Clinical Study Imagionbiosystems.com Detection of Nodal Metastases in HER2+ Breast Cancer No issues of safety or tolerability related to the imaging agent reported to date Data reported show the imaging agent results in a detectable magnetic signature by both imaging methods - MRI and MRX Blinded review by independent expert panel of radiologists has corroborated findings Trial to remain open for enrolment during 2023 to provide additional data to inform future study design and evaluate diagnostic performance 14 ® MagSense Imaging with MRI Imagionbiosystems.com Changing the way we look at cancer Pre-Dose T2 Data from the Phase I study indicates our molecularly targeted nanoparticles could be effective in detecting nodal disease when used in conjunction with conventional MRI scanners Improves radiological review compared to standard of care use of ultrasound and anatomical evaluation only Works within current standard of care diagnosis and staging protocols with MRI systems widely available in hospitals around the globe, making it easier to undertake clinical studies, and making market access easier and faster MagSense® nanoparticles enable molecular imaging by producing an identifiable change in image contrast when cancer cells are present Could eliminate unnecessary biopsies, or node removals, done today for most patients (to confirm cancer whether node suspicious or negative) reducing incidence of lymphedema and associated morbidity and reducing time to clinical decision and treatment Would save health providers US$ millions per year compared to the current standard of care Post-Dose T2 15 03 Growth Strategy 16 Leveraging MRI Imagionbiosystems.com Accelerating our path to commercial product The Market Path to Commercialisation R&D Benefits Increases addressable market by now targeting the large installed base of existing MRI sites worldwide Path to market simpler, eliminating the challenges and costs of introducing a new piece of capital equipment Pipeline of targeted imaging agents for additional disease classes including prostate and ovarian cancers already in process Makes total addressable market (TAM) of AU$500m per year in HER2 Breast Cancer immediately accessible Cost and time to commercialise reduced Partnerships to explore the utility of MRX technology for use in doctor's offices Improves ease of clinical adoption and subsequent commercial returns 17 17 Business Strategy Use MagSense® HER2 Test as a commercial launchpad Current Phase 1 study provides proof-of-concept that MagSense® imaging is effective and provides path to commercialization Expand the pipeline Build a pipeline of diagnostic imaging agents targeting other cancers and diseases with high unmet medical need Collaborate in other biomedical applications Create a high-value biomedical portfolio Generate revenue through collaboration with 3rd parties to leverage our nanoparticle expertise in other areas such as vaccines and therapy Align with strategic partners to commercialize our proprietary imaging and therapeutic products 18 MagSense® Product Pipeline Imagionbiosystems.com Applying targeted imaging to other cancers Note: The pipeline above provides no guidance as to timing and is indicative and subject to change 19 Outlook for 2023 • Corroboration by independent reviewers supports strategic shift to cancer detection by Magnetic Resonance Imaging (MRI) • Feedback from FDA informs plans to file an Investigational New Drug (IND) application to enter Phase 2 • New IP filed on nanoparticles and molecular detection of cancer • Strategic partnering data room established and outreach initiated • Closing of Phase 1 Study • File IND for MagSense® HER2 breast cancer Phase 2 study Imagionbiosystems.com IND Related Activities • Manufacture new lot of MagSense® HER2 imaging agent for use in the Phase 2 study • Complete preclinical and clinical studies in support of FDA requirements for a Phase 2 study IND clearance • Establish lead U.S. investigator(s) and initial site(s) 20 Compelling Business Model Imagionbiosystems.com Proprietary Consumables Drive Growth & Profitability Injectable MagSense® Imaging Agents Direct Sales Tests can be sold to any hospital or clinic with conventional clinical MRI scanners Each Cancer Test Billable ~$1,500 USD* ~80% Gross Margin* Partnerships Licensing Enables strategic commercial partnerships with medical imaging player(s) Licensing/milestone fees and shared revenue or royalties on sales 21 04 Leadership and Financials 22 Experienced Board and Management Imagionbiosystems.com Commercially focused team with deep industry & clinical experience ROBERT PROULX CHAIRMAN & CEO YALIA JAYALAKSHMI CHIEF DEVELOPMENT OFFICER MICHAEL HARSH NON-EXEC DIRECTOR DAVID LUDVIGSON NON-EXEC DIRECTOR DIANNE ANGUS NON-EXEC DIRECTOR • Operationally oriented executive • Over 25 years in life science & medical devices • Product development & commercialization • Over 25 years clinical translation of drug, device, nanoparticle delivery and diagnostic imaging product delivery • Former CTO of GE Healthcare • Over 35 years in medical imaging product development • Over 35 years in pharma, medical devices • Corporate strategy, M&A, & financing • Over 20 years in Australian & US listed Biotechnology companies GEOFF HOLLIS CFO & COSEC MARIE ZHANG VP R&D MARK VAN ASTEN NON-EXEC DIRECTOR JOVANKA NAUMOSKA NON-EXEC DIR • ASX experienced CFO with over 20 years as a Chartered Accountant • Over 20 years in drug development • Leadership in early stage and startup founder • Strong track record in diagnostics & healthcare • Over 25 years commercializing diagnostic products • Attorney with over 20 years experience advising research organisations • Expertise in commercialisation, regulatory compliance, governance & risk management 23 Scientific Advisory Board Imagionbiosystems.com Collective expertise in oncology, medical imaging, nanotechnology, clinical trial design DR JOHN HAZLE SCIENTIFIC ADVISORY BOARD CHAIR • Board certified in medical physics • 30 years in pre-clinical & clinical imaging research • Chairs Cancer Research at UT Graduate School of Biomedical Sciences PROF ANDREW SCOTT AM PROF LISA HORVARTH DR ROBERT IVKOV • Director, Department of Medical Oncology, Chris O’Brien Lifehouse • Head of Clinical Prostate Cancer Research, Garvan Institute of Medical Research • Expertise in radiation oncology and development and characterization of magnetic nanoparticles • Director, Department of Molecular Imaging, Olivia Newton-John Cancer Research Institute • Experience in pre-clinical development and first in-human trials. DR PAUL GRINT • Expertise in commercialization of molecules • Over 20 years experience in biologics and small molecule R&D 24 Collaborators and Partners MD Anderson Cancer Center - In 2015 the MD Anderson established a Magnetic Relaxometry Research Laboratory to help validate the Imagion technology for various cancer targets Imagionbiosystems.com World class scientific collaborations & partnerships: UC San Diego - Radiologists with expertise in biomagnetism have been helping develop the analytical algorithms associated with magnetic relaxometry measurements and magnetic resonance imaging Siemens - A research collaboration was established with Siemens Healthineers of Australia to assist with the optimization of MRI protocols currently being used in the MagSense® HER2 Breast Cancer Phase I study Monash University - A $50k CSIRO grant supports pre-clinical research at Monash University’s Biomedicine Discovery Institute for prostate cancer imaging. Work commenced later in 2021 Patrys Limited - A collaborative research program with Patrys Limited aims to combine technologies to improve brain tumor imaging and diagnosis. Research engagement with The University of Sydney Global Cancer Technology - A Joint Development Agreement aims to develop GCT’s novel nanoscintillator technology for the treatment of breast cancer. Preliminary work commenced under this agreement in 2021 NewPhase - Imagion supplies NewPhase with iron oxide nanoparticles for incorporation into their magnetic hyperthermia treatment for cancer. The high quality of Imagion’s nanoparticles enables effective heating of cancer cells resulting in cell death Massachusetts General Hospital - A Sponsored Research Agreement aims to evaluate the use of iron oxide nanoparticles for use in vascular, or other MR imaging applications 25 Capital and Financial Snapshot Imagionbiosystems.com Imagion ended Q1 2023 with $2.6 million Ordinary shares on issue 1,168 million Anticipated receipts of up to $4.9 million in Q2 2023: Listed and unlisted options 70 million • Receipt of $1.0m (pre-costs) for second tranche Mercer convertible securities (subject to shareholder approval) Share price (18 May 2023) $0.016 • Receipt of $3.5m for R&D tax credit in respect of 2022 tax year (lodged with ATO) 12-month range $0.014 - $0.049 Average daily volume (3 months to 18 May 2023) 1.7 million shares Market capitalization (18 May 2023) $18.6 million Cash (31 March 2023) $2.6 million Shareholder spread (18 May 2023) Top 20 shareholders own 21% • Receipt of $0.4m (pre-costs) from recent entitlement offer (received) Further liquidity available including: • • Potential for Mercer to invest up to $12.5m in additional tranches (subject to mutual agreement / placement capacity / shareholder approval) Ability to raise up to $1.97m relating to entitlement offer shortfall up to 14 July 2023 should favorable market conditions prevail 26 Mercer Transaction Imagionbiosystems.com Key terms of the agreement: Term • 18-month term for each tranche from drawdown Conversion • 90% lowest VWAP during 15 trading days (all tranches) or fixed at A$0.03 during first three months (first tranche only) • Imagion right to repurchase at 105% face value at anytime (Mercer can choose to convert up to 30%) Ownership limitation • At no point in time will Mercer own more than 9.99% of the shares of Imagion Option coverage • Imagion will issue 75% of the value of each tranche drawn in three year options with an exercise price at 140% of 20-day VWAP prior to drawdown Interest and costs • No interest payable on drawn unconverted funds • 2.5% of facility to be issued as value in equity to Mercer on commencement • Face value of notes 110% of funds advanced • 6% finders fee for each amount drawn 27 Historical Cash Flows Imagionbiosystems.com 2020 2021 2022 2023 Q2 AUD Q3 AUD Q4 AUD Q1 AUD Q2 AUD Q3 AUD Q4 AUD Q1 AUD Q2 AUD Q3 AUD Q4 AUD Q1 AUD '000 '000 '000 '000 '000 '000 '000 ’000 ’000 ‘000 ‘000 ‘000 26 82 65 41 48 34 84 95 143 88 88 85 (1,036) (794) (790) (490) (645) (640) (749) (839) (956) (873) (1,077) (839) (925) (1,085) (798) (1,002) (1,322) (1,572) (1,510) (1,518) (1,672) (2,022) (1,978) (2,171) (9) (9) (9) (3) 3 (2) (1) (15) (42) (58) (21) (33) Receipts from customers Payments - R&D Payments - other Interest - net Q1 AUD '000 50 (492) (1,183) (8) Grants and R&D incentive - 2,197 22 16 - 2,612 - - - - 22 2,501 23 (1,610) 22 275 26 (1,758) 26 (1,491) 46 (1,408) 695 (2,180) (2,176) (2,277) (2,527) 27 (2,816) 33 (454) (2,917) - - (4) (4) (20) (91) (95) (103) (182) 15 (300) (2) (7) Proceeds - shares (net) Proceeds – options - 2,195 - 4,403 1,568 5,563 1,038 1,334 253 134 3,785 - - 3 - - Proceeds – convertible debt Repayment of borrowings (leases) Costs / Other Total financing Net cashflows Forex - - - - - - - - - - - - 1,500 (97) (97) (1,707) 4 (67) 234 2,362 2,637 (9) (173) 5,799 4,037 (18) (144) 6,457 4,962 (107) (142) 1,192 (236) 43 (66) 187 791 130 (74) 59 (2,216) 273 (77) 3,708 1,429 (21) (53) (53) (2,512) (253) (236) (236) (2,748) 641 (369) (366) (3,481) 267 (307) (307) (763) (97) (306) (176) 1,018 (1,906) 23 Cash at start 3,402 1,698 4,327 8,345 13,201 13,007 13,928 11,986 13,394 10,629 8,522 5,307 4,446 Cash at end 1,698 4,327 8,345 13,201 13,007 13,928 11,986 13,394 10,629 8,522 5,307 4,446 2,563 Operating Other Total operating 41 Investing Payments – assets (net) Financing 28 www.imagionbiosystems.com info@imagionbio.com ASX:IBX