Imagion Biosystems:
Annual Report 2022

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Plain-text annual report

IMAGION BIOS YSTEMS LIM ITED ANNU AL REP ORT 2022 AN NUA L REPO RT CONT ENTS 2022 HIGH LIGHTS 2 3 5 7 2022 Highlights The future of molecular imaging Letter from the Chairman Directors’ Report 17 Remuneration Report (audited) 26 Auditor’s Independence Declaration 27 Consolidated Statement of Profit and Loss and Other Comprehensive Income 28 Consolidated Statement of Financial Position 29 Consolidated Statement of Changes in Equity 30 Consolidated Statement of Cash Flows 31 Notes to the Consolidated Financial Statements Directors’ Declaration Independent Auditor’s Report Shareholder Information Corporate Directory 58 59 62 65 1 RESEARCH & DEVELOPMENT • March 2022 - MagSense® HER2 Breast Cancer Phase I study interim results reported • April 2022 - Sponsored Research Agreement executed with researchers as Massachusetts General Hospital • July 2022 - Research collaboration with University of Sydney related to brain cancer project • September 2022 - Preclinical research for prostate cancer detection presented at World Molecular Imaging Conference • December 2022 - Clinical data for first cohort of MagSense® HER2 Breast Cancer Phase I Study reported at breast cancer meeting • Subsequent to year-end - Company announces shift to detection of MagSense® HER2 imaging agent by MRI to accelerate route to commercialization CORPORATE • Cash balance at 31 December 2022 $4.4M • Received $2.5M R&D tax incentive • Move to new facility completed, expanding IBX’s internal nanoparticle R&D capabilities and providing additional manufacturing capability to support clinical programs and can be leveraged to generate revenue 2 IBX ANNUAL REPORT 2022IBX ANNUAL REPORT 2022 PRE-DOSE T2 Pre-dose 2 POST-DOSE T2 The MagSense® imaging agent creates a detectable change in image contrast when tumour cells are in lymph nodes THE FUTURE O F MO LECULAR IMAG I NG CHANGING THE WAY WE LOOK AT CANCER Over the last 50 years, there have been significant improvements in medical imaging technologies largely in the areas of improving sensitivity and image resolution. But there’s still much to be done around providing a non- invasive, non-radioactive, and targeted solution that can make diagnosing cancer better. Improving the way doctors are able to detect and diagnose cancer is no easy task, but that is Imagion’s main mission. Our MagSense® technology has been designed to be more targeted and sensitive than conventional imaging methods, resulting in more successful treatments and improved patient outcomes. The MagSense® bio-functional nanoparticles produce a detectable molecular signature that indicates the presence of tumour cells in a patient’s body, rather than simply identifying a “region of interest” or “suspicious lesion”. Our Phase I study of the MagSense® HER2 breast cancer imaging agent has indicated that our magnetic molecular imaging technology has the potential to change clinical practices because they would be safe and could be incorporated into existing clinical workflows with conventional MRI machines. CLINICAL AND PRECLINICAL RESEARCH OF MAGSENSE® IMAGING AGENTS In 2022, we were very pleased to be able to share our progress in the research and development of two of our MagSense® targeted nanoparticle imaging projects – clinical data for our breast cancer product and preclinical data for our prostate cancer initiative. The progress we have reported provides strong support for Imagion to continue the development of its pipeline of MagSense® imaging agents for different types of cancers. PHASE I HER2 BREAST CANCER CLINICAL TRIAL Data collected to-date in our HER2 Breast Cancer study has given us the confidence that our targeted nanoparticles are likely to be safe, well-tolerated and able to detect cancer cells in a patient’s lymph nodes. A blinded review of the images by an independent panel of radiologists has corroborated our findings. The scans show that the contrast created by the MagSense® HER2 imaging agent in nodes highly suspicious for tumour is distinctly different from the contrast seen in non-involved nodes. The trial remains open for enrolment to provide additional data to inform future study design and evaluate diagnostic performance. PROSTATE CANCER PRECLINICAL RESEARCH The Imagion team also presented preclinical data at the World Molecular Imaging Conference related to a MagSense® imaging agent for the detection of like prostate cancer. The research demonstrated that MagSense® targeted particles accumulate preferentially in tissues expressing Prostate Specific Membrane Antigen (PSMA), similar to how PSMA-PET tracers work. A MagSense® imaging agent would be a bio-safe alternative and would eliminate the need to use radioactivity to diagnose prostate cancer. 3 4 IBX ANNUAL REPORT 2022IBX ANNUAL REPORT 2022 LETTE R FROM THE CHAIRM AN DEAR SHAREHOLDERS, 2022 was a momentous year for our company. It has been especially gratifying to be able to end the year with demonstrable evidence that our clinical study has resulted in a positive outcome and clarity for our development pathway in 2023 and beyond. Throughout the year, we remained focused on delivering results from our first-of-its-kind investigative study of our novel MagSense® imaging technology. We initiated the Phase I study as the initial proof-of-principle that our targeted nanoparticle technology could non-invasively detect cancer. While enrolment in the HER2 breast cancer study remained challenging in 2022, we were pleased to be able to share the initial safety review in mid-year and by year-end have sufficient data to report that our study objectives were being met. This is a remarkable achievement for our company and has been instrumental in giving us the confidence to move forward. In 2022, we were also able to make significant progress with our research efforts to build a pipeline of products based on our proprietary nanoparticle technology. In April, we entered into a research agreement with Massachusetts General Hospital to explore the use of IBX’s iron oxide nanoparticles for vascular imaging as an aid in diagnosing and treating cardiovascular diseases. In September, our team presented encouraging data from our preclinical studies using targeted nanoparticles for prostate cancer and we expanded our partnership with Patrys Limited to include the University of Sydney to investigate the use of the MagSense® technology to detect brain cancers. We look forward to reporting our progress on these projects and others in 2023. Establishing and maintaining these partnerships with leading companies and research institutions is vital in the development of a robust pipeline of products based on our nanoparticle technology, which can support our strategic goals and our mission of transforming how medical imaging can improve patient outcomes. At the beginning of 2022, we moved into our new R&D and manufacturing facility in San Diego. This move has helped us expand our internal R&D capabilities and provides the additional manufacturing capacity we will need to support our clinical product development and, ultimately, commercial production. Aided by an AU$2.5 million research and development tax incentive from the Australian Taxation Office (ATO) in respect of the 2021 year we managed our finances to achieve an important outcome for our shareholders without having to raise capital in 2022. The remarkable work our team and partners did in 2022 has led us to where we are now. We start 2023 with a clear direction for our company: focusing on clinical applications of our nanoparticle imaging agents in conjunction with the readily and widely- available MRI technology. This is an exciting step for our company, eliminating technical risks and bringing us one step closer to commercializing our technology. I started this letter indicating 2022 was a “momentous” year. It has been, in both the literal sense of being significant and consequential, but also in the sense of our company now having momentum. We believe we have demonstrated the path forward for Imagion and are hopeful you will support us as we look to execute this strategy in the new year, bringing value to our shareholders and realizing our technology’s potential to change the way we look at cancer. ROBERT PROULX Executive Chairman Imagion Biosystems Limited 5 6 IBX ANNUAL REPORT 2022IBX ANNUAL REPORT 2022 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 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 2022. 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 CEO and 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 a director (was formerly President & CEO) af 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 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Ms Jovanka Naumoska Non-Executive Director Jovanka is an Australian-qualified corporate lawyer with board-level experience in legal and regulatory issues pertaining to medical imaging technology. Jovanka is currently a non- executive director of Security Matters Limited (ASX:SMX) and serves Australian scientific development organisations in an expert capacity on matters relating to corporate law, business operations, intellectual property development and regulatory compliance. Mr Mark Van Asten Non-Executive Director Mark has over 30 years of experience in the medical diagnostics and life sciences industry. Much of this time has been in international business development, strategic planning and introduction of new technology. Through Diagnostic Technology, a company he founded, he has been responsible for the development and introduction of a number of innovative technology platforms and technologies into mainstream healthcare use, including HPV DNA testing for cervical cancer screening and the molecular monitoring for both viral infections and cancer treatments. He holds an Adjunct Senior Lectures position at the School of Biotechnology and Biomolecular Science, University of NSW where he has collaborated on a number of research projects related to biosynthetic pathways in bacteria. Ms Dianne Angus Non-Executive Director Dianne has worked as a senior executive within the biotechnology, medtech, agritech and healthcare sectors for over twenty years and currently serves as non-executive director with Neuren Pharmaceuticals Limited (ASX: NEU), Cyclopharm Limited (ASX:CYC) and Bionic Vision Technologies Limited as well as being a member of the Deakin University Council. She has built competitive and differentiated product portfolios, from investment in innovative research and product development to commercialisation and market entry. Dianne has created many global industry partnerships to accelerate asset development, financing and provide reputational validation & endorsement. With twenty years’ experience in ASX and NASDAQ listed companies, Dianne has expertise in corporate governance, capital raising and stakeholder engagement within the listed capital market sector. Dianne holds a B.Sc. (Ed), B.Sc. (Hons), M.(Biotechnology) and is a registered patent & trade mark attorney. Mr Geoff Hollis Company Secretary Prior to joining Imagion in December 2020 Geoff spent over 10 years in ASX listed companies as CFO and Company Secretary. Geoff commenced his career with almost 10 years at leading Melbourne based accounting and business advisory firm, Pitcher Partners. Geoff is experienced in capital and debt raisings along with ongoing investor relations function in addition to other CFO and Company Secretarial experience required for an ASX listed entity on a growth journey. Geoff is also a member of the Corporate Governance Institute and Chartered Accountants Australia and New Zealand. Company Secretary 8 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Principal activities During the financial year the principal continuing activities of the consolidated entity consisted of: Nanotechnology; Biotechnology; Cancer Diagnostics; and Medical Imaging using Magnetic Resonance and Superparamagnetic Relaxometry. Dividends There were no dividends paid, recommended or declared during the current or previous financial year. Review of operations Operating loss of $9,807,208 (2021: $6,024,706 loss) was materially in line with expectations and increased from 2021 due to increased expenses. Staffing and administrative expenditure, research and development expenditure and depreciation and finance expenditure all increased during 2022. Organisational capacity has continued to be expanded during 2022 leading to and increase in staffing and administrative expenditure. In relation to research and development, the consolidated entity incurred expenses in relation to its MagSense® HER2 Breast Cancer Phase I Study continuing in Australia during 2022. In addition to trial costs, research and development expenses were incurred in relation to other projects and initiatives during the year. Depreciation and finance expenses increased due to expenditure incurred in relation to its new leased premises (commenced in January 2022) including adoption of AASB 16 lease accounting provisions. Revenue Total revenue increased by $215,359 to $3,070,925 (2021: $2,855,566). Revenue and Other Income mainly comprised income generated through sales of nanoparticles manufactured by the consolidated entity to customers. Total receipts from sales of super-paramagnetic iron oxide nanoparticles during 2022 were $473,429 (2021: $232,865). These sales were undertaken directly through IBX and includes sales to New Phase, an Israeli-based company, for the exploratory use of their SaNP hyperthermia treatment as well as increased sales to other customers. During 2022 the consolidated entity received a research and development tax incentive of $2,500,966 (2021: $2,612,159) in relation to its research and development expenditure incurred in 2021 tax year. Operating expenses Total expenses increased by $3,997,861 to $12,878,133 (2021: $8,880,272). Research and development expenses Research and development expenses increased by $911,819 to $3,615,851 (2021: $2,704,032). Whilst expenses relating to the MagSense® HER2 Breast Cancer First-in-human Study reduced slightly year-on-year there were increases in other research and development initiatives including: increased animal studies and in-house R&D supporting other indications including prostate cancer, ovarian cancer and brain tumour imaging; outsourced support to increase CMC and GMP manufacturing capabilities to support further clinical and manufacturing requirements; and expenses in relation to investigating the use of a non-targeted nanoparticle to be used in conjunction with conventional Magnetic Resonance Imaging (MRI) including expenses associated with the Sponsored Research Agreement with Massachusetts General Hospital. 9 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Employment expenses Employment expenses increased by $1,601,772 to $4,863,506 (2021: $3,261,734). In addition to salary increases and promotions in the ordinary course of business (including operating in a high inflationary environment) the consolidated entity has increased its organisational capability with key hires including: Chief Development Officer and other clinical operations employees to increase clinical operations capabilities as we plan for the next phase of development; Director of Operations to improve manufacturing capabilities to supporting development plans and external sales; Director of Quality to support clinical operations and manufacturing; Medical Physicist to increase imaging capabilities; and a Marketing and Communications Manager to reduce reliance on outsourced providers. Depreciation and finance expenses Depreciation and finance costs increased by $870,253 to $1,282,510 (2021: $412,257). Expenses related to the consolidated entity's San Diego premises comprised $846,817 of the increase. These expenses arise due to adopting AASB 16 lease accounting provision. The consolidated entity took occupancy of new premises in January 2022. Other expenses All other expenses increased by $614,016 to $3,116,266 (2021: $2,502,250). Professional fees reduced by $148,597 due to a reduction in recruitment costs (due to timing) and a reduction in listing and filing fees. General expenses increased by $607,637 mainly due to increased in rent outgoings, utilities and travel related expenses (as a result of post-Covid travel recommencing). Liquidity The consolidated entity has a positive cash position with $4.4 million in cash at the end of 2022 (2021: $13.4 million) with further potential liquidity in the form of an R&D tax incentive in respect of its 2022 R&D expenditure. The consolidated entity is cognisant of its liquidity requirements and will provide further updates as and when required. Clinical development MagSense® HER2 Breast Cancer Clinical Development The consolidated entity recently announced that its MagSense® HER2 breast cancer Phase 1 study has achieved promising results showing that the MagSense® HER2 imaging agent produces a change in image contrast and that the contrast in nodes highly suspicious for tumour is distinctly different from the MR image contrast seen in non- involved nodes. These findings were corroborated by an independent panel of expert breast cancer radiologists and comprised the first cohort of six patients. The confirmation by the panel of the consolidated entity's assessment that cancer detection can be achieved when using the MagSense® imaging agent with MRI has significant implications for the consolidated entity. • • MRI is already part of clinical workflow and clinical decision making with a large installed base of scanners and trained radiologists throughout the world, which will help drive faster clinical adoption. It eliminates the near-term expense and risks associated with developing and introducing a new type of detection technology. • It demonstrates the clinical potential for the consolidated entity's pipeline of imaging agents targeting other cancers. 10 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Since all MagSense® targeted imaging agents use the same underlying magnetic nanoparticle technology, the consolidated entity now plans to prioritise the development of its MagSense® nanoparticle technology for use with mainstream clinical MRI scanners. The MagSense® HER2 Breast Cancer Phase 1 study is the first clinical investigation of the consolidated entity's proprietary MagSense® magnetic nanoparticle technology. The study was designed to be an initial proof-of- principle in human subject to assess whether targeted magnetic nanoparticles can provide molecular imaging without the use of radiation in humans. The study is investigating the potential for the MagSense® HER2 imaging agent to detect HER2 positive breast cancer cells that may have metastasized to the lymph nodes. A total of nine patients have been enrolled into the study with the study remaining open for enrolment to continue to accumulate valuable information that may inform future study considerations and gather a larger data set that may be used for training purposes. The study is currently recruiting through four sites in three states – Monash Health, Austin Health, Royal Brisbane Women’s Hospital and Lake Macquarie Private Hospital. All enrolled trial patients receive a dose of the MagSense® HER2 targeted imaging agent, followed by exploratory assessment by two forms of imaging modalities: • • our proprietary magnetic relaxometry imaging method (MRX); and a standard magnetic resonance imaging method (MRI). The consolidated entity's proprietary magnetic relaxometry imaging method (MRX) will continue to be developed with academic and industry partners, focusing on a new generation of small magnetic sensors that could enable the use of magnetic relaxometry in the doctor's office. The consolidated entity anticipates that this will be a longer-term project. The consolidated entity would like to acknowledge and thank the patients that have enrolled in the Phase 1 study to-date, without whom we would not be able to advance our idea of improving cancer detection. Additionally, the consolidated entity would like to acknowledge the consolidated entity's founder, Dr. Edward Flynn, for his foresight and for pioneering the idea that magnetic nanoparticles could be used in a targeted way to non- invasively detect cancers. Prostate cancer The consolidated entity continued to advance its preclinical prostate cancer research during 2022. In September 2022 the consolidated entity presented a poster at the World Molecular Imaging Congress noting that its MagSense® molecular imaging agent shows high specificity and selectivity with both Magnetic Resonance imaging method (MRI) and its proprietary Magnetic Relaxometry imaging method (MRX). The preclinical research provided strong evidence that the consolidated entity's magnetic nanoparticle technology has the potential to target prostate cancer tumours expressing the Prostate Specific Membrane Antigen (PSMA) with high specificity, accumulating preferentially in tissues expressing PSMA and not in other vital organs. The data presented follow from the initial work supported by a CSIRO Innovations Connections grant received in 2021. 11 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Brain cancer The consolidated entity is collaborating with Patrys Limited to investigate the use of a Patrys’ PAT-DX1 deoxymabs antibody with the consolidated entity’s MagSense® nanoparticles to improve brain tumour imaging and diagnosis. This collaboration further explores the utility of the consolidated entity’s nanoparticles in other complex indications. Should this collaborative work progress positively, the consolidated entity will have an exclusive option to a future license agreement. Use of non-targeted nanoparticles with conventional Magnetic Resonance Imaging (MRI) During the year the consolidated entity entered into a Sponsored Research Agreement with researchers at Massachusetts General Hospital to investigate the potential for the consolidated entity's iron oxide nanoparticle technology to be used in conjunction with conventional MRI. Gadolinium-based Contrast Agents (GBCAs) are the primary contrast media products approved for use with MRI for cardiovascular applications. Certain patient populations such as patients with chronic kidney disease, pregnant women and paediatric patients often avoid use of GBCAs due to the potential side effects. An iron oxide nanoparticle-based agent would be a safe alternative for vascular imaging applications where contrast media are required. The consolidated entity's research program aims to leverage our underlying know-how with iron oxide nanoparticle technology to investigate their possible use for vascular imaging. This would be a non-targeted nanoparticle with properties providing for it to remain in circulation to enhance the visualization of arterial and venous blood flow which is important in diagnosing and treating certain cardiovascular diseases. The consolidated entity expects these ongoing projects to continue to progress throughout 2023, effectively positioning the Company’s imaging and nanoparticle technology for future commercial and clinical growth in the coming years. New facility The fit-out of a new San Diego R&D facility was largely completed by the end of 2021 with the consolidated entity taking occupancy early in 2022. This new facility significantly expands the consolidated entity’s internal nanoparticle research & development capabilities, provides additional manufacturing capacity to support clinical programs and can be leveraged to generate revenue through third party commercial relationships. Outlook As the planning for the consolidated entity’s MagSense® HER2 breast cancer clinical program progresses and the consolidated entity advances its development pipeline, the consolidated entity is budgeting for research and development expenditures and staffing costs to increase in 2023, particularly in the second-half of the year. The consolidated entity has initiated the regulatory process with the US Food and Drug Administration (FDA) regarding bringing the HER2 Breast Cancer clinical studies to the United States where there will be access to a larger number of sites and a more substantial patient population. The consolidated entity is well positioned to continue the progression of its MagSense® HER2 Breast Cancer program as well as other indications and collaborations. 12 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Significant changes in state of affairs There were no significant changes in the state of affairs of the consolidated entity. Matters subsequent to the end of the financial year No matters or circumstances have arisen since the end of the financial period that has significantly affected or may significantly affect the operations of the consolidated entity, the results of those operations, or the state of affairs of the consolidated entity in future financial years. Likely developments and expected results of operations Management expects spending to increase in 2023 and future periods as it progresses the clinical development of the consolidated entity's MagSense® HER2 Breast Cancer imaging agent. The consolidated entity also expects to carry out other research and development projects throughout 2023. Environmental regulation The Consolidated Entity is not subject to any significant environment regulation under Australian Commonwealth or State Law. Information on Directors Name and title: Qualifications: Expertise and experience: Other current directorships: Former directorships (last 3 years): Membership of committees: Interest in shares: Interest in options: Interest in rights: Contractual rights to shares: Mr Robert Proulx (Executive Chair / President) - Master of Arts and Bachelor of Arts, The State University of New York at Albany; - Executive Master of Business Administration, Penn State Smeal College of Business. Robert has over 25 years’ experience bringing life science and medical device products through development and commercialisation and joined the predecessor company, Senior Scientific as President and Chief Operating Officer. None None None 6,163,250 shares 6,282,000 options 5,000,000 performance rights 5,000,000 performance rights are issued under the company's long- term incentive plan and will vest into one ordinary share each subject to achievement of prescribed performance conditions. 13 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Name and title: Qualifications: Expertise and experience: Other current directorships: Former directorships (last 3 years): Membership of committees: Interest in shares: Interest in options: Interest in rights: Contractual rights to shares: Name and title: Qualifications: Expertise and experience: Other current directorships: Former directorships (last 3 years): Membership of committees: Interest in shares: Interest in options: Interest in rights: Contractual rights to shares: Mr Michael Harsh (Non-Executive Director) - Bachelor’s degree in Electrical Engineering, Marquette University With over 36 years’ service to GE, mostly with GE Healthcare on his résumé, Michael Harsh is extraordinarily fluent in the complex processes of transforming high-potential platform technologies into successful medical diagnostic products. ENDRA Life Sciences (2016 – present); EmOpti, Inc. (2015 – present); Compute Health Acquisition Corp (2021-present). NociMed (2019-2020). Audit and Risk Committee, Remuneration and Nomination Committee 260,000 shares 560,000 options Nil Nil Mr David Ludvigson (Non-Executive Director) - Bachelor of Science in Accounting, University of Illinois - Masters in Accounting Science, University of Illinois. David is a director (formerly President and CEO) of Nanomix, Inc, a mobile diagnostics company. Previously, David held executive leadership positions with Nanogen, Matrix Pharmaceutical, IDEC Pharmaceuticals, MIPS Computer Systems, and other high-tech companies. He began his career at Price Waterhouse. China Stem Cells Ltd (2010-present); Nanōmix Inc. (2014-present); One BioMed PTE Ltd (2021-present). None Audit and Risk Committee, Disclosure Committee 545,000 shares 620,000 options Nil Nil 14 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Name and title: Qualifications: Expertise and experience: Other current directorships: Former directorships (last 3 years): Membership of committees: Interest in shares: Interest in options: Interest in rights: Contractual rights to shares: Name and title: Qualifications: Expertise and experience: Other current directorships: Former directorships (last 3 years): Membership of committees: Interest in shares: Interest in options: Interest in rights: Contractual rights to shares: Ms Jovanka Naumoska (Non-Executive Director) - Bachelor of Science degree, University of Wollongong; - Bachelor of Law degree and the Graduate Diploma in Legal Practice, University of Wollongong; -Graduate Diploma in Applied Corporate Governance, Governance Institute of Australia. Jovanka is an Australian-qualified corporate lawyer with board-level experience in legal and regulatory issues pertaining to medical imaging technology. Jovanka serves Australian scientific development organisations in an expert capacity on matters relating to corporate law, business operations, intellectual property development and regulatory compliance. Security Matters Limited; National Accreditation Authority for Translators and Interpreters None Disclosure Committee 260,000 shares 560,000 options Nil Nil Mr Mark Van Asten (Non-Executive Director) - Bachelor of Science, University of New South Wales As the Managing Director and founder of Diagnostic Technology Pty Ltd, Mark has been responsible for the development, introduction, and mainstream healthcare adoption of technologies throughout Australia and Asia. Mark has also held several director-level business development positions with US and Australian diagnostics corporations. None Cimtech Limited Audit and Risk Committee, Remuneration and Nomination Committee 545,000 shares 620,000 options Nil Nil 15 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Name and title: Qualifications: Expertise and experience: Other current directorships: Former directorships (last 3 years): Membership of committees: Interest in shares: Interest in options: Interest in rights: Contractual rights to shares: Ms Dianne Angus (Non-Executive Director) - Bachelor of Science (Hons), University of Melbourne; Masters in Biotechnology, Monash University. Dianne has worked as a senior executive or director within the biotechnology, medtech, agritech and healthcare sectors for over twenty years. With numerous years’ experience in ASX and NASDAQ listed companies, Dianne has expertise in corporate governance, capital raising and stakeholder engagement within the listed capital market sector. Neuren Pharmaceuticals Limited; Cyclopharm Limited. None Remuneration and Nomination Committee, Disclosure Committee 243,000 shares 500,000 options Nil Nil Other current directorships quoted above are current directorships for listed entities only and excludes directorships of all other types of entities, unless otherwise stated. Former directorships (last 3 years) quoted above are directorships held in the last 3 years for listed entities only and excludes directorships of all other types of entities, unless otherwise stated. Company secretary Geoff is a member of Chartered Accountant Australia and New Zealand, holds a Graduate Diploma in Applied Corporate Governance from the Governance Institute of Australia and a Bachelor of Commerce from Deakin University. Geoff has 3,000,000 options which are subject to prescribed vesting conditions and 5,000,000 performance rights which are subject to the achievement of prescribed performance conditions. Meetings of directors The number of meetings of the company's Board of Directors ('the Board') and of each Board committee held during the year ended 31 December 2022, and the number of meetings attended by each director were: Board No. of meetings eligible to attend 6 6 6 6 6 6 Attended 6 6 6 6 6 6 Mr Robert Proulx Mr Michael Harsh Mr David Ludvigson Ms Jovanka Naumoska Mr Mark Van Asten Ms Dianne Angus Remuneration & Nomination Committee No. of meetings eligible to attend - - - 2 2 2 Attended - - - 2 2 2 Attended Audit & Risk Management Committee No. of meetings eligible to attend - - 2 2 2 - - 2 2 2 - - 16 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Remuneration Report (audited) The remuneration report details the key management personnel remuneration arrangements for the consolidated entity, in accordance with the requirements of the Corporations Act 2001 and its Regulations. Key management personnel are those persons having authority and responsibility for planning, directing and controlling the activities of the entity, directly or indirectly, including all directors. The remuneration report is set out under the following main headings: • • • • • • Principles used to determine the nature and amount of remuneration; Details of remuneration; Service agreements; Share-based compensation; Additional information; and Additional disclosures relating to key management personnel. Principles used to determine the nature and amount of remuneration (a) The objective of the consolidated entity's executive reward framework is to ensure reward for performance is competitive and appropriate for the results delivered. The framework aligns executive reward with the achievement of strategic objectives and the creation of value for shareholders. The Board of Directors ('the Board') ensures that executive reward satisfies the following key criteria for good reward governance practices: Having strategic objectives as a core component of the reward framework design; Focusing on sustained growth in shareholder wealth, which may comprise growth in share price, increasing opportunities for the consolidated entity as well as focusing the executive on key non-financial drivers of value; Alignment of executive compensation to performance; and Acceptability to shareholders. The performance of the consolidated entity depends on the quality of its directors and executives. The remuneration philosophy is to attract, motivate and retain high performance and high-quality personnel. Accordingly, the reward framework should seek to enhance executives' interests by: Rewarding capability and application of relevant experience; Being competitive and providing a reasonable framework with regard to applicable industry standards; Reflecting competitive rewards for contribution to growth in shareholder wealth; and Providing a clear and transparent structure for earning rewards. The Remuneration and Nomination Committee reviews, recommends and reports to the Board on remuneration and performance appraisal policies and practices. In accordance with best practice corporate governance, the structure of non-executive director and executive director remuneration are treated separately. Non-executive director's remuneration Fees and payments to non-executive directors reflect the demands and responsibilities of their role. Non- executive directors' fees and payments are reviewed annually by the Board. The Board may, from time to time, receive advice from independent remuneration consultants to ensure non-executive directors' fees and payments are appropriate and in line with applicable industry standards. 17 • • • • • • • • (b) Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 ASX listing rules require the aggregate non-executive director’s remuneration be determined periodically by a general meeting. At the 2021 Annual General Meeting the non-executive directors fee pool was increased to $450,000 (from $250,000). The fee pool: • • • More closely aligns to fee pools for non-executive directors of comparable companies; Provides greater flexibility for the consolidated entity to attract and retain non-executive directors of a high calibre; and Provides headroom for future adjustments to non-executive directors fees in line with changing market conditions and to reflect the increasing demands of non-executive directors. Executive remuneration The consolidated entity aims to reward executives based on their position and responsibility, with a level and mix of remuneration which has both fixed and variable components. The executive remuneration and reward framework has five components: • • • • • Base pay and non-monetary benefits; Short-term performance incentives; Share-based payments; Health care benefits (applicable to US based personnel); and Other remuneration such as superannuation and long service leave. The combination of these components comprises the executive's total remuneration. The CEO consults with the Remuneration and Nomination Committee in relation to executive remuneration. Executive fixed remuneration, consisting of base salary and non-monetary benefits, are reviewed annually based on individual and business performance, the overall performance of the consolidated entity and comparable market remunerations. The short-term incentives ('STI') program is designed to align short-term organisational goals with the short-term performance hurdles of executives. STI payments are granted to executives based on specific annual targets and key performance indicators ('KPI's') being achieved. No STI payments were proposed or paid during the financial year to executives. The long-term incentives ('LTI') include share-based payments. Shares are awarded to executives over a period of three or four years based on strategic objectives and long-term incentive measures. These include increase in shareholders’ value relative to the entire market and the increase compared to the consolidated entity's direct competitors. Executive Director and CEO remuneration In 2021 the Remuneration and Nomination Committee undertook benchmarking of Mr Proulx's salary to align it more closely with comparable roles in the market and a performance review. Mr Proulx's base salary was increased to US$320,000 per annum (from US$240,000) on 1 July 2021. Mr Proulx continues to provide invaluable service to the consolidated entity and had not had an increase in salary since the IPO of the consolidated entity in 2017. The CEO’s fixed remuneration, consisting of base salary and non-monetary benefits, are reviewed annually by the Remuneration and Nomination Committee based on individual and business performance, the overall performance of the consolidated entity and comparable market remunerations. 18 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Details of remuneration Details of the remuneration of key management personnel of the consolidated entity are set out in the following tables. The key management personnel of the consolidated entity are: Non-Executive Directors; Executive Director and CEO - Robert Proulx; Chief Development Officer - Yalia Jayalakshmi; and Chief Financial Officer - Geoff Hollis. 2022 Non-Executive Directors Michael Harsh David Ludvigson Jovanka Naumoska Mark Van Asten Dianne Angus Executive Directors Robert Proulx Other Key Management Yalia Jayalakshmi Geoff Hollis Total 2021 Non-Executive Directors Michael Harsh David Ludvigson Jovanka Naumoska Mark Van Asten Dianne Angus Executive Directors Robert Proulx Other Key Management Yalia Jayalakshmi(1) Geoff Hollis Short-term benefits Share-based payment Cash salary & $ Cash bonus $ Non- monetary $ Equity-settled shares $ Equity-settled options $ Total $ 48,582 48,582 45,102 45,102 45,102 - - - - - - - - - - 735 735 735 735 735 49,317 49,317 45,837 45,837 45,837 512,035 - - 47,093 15,408 574,535 479,511 299,835 - - - 92,469 - 127,622 105,030 55,720 699,602 460,585 1,523,851 - - 244,592 202,424 1,970,867 Short-term benefits Share-based payment Cash salary & $ Cash bonus $ Non- monetary $ Equity-settled shares $ Equity-settled options $ Total $ 32,038 32,038 33,450 33,450 41,663 - - - - - - - - - - - 7,038 - 7,038 - 7,038 - 7,038 - 7,038 39,076 39,076 40,488 40,488 48,701 432,902 - - 47,093 31,062 511,057 142,354 300,165 - - 4,307 - - 105,030 6,132 101,004 152,793 506,199 Total 1,048,060 (1) Represents remuneration from 1 September 2021 to 31 December 2021. - - 156,430 173,388 1,377,878 19 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 The proportion of remuneration linked to performance and the fixed proportion are as follows: Non-Executive Directors Michael Harsh David Ludvigson Jovanka Naumoska Mark Van Asten Dianne Angus Executive Directors Robert Proulx Other Key Management Yalia Jayalakshmi Geoff Hollis Fixed Remuneration 2022 2021 At Risk - STI 2022 At Risk - LTI 2021 2022 2021 99% 99% 98% 98% 98% 82% 82% 83% 83% 86% - - - - - - - - - - 1% 1% 2% 2% 2% 18% 18% 17% 17% 14% 89% 85% - - 11% 15% 69% 65% 93% 59% - - - - 31% 35% 7% 41% Service agreements Remuneration and other terms of employment for key management personnel are formalised in service agreements. Details of these agreements are as follows: Name: Title: Agreement commenced: Term of agreement: Details: Name: Title: Agreement commenced: Term of agreement: Details: Name: Title: Agreement commenced: Term of agreement: Details: Mr Robert Proulx Executive Chair / President 1 May 2020 3 years, unless extended by mutual agreement -Base salary of US$320,000 per annum (increased from US$240,000 effec(cid:415)ve 1 July 2021), to be reviewed by the Remuneration and Nomination Committee; -En(cid:415)tled to up to 16,000,000 Rights and Op(cid:415)ons under the Equity Incen(cid:415)ve Plan (subject to certain milestones being met) (issued in 2020); -12 months termina(cid:415)on no(cid:415)ce by the Company. Ms Yalia Jayalakshmi Chief Development Officer 1 September 2021 Ongoing -Base salary of US$300,000 per annum, to be reviewed annually; -En(cid:415)tled to up to 15,000,000 Rights and Op(cid:415)ons under the Equity Incen(cid:415)ve Plan (subject to certain milestones being met) (issued in 2021); -At-will employee. Mr Geoff Hollis Chief Financial Officer / Company Secretary 1 December 2020 Ongoing -Base salary of AUD$300,000 per annum, to be reviewed annually by the Nomination and Remuneration Committee; -En(cid:415)tled to up to 8,000,000 Rights and Op(cid:415)ons under the Equity Incen(cid:415)ve Plan (subject to certain milestones being met) (issued in 2020); -3 months termina(cid:415)on no(cid:415)ce by either party. Key management personnel have no entitlement to termination payments in the event of removal for misconduct. 20 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Share-based compensation Issue of shares No shares were issued to directors in 2022. Options The terms and conditions of each grant of options over ordinary shares affecting remuneration of directors and other key management personnel in this financial year or future reporting years are as follows: Name Number of options granted Grant date Vesting and exercisable date Expiry date Robert Proulx Robert Proulx Robert Proulx Michael Harsh Michael Harsh David Ludvigson David Ludvigson Jovanka Naumoska Jovanka Naumoska Mark Van Asten Mark Van Asten Dianne Angus Dianne Angus Geoff Hollis Geoff Hollis Geoff Hollis Yalia Jayalakshmi Yalia Jayalakshmi Yalia Jayalakshmi Yalia Jayalakshmi Yalia Jayalakshmi(1) (1) Options are in two equal tranches and subject to performance milestones Options granted carry no dividend or voting rights. 2,000,000 2,000,000 2,000,000 250,000 250,000 250,000 250,000 250,000 250,000 250,000 250,000 250,000 250,000 1,000,000 1,000,000 1,000,000 1,000,000 1,000,000 1,000,000 1,000,000 2,000,000 1-May-21 1-May-22 1-May-23 1-May-21 1-May-22 1-May-21 1-May-22 1-May-21 1-May-22 1-May-21 1-May-22 1-May-21 1-May-22 30-Nov-21 30-Nov-22 30-Nov-23 30-Nov-22 30-Nov-23 30-Nov-24 30-Nov-25 Refer below 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 6-Aug-20 9-Dec-20 9-Dec-20 9-Dec-20 14-Dec-21 14-Dec-21 14-Dec-21 14-Dec-21 14-Dec-21 1-May-26 1-May-27 1-May-28 1-May-26 1-May-27 1-May-26 1-May-27 1-May-26 1-May-27 1-May-26 1-May-27 1-May-26 1-May-27 30-Nov-26 30-Nov-27 30-Nov-28 30-Nov-27 30-Nov-28 30-Nov-29 30-Nov-30 30-Nov-25 Fair value per option at grant $ $0.039- $0.033- $0.029- $0.039- $0.033- $0.039- $0.033- $0.039- $0.033- $0.039- $0.033- $0.039- $0.033- $0.021- $0.016- $0.014- 0.047 0.053 0.058 0.061 0.041 Exercise price $ 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.140 0.140 0.140 0.087 0.087 0.087 0.087 0.087 21 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Performance rights The terms and conditions of each grant of performance rights over ordinary shares affecting remuneration of directors and other key management personnel in this financial year or future reporting are as follows: Name Number of rights granted Grant date Expiry date Robert Proulx(1) Geoff Hollis Yalia Jayalakshmi Yalia Jayalakshmi (1) Note: 5,000,000 performance rights were converted into ordinary shares during the 2020 financial year upon achievement of performance milestones. Performance rights granted carry no dividend or voting rights. 10,000,000 5,000,000 6,500,000 2,500,000 30-Apr-23 30-Nov-23 30-Nov-25 30-Nov-25 6-Aug-20 9-Dec-20 14-Dec-21 14-Dec-21 Fair value per right at grant date $ 0.028 0.063 0.073 0.064 Exercise price $ - - - - Additional information The historical earnings of the Consolidated Entity are summarised below: Revenue Net loss before tax Net loss after tax 2022 $ 3,070,925 9,807,208 9,807,208 2021 $ 2,855,566 6,024,706 6,024,706 2020 $ 2,696,964 5,364,007 5,364,007 2019 $ 2,490,000 3,432,506 3,432,506 The factors that are considered to affect total shareholders return (‘TSR’) are summarised below: Share price at the start of the financial year ($) Share price at the end of the financial year ($) 2022 0.076 0.024 2021 0.145 0.076 2020 0.025 0.145 2019 0.030 0.025 Basic earnings per share (cents per share) Diluted earnings per share (cents per share) (0.009) (0.009) (0.006) (0.007) (0.006) (0.007) (0.010) (0.010) Additional disclosures relating to key management personnel Shareholding The number of shares in the company held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below: Name Robert Proulx Michael Harsh David Ludvigson Jovanka Naumoska Mark Van Asten Dianne Angus Geoff Hollis Yalia Jayalakshmi Total Balance at start of year 6,163,250 260,000 545,000 260,000 545,000 - - - 7,773,250 Received Additions remuneration - - - - - - - - - - - 243,000 - - - - - 243,000 Balance at the end of the year 6,163,250 260,000 545,000 260,000 545,000 243,000 - - 8,016,250 Disposals - - - - - - - - - 22 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Option holding The number of options over ordinary shares in the company held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below: Name Robert Proulx Michael Harsh David Ludvigson Jovanka Naumoska Mark Van Asten Dianne Angus Yalia Jayalakshmi Geoff Hollis Total Balance at start of year 6,282,000 560,000 620,000 560,000 620,000 500,000 6,000,000 3,000,000 18,142,000 Granted - - - - - - - - - Exercised - - - - - - - - - Expired / forfeited / other - - - - - - - - - Balance at the end of the year 6,282,000 560,000 620,000 560,000 620,000 500,000 6,000,000 3,000,000 18,142,000 Performance rights holding The number of performance shares in the company held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below: Name Robert Proulx Yalia Jayalakshmi Geoff Hollis Total Balance at start of year 5,000,000 9,000,000 5,000,000 19,000,000 Granted - - - - Vested - - - - Expired / forfeited / other - - - - Balance at the end of the year 5,000,000 9,000,000 5,000,000 19,000,000 Voting and comments made at the Company's 2022 Annual General Meeting At the 2022 Annual General Meeting , 81% of the votes received supported the adoption of the remuneration report for the year ended 31 December 2021. The company did not receive any specific feedback at the Annual General Meeting regarding its remunerations practices. This concludes the remuneration report, which has been audited. 23 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Shares under option Unissued ordinary shares of Imagion Biosystems Limited under option at the date of this report are as follows: Grant date 24-Jun-19 22-Oct-19 22-Oct-19 22-Oct-19 28-Apr-20 6-Aug-20 6-Aug-20 6-Aug-20 29-Sep-20 9-Dec-20 9-Dec-20 9-Dec-20 7-Jun-21 14-Dec-21 14-Dec-21 14-Dec-21 17-Feb-22 8-Apr-22 25-Jul-22 26-Aug-22 25-Oct-22 21-Dec-22 Expiry date 24-Jun-24 20-Sep-24 22-Aug-24 7-Oct-24 28-Apr-23 1-May-26 1-May-27 1-May-28 30-Sep-25-31-Aug-28 30-Nov-26 30-Nov-27 30-Nov-28 30-Jun-26-31-May-29 30-Nov-27-30-Nov-30 31-Dec-26-30-Nov-29 30-Nov-25 28-Feb-27-31-Jan-30 30-Apr-27-31-Mar-30 31-Jul-27-28-Feb-28 31-Aug-27-31-Jul-30 31-Oct-27-30-Sep-30 31-Dec-27-30-Nov-30 Exercise price Number under option $0.0280 2,050,000 $0.0600 100,000 $0.0600 300,000 $0.0600 200,000 $0.0300 233,301,933 $0.0280 3,250,000 $0.0280 3,250,000 $0.0280 2,000,000 $0.0909 6,650,000 $0.1400 1,000,000 $0.1400 1,000,000 $0.1400 1,000,000 $0.1150 200,000 $0.0872 4,000,000 $0.0872 1,500,000 $0.0872 2,000,000 $0.0679 1,000,000 $0.0580 2,000,000 $0.0420 871,000 $0.0420 700,000 $0.0340 2,000,000 $0.0290 3,000,000 271,372,933 Shares issued on the exercise of options The following ordinary shares of Imagion Biosystems Limited were issued during the year ended 31 December 2022 and up to the date of this report on the exercise of options granted: Date options granted 26-Jul-22 Exercise price $0.0280 Number of shares issued 100,000 100,000 24 Imagion Biosystems Limited Directors' Report For the year ended 31 December 2022 Indemnity and insurance of officers The company has indemnified the directors and executives of the company for costs incurred, in their capacity as a director or executive, for which they may be held personally liable, except where there is a lack of good faith. During the financial year, the company paid a premium in respect of a contract to insure the directors and executives of the company against a liability to the extent permitted by the Corporations Act 2001. The contract of insurance prohibits disclosure of the nature of the liability and the amount of the premium. Proceedings on behalf of the company No person has applied to the Court under Section 237 of the Corporations Act 2001 for leave to bring proceedings on behalf of the company, or to intervene in any proceedings to which the company is a party for the purpose of taking responsibility on behalf of the company for all or part of those proceedings. Non-audit services Non-audit services provided during the financial year by the auditor included $750 for general consultancy services. The Directors are satisfied that the provision of these non-audit services is compatible with the general standard of independence for auditors imposed by the Corporations Act 2001. The nature and scope of these non- audit services mean that auditor independence was not compromised. Rounding of amounts The company is of a kind referred to in Corporations Instrument 2016/191, issued by the Australian Securities and Investments Commission, relating to 'rounding-off'. Amounts in this report have been rounded off in accordance with that Corporations Instrument to the nearest dollar. Auditor's independence declaration A copy of the auditor's independence declaration as required under section 307C of the Corporations Act 2001 is set out immediately after this directors' report. On behalf of the directors Robert Proulx Director 28 February 2023 25 AUDITOR’S INDEPENDENCE DECLARATION As lead auditor for the audit of the financial report of Imagion Biosystems Limited and its Controlled Entity for the year ended 31 December 2022, I declare that, to the best of my knowledge and belief, there have been no contraventions of: (i) (ii) the auditor independence requirements of the Corporations Act 2001 in relation to the audit; and any applicable code of professional conduct in relation to the audit. RSM AUSTRALIA PARTNERS B Y CHAN Partner Melbourne, Victoria Dated: 28 February 2023 Imagion Biosystems Limited Consolidated Statement of Profit and Loss and Other Comprehensive Income For the year ended 31 December 2022 Revenue Revenue and other income Research & development tax incentives Operating Expenses Research & development expenses Employment expenses Professional fees General expenses Share based payments expense Depreciation expense Foreign exchange gain/(loss) Finance expenses Note 4 5 5 2022 $ 569,959 2,500,966 3,070,925 (3,615,851) (4,863,506) (1,037,811) (1,423,984) (653,059) (1,108,183) (1,412) (174,327) (12,878,133) 2021 $ 243,407 2,612,159 2,855,566 (2,704,032) (3,261,734) (1,186,408) (816,347) (497,534) (404,437) (1,960) (7,820) (8,880,272) Loss before income tax expense (9,807,208) (6,024,706) Income tax expense (benefit) Loss after Income Tax Expense Other comprehensive income - - (9,807,208) (6,024,706) Items that may be reclassified subsequently to profit or loss Foreign currency translation reserve 16 523,566 413,102 Income tax relating to these items - - Other comprehensive income/(loss), net of tax 523,566 413,102 Total comprehensive Income (loss) for the year Attributable to the Owners of Imagion Biosystems Limited (9,283,642) (5,611,604) Basic earnings (loss) per share Diluted earnings (loss) per share Cents (0.009) (0.009) Cents (0.006) (0.006) 24 24 These financial statements should be read in conjunction with the accompanying notes. 27 Imagion Biosystems Limited Consolidated Statement of Financial Position As at 31 December 2022 Current Assets Cash and cash equivalents Trade and other receivables Other current assets Total Current Assets Non-Current Assets Property, plant and equipment Right-of-use assets Total Non-Current Assets Total Assets Current Liabilities Trade and other payables Lease liabilities Employee benefits Other liabilities Total Current Liabilities Non-Current Liabilities Lease liabilities (NCA) Employee benefits Total Non-Current Liabilities Total Liabilities Net Assets Equity Issued capital Reserves Accumulated losses Total Equity Note 2022 $ 2021 $ 6 7 8 9 10 11 12 13 14 12 13 15 16 17 4,446,102 92,463 449,985 4,988,550 703,276 4,283,796 4,987,072 13,393,768 31,345 343,946 13,769,059 346,096 - 346,096 9,975,622 14,115,155 436,788 1,041,051 175,032 80,033 1,732,904 3,563,318 1,904 3,565,222 585,866 15,141 140,462 34,496 775,965 30,877 3,034 33,911 5,298,126 809,876 4,677,496 13,305,279 56,830,408 3,688,550 (55,841,462) 4,677,496 56,827,608 2,511,925 (46,034,254) 13,305,279 These financial statements should be read in conjunction with the accompanying notes. 28 Imagion Biosystems Limited Consolidated Statement of Changes in Equity For the year ended 31 December 2022 Issued Capital $ Reserves $ Accumulated Losses $ Total Equity $ Balance as at 1 January 2021 51,322,126 1,601,289 (40,009,548) 12,913,867 Loss after income tax Other comprehensive income/(loss) after tax Total comprehensive income/(loss) - - - - 413,102 (6,024,706) - (6,024,706) 413,102 413,102 (6,024,706) (5,611,604) Transactions with owners in their capacity as owners Contributions of equity Costs of contributions of equity Transfer from reserves Share based payments Balance as at 31 December 2021 5,511,399 (5,917) - - 56,827,608 Issued Capital $ - - - 497,534 2,511,925 Reserves $ - - - - (46,034,254) Accumulated Losses $ 5,511,399 (5,917) - 497,534 13,305,279 Total Equity $ Balance as at 1 January 2022 56,827,608 2,511,925 (46,034,254) 13,305,279 Loss after income tax Other comprehensive income/(loss) after tax Total comprehensive income/(loss) - - - - 523,566 (9,807,208) - (9,807,208) 523,566 523,566 (9,807,208) (9,283,642) Transactions with owners in their capacity as owners Contributions of equity Costs of contributions of equity Transfer from reserves Share based payments Balance as at 31 December 2022 2,800 - - - 56,830,408 - - - 653,059 3,688,550 - - - - (55,841,462) 2,800 - - 653,059 4,677,496 These financial statements should be read in conjunction with the accompanying notes. 29 Imagion Biosystems Limited Consolidated Statement of Cash Flows For the year ended 31 December 2022 Note Cash Flows from Operating Activities Receipts from customers (inc of sales and other taxes) Payments to suppliers and employees (inc of sales and other taxes) Interest received Interest and other finance costs paid Government grants and tax incentives Net cash outflow from operating activities 23 Cash Flows from Investing Activities Payment for property, plant and equipment Proceeds from return of security deposit Net cash outflow from investing activities Cash Flows from Financing Activities Proceeds from the issue of shares Share issue costs Proceeds from the exercise of options Lease repayments Net cash inflow from financing activities 2022 $ 473,337 (10,934,165) 29,827 (166,179) 2,522,966 (8,074,214) (507,315) 38,588 (468,727) - - 2,759 (964,820) (962,061) 2021 $ 251,950 (7,929,019) 12,999 (16,581) 2,612,159 (5,068,492) (218,833) (91,260) (310,093) - (6,109) 5,511,399 (359,252) 5,146,038 Net increase (decrease) in cash and cash equivalents (9,505,002) (232,546) Cash and cash equivalents at start of year Effects of exchange rate changes on cash and cash equivalents 13,393,768 557,337 13,200,547 425,767 Cash and cash equivalents at end of year 6 4,446,103 13,393,768 These financial statements should be read in conjunction with the accompanying notes. 30 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies The principal accounting policies adopted in the preparation of the financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. The financial statements of Imagion Biosystems Limited & Controlled Entities (the "consolidated entity") for 31 December 2022 were authorised for issue by the Directors on 28 February 2023. Basis of Preparation a) These general purpose financial statements have been prepared in accordance with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board ('AASB') and the Corporations Act 2001 , as appropriate for for-profit oriented entities. These financial statements also comply with International Financial Reporting Standards as issued by the International Accounting Standards Board ('IASB'). Historical cost convention The financial statements have been prepared under the historical cost convention, except for, where applicable, the revaluation of available-for-sale financial assets, financial assets and liabilities at fair value through profit or loss, investment properties, certain classes of property, plant and equipment and derivative financial instruments. Critical accounting estimates The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entity's accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 2. Parent entity information In accordance with the Corporations Act 2001 , these financial statements present the results of the consolidated entity only. Supplementary information about the parent entity is disclosed in note 21. Principles of consolidation The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Imagion Biosystems Limited as at 31 December 2022 and the results of all subsidiaries for the year then ended. Imagion Biosystems Limited and its subsidiaries together are referred to in these financial statements as the 'consolidated entity'. Subsidiaries are all those entities over which the consolidated entity has control. The consolidated entity controls an entity when the consolidated entity is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the consolidated entity. They are de-consolidated from the date that control ceases. Intercompany transactions, balances and unrealised gains on transactions between entities in the consolidated entity are eliminated. Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the consolidated entity. 31 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) The acquisition of subsidiaries is accounted for using the acquisition method of accounting. A change in ownership interest, without the loss of control, is accounted for as an equity transaction, where the difference between the consideration transferred and the book value of the share of the non-controlling interest acquired is recognised directly in equity attributable to the parent. Non-controlling interest in the results and equity of subsidiaries are shown separately in the statement of profit or loss and other comprehensive income, statement of financial position and statement of changes in equity of the consolidated entity. Losses incurred by the consolidated entity are attributed to the non-controlling interest in full, even if that results in a deficit balance. Where the consolidated entity loses control over a subsidiary, it derecognises the assets including goodwill, liabilities and non-controlling interest in the subsidiary together with any cumulative translation differences recognised in equity. The consolidated entity recognises the fair value of the consideration received and the fair value of any investment retained together with any gain or loss in profit or loss. Comparatives Comparative figures for the prior year have been re-classified where appropriate to align with current year disclosures. Going Concern b) The financial statements have been prepared on the going concern basis, which contemplates the continuity of normal business activities and the realisation of assets and discharge of liabilities in the normal course of business. As disclosed in the financial statements, the consolidated entity incurred a loss of $9,807,208 (2021: $6,024,706), and had net cash outflows from operating activities of $8,074,214 (2021: $5,068,492) for the year ended 31 December 2022. The consolidated entity is still in the product development phase recording minimal sales revenue, consequently, it is dependent on external funding to cover ongoing product development and has forecast losses for the next financial year. These factors indicate a material uncertainty which may cast significant doubt as to whether the consolidated entity will continue as a going concern and therefore whether it will realise its assets and extinguish its liabilities in the normal course of business and at the amounts stated in the financial report. The Directors believe that there are reasonable grounds to believe that the consolidated entity will be able to continue as a going concern after considering the following factors: • • • The consolidated entity has a proven record of being able to raise funds to support its ongoing activities and is currently exploring future funding opportunities. The consolidated entity has the ability to implement a cost optimisation plan to reduce discretionary expenditures if necessary to reduce operating cash requirements; and The consolidated entity has historically received some cost relief through the receipt of research & development income tax incentives, and the directors expect this to continue. Accordingly, the Directors believe that the consolidated entity will be able to continue as a going concern and that it is appropriate to adopt the going concern basis in the preparation of the financial report. The financial report does not include any adjustments relating to the amounts or classification of recorded assets or liabilities that might be necessary if the consolidated entity does not continue as a going concern. 32 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) Foreign currency translation c) The financial statements are presented in Australian dollars, which is Imagion Biosystems Limited's functional and presentation currency. Foreign currency transactions Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at financial year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit or loss. Foreign operations The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates at the reporting date. The revenues and expenses of foreign operations are translated into Australian dollars using the average exchange rates, which approximate the rates at the dates of the transactions, for the period. All resulting foreign exchange differences are recognised in other comprehensive income through the foreign currency reserve in equity. The foreign currency reserve is recognised in profit or loss when the foreign operation or net investment is disposed of. d) Revenue recognition Revenue from contracts with customers Revenue is recognised at an amount that reflects the consideration to which the consolidated entity is expected to be entitled in exchange for transferring goods or services to a customer. For each contract with a customer, the consolidated entity: identifies the contract with a customer; identifies the performance obligations in the contract; determines the transaction price which takes into account estimates of variable consideration and the time value of money; allocates the transaction price to the separate performance obligations on the basis of the relative stand-alone selling price of each distinct good or service to be delivered; and recognises revenue when or as each performance obligation is satisfied in a manner that depicts the transfer to the customer of the goods or services promised. Variable consideration within the transaction price, if any, reflects concessions provided to the customer such as discounts, rebates and refunds, any potential bonuses receivable from the customer and any other contingent events. Such estimates are determined using either the 'expected value' or 'most likely amount' method. The measurement of variable consideration is subject to a constraining principle whereby revenue will only be recognised to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur. The measurement constraint continues until the uncertainty associated with the variable consideration is subsequently resolved. Amounts received that are subject to the constraining principle are recognised as a refund liability. Sale of goods Revenue from the sale of goods is recognised at the point in time when the customer obtains control of the goods, which is generally at the time of delivery. 33 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) Interest Interest revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the amortised cost of a financial asset and allocating the interest income over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset. Other revenue Other revenue is recognised when it is received or when the right to receive payment is established. Income tax e) The income tax expense or benefit for the period is the tax payable on that period's taxable income based on the applicable income tax rate for each jurisdiction, adjusted by the changes in deferred tax assets and liabilities attributable to temporary differences, unused tax losses and the adjustment recognised for prior periods, where applicable. Deferred tax assets and liabilities are recognised for temporary differences at the tax rates expected to be applied when the assets are recovered, or liabilities are settled, based on those tax rates that are enacted or substantively enacted, except for: • • When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting nor taxable profits; or When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and the timing of the reversal can be controlled, and it is probable that the temporary difference will not reverse in the foreseeable future. Deferred tax assets are recognised for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilise those temporary differences and losses. The carrying amount of recognised and unrecognised deferred tax assets are reviewed at each reporting date. Deferred tax assets recognised are reduced to the extent that it is no longer probable that future taxable profits will be available for the carrying amount to be recovered. Previously unrecognised deferred tax assets are recognised to the extent that it is probable that there are future taxable profits available to recover the asset. Deferred tax assets and liabilities are offset only where there is a legally enforceable right to offset current tax assets against current tax liabilities and deferred tax assets against deferred tax liabilities; and they relate to the same taxable authority on either the same taxable entity or different taxable entities which intend to settle simultaneously. Current and non-current classification f) Assets and liabilities are presented in the statement of financial position based on current and non-current classification. An asset is classified as current when: it is either expected to be realised or intended to be sold or consumed in the consolidated entity's normal operating cycle; it is held primarily for the purpose of trading; it is expected to be realised within 12 months after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at least 12 months after the reporting period. All other assets are classified as non-current. 34 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) A liability is classified as current when: it is either expected to be settled in the consolidated entity's normal operating cycle; it is held primarily for the purpose of trading; it is due to be settled within 12 months after the reporting period; or there is no unconditional right to defer the settlement of the liability for at least 12 months after the reporting period. All other liabilities are classified as non-current. Deferred tax assets and liabilities are always classified as non-current. Cash and cash equivalents g) Cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short- term, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value. For the statement of cash flows presentation purposes, cash and cash equivalents also includes bank overdrafts, which are shown within borrowings in current liabilities on the statement of financial position. Trade and other receivables h) Trade receivables are initially recognised at fair value and subsequently measured at amortised cost using the effective interest method, less any allowance for expected credit losses. Trade receivables are generally due for settlement within 30 days. The consolidated entity has applied the simplified approach to measuring expected credit losses, which uses a lifetime expected loss allowance. To measure the expected credit losses, trade receivables have been grouped based on days overdue. Other receivables are recognised at amortised cost, less any allowance for expected credit losses. Investments and other financial assets i) Investments and other financial assets are initially measured at fair value. Transaction costs are included as part of the initial measurement, except for financial assets at fair value through profit or loss. Such assets are subsequently measured at either amortised cost or fair value depending on their classification. Classification is determined based on both the business model within which such assets are held and the contractual cash flow characteristics of the financial asset unless, an accounting mismatch is being avoided. Financial assets are derecognised when the rights to receive cash flows have expired or have been transferred and the consolidated entity has transferred substantially all the risks and rewards of ownership. When there is no reasonable expectation of recovering part or all a financial asset, it's carrying value is written off. Financial assets at fair value through profit or loss Financial assets not measured at amortised cost or at fair value through other comprehensive income are classified as financial assets at fair value through profit or loss. Typically, such financial assets will be either: (i) held for trading, where they are acquired for the purpose of selling in the short-term with an intention of making a profit, or a derivative; or (ii) designated as such upon initial recognition where permitted. Fair value movements are recognised in profit or loss. Financial assets at fair value through other comprehensive income Financial assets at fair value through other comprehensive income include equity investments which the consolidated entity intends to hold for the foreseeable future and has irrevocably elected to classify them as such upon initial recognition. 35 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) Impairment of financial assets The consolidated entity recognises a loss allowance for expected credit losses on financial assets which are either measured at amortised cost or fair value through other comprehensive income. The measurement of the loss allowance depends upon the consolidated entity's assessment at the end of each reporting period as to whether the financial instrument's credit risk has increased significantly since initial recognition, based on reasonable and supportable information that is available, without undue cost or effort to obtain. Where there has not been a significant increase in exposure to credit risk since initial recognition, a 12-month expected credit loss allowance is estimated. This represents a portion of the asset's lifetime expected credit losses that is attributable to a default event that is possible within the next 12 months. Where a financial asset has become credit impaired or where it is determined that credit risk has increased significantly, the loss allowance is based on the asset's lifetime expected credit losses. The amount of expected credit loss recognised is measured on the basis of the probability weighted present value of anticipated cash shortfalls over the life of the instrument discounted at the original effective interest rate. For financial assets measured at fair value through other comprehensive income, the loss allowance is recognised within other comprehensive income. In all other cases, the loss allowance is recognised in profit or loss. Property, plant and equipment j) Plant and equipment is stated at historical cost less accumulated depreciation and impairment. Historical cost includes expenditure that is directly attributable to the acquisition of the items. Depreciation is calculated using straight-line and diminishing value methods to write off the net cost of each item of property, plant and equipment (excluding land) over their expected useful lives as follows: Plant and equipment Leasehold improvements 3-10 years 10 years The residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, at each reporting date. An item of property, plant and equipment is derecognised upon disposal or when there is no future economic benefit to the consolidated entity. Gains and losses between the carrying amount and the disposal proceeds are taken to profit or loss. Any revaluation surplus reserve relating to the item disposed of is transferred directly to retained profits. Right-of-use assets k) A right-of-use asset is recognised at the commencement date of a lease. The right-of-use asset is measured at cost, which comprises the initial amount of the lease liability, adjusted for, as applicable, any lease payments made at or before the commencement date net of any lease incentives received, any initial direct costs incurred, and, except where included in the cost of inventories, an estimate of costs expected to be incurred for dismantling and removing the underlying asset, and restoring the site or asset. Right-of-use assets are depreciated on a straight-line basis over the unexpired period of the lease or the estimated useful life of the asset, whichever is the shorter. Where the consolidated entity expects to obtain ownership of the leased asset at the end of the lease term, the depreciation is over its estimated useful life. Right-of use assets are subject to impairment or adjusted for any remeasurement of lease liabilities. 36 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) The consolidated entity has elected not to recognise a right-of-use asset and corresponding lease liability for short-term leases with terms of 12 months or less and leases of low-value assets. Lease payments on these assets are expensed to profit or loss as incurred. Research and development l) Research costs for the development of intellectual property are expenses in the period in which they are incurred. Development costs are capitalised when it is probable that the project will be a success considering its commercial and technical feasibility; the consolidated entity is able to use or sell the asset; the consolidated entity has sufficient resources; and intent to complete the development and its costs can be measured reliably. Following the initial recognition of the development expenditure, the cost model is applied requiring the asset to be carried at cost less any accumulated amortisation and accumulated impairment losses. Any expenditure is capitalised and is amortised on a straight-line basis over the period of expected benefits from the related project. Trade and other payables m) These amounts represent liabilities for goods and services provided to the consolidated entity prior to the end of the financial year and which are unpaid. Due to their short-term nature they are measured at amortised cost and are not discounted. The amounts are unsecured and are usually paid within 30 days of recognition. Borrowings n) Loans and borrowings are initially recognised at the fair value of the consideration received, net of transaction costs. They are subsequently measured at amortised cost using the effective interest method. Lease liabilities o) A lease liability is recognised at the commencement date of a lease. The lease liability is initially recognised at the present value of the lease payments to be made over the term of the lease, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the consolidated entity's incremental borrowing rate. Lease payments comprise of fixed payments less any lease incentives receivable, variable lease payments that depend on an index or a rate, amounts expected to be paid under residual value guarantees, exercise price of a purchase option when the exercise of the option is reasonably certain to occur, and any anticipated termination penalties. The variable lease payments that do not depend on an index or a rate are expensed in the period in which they are incurred. Lease liabilities are measured at amortised cost using the effective interest method. The carrying amounts are remeasured if there is a change in the following: future lease payments arising from a change in an index or a rate used; residual guarantee; lease term; certainty of a purchase option and termination penalties. When a lease liability is remeasured, an adjustment is made to the corresponding right-of use asset, or to profit or loss if the carrying amount of the right-of-use asset is fully written down. Finance costs p) Finance costs attributable to qualifying assets are capitalised as part of the asset. All other finance costs are expensed in the period in which they are incurred. 37 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) Provisions q) Provisions are recognised when the consolidated entity has a present (legal or constructive) obligation as a result of a past event, it is probable that the consolidated entity will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation. The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. If the time value of money is material, provisions are discounted using a current pre-tax rate specific to the liability. The increase in the provision resulting from the passage of time is recognised as a finance cost. r) Employee benefits Short-term employee benefits Liabilities for wages and salaries, including non-monetary benefits and annual leave expected to be settled wholly within 12 months of the reporting date are measured at the amounts expected to be paid when the liabilities are settled. Other long-term employee benefits The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting date are measured at the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using market yields at the reporting date on corporate bonds with terms to maturity and currency that match, as closely as possible, the estimated future cash outflows. Share-based payments Equity-settled and cash-settled share-based compensation benefits are provided to employees. Equity-settled transactions are awards of shares, or options over shares, that are provided to employees in exchange for the rendering of services. Cash-settled transactions are awards of cash for the exchange of services, where the amount of cash is determined by reference to the share price. The cost of equity-settled transactions are measured at fair value on grant date. Fair value is independently determined using either the Binomial or Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option, together with non-vesting conditions that do not determine whether the consolidated entity receives the services that entitle the employees to receive payment. No account is taken of any other vesting conditions. The cost of equity-settled transactions are recognised as an expense with a corresponding increase in equity over the vesting period. The cumulative charge to profit or loss is calculated based on the grant date fair value of the award, the best estimate of the number of awards that are likely to vest and the expired portion of the vesting period. The amount recognised in profit or loss for the period is the cumulative amount calculated at each reporting date less amounts already recognised in previous periods. The cost of cash-settled transactions is initially, and at each reporting date until vested, determined by applying either the Binomial or Black-Scholes option pricing model, taking into consideration the terms and conditions on which the award was granted. 38 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) The cumulative charge to profit or loss until settlement of the liability is calculated as follows: • • during the vesting period, the liability at each reporting date is the fair value of the award at that date multiplied by the expired portion of the vesting period; and from the end of the vesting period until settlement of the award, the liability is the full fair value of the liability at the reporting date. All changes in the liability are recognised in profit or loss. The ultimate cost of cash-settled transactions is the cash paid to settle the liability. Market conditions are taken into consideration in determining fair value. Therefore any awards subject to market conditions are considered to vest irrespective of whether or not that market condition has been met, provided all other conditions are satisfied. If equity-settled awards are modified, as a minimum an expense is recognised as if the modification has not been made. An additional expense is recognised, over the remaining vesting period, for any modification that increases the total fair value of the share-based compensation benefit as at the date of modification. If the non-vesting condition is within the control of the consolidated entity or employee, the failure to satisfy the condition is treated as a cancellation. If the condition is not within the control of the consolidated entity or employee and is not satisfied during the vesting period, any remaining expense for the award is recognised over the remaining vesting period, unless the award is forfeited. If equity-settled awards are cancelled, it is treated as if it has vested on the date of cancellation, and any remaining expense is recognised immediately. If a new replacement award is substituted for the cancelled award, the cancelled and new award is treated as if they were a modification. Fair value measurement s) When an asset or liability, financial or non-financial, is measured at fair value for recognition or disclosure purposes, the fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date; and assumes that the transaction will take place either: in the principal market; or in the absence of a principal market, in the most advantageous market. Fair value is measured using the assumptions that market participants would use when pricing the asset or liability, assuming they act in their economic best interests. For non-financial assets, the fair value measurement is based on its highest and best use. Valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, are used, maximising the use of relevant observable inputs and minimising the use of unobservable inputs. Assets and liabilities measured at fair value are classified, into three levels, using a fair value hierarchy that reflects the significance of the inputs used in making the measurements. Classifications are reviewed at each reporting date and transfers between levels are determined based on a reassessment of the lowest level of input that is significant to the fair value measurement. 39 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) For recurring and non-recurring fair value measurements, external valuers may be used when internal expertise is either not available or when the valuation is deemed to be significant. External valuers are selected based on market knowledge and reputation. Where there is a significant change in fair value of an asset or liability from one period to another, an analysis is undertaken, which includes a verification of the major inputs applied in the latest valuation and a comparison, where applicable, with external sources of data. Issued capital t) Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds. Dividends u) Dividends are recognised when declared during the financial year and no longer at the discretion of the company. v) Earnings per share Basic earnings per share Basic earnings per share is calculated by dividing the profit attributable to the owners of Imagion Biosystems Limited, excluding any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the financial year. Diluted earnings per share Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account the after-income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares. w) Goods and Services Tax ('GST') and other similar taxes Revenues, expenses and assets are recognised net of the amount of associated GST, unless the GST incurred is not recoverable from the tax authority. In this case it is recognised as part of the cost of the acquisition of the asset or as part of the expense. Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the tax authority is included in other receivables or other payables in the statement of financial position. Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the tax authority, are presented as operating cash flows. Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority. 40 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 1 Significant accounting policies (continued) Rounding of amounts x) The company is of a kind referred to in Corporations Instrument 2016/191, issued by the Australian Securities and Investments Commission, relating to 'rounding-off'. Amounts in this report have been rounded off in accordance with that Corporations Instrument to the nearest thousand dollars, or in certain cases, the nearest dollar. New Accounting Standards and Interpretations not yet mandatory or early adopted y) Australian Accounting Standards and Interpretations that have recently been issued or amended but are not yet mandatory, have not been early adopted by the consolidated entity for the annual reporting period ended 31 December 2022. The consolidated entity has not yet assessed the impact of these new or amended Accounting Standards and Interpretations. 2 Critical Accounting Estimates, Assumptions and Judgements The preparation of the financial statements requires management to make judgements, estimates and assumptions that affect the reported amounts in the financial statements. Management continually evaluates its judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements, estimates and assumptions on historical experience and on other various factors, including expectations of future events, management believes to be reasonable under the circumstances. The resulting accounting judgements and estimates will seldom equal the related actual results. The judgements, estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities (refer to the respective notes) within the next financial year are discussed below. Fair value measurement hierarchy The consolidated entity is required to classify all assets and liabilities, measured at fair value, using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date; Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3: Unobservable inputs for the asset or liability. Considerable judgement is required to determine what is significant to fair value and therefore which category the asset or liability is placed in can be subjective. Estimation of useful lives of assets The consolidated entity determines the estimated useful lives and related depreciation and amortisation charges for its property, plant and equipment and finite life intangible assets. The useful lives could change significantly as a result of technical innovations or some other event. The depreciation and amortisation charge will increase where the useful lives are less than previously estimated lives, or technically obsolete or non-strategic assets that have been abandoned or sold will be written off or written down. Share-based payment transactions The consolidated entity measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by using either the Binomial or BlackScholes model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next annual reporting period but may impact profit or loss and equity. 41 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 2 Critical Accounting Estimates, Assumptions and Judgements (continued) Lease term The lease term is a significant component in the measurement of both the right-of-use asset and lease liability. Judgement is exercised in determining whether there is reasonable certainty that an option to extend the lease or purchase the underlying asset will be exercised, or an option to terminate the lease will not be exercised, when ascertaining the periods to be included in the lease term. In determining the lease term, all facts and circumstances that create an economical incentive to exercise an extension option, or not to exercise a termination option, are considered at the lease commencement date. Factors considered may include the importance of the asset to the consolidated entity's operations; comparison of terms and conditions to prevailing market rates; incurrence of significant penalties; existence of significant leasehold improvements; and the costs and disruption to replace the asset. The consolidated entity reassesses whether it is reasonably certain to exercise an extension option, or not exercise a termination option, if there is a significant event or significant change in circumstances. Incremental borrowing rate Where the interest rate implicit in a lease cannot be readily determined, an incremental borrowing rate is estimated to discount future lease payments to measure the present value of the lease liability at the lease commencement date. Such a rate is based on what the consolidated entity estimates it would have to pay a third party to borrow the funds necessary to obtain an asset of a similar value to the right-of-use asset, with similar terms, security and economic environment. 3 Operating segments Identification of reporting operating segments The consolidated entity is organised into one operating segment being Research & Development. This operating segment is based on internal reports that are reviewed and used by the Board of Directors (who are identified as the Chief Operating Decision Makers (CODM) in assessing performance and in determining the allocation of resources). Geographical information The consolidated entity has non-current assets and derives revenue in two geographical areas as outlined below: Geographical location of non-current assets Property, plant and equipment United States of America Australia Right-of-use assets United States of America Australia Geographical derivation of revenue Revenue and other income United States of America Australia Research and development tax incentives are derived in Australia. 42 31-Dec-22 $ 31-Dec-21 $ 700,740 2,536 703,276 4,283,796 - 4,283,796 31-Dec-22 $ 520,205 49,754 569,959 344,711 1,385 346,096 - - - 31-Dec-21 $ 232,932 10,475 243,407 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 4 Revenue Sales revenue Sale of goods Other revenue: Interest Sub-lease revenue Government grant received Other revenue 2022 $ 2021 $ 473,429 473,429 232,865 232,865 29,833 46,245 20,000 452 96,530 10,542 - - 10,542 569,959 243,407 Sale of goods includes $462,731 (2021: $215,641) relating to contracted sales which were delivered at a point in time. Sale of goods revenue ($473,429) was derived in the United States of America (2021: $232,865). 5 Expenses Depreciation: Plant and equipment Right-of-use assets Finance costs: Interest payable on hire purchase liabilities Unwinding of the lease liability interest Other interest 6 Cash and cash equivalents Cash on hand Cash at bank 7 Trade and other receivables Current Trade receivables Trade receivable are typically received within 30 days. Note 9 10 12 12 2022 $ 144,702 963,481 1,108,183 1,794 172,342 191 174,327 2021 $ 118,948 285,489 404,437 3,420 3,518 882 7,820 2022 $ 2 4,446,100 4,446,102 2021 $ 16 13,393,752 13,393,768 2022 $ 2021 $ 92,463 31,345 43 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 8 Other current assets Prepayments GST refundable Security deposits Other assets 9 Property, plant and equipment Plant and equipment, at cost Less: accumulated depreciation Leasehold improvements, at cost Less: accumulated depreciation 2022 $ 315,122 20,622 113,009 1,232 449,985 2022 $ 1,099,507 (877,510) 558,301 (77,022) 703,276 2021 $ 174,534 25,889 143,523 - 343,946 2021 $ 857,216 (752,740) 241,620 - 346,096 Reconciliation Reconciliations of the written down values at the beginning and end of the current and previous financial years are set out below: Opening balance Additions Assets written-off Foreign currency revaluation movements Depreciation expense Closing balance 346,096 467,200 - 34,682 (144,702) 703,276 160,432 298,983 (4,231) 9,860 (118,948) 346,096 10 Right-of-use assets Land and buildings: right-of-use Less: accumulated depreciation 2022 $ 5,271,740 (987,944) 4,283,796 2021 $ - - - Reconciliation Reconciliations of the written down values at the beginning and end of the current and previous financial years are set out below: Opening balance Additions Adjustment to reflect shorter lease-term Other Foreign currency revaluation movements Depreciation expense Closing balance 2022 $ - 5,271,740 - - (24,463) (963,481) 4,283,796 2021 $ 524,585 - (262,091) (116) 23,111 (285,489) - The consolidated entity entered a lease for its current premises in January 2022. The lease has a 62 month initial term with a five-year options to extend. 44 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 10 Right-of-use assets (continued) The consolidated entity leased land and buildings for its prior premises in December 2019 under an agreement of 25 months with an option to extend. The option to extend wasn't exercised and the consolidated entity's lease ceased in December 2021. The consolidated entity leases office equipment under agreements of less than two years. These leases are either short-term or low-value, so have been expensed as incurred and not capitalised as right-of-use assets. Interest rate 3.7% 7.4% 3.7% 5.0% 2022 $ 325,063 111,725 436,788 2022 $ 961,229 79,822 1,041,051 3,539,806 23,512 3,563,318 1,194,631 3,772,347 4,966,978 2022 $ 172,342 1,794 174,136 2021 $ 428,278 157,588 585,866 2021 $ - 15,141 15,141 - 30,877 30,877 10,988 26,579 37,567 2021 $ 3,518 3,420 6,938 964,820 359,252 11 Trade and other payables Trade payables Other payables and accruals 12 Lease liabilities Current Lease liability - premises Hire purchase liabilities Non-current Lease liability - premises Hire purchase liabilities Information in relation to the lease liability - premises is below: Maturity analysis - contractual undiscounted cash flows Less than one year One to five years Total undiscounted lease liabilities Amounts recognised in profit and loss Interest on lease liabilities Interest on hire purchase liabilities Amounts recognised in cash flows Total cash outflow for leases 45 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 13 Employee benefits Current Provision for annual leave Non-current Provision for long service leave 14 Other liabilities Make good provision Security deposit (sub-lease) 15 Issued capital 2022 $ 2021 $ 175,032 140,462 1,904 3,034 2022 $ 69,749 10,284 80,033 2021 $ 34,496 - 34,496 Ordinary shares Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the company in proportion to the number of and amounts paid on the shares held. The fully paid ordinary shares have no par value and the company does not have a limited amount of authorised capital. Ordinary shares - fully paid 2022 Shares 1,121,318,534 2021 Shares 1,121,218,534 2022 $ 56,830,408 2021 $ 56,827,608 Movements in ordinary share capital - 2021 Details Opening balance Issue of shares (exercise of supplier options) Costs of issue of supplier options Issue of shares (exercise IBXO listed options) Costs of issue of IBXO listed options Issue of shares (exercise IBXOA listed options) Various Various Date 1-Jan-21 15-Feb-21 24-Feb-21 30-Nov-21 Shares 998,367,288 2,986,604 - 91,581,395 - 28,283,247 31-Dec-21 1,121,218,534 Movements in ordinary share capital - 2022 Details Opening balance Issue of shares (exercise of employee options) Date Shares 1-Jan-22 1,121,218,534 100,000 26-Jul-22 31-Dec-22 1,121,318,534 Issue Price - 0.028 - 0.050 - 0.030 Issue Price - 0.028 $ 51,322,126 83,827 (1,922) 4,579,075 (3,995) 848,497 56,827,608 $ 56,827,608 2,800 56,830,408 On 26 July 2022, 100,000 vested employee options were converted into ordinary shares. 46 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 15 Issued capital (continued) Listed options As part of two separate renounceable rights issues (in November 2019 and April 2020) the Company issued listed options. In November 2019 'IBXO options' were issued with an exercise price of $0.05. In April 2020 'IBXOA options' were issues with an exercise price of $0.03. IBXO options expired on 26 November 2021 (and were fully exercised) and IBXOA options expire on 28 April 2023. The listed options entitle the holder to convert one option to one ordinary share upon application and payment. Movements in listed options during the current and previous financial year are set out below: 2021 Details Opening balance Options converted to ordinary shares Closing balance 2022 Details Opening balance Closing balance IBXO IBXOA Date 1-Jan-21 Options 91,581,395 (91,581,395) 31-Dec-21 - Various Date 1-Jan-21 Options 261,585,180 (28,283,247) 31-Dec-21 233,301,933 Various IBXOA Date 1-Jan-22 Options 233,301,933 31-Dec-22 233,301,933 Capital risk management The consolidated entity's objectives when managing capital is to safeguard its ability to continue as a going concern, so that it can provide returns for shareholders and benefits for other stakeholders and to maintain an optimum capital structure to reduce the cost of capital. Capital is regarded as total equity, as recognised in the statement of financial position, plus net debt. Net debt is calculated as total borrowings less cash and cash equivalents. 16 Reserves Foreign currency translation reserve Share based payment reserve 2022 $ 877,095 2,811,455 3,688,550 2021 $ 353,529 2,158,396 2,511,925 Foreign currency translation reserve The reserve is used to recognise exchange differences arising from the translation of the financial statements of foreign operations to Australian dollars. It is also used to recognise gains and losses on hedges of the net investments in foreign operations. 47 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 16 Reserves (continued) Movements in reserves Movements in each class of reserve during the current and previous financial year are set out below: Foreign currency reserve $ (59,573) Share based payment reserve $ 1,660,862 Balance as at 1 January 2021 Movements in revaluation of foreign currency Share based payments for key management, non-executive directors and employees Balance at 31 December 2021 Balance as at 1 January 2022 - 413,102 497,534 2,158,396 Share based payment reserve $ 2,158,396 - 353,529 Foreign currency reserve $ 353,529 Total $ 1,601,289 413,102 - 497,534 2,511,925 Total $ 2,511,925 Movements in revaluation of foreign currency Share based payments for key management, non-executive directors and employees Balance at 31 December 2022 - 523,566 523,566 653,059 2,811,455 - 877,095 653,059 3,688,550 17 Accumulated losses Accumulated losses at the beginning of the financial year Losses after income tax expense for the year Accumulated losses at the end of the financial year 18 Key management personnel 2022 $ (46,034,254) (9,807,208) (55,841,462) 2021 $ (40,009,548) (6,024,706) (46,034,254) Compensation The aggregate compensation made to directors and other members of key management personnel of the consolidated entity is set out below: Short-term employee benefits Share based payments 2022 $ 1,523,851 447,016 1,970,867 2021 $ 1,048,060 329,818 1,377,878 48 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 19 Remuneration of auditors During the financial year the following fees were paid or payable for services provided by RSM Australia Partners, the auditor of the company, its network firms and unrelated firms: Audit services - RSM Australia Partners Audit or review of the financial statements Other services in relation to general consultancy services 20 Commitments 2022 $ 63,750 750 64,500 2021 $ 61,200 1,800 63,000 The consolidated entity had contracted commitments for services in relation to its MagSenseTM HER2 breast cancer Phase I first-in-human study totalling $336,327. These expenses are expected to be incurred in 2023. The consolidated entity had no other commitments (2021: $460,373). 21 Parent entity information Set out below is the supplementary information about the parent entity. Statement of profit or loss and other comprehensive income (Loss) after income tax Total comprehensive income Statement of financial position Total current assets Total assets Total current liabilities Total liabilities Equity Issued capital Reserves Retained earnings Total equity 2022 $ (4,947,365) 2021 $ (4,411,522) (4,947,365) (4,411,522) 2022 $ 2,931,412 2021 $ 7,354,843 2,933,961 7,356,241 312,962 442,605 314,866 445,639 56,830,408 3,098,582 (57,309,895) 2,619,095 56,827,608 2,445,524 (52,362,530) 6,910,602 Contingent liabilities The parent entity had no contingent liabilities as at 31 December 2022 and 31 December 2021. Capital commitments The parent entity had contracted commitments for services in relation to its MagSenseTM HER2 breast cancer Phase I first-in-human study totalling $336,327. These expenses are expected to be incurred in 2023. The consolidated entity had no other commitments (2021: $460,373). 49 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 21 Parent entity information (continued) Significant accounting policies The accounting policies of the parent entity are consistent with those of the consolidated entity, as disclosed in note 1, except for the following: • Investments in subsidiaries are accounted for at cost, less any impairment, in the parent entity. 22 Interests in subsidiaries The consolidated financial statements incorporate the assets, liabilities and results of the following wholly owned subsidiaries in accordance with the accounting policy described in note 1: Name Imagion Biosystems Inc Principal place of business / Country of incorporation Unites States of America 23 Reconciliation of loss after income tax to net cash flows from operating activities Ownership interest 2022 % 100 2022 $ 2021 % 100 2021 $ Loss after income tax expense for the year (9,807,208) (6,024,706) Adjustments for: Depreciation expense Assets written-off Foreign exchange loss Share based payments expense Changes in operating assets and liabilities: Trade and other receivables Trade and other payables 24 Earnings per share Loss after income tax 1,108,183 - 1,412 653,059 (8,044,554) (197,671) 168,011 (8,074,214) 404,437 4,231 1,960 497,534 (5,116,544) (34,133) 82,185 (5,068,492) 2022 $ (9,807,208) 2021 $ (6,024,706) Loss after income tax attributable to the owners of Imagion Biosystems Limited (9,807,208) (6,024,706) 50 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 24 Earnings per share (continued) Weighted average number of ordinary shares used in calculating basic earnings per share 1,121,261,822 1,047,531,564 Weighted average number of ordinary shares used in calculating diluted earnings per share 1,121,261,822 1,047,531,564 2022 Number 2021 Number Loss after income tax Loss after income tax attributable to the owners of Imagion Biosystems Limited 25 Share based payments 2022 Cents (0.009) (0.009) 2021 Cents (0.006) (0.006) Performance shares Since listing on the Australian Stock Exchange, the consolidated entity has established various incentive arrangements to assist in the attraction, retention and motivation of its employee and management group. Employees No performance rights were issued to employees in 2022 (2021: nil). There are no performance rights outstanding for employees at end of 2022 (2021:nil). Key management personnel and directors No performance rights were issues to key management personnel in 2022. On 14 December 2021, 9,000,000 rights over shares were issued to key management personnel. These rights vest four years after the date of issue with all rights being subject to performance milestones. Each right is convertible into one ordinary share upon vesting. Performance rights are unquoted. 2021 1 January 2021 Issued Balance 31 December 2021 2022 Issued Balance 31 December 2022 Employees Directors & Key Management Unvested - - - Vested - - - Unvested 10,000,000 9,000,000 19,000,000 Vested / not exercised - - - - - - - - 19,000,000 - - 51 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 25 Share based payments (continued) Options A share option plan has been established by the consolidated entity and approved by shareholders at a general meeting, whereby the consolidated entity may, at the discretion of the Board, grant options over ordinary shares in the company to certain key management personnel of the consolidated entity. The options are issued for nil consideration and are granted in accordance with performance guidelines established by the Board. Employees A total of 1,000,000 options were issued to employees on 17 February 2022. The options have an exercise price of $0.0679 with options vesting monthly over three years with expiry dates between 28 February 2027 and 31 January 2030. A total of 2,000,000 options were issued to an employee on 8 April 2022. The options have an exercise price of $0.058 with options vesting monthly over three years with expiry dates between 30 April 2027 and 31 March 2030. A total of 700,000 options were issued to employees on 26 August 2022. The options have an exercise price of $0.042 with options vesting monthly over three years with expiry dates between 31 August 2027 and 31 July 2030. A total of 2,000,000 options were issued to an employee on 25 October 2022. The options have an exercise price of $0.034 with options vesting monthly over three years with expiry dates between 31 October 2027 and 30 September 2030. A total of 3,000,000 options were issued to employees on 21 December 2022. The options have an exercise price of $0.029 with options vesting monthly over three years with expiry dates between 31 December 2027 and 30 November 2030. No options were issues to key management personnel or directors in 2022. Set out below are summaries of options granted under the plans: 2022 Expiry Grant date date 24-Jun-24 24-Jun-19 1-May-26 1-Jun-20 1-May-27 1-Jun-20 1-Jun-20 1-May-28 29-Sep-20 30-Sep-28 30-Nov-26 9-Dec-20 30-Nov-27 9-Dec-20 9-Dec-20 30-Nov-28 7-Jun-21 31-May-29 14-Dec-21 30-Nov-30 31-Jan-30 17-Feb-22 31-Mar-30 8-Apr-22 26-Aug-22 31-Jul-30 25-Oct-22 30-Sep-30 21-Dec-22 30-Nov-30 Exercise price $0.028 $0.028 $0.028 $0.028 $0.091 $0.140 $0.140 $0.140 $0.115 $0.087 $0.068 $0.058 $0.042 $0.034 $0.029 Balance at 1- Jan-2022 2,150,000 3,250,000 3,250,000 2,000,000 7,150,000 1,000,000 1,000,000 1,000,000 200,000 7,500,000 - - - - - 28,500,000 Granted - - - - - - - - - - 1,000,000 2,000,000 700,000 2,000,000 3,000,000 8,700,000 Expired / forfeited / other - - - - (500,000) - - - - - Exercised (100,000) - - - - - - - - - (100,000) (500,000) Balance at 31- Dec-2022 2,050,000 3,250,000 3,250,000 2,000,000 6,650,000 1,000,000 1,000,000 1,000,000 200,000 7,500,000 1,000,000 2,000,000 700,000 2,000,000 3,000,000 36,600,000 Weighted average exercise price $0.072 $0.042 $0.028 $0.091 $0.065 52 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 25 Share based payments (continued) 2021 Expiry Grant date date 24-Jun-24 24-Jun-19 1-Jun-20 1-May-26 1-May-27 1-Jun-20 1-Jun-20 1-May-28 29-Sep-20 30-Sep-28 30-Nov-26 9-Dec-20 30-Nov-27 9-Dec-20 30-Nov-28 9-Dec-20 31-Jan-29 4-Feb-21 7-Jun-21 31-May-29 14-Dec-21 30-Nov-30 Balance at 1- Exercise Jan-2021 price 2,150,000 $0.028 3,250,000 $0.028 3,250,000 $0.028 $0.028 2,000,000 $0.091 10,150,000 1,000,000 $0.140 1,000,000 $0.140 $0.140 1,000,000 $0.175 $0.115 $0.087 - - - 23,800,000 Granted - - - - - - - - 2,500,000 1,700,000 7,500,000 11,700,000 Expired / forfeited / other - - - - (3,000,000) - - - (2,500,000) (1,500,000) - (7,000,000) Balance at 31- Dec-2021 2,150,000 3,250,000 3,250,000 2,000,000 7,150,000 1,000,000 1,000,000 1,000,000 - 200,000 7,500,000 28,500,000 Exercised - - - - - - - - - - - - Weighted average exercise price $0.069 $0.110 - $0.126 $0.072 Set out below are the options exercisable at the end of the financial year: Grant date Expiry date 24-Jun-19 24-Jun-24 29-Sep-20 30-Sep-28 1-May-26 1-Jun-20 1-May-27 1-Jun-20 30-Nov-26 9-Dec-20 9-Dec-20 30-Nov-27 31-May-29 7-Jun-21 14-Dec-21 30-Nov-30 31-Jan-30 17-Feb-22 8-Apr-22 31-Mar-30 31-Jul-30 26-Aug-22 25-Oct-22 30-Sep-30 21-Dec-22 30-Nov-30 2022 Number 2021 Number 2,050,000 4,987,500 3,250,000 3,250,000 1,000,000 1,000,000 105,556 541,667 305,556 500,000 97,222 166,667 83,333 17,337,501 2,150,000 2,979,167 3,250,000 - 1,000,000 - 38,889 41,667 - - - - - 9,459,723 The weighted average share price during the financial year was $0.047 (2021: $0.112). The weighted average remaining contractual life of options outstanding at the end of the financial year was 4.81 years (2021: 5.38 years). 53 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 25 Share based payments (continued) For the options granted during the current and previous financial year, the valuation model inputs used to determine the fair value at the grant date, are as follows: Share price at grant date $0.115 $0.073 $0.064 $0.057 $0.042 $0.040 $0.030 $0.026 Grant date Expiry date 7-Jun-21 31-May-29 14-Dec-21 30-Nov-30 31-Jan-30 17-Feb-22 31-Mar-30 8-Apr-22 28-Feb-28 25-Jul-22 31-Jul-30 26-Aug-22 25-Oct-22 30-Sep-30 21-Dec-22 30-Nov-30 26 Financial instruments Exercise price $0.115 $0.087 $0.068 $0.058 $0.042 $0.042 $0.034 $0.029 Expected volatility Dividend yield 0.00% 110.00% 0.00% 120.00% 0.00% 100.00% 0.00% 100.00% 0.00% 110.00% 0.00% 110.00% 0.00% 110.00% 0.00% 110.00% Risk-free interest rate Fair value at grant date 0.68% $0.066-$0.089 0.86%-1.165% $0.039-$0.061 0.02% $0.033-$0.044 0.03% $0.029-$0.040 0.03% $0.022-$0.024 0.03% $0.021-$0.031 0.04% $0.016-$0.023 0.03% $0.014-$0.020 The consolidated entity’s activities expose it to a variety of financial risks: market risk (including foreign currency risk, price risk and interest rate risk), credit risk and liquidity risk. The consolidated entity’s overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the financial performance of the consolidated entity. The consolidated entity uses different methods to measure different types of risk to which it is exposed. These methods include sensitivity analysis in the case of interest rate, foreign exchange and other price risks, ageing analysis for credit risk and beta analysis in respect of investment portfolios to determine market risk. Derivatives are not currently used by the consolidated entity for hedging purposes. The consolidated entity does not speculate in the trading of derivative instruments. Market risk Foreign currency risk The consolidated entity undertakes certain transactions denominated in foreign currency and is exposed to foreign currency risk through foreign exchange rate fluctuations, in particular United States dollars. Foreign exchange risk arises from future commercial transactions and recognised financial assets and financial liabilities denominated in a currency that is not the entity’s functional currency. The risk is measured using sensitivity analysis and cash flow forecasting. The consolidated entity had net assets denominated in foreign currencies of US$1,394,575 (assets of US$4,770,734 less liabilities of US$3,376,159) as at 31 December 2022 (2021: Net assets US$6,394,690 (assets of US$6,758,926 less liabilities of US$364,236)). Based on this exposure, had the Australian dollar weakened by 5%/strengthened by 5% (2021: weakened by 5%/strengthened by 5%) against these foreign currencies with all other variables held constant, the consolidated entity's loss before tax for the year would have been $100,372 lower/$100,372 higher (2021: $425,490 lower/$425,490 higher) . 54 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 26 Financial instruments (continued) The carrying amount of the consolidated entity’s foreign currency denominated financial assets and financial liabilities at the reporting date were as follows (holdings are shown in AUD equivalent): US dollars Assets 2022 4,770,734 2021 6,758,926 Liabilities 2022 3,376,159 2021 364,236 Price risk The Consolidated Entity is not exposed to any significant price risk. Credit risk Credit risk refers to the risk that the counter party will default on its contractual obligations resulting in financial loss to the consolidated entity. Credit risk is the risk of financial loss to the consolidated entity if a customer or counterparty to a financial instrument fails to meet its contractual obligations and arises principally from the consolidated entity’s receivables from customers and investment securities. The consolidated entity has only minimal sales revenue and consequently does not have credit exposure to outstanding receivables. Interest rate risk Interest rate risk is the risk that the value of a financial instrument or cash flows associated with the instrument will fluctuate due to changes in market interest rates. Interest rate risk arises from fluctuations in interest bearing financial assets and liabilities that the consolidated entity uses. Interest bearing assets comprise cash and cash equivalents which are considered to be short-term liquid assets and investment decisions are governed by the monetary policy. During the year, the consolidated entity had no variable rate interest bearing liability. It is the consolidated entity's policy to settle trade payables within the credit terms allowed and therefore not incur interest on overdue balances. Liquidity risk Liquidity risk is the risk that the consolidated entity will not be able to meet its financial obligations as they fall due. The consolidated entity’s approach to managing liquidity is to ensure, as far as possible, that it will always have sufficient liquidity to meet its liabilities when due, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to the consolidated entity’s reputation. The consolidated entity’s objective is to maintain a balance between continuity of funding and flexibility. The consolidated entity’s exposure to financial obligations relating to corporate administration and projects expenditure, are subject to budgeting and reporting controls, to ensure that such obligations do not exceed cash held and known cash inflows for a period of at least 1 year. Remaining contractual maturities The following tables detail the consolidated entity’s remaining contractual maturity for its financial instrument liabilities. The tables have been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the financial liabilities are required to be paid. The tables include both interest and principal cash flows disclosed as remaining contractual maturities and therefore these totals may differ from their carrying amount in the statement of financial position. 55 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 26 Financial instruments (continued) 2022 Non-interest bearing Trade payables Other payables Interest bearing Lease liability Hire purchase liability 2021 Non-interest bearing Trade payables Other payables Interest bearing Lease liability Hire purchase liability Weighted average % 1 year or less $ Between 1 and 2 years $ Between 2 and 5 years $ Over 5 years $ Total $ 325,063 111,725 - - - - 3.7% 6.8% 961,229 79,822 1,477,839 1,028,096 15,480 1,043,576 2,511,710 8,032 2,519,742 - - - - - 325,063 111,725 4,501,035 103,334 5,041,157 Weighted average % 1 year or less $ Between 1 and 2 years $ Between 2 and 5 years $ Over 5 years $ Total $ 428,278 157,588 - 15,141 601,007 5.0% - - - 9,979 9,979 - - - 20,898 20,898 - - - - - 428,278 157,588 - - 46,018 631,884 The cash flows in the maturity analysis above are not expected to occur significantly earlier than contractually disclosed above. 27 Fair value measurement There are no assets or liabilities held at fair value on a recurring or non-recurring basis. The carrying amounts of trade and other receivables and trade and other payables are assumed to approximate their fair values due to their short-term nature. The fair value of financial liabilities are estimated by discounting the remaining contractual maturities at the current market interest rate that is available for similar financial liabilities. Valuation techniques for fair value measurements categorised within level 2. Unquoted investments have been valued using a discounted cash flow model. Derivative financial instruments have been valued using quoted market rates. This valuation technique maximises the use of observable market data where it is available and relies as little as possible on entity specific estimates. 56 Imagion Biosystems Limited Notes to the Financial Statements For the year ended 31 December 2022 28 Income tax benefit 2022 $ 2021 $ Tax losses not recognised Unused tax losses for which no deferred tax asset has been recognised (Australia) 10,388,786 9,074,207 Potential tax benefit at 25.0% for 2022 (2021: 25.0%) 2,597,196 2,268,552 Unused tax losses for which no deferred tax asset has been recognised (USA) 14,859,358 11,599,257 The above potential tax benefit for tax losses has not been recognised in the statement of financial position. These tax losses can only be utilised in the future if the company satisfies the relevant tax loss rules in the relevant jurisdictions and the Company earns sufficient taxable profit to absorb the losses. 29 Contingent liabilities As of 31 December 2022, the Company was not party to any material litigation, claims or suit whose outcome could have a material effect on the financial statements (31 December 2021: Nil). 30 Related party transactions Parent entity Imagion Biosystems Limited is the parent entity. Subsidiaries Interest in subsidiaries are set out in Note 22. Key management personnel Disclosures relating to key management personnel are set out in note 18 and the remuneration report included in the directors' report. Transactions with related parties The following transactions occurred with related parties: Payment for contracting services - Michael Harsh There are no receivables or payables to related parties. 31 Events after the reporting period 2022 $ 1,439 2021 $ - No matters or circumstances have arisen since the end of the financial period that has significantly affected or may significantly affect the operations of the consolidated entity, the results of those operations, or the state of affairs of the consolidated entity in future financial years. 57 Imagion Biosystems Limited Directors' Declaration For the year ended 31 December 2022 In the directors' opinion: • • • • the attached financial statements and notes and the remuneration disclosures that are contained within the Remuneration report within the Directors' report comply with the Corporations Act 2001 , the Accounting Standards, the Corporations Regulations 2001 and other mandatory professional reporting requirements; the attached financial statements and notes comply with International Financial Reporting Standards as issued by the International Accounting Standards Board as described in note 1 to the financial statements; the attached financial statements and notes give a true and fair view of the consolidated entity's financial position as at 31 December 2022 and of its performance for the financial year ended on that date; and there are reasonable grounds to believe that the company will be able to pay its debts as and when they become due and payable. The directors have been given the declarations required by section 295A of the Corporations Act 2001. Signed in accordance with a resolution of directors made pursuant to section 295(5)(a) of the Corporations Act 2001. On behalf of the directors Robert Proulx Executive Chair Imagion Biosystems Limited 28 February 2023 58 INDEPENDENT AUDITOR'S REPORT To the Members of Imagion Biosystems Limited Opinion We have audited the financial report of Imagion Biosystems Limited (the Company) and its Controlled Entities (the Consolidated Entity), which comprises the consolidated statement of financial position as at 31 December 2022, the consolidated statement of profit or loss and other comprehensive income, the consolidated statement of changes in equity and the consolidated statement of cash flows for the year then ended, and notes to the financial statements, including a summary of significant accounting policies, and the directors' declaration. In our opinion the accompanying financial report of Imagion Biosystems Limited is in accordance with the Corporations Act 2001, including: (i) giving a true and fair view of the Consolidated Entity's financial position as at 31 December 2022 and of its financial performance for the year then ended; and (ii) complying with Australian Accounting Standards and the Corporations Regulations 2001. Basis for Opinion We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those standards are further described in the Auditor's Responsibilities for the Audit of the Financial Report section of our report. We are independent of the Consolidated Entity in accordance with the auditor independence requirements of the Corporations Act 2001 and the ethical requirements of the Accounting Professional and Ethical Standards Board's APES 110 Code of Ethics for Professional Accountants (the Code) that are relevant to our audit of the financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code. We confirm that the independence declaration required by the Corporations Act 2001, which has been given to the directors of the Company, would be in the same terms if given to the directors as at the time of this auditor's report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Material Uncertainty Related to Going Concern We draw attention to Note 1 in the financial report, which indicates that the Consolidated Entity incurred a net loss of $9,807,208 and reported net operating cash outflows of $8,074,214 during the year ended 31 December 2022. As stated in Note 1, these events or conditions, along with other matters as set forth in Note 1, indicate that a material uncertainty exists that may cast significant doubt on the Consolidated Entity’s ability to continue as a going concern. Our opinion is not modified in respect of this matter. Key Audit Matters Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the financial report of the current period. These matters were addressed in the context of our audit of the financial report as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. In addition to the matter described in the Material Uncertainty Related to Going Concern section, we have determined the matters described below to be the key audit matters to be communicated in our report. Key Audit Matter How our audit addressed this matter Fair Value of the share-based payments Refer to Note 25 in the financial statements In the current year, share-based payments in the form of performance rights and share options were awarded to employees. In addition, options were converted to shares for various employees during the current year. There is an element of subjectivity in management's assessment around achievement of vesting conditions relating to the performance rights. We identified share-based payments as a key audit area due the complexity in the valuation of the options and performance rights issued. Our audit procedures included, among others: - - - - - - - reviewing the minutes of directors' meetings and ASX announcements for the approvals in relation to the granting of the instruments; reviewing the key terms and conditions of the share-based payment arrangements; reviewing managements achieving vesting performance rights performance in the current period; conditions estimates for issued based on of the the involving our valuation specialists in assessing the key assumptions used in the valuations model including the risk free rate relevant share prices of the company and volatility rates reflecting likely share price movements over the life of the option; the challenging reasonableness of key assumptions used by management relative to the valuation at the grant date; verifying the mathematical accuracy of the computation; and reviewing the adequacy and accuracy of the relevant financial statements. disclosures the in Other Information The directors are responsible for the other information. The other information comprises the information included in the Consolidated Entity's annual report for the year ended 31 December 2022 but does not include the financial report and the auditor's report thereon. Our opinion on the financial report does not cover the other information and accordingly we do not express any form of assurance conclusion thereon. In connection with our audit of the financial report, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial report or our knowledge obtained in the audit or otherwise appears to be materially misstated. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard. 60 Responsibilities of the Directors for the Financial Report The directors of the Company are responsible for the preparation of the financial report that gives a true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal control as the directors determine is necessary to enable the preparation of the financial report that gives a true and fair view and is free from material misstatement, whether due to fraud or error. In preparing the financial report, the directors are responsible for assessing the ability of the Consolidated Entity to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the Consolidated Entity or to cease operations, or have no realistic alternative but to do so. Auditor's Responsibilities for the Audit of the Financial Report Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of this financial report. A further description of our responsibilities for the audit of the financial report is located at the Auditing and Assurance Standards Board website at: https://www.auasb.gov.au/admin/file/content102/c3/ar2_2020.pdf. This description forms part of our auditor's report. Report on the Remuneration Report Opinion on the Remuneration Report We have audited the Remuneration Report included in the directors' report for the year ended 31 December 2022. In our opinion, the Remuneration Report of Imagion Biosystems Limited for the year ended 31 December 2022, complies with section 300A of the Corporations Act 2001. Responsibilities The directors of the Company are responsible for the preparation and presentation of the Remuneration Report in accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the Remuneration Report, based on our audit conducted in accordance with Australian Auditing Standards. RSM AUSTRALIA PARTNERS B Y CHAN Date: 28 February 2023 Melbourne, Victoria 61 Imagion Biosystems Limited Shareholder Information For the year ended 31 December 2022 Corporate Governance Statement The Company's Directors and management are committed to conducting the business of the Group in an ethical manner and in accordance with the highest standards of corporate governance. The Company has adopted and substantially complies with the ASX Corporate Governance Principles and Recommendations (Fourth Edition) (Recommendations) to the extent appropriate to the size and nature of the Group's operations. The Company has prepared a statement which sets out the corporate governance practices that were in operation throughout the financial year for the Company, identifies any Recommendations that have not been followed, and provides reasons for not following such Recommendations (Corporate Governance Statement). In accordance with ASX Listing Rules 4.10.3 and 4.7.4, the Corporate Governance Statement will be available for review on the Company's website (www.imagionbiosystems.com), and will be lodged together with an Appendix 4G with the ASX at the same time that this Annual Report is lodged with the ASX. The Appendix 4G will particularise each Recommendation that needs to be reported against by the Company and will provide shareholders with information as to where relevant governance disclosures can be found. The Company's corporate governance policies and charters are all available on the Company's website (www.imagionbiosystems.com). Additional Securities Information In accordance with ASX Listing Rule 4.10, the Company provides the following information to shareholders no elsewhere disclosed in this Annual Report. The information provided is current as at 23 February 2023 (Reporting Date). Quoted equity securities - ordinary shares As at the Reporting Date, the Company had a total of 1,121,318,534 fully paid ordinary shares on issue. The Company's shares are quoted on the ASX, and form the only class of securities on issue in the Company that is quoted on the ASX, and that carries voting rights. At a general meeting of the Company, every holder of ordinary shares is entitled to vote in person or by proxy or attorney; and on a show of hands (every person present who is a member has one vote); and on a poll (every person present in person or by proxy or attorney has one vote for each ordinary share they hold). Range of holdings An analysis of the number of shareholders in the Company by size of holding is as follows: Share Range 1-1,000 1,001-5,001 5,001-10,000 10,001-100,000 100,001 and over Total Number of Holders 95 831 1,453 4,724 1,733 8,836 Units 16,812 3,065,796 11,189,784 184,464,470 922,581,672 1,121,318,534 % 0.001% 0.273% 0.998% 16.451% 82.277% 100.000% Unmarketable Parcels The number of shareholders holding less than a marketable parcel of shares as at the Reporting Date (based on a closing price of $0.023 per share) was 4,040. 62 Imagion Biosystems Limited Shareholder Information For the year ended 31 December 2022 Top 20 Shareholders The names of the 20 largest holders of ordinary shares as at the Reporting Date are listed below: Name Rank HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED CITICORP NOMINEES PTY LIMITED BNP PARIBAS NOMINEES PTY LTD MR HAOJIE LI THE BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM BNP PARIBAS NOMS PTY LTD MR YUSUF KUCUKBAS E & W NOMINEE PTY LTD MR ANESTIS LAZARIDIS WH & PR PTY LTD G & D FINN PTY LTD MR FEERAS NAJJAR MR GJ HOWLETT & MRS MW HOWLETT MR ROBERT PROULX MR YOANTO WAKIMIN HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED - A/C 2 BAIRDOS PTY LTD AZZAMS TRADING PTY LTD DR RUSSELL KAY HANCOCK Total 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 No. of shares 56,178,508 27,944,616 11,369,662 11,000,000 10,529,053 10,310,929 9,999,990 9,609,498 8,830,703 8,000,000 7,000,000 6,750,000 6,740,000 6,163,250 5,594,681 5,401,069 5,161,262 5,000,000 5,000,000 4,000,000 220,583,221 % 5.010% 2.492% 1.014% 0.981% 0.939% 0.920% 0.892% 0.857% 0.788% 0.713% 0.624% 0.602% 0.601% 0.550% 0.499% 0.482% 0.460% 0.446% 0.446% 0.357% 19.672% Balance of register Grand total 900,735,313 1,121,318,534 80.328% 100.000% Substantial Shareholders There were no substantial holders of shares in the Company as at the Reporting Date. Escrowed securities There are no escrowed securities in the Company as at the Reporting Date. Unquoted equity securities The Company has two classes of unquoted equity securities on issue, being Performance Rights and Options. Performance Rights The Performance Rights will vest into ordinary shares (on a 1-for-1 basis), subject to satisfaction of prescribed vesting conditions. None of the Performance Rights carry any voting rights. However, any underlying shares issued upon the vesting or conversion of the Performance Rights will carry equal voting rights with the other share on issue in the Company. As at the Reporting Date, there were a total of 19,000,000 Performance Rights on issue, held by three holders. 63 Imagion Biosystems Limited Shareholder Information For the year ended 31 December 2022 An analysis of the number of Performance Rights holders by size of holding is as follows: Range 1-1,000 1,001-5,001 5,001-10,000 10,001-100,000 100,001 and over Total Number of Holders - - - - Units - - - - 3 3 19,000,000 19,000,000 % 0.000% 0.000% 0.000% 0.000% 100.000% 100.000% Options The Options upon exercise will convert into ordinary shares (on a 1-for-1 basis), subject to various exercise prices and expiry dates. None of the Options carry any voting rights. However, any underlying shares issued upon the vesting or conversion of the Options will carry equal voting rights with the other share on issue in the Company. As at the Reporting Date, there were a total of 271,372,933 Options on issue, held by 641 holders. An analysis of the number of Option holders by size of holding is as follows: Range 1-1,000 1,001-5,001 5,001-10,000 10,001-100,000 100,001 and over Total Number of Holders 8 21 34 261 317 641 Units 362 81,918 271,797 12,688,670 258,330,186 271,372,933 % 0.000% 0.030% 0.100% 4.676% 95.194% 100.000% 64 Imagion Biosystems Limited Corporate Directory For the year ended 31 December 2022 Corporate Directory Directors Mr Robert Proulx Mr Michael Harsh Mr David Ludvigson Ms Jovanka Naumoska Mr Mark Van Asten Ms Dianne Angus Company Secretary Mr Geoff Hollis Executive Chairman / President Non-Executive Director Non-Executive Director Non-Executive Director Non-Executive Director Non-Executive Director Registered Office c/o - K&L Gates Level 25, 525 Collins Street Melbourne, VIC, 3000, Australia Principal Place of Business 5601 Oberlin Drive Suite 100 San Diego, CA, 92121, USA Share Registry Boardroom Pty Limited Level 12, 225 George Street Sydney, NSW, 2000, Australia Auditor RSM Australia Partners Level 21, 55 Collins St Melbourne, VIC, 3000, Australia Australian Legal Advisor K&L Gates Level 25, 525 Collins Street Melbourne, VIC, 3000, Australia United States Legal Advisor The Grafe Law Office, PC PO Box 2689 Corrales, NM, 87048, USA Stock Exchange Imagion Biosystems Limited's shares are listed on the Australian Stock Exchange (ASX ticker: IBX) 65

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