Next-generation diagnostics and therapeutics for cancer INOVIQ Ltd Annual Report 2024
1 Chairman’s Letter 2 CEO’s Report 4 Review of Operations 18 Directors’ Report 31 Auditor’s Independence Declaration 32 Consolidated Statement of Comprehensive Income 33 Consolidated Statement of Financial Position 34 Consolidated Statement of Changes in Equity 35 Consolidated Statement of Cash Flows 36 Notes to the Financial Statements 62 Consolidated Entity Disclosure Statement 63 Directors’ Declaration 64 Corporate Governance Statement 65 Independent Auditor’s Report 69 Shareholder Information 72 Corporate Directory Contents Our Misson INOVIQ is pioneering next-generation diagnostics and therapeutics to enhance patient outcomes in cancer and other diseases. For more information visit www.inoviq.com
1 Annual Report 2024 Chairman’s Letter We are delighted to present INOVIQ’s Annual Report for the financial year ended 30 June 2024. OUTLOOK AND PLANS INOVIQ is a leading biotechnology company pioneering next-generation diagnostics and therapeutics to enhance patient outcomes in cancer and other diseases. Over the next 12-months, our priorities include: › expanding our exosome isolation tools, › partnering our lead SubB2M diagnostics, › accelerating the development of our exosome diagnostics and therapeutics pipeline, and › growing revenues from EXO-NET product sales and partnering. INOVIQ is strongly positioned with disruptive technology, a multiproduct pipeline, commercial partners validating its technology, and an experienced leadership team to execute on strategy. The Company is well-funded to leverage our existing technologies while exploring strategic M&A opportunities. I thank shareholders for their ongoing support and look forward to keeping you informed on our progress. Mr David Williams Chairman Dear shareholder, We are delighted to present INOVIQ’s Annual Report for the financial year ended 30 June 2024. STRATEGIC DIAGNOSTICS FOCUS INOVIQ has been transformed from a single-asset diagnostics company developing a lung cancer test to a biotechnology company developing next-generation diagnostics and therapeutics for cancer. The Company is leveraging its core technologies to build a portfolio of revenue-generating research tools and high-value diagnostics and therapeutics including: › EXO-NET and NEURO-NET research tools for isolating panexosomes or specific-exosomes from the brain › Exosome test for screening ovarian cancer in asymptomatic women › Tests for monitoring breast or ovarian cancer treatment response and recurrence ACHIEVEMENTS The Company partnered with Promega to distribute its exosome research tools globally and enable other researchers to develop exosome diagnostics using our exosome platform. INOVIQ progressed its SubB2M diagnostics towards commercialisation for monitoring breast and ovarian cancers. It also expanded our exosome capabilities to develop third-generation immunotherapies for solid tumours. These initiatives will de-risk INOVIQ’s business including through early EXO-NET revenue. STRATEGIC THERAPEUTICS FOCUS While continuing to expand our exosome diagnostic capabilities, the Company is giving more focus to cancer therapeutics. This includes an exosome therapeutic to target and kill breast cancer. FINANCIAL PERFORMANCE INOVIQ ended FY24 with a cash balance of $9.2m, following a placement. The Share Purchase Plan component of the capital raise completed post 30 June 2024, delivering a further $2.4m in July 2024. Funds are being primarily employed in advancing our SubB2M and EXO-NET programs. The Company reported a net loss from operating activities (after income tax) for the year of $6.6 million. Chairman’s Letter
EXOSOME POWERED Exosome solutions for early detection and treatment of cancer DISRUPTIVE TECHNOLOGY Proprietary exosome and SubB2M technologies PRODUCTS IN MARKET Exosome research tools and bladder cancer test generating revenues PIPELINE Differentiated, multi-stage exosome research tool, diagnostic and therapeutic pipeline for cancer CLINICAL DATA Data showing superior exosome isolation, accurate cancer detection and in vitro cancer killing activity PARTNERING FOR GROWTH Global partners for sales of EXO-NET and development of exosome diagnostics to accelerate growth INOVIQ is pioneering next-generation diagnostics and therapeutics to enhance patient outcomes for cancer and other diseases. The product portfolio includes products in-market for exosome research 2 INOVIQ Limited CEO’s Report INOVIQ is pioneering next-generation diagnostics and therapeutics to enhance patient outcomes for cancer and other diseases. and bladder cancer diagnosis, clinical-stage cancer diagnostics for detection and monitoring of breast and ovarian cancers, and an early-stage exosome therapeutic for solid tumours. EXOSOME CAPTURE TOOLS IN-MARKET, GENERATING REVENUE AND GLOBAL DISTRIBUTION INOVIQ’s best-in-class exosome capture technology for exosome biomarker discovery and diagnostics is now commercially available worldwide. The global joint marketing agreement with leading life sciences company Promega Corporation was expanded to a global supply and distribution agreement in April 2024 to market, distribute and sell EXONET worldwide. INOVIQ received its first order from Promega under the new agreement in June 2024, with the partnership expected to be a major driver of EXO-NET revenues. The exosome research tool portfolio was expanded with the development and validation of NEURO-NET™ for isolation and analysis of brain-derived exosomes that are present in blood of Alzheimer’s Disease and Parkinson’s Disease patients. Exosomes cross the “blood-brain barrier” and provide a “fingerprint” of the health or disease status of the brain for use in brain cancer, neuropsychiatric disorders and neurodegenerative diseases. NEURO-NET expands INOVIQ’s exosome capabilities and partnering opportunities to develop novel diagnostics for neurological conditions.
EXOSOME DIAGNOSTICS PIPELINE PROGRESSING The Company’s first exosome diagnostic collaboration with the University of Queensland (UQ) to develop an exosome ovarian cancer screening test delivered data from an equivalence study showing that EXO-NET was effective for capturing exosomes from serum or plasma. Subsequently, a biomarker validation study commenced to evaluate the test in 500-samples with a data read-out expected by December 2024. INOVIQ plans to expand its exosome diagnostic program over the next 12-months through collaborations with academic, diagnostic and therapeutic companies for liquid biopsies and companion diagnostics. 3 Annual Report 2024 Dr Leearne Hinch CEO EARLY-STAGE EXOSOME THERAPEUTICS PROGRAM INOVIQ is developing exosome therapeutics engineered to target and kill cancer. This groundbreaking program builds on our innovative exosome diagnostic work. INOVIQ has leveraged its proprietary exosome platform, in-house capabilities and expertise in exosome science to commence an in-house exosome therapeutics program. The Company has established core capabilities to engineer, load and produce exosomes for therapeutic applications. Proof-of-concept data highlighted the potential of INOVIQ’s immune-cell derived CAR-exosomes as an effective cancer therapy and the potential for RNA drug-loaded exosome therapeutics. The Company is scaling its exosome production capacity using its proprietary EXOACE technology to isolate exosomes and is advancing its CAR-exosome program towards key preclinical in vitro and in vivo milestones for cancer over the next 12-months. In vivo data are expected to support discussions with pharmaceutical companies for potential partnering opportunities in exosome therapeutics. SUBB2M TECHNOLOGY ADVANCING TOWARDS COMMERCIALISATION The SubB2M technology has been analytically and clinically validated to detect breast cancer across all stages (81% sensitivity and 93% specificity), key breast cancer types and subtypes, and is effective for breast cancer monitoring. INOVIQ has initiated discussions with potential partners and key opinion leaders to secure a laboratory partner in the US for commercialisation of the SubB2M-CA15-3 test. Additionally, a scientific paper on SubB2M-CA15-3 has been prepared for submission to an international peer-reviewed scientific journal. The next milestones for the SubB2MCA15-3 test are translation to other high-throughput instrument platforms, additional in-clinic breast cancer monitoring studies and securing a CLIA-accredited laboratory partner in the US for commercialisation of the test as a Laboratory Developed Test in 2025. FUTURE MILESTONES The Company expects to report data readouts across its SubB2M tests, exosome diagnostic and therapeutic programs, as well as commercial progress for its EXO-NET research tools and partnering activities over the next 12 months. CEO’s Report
BUSINESS OVERVIEW INOVIQ Ltd (ASX:IIQ) is a biotechnology company pioneering next-generation diagnostics and therapeutics for cancer. INOVIQ has commercialised its fast, efficient and specific EXONET exosome isolation technology for biomarker discovery and diagnostics development, and the hTERT test as an adjunct test for bladder cancer. The company is advancing clinical-stage diagnostics for detection and monitoring of ovarian and breast cancers, and earlystage exosome therapeutics for solid tumours. HIGHLIGHTS INOVIQ made significant progress during financial year 2024 and up to the date of this report. The Company secured a global distribution partnership for its in-market EXO-NET® exosome research tools, advanced its cancer diagnostics pipeline towards key development milestones, progressed its research-stage exosome therapeutics program, expanded its Board and completed a capital raising. 4 INOVIQ Limited Commercial › Global supply and distribution agreement for EXO-NET® signed with leading US life sciences company, Promega Corporation › First EXO-NET order received from Promega under distribution agreement › INOVIQ and ResearchDx signed a license and supply agreement for INOVIQ’s EXO-NET panexosome capture product to provide EXO-NET services in the US › Multiple EXO-NET (Pan and Neuro) feasibility studies ongoing with pharma/diagnostic companies for potential exosome diagnostics › Intellectual property for exosome platform expanded with new patent applications protecting NEURO-NET brain-derived exosome isolation and EXOACE isolation of therapeutic exosomes Review of Operations We are pleased to present the Group’s Annual Report for the financial year ended 30 June 2024 and provide an update on further strategic and operational progress since year end.
5 Annual Report 2024 Review of Operations Research and Development Corporate Financial › New data presented on the effectiveness and utility of EXO-NET at the Australia and New Zealand Society for Extracellular Vesicles (ANSEV) conference › New data presented on high-throughput EXO-NET exosome isolation and biomarker discovery in breast and ovarian cancers at Promega hosted workshop at the Association for Molecular Pathology (AMP) annual meeting › Validation of NEURO-NET demonstrating isolation of brain-derived exosomes in Alzheimer’s Disease › Serum equivalence study confirmed EXO-NET isolates exosomes from both plasma and serum samples, enabling access to large ovarian cancer serum biobanks for further development of the EXO-OC test › In vitro proof-of-concept for breakthrough CAR-exosome therapy to target and kill breast cancer › Monitoring study demonstrated SubB2M-CA15-3 test detected key breast cancer subtypes, correctly identified 19% more breast cancers than a leading test and was effective for monitoring breast cancer › Analytical validation of SubB2M-CA125 test showing assay reproducibility and discrimination of both early and latestage ovarian cancers from healthy controls › Completed SubB2M-based SPR assay evaluation on Nicoya ALTO instrument for potential multi-cancer risk assessment test › David Williams, experienced director and investment banker, appointed Non-Executive Director and Chairman, bringing substantial financial, governance and corporate expertise › Successful capital raise with total funds raised of $9.4m via a placement to institutional and sophisticated investors ($7m) and SPP ($2.4m - received post year-end) › Cash of $9.2 million at 30 June 2024 to advance product development and commercial › Net loss of $6.6 million for the year ended 30 June 2024 › Research and Development Tax Refund of $1.02m recognised for the 2024 financial year $9.2m Cash Balance
DELIVERING VALUE INOVIQ’s vision is to be a leading biotechnology company delivering next-generation cancer diagnostics and therapeutics to enhance patient outcomes in cancer and other diseases. The Company has proprietary technologies, in-market products and a strong development pipeline of cancer diagnostics and therapeutics. INOVIQ is developing best-in-class diagnostics and therapeutics for global markets that deliver value to patients, clinicians, the health system and investors. The Company has three key business pillars built around our disruptive technologies that underpin its short and longer-term product development and revenue generating opportunities: 1. Research tools: The EXO-NET technology is a source of current and future revenue streams including EXO-NET pan-exosome sold for research purposes, custom EXO-NET products and exosome services to develop exosome-based diagnostics for contract research fees and potential future licensing revenue; 2. Diagnostics: The diagnostic pipeline includes both internal and partnered diagnostic tests developed using our SubB2M and EXO-NET technologies for improved screening, diagnosis, treatment selection and monitoring of cancer and other diseases; and 3. Therapeutics: The longer-term focus is on developing high-value exosome therapeutics to target and kill cancer, enabled by our EXO-ACE technology for therapeutic exosome isolation and production. INOVIQ is growing shareholder value through commercialisation of the Company’s lead SubB2M cancer diagnostics, developing a multi-product exosome pipeline, diversifying risk across multiple applications and building a revenue generating business. The Company’s strategic focus and business pillars supporting our current pipeline and future growth are depicted below: STRATEGIC FOCUS Next-generation exosome diagnostics and therapeutics for cancer RESEARCH TOOLS DIAGNOSTICS THERAPEUTICS Exosome therapeutics to target and kill solid tumours CORE TECHNOLOGIES BUSINESS SEGMENTS Exosome Platform NETs™ immunoaffinity, magnetic bead-based EV isolation EXO-ACE™ affinity chromatography large-scale EV isolation SubB2M Technology Proprietary neu5Gc probe for improved cancer detection 6 INOVIQ Limited Review of Operations continued EXO-NET® exosome isolation tools for biomarker discovery and diagnostics development Exosome tests for screening, liquid biopsies & companion diagnostics SubB2M tests for cancer detection & monitoring US$661m US$6.1b US$55.3b
CANCER DIAGNOSTICS MARKET The global cancer burden encompassed 50.6 million people living with cancer, 19.3 million new cases and 10.0 million deaths in 2020.1 The incidence of cancer is expected to reach 28.4 million new cases by 2040 due to population aging and growth. Cancer is a leading cause of premature death with the highest burdens in China, Europe and North America. The cancer burden can be reduced by improved prevention, early detection, cancer screening programs and effective treatment to improve patient outcomes and reduce mortality. Cancer is often detected at late-stage (stages III and IV) after symptoms have appeared, resulting in a poor prognosis. Many existing diagnostic tests have high false-positives and/or insufficient sensitivity for earlystage cancer (stages I and II) and screening programs have poor participation rates due to the test invasiveness, inconvenience, inaccessibility and cost. Earlier, more accurate and cost-effective diagnostics could improve treatment options, patient outcomes and survival.2 INOVIQ is developing non-invasive, diagnostics using its proprietary SubB2M (improves existing cancer biomarker tests) and exosome (liquid biopsies and companion diagnostics) technologies for screening, diagnosis, treatment selection and monitoring of cancer and other diseases. INOVIQ’s diagnostics pipeline currently includes blood tests for detection and monitoring of breast and ovarian cancers. Breast cancer is the most common cancer with 2.3 million cases and 685 million deaths worldwide1, and a global diagnostics market valued at US$4.3 billion in 2022.3 Ovarian cancer is the world’s deadliest gynaecological cancer with 314,000 cases and 207,000 deaths worldwide1, and a global diagnostic market expected to reach over US$1.8 billion by 2026.4 EXOSOMES MARKET FOR RESEARCH, DIAGNOSTIC AND THERAPEUTIC APPLICATIONS Exosomes (or small extracellular vesicles, sEVs) are released by all cells and perform key roles in intercellular communication, immune regulation and disease progression. They carry molecular cargo including DNA, RNAs, proteins and lipids that act as cell messengers or biomarkers of disease. Exosomes have enormous potential in applications for research, diagnosis and treatment of cancer, neurodegenerative, cardiovascular, infectious and other diseases. The global exosomes market for research, diagnostics and therapeutics was valued at US$325.8 million in 2023 and is forecast to reach US$2.6 billion by 2030, growing at a CAGR of 29.9%.5 It is predicted the market will be $6.8B by 2032 as more diagnostics and therapeutics are commercialised.6 Market growth is driven by increased investment in exosome research, the rising prevalence of chronic diseases, and adoption of liquid biopsies and precision medicine. The key challenge remains inadequate exosome isolation and production methods. INOVIQ is harnessing the power of exosomes for biomarker discovery, diagnostic and therapeutic applications. The Company has commercialised its EXONET exosome isolation technology with global distribution partner Promega, is advancing diagnostic tests for early detection of ovarian cancer, and progressing early-stage exosome therapeutics for solid tumours. 1 Sung H et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021. https://doi.org/10.3322/caac.21660 2 SEER18 2010-2016 3 2023. Breast Cancer Diagnostics Market, 2023-2030: https://www.grandviewresearch.com/industry-analysis/ breast-cancer-diagnostics-market 4 2019. Ovarian Cancer Diagnostics Market. https://www. globenewswire.com/news-release/2019/08/07/1898453/0/ en/Ovarian-Cancer-Diagnostics-Market-Size-Worth-US-1-8Bn-by-2026.html 5 2024. Exosomes Market: Global Industry Analysis and Forecast for the Period 2024-2030. MMR: https://www. maximizemarketresearch.com/market-report/exosomesmarket/189733/ 6 2023. Exosome Diagnostics and Therapeutics Market to 2032. MarketsandMarkets: https://www.marketsandmarkets. com/Market-Reports/exosome-diagnostics-therapeuticsmarket-198025144.html Click to edit Master title style 4 Lipid bilayer DNA RNA Surface proteins Protein Extracellular Vesicle (EV) 7 Annual Report 2024 Review of Operations
PRODUCT PORTFOLIO INOVIQ’s product portfolio includes in-market exosome research tools and an adjunct test for bladder cancer detection, clinical-stage diagnostics for detection and monitoring of ovarian and breast cancers, and an early-stage exosome therapeutics program for solid tumours. COMMERCIAL UPDATE Commercial activities during the year focused on EXONET direct sales, partnering and conference activities. EXO-NET® PAN-EXOSOME CAPTURE EXO-NET pan-exosome capture is a research use only (RUO) tool for isolating exosomes from biofluids for biomarker discovery and diagnostic applications. EXONET offers speed, efficiency and scalability advantages over competitor exosome isolation products. EXO-NET Pan has been commercialised as an exosome isolation tool for sale in the rapidly growing exosome research market. EXO-NET Pan is manufactured by INOVIQ in 1.6mL, 1mL and 0.25mL pack sizes containing EXO-NET coated magnetic beads for processing up to 96, 60 or 15 samples. EXO-NET® 8 INOVIQ Limited Review of Operations continued 1. Adjunct to urine cytology to assist the detection of bladder cancer; 2. Umbrella Research & Option Agreement with University of Queensland Technology Research Tools Indication Use Discovery Verification Validation In-market Exosomes EXO-NET Multiple Pan-EV Capture Exosomes NEURO-NET Neurology Brain Derived-EV Capture Exosomes TEXO-NET Oncology Tumour Derived-EV Capture Diagnostics Indication Use Discovery Assay Development Clinical Validation In-market hTERT hTERT ICC1 Bladder Cancer Adjunct to Cytology SubB2M neuCA15-3 Breast Cancer Monitoring SubB2M neuCA125 Ovarian Cancer Monitoring Exosomes EXO-OC2 Ovarian Cancer Screening Therapeutics Indication Use Discovery Pre-clinical Clinical Approval Exosomes EEV-001 Breast Cancer CAR-Exosome therapy RUO RUO RUO LDT LDT IVD IVD-CLASS 1 USA
On 6 July 2023, INOVIQ signed a global joint marketing agreement with multinational lifesciences company Promega Corporation to co-market INOVIQ’s EXO-NET exosome capture technology and Promega Nucleic Acid purification systems worldwide. On 5 September 2023, INOVIQ signed a license and supply agreement with contract research organisation ResearchDx enabling provision of EXO-NET enabled exosome isolation, biomarker discovery and diagnostics development services to biotech and pharma customers in the US. On 23 December 2023, INOVIQ signed a research collaboration with a biotechnology company to evaluate the feasibility of using EXO-NET to develop an exosome diagnostic for a targeted therapeutic. This was INOVIQ’s first fee-paying collaborative agreement to provide EXO-NET services to a biotech partner from its recently upgraded Australian laboratory. On 15 April 2024, INOVIQ signed a global supply and distribution agreement with Promega Corporation to sell EXO-NET worldwide. Promega is a global leader in innovative technologies, tools and technical support to the life sciences industry. The agreement leverages the speed and efficiency of INOVIQ’s EXO-NET exosome isolation technology with Promega’s nucleic acid purification systems to offer world-class exosome solutions to researchers for manual, automated and high-throughput exosome isolation and nucleic acid extraction. This agreement is expected to drive EXONET sales and lead to transformative research unlocking the commercial potential of EXO-NET for exosome diagnostics. INOVIQ received an initial EXO-NET order of US$20k (approx. A$30k) under the Promega comarketing agreement in February 2024 and its first purchase order of US$64k (approx. A$96k) under the Promega distribution agreement in June 2024. On 17 May 2024, a key EXO-NET paper entitled HighThroughput Surface Epitope Immunoaffinity Isolation of Extracellular Vesicles and Downstream Analysis was published online in Biology Methods & Protocols. The paper provides analytical and clinical data demonstrating that EXO-NET is a fast, efficient and scalable method for isolating enriched populations of EVs for biomarker discovery and the development of diagnostics. During the year, INOVIQ and Promega developed a data package for high-throughput (HT) EXO-NET and engaged with key opinion leaders, research facilities, contract research organisations and biotechnology/ pharmaceutical companies to highlight the advantages of its EXO-NET and RNA extraction solution for exosome isolation, biomarker discovery and diagnostics development. Additionally, the Company attended, exhibited and delivered poster presentations at multiple scientific conferences showcasing the speed, efficiency and specificity of manual and high-throughput EXO-NET in breast and ovarian cancers. hTERT ICC TEST The hTERT test is an immunocytochemistry (ICC) assay registered for the detection of human telomerase reverse transcriptase (hTERT) in cytopathology samples. It is used in a clinical setting as an adjunct to urine cytology to help resolve indeterminate cytology results and identify patients with increased risk of bladder cancer. The hTERT test is registered as an IVD medical device in the United States (Class I IVD), Europe (CE-IVD marking), Australia (Class I IVD) and South Korea (Class II IVD) for use as a clinical diagnostic by pathology laboratories for the detection of hTERT in cytopathology samples.7 INOVIQ sells the hTERT test direct to laboratory customers in the US achieving revenues of $333,255 during the year (2023: $363,209). hTERT sales revenues are expected to remain flat in FY2025 due to the limited market size and increased competition from new product entrants. hTERT ICC test 7 Allison et al. Evaluation of Sienna Cancer Diagnostics hTERT Antibody on 500 Consecutive Urinary Tract Specimens. Acta Cytologica 2018. DOI: 10.1159/000489181 9 Annual Report 2024 Review of Operations
Review of Operations continued EXOSOME PROGRAM INOVIQ is developing a portfolio of EXO-NET capture tools and exosome diagnostics for detection, treatment selection and monitoring of cancer and other diseases. INOVIQ is engaging with academia and industry focused on exosome research to establish collaborations for the development of more accurate and reliable exosome diagnostics. The Company is progressing feasibility studies with various parties to evaluate the use of EXO-NET and NEURO-NET™ for both biomarker discovery and diagnostics. Successful feasibilities are expected to progress to the developmentstage for exosome diagnostics for cancer and neurological diseases over the next 12-months. Exosome research tools EXO-NET® is INOVIQ’s proprietary immuno-affinity capture technology designed for high-throughput isolation of exosomes in diagnostic applications. EXO-NET comprises a multi-layered matrix of capture antibodies coated onto magnetic beads that enable fast, efficient and specific exosome isolation that outperforms competitor products. EXO-NET can be customised to isolate sub-populations of exosomes for specific diseases. INOVIQ has developed NEURONET™ for isolation of brain-derived exosomes for use in neurological conditions. NEURO-NET™ comprises multiple antibodies to capture surface proteins found on exosomes released by brain cells including neurons, microglia, oligodendrocytes and astrocytes. Brain-derived exosomes have potential applications for brain cancer, neuropsychiatric disorders and neurodegenerative diseases. The Company plans to use NEURO-NET™ for both its own and partnered development of exosome diagnostics for neurological diseases. RESEARCH & DEVELOPMENT (R&D) PROGRESS INOVIQ technologies have the potential to deliver significant clinical and commercial benefits to patients, the healthcare system and shareholders. R&D activities during FY24 focused on expanding the exosome program across its research tools, diagnostics and discovery-stage therapeutics pipeline, and advancing the lead SubB2M diagnostics pipeline for monitoring cancer towards key development milestones. 10 INOVIQ Limited
On 12 June 2024, INOVIQ announced that its NEURONET™ technology could isolate brain-derived exosomes in Alzheimer’s Disease. Exosomes provide a “fingerprint” of the health or disease status of the parent cell and can cross the “blood-brain barrier”, making them promising candidates as diagnostics for neurological diseases. Initial analytical and clinical validation of NEURO-NET™ showed that exosomes isolated from blood contained proteins known to be expressed by brain cells including the identification of known Alzheimer’s biomarkers that could not be detected by other methods. Analysis of NEURO-NET-captured exosomes identified more than 200 proteins that were differentially expressed in Alzheimer’s Disease (AD) patients when compared with healthy individuals. These results were further validated by a larger study (48 cases and 44 controls) conducted by the Walter & Elisa Hall Institute, confirming the presence of previously identified biomarkers of AD. Importantly, 47 proteins were uniquely expressed in exosomes isolated from AD blood samples and provided robust discrimination between cases and controls. INOVIQ has presented these data to diagnostic and biopharma companies interested in using NEURO-NET™ to develop blood-based neurodegenerative disease tests and companion diagnostics for neuro-therapeutics. The next milestones for NEURO-NET™ include additional clinical validation data and collaborations with academia and industry in neurological diseases. Discussions with interested parties are progressing and multiple feasibility studies are underway. Exosome diagnostics INOVIQ is harnessing the power of exosomes to develop its own and partnered next-generation diagnostics for early detection, therapeutic selection and treatment monitoring in cancer and neurodegenerative diseases. The EXO-Ovarian Cancer Screening test (EXO-OC) is an exosome multi-marker blood test in development for early detection of ovarian cancer in asymptomatic high-risk women. On 9 August 2023, positive results were released from an equivalence study performed by INOVIQ’s collaborator, the University of Queensland (UQ), to evaluate exosome-based biomarkers and performance of the EXO-OC test algorithm in 250 paired plasma and serum samples. The study confirmed that EXO-NET can be used to isolate exosomes from biobanked plasma and serum samples. This enables large ovarian cancer serum biobanks to be used for further development of the EXO-OC test. During the year, UQ sourced over 500 samples of ovarian cancer and matched healthy controls from Westmead Hospital for a biomarker validation study of targeted proteins and miRNAs in the EXO-OC Test. The study to evaluate the performance of the EXO-OC test to discriminate ovarian cancer across all stages has commenced and is expected to complete by December 2024. INOVIQ has an Option to license the development and commercialisation of the EXO-OC test upon successful test validation (ASX: 1 April 2022). The next milestones include analytical and clinical validation studies in CY25, followed by submission of an Investigational Device Exemption (IDE) to undertake a clinical study in asymptomatic, high-risk ovarian cancer individuals in CY26. INOVIQ expects to expand its exosome diagnostic program in FY25 through collaborations with academic, diagnostic and therapeutic companies for liquid biopsies and companion diagnostics. Exosome therapeutics INOVIQ is developing exosomes therapeutics engineered to target and kill cancer. The exosome therapeutics program is a very exciting extension of our exosome diagnostic work. INOVIQ has leveraged its proprietary exosome platform, in-house capabilities and expertise in exosome science to commence its first in-house exosome therapeutics program. INOVIQ’s exosome therapeutics program uses chimeric antigen receptor (CAR)-exosomes that are released from genetically engineered CAR-T (T-lymphocytes) and CAR-NK (Natural-Killer) cells. These CAR-exosomes have enormous potential as cell-free therapeutics, with manufacturing, safety and efficacy advantages over autologous cell therapies for treating solid tumours. CAR-exosomes inherit the tumour-targeting and cytotoxic capabilities of their parent CAR-T/NK cells, specifically targeting and killing cancer cells. During the year, multiple in-house studies were performed including evaluation of various immune cell lines (T-cells and Natural Killer (NK)-cells) that release exosomes, establishment of a Master Cell Bank of NK cells, design and testing of proprietary cancer antigens to target solid tumours (i.e., chimeric antigen receptors, CAR), evaluation of the purity and yield of exosomes isolated using INOVIQ’s EXO-ACE technology and initial in vitro proof-of-concept studies for CAR-exosomes in breast cancer. 11 Annual Report 2024 Review of Operations
On 3 June 2024 INOVIQ announced that it had successfully produced and isolated engineered exosomes (EEVs) that target and kill breast cancer cells in vitro. A proof-of-concept study demonstrated that a breast cancer targeting protein (CAR) was expressed in exosomes released by immune cells. The engineered exosomes were isolated and concentrated from immune cell-conditioned media using INOVIQ’s proprietary EXOACE™ technology (for isolating exosomes at scale for therapeutic use). EXO-ACE recovered more than 80% of exosomes from cell-conditioned media with over 95% purity. When treated with these exosomes, 75% of breast cancer cells underwent cell death within 72 hours. Based on these excellent results, INOVIQ is progressing its exosome therapeutics program, initially focusing on immune-cell derived exosome therapeutics for breast and ovarian cancers. The next milestones are to complete further in vitro efficacy testing in NK-cell lines by end of CY24, followed by in vivo testing in animal models in CY25. INOVIQ is engaging with key opinion leaders in the immunotherapy field and expanding collaborations with leading research groups to fast-track this program. SUBB2M PROGRAM SubB2M is an engineered protein that specifically detects the pan-cancer biomarker neu5Gc that is found in multiple human cancers. INOVIQ is developing simple, accurate and affordable SubB2M-based blood tests for cancer detection and monitoring. SubB2M-based immunoassays have been designed using a protein specific monoclonal capture antibody combined with INOVIQ’s proprietary detection reagent to monitor the biomarker produced by cancer cells, resulting in improved specificity for cancer and potentially less false positives. Test for Breast Cancer Monitoring (neu-CA15-3) The neu-CA15-3 test is a blood test in development for monitoring breast cancer in women diagnosed with the disease. The test has been clinically validated to detect breast cancer across all stages with 81% sensitivity and 93% specificity. On 22 February 2024, INOVIQ announced the successful completion of a monitoring study showing that INOVIQ’s test detected key breast cancer subtypes (HR+, HER2+ and TNBC), correctly identified 19% more breast cancers than a leading approved CA15-3 test and is effective for monitoring breast cancer. The neuCA15-3 test has now been clinically validated to detect breast cancer across all stages, key breast cancer types and subtypes, and is effective for breast cancer monitoring. INOVIQ has initiated discussions with potential partners and key opinion leaders to secure a laboratory partner in the US for commercialisation of the test. A key scientific paper on neuCA15-3 for breast cancer detection and monitoring has been prepared for submission to an international peer-reviewed scientific journal. The Company also initiated a feasibility program to transfer the current ELISA to a bead-based assay that can be used on high-throughput automated laboratory equipment. Plans for an in-clinic study of the test for monitoring treatment response were also progressed to support commercialisation of the test. Test for Ovarian Cancer Monitoring (neu-CA125) The neu-CA125 test is a blood test in development for monitoring ovarian cancer in women diagnosed with the disease. On 19 April 2024, INOVIQ announced the successful completion of an analytical validation study for its neu-CA125 blood test for ovarian cancer. Overall, the test correctly identified 85% of all samples tested including 76% of the cancer samples and 94% of the cancer free samples. Analytical validation confirmed that the test is working properly and can reliably detect women with ovarian cancer. Further development of neu-CA125 test will include evaluation of new fit-forpurpose CA125 antibodies currently in production by a contract manufacturer. Surface Plasmon Resonance (SPR) test for cancer risk-assessment (neu-SPR test) INOVIQ completed a feasibility study with Nicoya Lifesciences Inc to evaluate a SubB2M-based SPR test on the Alto™ Digital SPR instrument (ASX: 13 October 2022). In December 2023, the study was finalised with results demonstrating that the SPR test could discriminate between cancer and healthy control samples. These initial results hold promise for developing a SPR-based multi-cancer risk assessment test, pending medical device approval of the ALTO platform. Review of Operations continued 12 INOVIQ Limited
INTELLECTUAL PROPERTY PORTFOLIO The Group owns or exclusively licenses a broad intellectual property (IP) portfolio of granted patents, patent applications, trade secrets and trademarks protecting INOVIQ’s technologies, products, processes and brands. The Group had 21 granted patents, 15 patents pending and 2 international provisional patent applications as at 30 June 2024, covering its SubB2M, Molecular NET, BARD1 and hTERT technologies and products across key jurisdictions including the United States, Europe, Asia, and Australia. Additionally, it owns registered trademarks for INOVIQ®, EXO-NET® and Acuris®. INOVIQ filed several provisional patent applications to expand its exosome intellectual property (IP) portfolio during the period: › An Australian Provisional Patent Application (APPA) was filed in October 2023 covering its NEURO-NET technology for isolation of brain-derived exosomes for biomarker discovery and diagnostic development. The APPA covers compositions for capturing extracellular vesicles derived from various brain cells in a sample and uses for commercial applications. › An APPA was filed in March 2024 covering its cutting-edge EXO-ACE technology for large scale isolation of exosomes for therapeutic use. The APPA covers compositions for use in capturing extracellular vesicles for large scale commercial applications. 13 Annual Report 2024 Review of Operations Patent Family Title Granted Pending Expiry SubB2M PCT/AU2017/051230 (WO2018/085888) Subtilase cytotoxin B subunit mutant AU, EP, JP, US BR, CA, CN, IN, KR, US (cont) 2037 US 2038 PCT/AU2022/050470 (WO2022/236383) Methods of analysing a sample US 2042 US7078489 Cytotoxin with subtilaise domain US BARD1 PCT/FR01/02731 (WO2002/018536) Truncated BARD1 protein, and its diagnostic and therapeutic uses US 2024 PCT/IB2011/054194 (WO2012/038932) Kits for detecting breast or ovarian cancer in a body fluid sample and use thereof EP, US, US (cont) 2031 US and US (cont) 2032 EP14002398.7 Non-coding RNA as diagnostic marker and treatment target US 2035 hTERT PCT/AU2015/050060 (WO2015/120523) Method of resolving inconclusive cytology to detect cancer AU, CN, EP, IL, JP, US US (cont) 2035 PCT/AU2016/050764 (WO2017/027928) Method of detecting cancer in morphologically normal cells US 2036 Molecular NETs PCT/US2010/058086 (WO2011/066449) Devices for detection of analytes CN, US (cont1), US cont2), US (cont3) US (cont6) 2030 US (cont1) 2033 US (cont2&3) 2031 PCT/US2013/049779 (WO2014/011673) Molecular Nets EP 2033 PCT/AU2022/050428 (WO2022/232886) Methods relating to tumourderived extracellular vesicles CN, EP, JP, SG, KR, US 2042 AU2023903359 Extracellular vesicle compositions and uses thereof AU (provisional) 2044 Therapeutic Evs AU2024900609 Resin compositions and methods of use AU (provisional) 2024 cont = continuation; div = divisional
Review of Operations continued CORPORATE UPDATE BOARD CHANGES AND EXPANSION David Williams was appointed Non-Executive Director and Chairman of INOVIQ on 29 November 2023. David Williams B.Ec(Hons), M.Ec, FAICD is an experienced Director and investment banker with a track record in business development, mergers and acquisitions and capital raising. He has experience advising ASX-listed companies in the food, medical device and pharmaceutical sectors. Mr Williams is currently Chairman of PolyNovo (ASX:PNV), Chairman of RMA Global (ASX:RMY) and is Managing Director of corporate advisory firm Kidder Williams. STRENGTHENED CAPABILITIES TO TAKE ADVANTAGE OF HIGH-GROWTH EXOSOME MARKET During the year, INOVIQ invested in its people across exosome science, product development and commercial, as well as in state-of-the-art equipment to support its in-house and partnered exosome-based product development for research, diagnostic and therapeutic applications. CAPITAL RAISE In June 2024, INOVIQ completed a placement to institutional and sophisticated investors, raising $7.0 million (before costs) via 14 million new fully paid ordinary shares in the Company at $0.50 per Share, with one free quoted option for every two new Shares issued under the Placement with an exercise price of $1.00 and two-year expiry. The pricing of the Placement represented an 11.5% discount to the last traded market price. $0.25m (500,000 Shares) of the Placement (and 250,000 attaching Placement Options), representing the Board’s participation in the capital raise, are subject to shareholder approval at an extraordinary general meeting to be held on 21 August 2024. On 5 July 2024 INOVIQ announced the successful completion of the share purchase plan (SPP), with applications totalling $7.293 million, exceeding the initial target of $2m. INOVIQ Directors exercised discretion to accept allocations to the maximum capacity of A$2.379m and scale back applications pro-rata. The SPP also provided investors with one free quoted option for every two new Shares issued at an exercise price of $1.00 expiring on 8 July 2026. INVESTOR PROMOTION AND AWARENESS INOVIQ continued to drive awareness of its investment proposition, product pipeline, progress and plans with investors and media through the period. INOVIQ presented at multiple investor conferences and numerous media outlets reported on INOVIQ news, see Presentation tab www.inoviq. com/site/investors/presentations and Media tab www.inoviq.com/site/media/inoviq-in-the-news. 14 INOVIQ Limited
OUTLOOK AND PLANS INOVIQ remains focused on its vision to be a leading biotechnology company pioneering next-generation diagnostics and therapeutics to enhance patient outcomes in cancer and other diseases. The Company’s priorities over the next 12-months are to expand its EXO-NET exosome isolation tools, partner its lead SubB2M diagnostics, accelerate development of its exosome diagnostics and therapeutics pipeline, and grow revenues from EXO-NET product sales and partnering. The Company expects to report data readouts across its SubB2M tests, exosome diagnostic and therapeutic programs, as well as commercial progress for its EXO-NET research tools and partnering activities over the next 12 months. INOVIQ is strongly positioned with disruptive technology, a multi-product pipeline, commercial partners validating its technology, and an experienced leadership team to execute on strategy, deliver key milestones and grow shareholder value over the next 12 months. INOVIQ thanks shareholders for their ongoing support and looks forward to keeping you informed on our progress. 15 Annual Report 2024 Review of Operations CY 2024 CY 2025 • EXO-NET Supply & Distribution Agreement with Promega • Exosome diagnostic agreement • NEURO-NET validation data • EXO-OC test biomarker validation data • Exosome therapeutic in vitro data • SubB2M breast cancer monitoring study data • Laboratory partner for SubB2M tests • Commence exosome diagnostic development for Alzheimer’s Disease • Commence EXO-OC test clinical validation for ovarian cancer screening • Exosome therapeutic in vivo data • First sales of SubB2M breast cancer monitoring test • SubB2M ovarian cancer clinical validation study data • SubB2M breast cancer in-clinic monitoring study data Exosome program SubB2M program
FINANCIAL RESULTS The Group recorded a net loss from operating activities after income tax of $6,554,350 (2023: $8,969,241) and ended the financial year with a cash balance of $9,233,192 (2023: $7,812,511). Product revenues from sales of the hTERT test totalled $333,255 (2023: $363,209) and from EXO-NET totalled $201,863 (2023: $34,984). Income from other sources was $1,283,025 (2023: $1,506,730) including an accrual of $1,017,344 for the Research and Development Tax Incentive Refund for the 2024 financial year (2023: $949,501). The refund for 2024 is expected to be received in the coming months. No grant income was received in 2024 (2023: $58,130). Miscellaneous income added $256,581 (2023: $353,721). General and administration costs were $5,158,586 (2023: $6,832,901) with the following significant contributors: › employee expenditure $2,672,483 (2023: $1,914,513) including non-cash share options expense of $834,774 (2023: $285,111); › Professional and legal fees $612,005 (2023: $2,147,043), where the majority of prior year costs related to fees paid to defend the Supreme Court Writ and achieve the settlement outcome; › amortisation of intangible assets $947,514 (2023: $944,933) for the hTERT and NETs intangible assets; and › ASX listing and share registry fees of $134,137 (2023: $132,421). Research and Development expenditure was $2,699,591 (2023: $3,224,469) including employee related expenditure of $1,208,243 (2023: $1,334,274) and $1,251,411 (2023: $1,649,970) paid to external contractors and suppliers. The majority of expenditure was incurred on the SubB2M and NETs programs. Sales and Marketing expenditure was $433,303 (2023: $772,312) of which employee related expenditure contributed $272,181 (2023: $413,344). Non-cash expenditures recorded (within the three categories of expenditure – General and Administration, Research and Development, and Sales and Marketing) for the reporting period included: › amortisation of intangible assets $947,514 (2023: $944,933) for the hTERT and Molecular NETs intangible assets and $28,385 (2023: $20,030) related to granted patents; › depreciation of right-of-use assets (required by accounting standard AASB16 – Leases) $275,753 (2023: $274,998); › depreciation of building improvements $33,548 (2023: $33,154) and depreciation of plant and equipment $158,726 (2023: $120,617); › share based payments expense of $834,773 (2023: $285,111); › lease liability interest expense, as required by AASB16, $40,766 (2023: $59,524). Review of Operations continued 16 INOVIQ Limited
18 Directors’ Report 31 Auditor’s Independence Declaration 32 Consolidated Statement of Comprehensive Income 33 Consolidated Statement of Financial Position 34 Consolidated Statement of Changes in Equity 35 Consolidated Statement of Cash Flows 36 Notes to the Financial Statements 62 Consolidated Entity Disclosure Statement 63 Directors’ Declaration 64 Corporate Governance Statement 65 Independent Auditor’s Report Contents 17 Annual Report 2024 Financial Report
Directors’ Report 18 INOVIQ Limited The directors present their report together with the financial report of INOVIQ Limited (INOVIQ or the Company) and its controlled entities (collectively referred to as the Group) for the financial year ended 30 June 2024 and the independent auditor’s report thereon. PRINCIPAL ACTIVITIES The principal activities of the Group are the development and commercialisation of an innovative portfolio of diagnostic and therapeutic products to enhance patient outcomes for cancer and other diseases. INOVIQ’s product portfolio includes products in-market for exosome research and bladder cancer diagnosis, clinical-stage cancer diagnostics for detection and monitoring of breast and ovarian cancers, and an early-stage exosome therapeutic for solid tumours. CORPORATE INFORMATION INOVIQ Limited is a Company limited by shares and is incorporated and domiciled in Australia. It is the ultimate legal parent entity of the INOVIQ Group. As at 30 June 2024 it had one operating wholly owned subsidiary, Sienna Cancer Diagnostics Ltd (an Australian public company). DIRECTORS The names and details of the directors of the Company in office during the year ended 30 June 2024 and until the date of this report are as follows (Directors were in office for this entire period unless otherwise stated): MR DAVID WILLIAMS Non-Executive Chairman (appointed 29 November 2023) Mr Williams is an experienced Director and investment banker with a track record in business development as well as in mergers and acquisitions and capital raising. He has experience advising ASX-listed companies in the food, medical device and pharmaceutical sectors. Mr Williams is currently Chairman of PolyNovo (ASX:PNV), Chairman of RMA Global (ASX:RMY) and is Managing Director of corporate advisory firm Kidder Williams. David is also a former Chairman and Non-Executive of Medical Developments International Ltd (ASX: MVP). Mr Williams is Chair of the INOVIQ Limited Remuneration Committee. DR GEOFFREY CUMMING BSc (Hons) BAppSc PhD MBA MAICD Non-Executive Director (appointed 28 July 2020 and served as Non Executive Chairman until 29 November 2023 and Non-Executive Director thereafter) Dr Cumming has held senior roles in the global healthcare and biotechnology sector for more than 20 years. As Managing Director, Roche Diagnostic Systems (Oceania), Dr Cumming transformed the loss-making entity the Swiss parent was intending to divest, into the fastest growing and most profitable affiliate in the Roche group. In his role as Managing Director/CEO of Biosceptre International Ltd, Dr Cumming was successful in designing and securing key funding arrangements through a skilful range of capital raising initiatives, including large government grants, partnering and co-development deals. His most recent executive role was as Managing Director/CEO of Anteo Diagnostics Ltd (ASX: ADO). He is currently a Non-executive Director of Anteo Diagnostics Ltd and was previously Chairman of Sienna Cancer Diagnostics Ltd and a Non-executive Director of Medical Australia Ltd (ASX: MLA). Dr Cumming is a member of the INOVIQ Limited Remuneration Committee and a member of the Audit & Risk Committee. Dr Cumming has not been a director of any listed companies in the last three years other than those listed above. MR ROBERT (MAX) JOHNSTON Non-Executive Director (appointed 17 June 2019) Mr Johnston held the position of President and Chief Executive Officer of Johnson & Johnson Pacific, a division of the world’s largest medical, pharmaceutical and consumer healthcare company for 11 years. Prior to joining Johnson & Johnson, Mr Johnston’s career also included senior roles with Diageo and Unilever in Australia, Africa, and Europe. Mr Johnston has also held several prominent industry roles as a past President of ACCORD Australasia Limited, a former Vice Chairman of the Australian Food and Grocery Council and a former member of the board of the Australian Self Medication Industry (ASMI). Mr Johnston has had extensive overseas experience during his career in leading businesses in both Western and Central-Eastern Europe and Africa as well as the Asia-Pacific region. Mr Johnston is a current Non-Executive Director of Neurotech International Limited (ASX: NTI). Mr Johnston is a former Non-Executive Director of Medical Developments International Ltd (ASX: MVP), Tissue Repair Ltd (ASX: TRP), Enero Group Limited (ASX: EGG) and PolyNovo Ltd (ASX: PNV), and a former Non-Executive Chairman of Probiotec Ltd (ASX: PBP) and AusCann Group Holdings Ltd (ASX: AC8). Mr Johnston is a member of the Company’s Remuneration and Audit & Risk Committees. Mr Johnston has not been a director of any listed companies in the last three years other than those listed above.
RkJQdWJsaXNoZXIy MjE2NDg3