Next-generation diagnostics and therapeutics for cancer INOVIQ Ltd Annual Report 2025
1 Chairman’s Letter 2 CEO’s Report 4 Review of Operations 16 Directors’ Report 29 Auditor’s Independence Declaration 30 Consolidated Statement of Comprehensive Income 31 Consolidated Statement of Financial Position 32 Consolidated Statement of Changes in Equity 33 Consolidated Statement of Cash Flows 34 Notes to the Financial Statements 60 Consolidated Entity Disclosure Statement 61 Directors’ Declaration 62 Corporate Governance Statement 63 Independent Auditor’s Report 66 Shareholder Information 69 Corporate Directory Contents For more information visit www.inoviq.com
1 Annual Report 2025 Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information Chairman’s Letter We are delighted to present INOVIQ’s Annual Report for the financial year ended 30 June 2025. Mr David Williams Chairman Dear shareholder, INOVIQ achieved significant progress in FY25, with major milestones in both diagnostics and therapeutics. The EXOOC™ ovarian cancer screening test demonstrated 100% sensitivity for early-stage disease with no false positives, positioning it as a potential breakthrough in non-invasive cancer screening. The CAR-exosome therapeutic program showed promising results, killing 88% of triple-negative breast cancer and non-small cell lung cancer cells in vitro. The company also expanded its EXO-NET® research tool business in partnership with Promega Corporation, and neuCA15-3 data was published in a peer-reviewed journal. On the corporate side, INOVIQ appointed key leaders, including Mary Harney as Non-Executive Director and Dr Emma Ball as Chief Commercial Officer, and established a Medical and Scientific Advisory Board to guide future development. Financially, INOVIQ ended FY25 with $6.5 million in cash but reported a net loss of $6.9 million as it continued to invest heavily in its programs. Looking ahead, INOVIQ’s FY26 priorities include expanding the EXO-NET® business, advancing EXO-OC™ toward commercialisation, progressing CAR-exosome therapy, and forming strategic partnerships to accelerate diagnostic tech commercialisation. INOVIQ is well-positioned for future growth, with an experienced leadership team and a promising multi-product pipeline. Thank you to our shareholders for your continued support as we enter this exciting phase of growth and innovation. FY25 ACHIEVEMENTS Expand exosome platform across research tools, diagnostics and therapeutics › EXO-NET customers hit 60 in pre-launch phase › EXO-OC test se 77% / sp >99.6% all-stages and detects 100% Stage I/II › CAR-EVs kill 88% TNBC & NSCLC cells in vitro and collaboration with Peter Mac › NeuCA15-3 peer reviewed publication › Advisory Board established & leadership team expanded FY26 CATALYSTS Partner diagnostic programs, accelerate development of exosome therapeutics and grow revenues › EXO-NET >200% customer growth & first diagnostic partner › Partner EXO-OC test for LDT commercialisation and progress IVD development › in vivo data for CAR-EV in TNBC mouse model & commence INDenabling studies › Partner NeuCA15-3 test 3-YEAR OBJECTIVES INOVIQ established as a leading exosome company with best-in-class diagnostics and therapeutics for cancer › EXO-NET established as a best- in-class EV isolation technology › EXO-OC established as a bestin-class screening test for ovarian cancer › CAR-NK-EV validated as a potential first-in-class exosome therapeutic for cancer › NeuCA15-3 generating partner revenue › Yoy growth across partner, product and revenue metrics
1 Exosomes Market Size And Share | Industry Report, 2030 2 Grand View Research, Ovarian Cancer Diagnostics Market 2024-2030 3 Breast Cancer Therapeutics Market Growth, Trends & Dynamics, 2027 (fortunebusinessinsights.com) 2 INOVIQ Limited CEO’s Report INOVIQ is advancing nextgeneration diagnostics and therapeutics for significant unmet needs in global oncology markets. INOVIQ is advancing next-generation diagnostics and therapeutics for significant unmet needs in global oncology markets. Our FY25 achievements have strengthened our exosome leadership position with proprietary technologies, commercial products and a robust pipeline of research tools, diagnostics and therapeutics. EXOSOME PLATFORM DRIVING GROWTH AND VALUE The strategic pillars driving growth and value across our business are underpinned by our proprietary technology platforms that are embedded in our on-market research tools and higher-value diagnostics and therapeutics pipeline. Research tools are our commercially available ‘technology-in-a-box’ solutions for exosome isolation that are generating revenue and accelerating adoption of exosome diagnostics. These exosome technologies underpin our clinical-stage ovarian cancer diagnostic and our preclinical CAR-exosome therapy for solid tumours. Our product strategy leverages the exosome platform to deliver integrated solutions for earlier cancer detection and treatment to transform patient outcomes. INOVIQ aims to deliver increasing return on investment as we scale from research tools to diagnostics and therapeutics, aligning our priorities with higher-value global market opportunities. EXOSOME PLATFORM Proprietary exosome technology platform underpinning products & pipeline Embedded value in INOVIQ products and services US$794.2m global exosome research market by 20301 US$5.5b global ovarian cancer diagnostics market by 20302 US$55.3b global breast cancer therapeutics market in 20273 › Establishes INOVIQ as a leading exosome company › Delivers solutions for precise exosome isolation, engineering and loading › Enables transformative applications across research, diagnostics and therapeutics RESEARCH TOOLS Exosome isolation tools for biomarker discovery and diagnostics › Global distribution partner in place for market development and commercial success › Delivers early revenue from sales of research tools and services › Potential licensing income from future commercial diagnostics using EXONET DIAGNOSTICS Exosome tests for screening, liquid biopsies & companion diagnostics › Faster-to-market diagnostics to deliver mid-term partners and revenue › Commercialisation pathway established with existing exosome diagnostics on-market as LDTs and BDD from US FDA THERAPEUTICS Exosome therapeutics to target and destroy solid tumours › High-value therapeutics to deliver blue-sky ROI › Leverages existing exosome technology, capabilities & expertise › Potential first-in-class CAR-exosome therapy with cost, logistics, safety & efficacy advantages 1 2 3 4
Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information 3 Annual Report 2025 Dr Leearne Hinch CEO EXOSOME ISOLATION TOOLS DELIVERING REVENUE AND COLLABORATIONS INOVIQ’s best-in-class EXO-NET® exosome isolation technology for biomarker discovery and diagnostics is commercially available worldwide through our global distribution partner, Promega Corporation, delivering revenue and collaborations. Our research tool portfolio was expanded with the development and validation of NEURO-NET™ for isolating brain-derived exosomes from blood samples of Alzheimer’s and Parkinson’s patients. NEURO-NET broadens INOVIQ’s research tool portfolio and partnering opportunities for novel neurological diagnostics. EXOSOME DIAGNOSTIC ADVANCING TOWARD COMMERCIALISATION Our EXO-OC™ ovarian cancer screening test addresses a critical unmet need for early detection in asymptomatic, averagerisk women. Recent results demonstrated 77% overall sensitivity at >99.6% specificity, and 100% detection of early-stage I and II ovarian cancers. Leveraging our proprietary EXO-NET® technology, strategic collaborations and a staged regulatory approach, INOVIQ is preparing for rapid US commercialization as a Laboratory Developed Test (LDT), followed by global In Vitro Diagnostic (IVD) rollout to expand market access, support reimbursement and drive future revenue growth. EXOSOME THERAPEUTIC PROGRESSING TOWARD IN VIVO MILESTONE INOVIQ is developing next-gen exosome therapeutics engineered to target and destroy solid tumours. Our lead CAR-exosome therapy program aims to deliver potential cost, logistics, safety and efficacy advantages over autologous CAR-T therapies for solid tumours. In vitro studies demonstrated that CARNK-exosomes killed 88% of triple negative breast cancer cells in vitro. First in vivo data in a TNBC mouse model are expected in Q4 CY2025, informing our development plans and enabling potential pharmaceutical partnering discussions. SUBB2M PROGRAM ADVANCING WITH A PARTNERING FOCUS Our 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. A peer-reviewed publication on the neuCA15-3 test in May 2025 reinforces the scientific robustness of the SubB2M technology and test performance. We are advancing product development to transfer the test onto an automated instrument platform to facilitate scalability and discussions with strategic partners for commercialisation. FUTURE MILESTONES DELIVERING VALUE INOVIQ is positioned as a leader in exosome technology, focused on delivering sustainable growth and shareholder value as we advance our pipeline toward key development and commercial milestones. In FY26, we expect to deliver key milestones, including commercial expansion of our EXO-NET® research tools, development progress across our exosome diagnostic and therapeutic programs, and strategic partnerships to accelerate commercialisation of our diagnostic technologies.
BUSINESS OVERVIEW INOVIQ Ltd (ASX:IIQ) is a leader in exosome technology focused on advancing next-generation diagnostics and therapeutics that transform cancer care and improve patient outcomes. The product portfolio includes commercial exosome isolation products and an adjunct bladder cancer test, clinicalstage diagnostics for breast and ovarian cancers, and a preclinical-stage CAR-exosome therapeutic program for solid tumours. HIGHLIGHTS INOVIQ made significant progress during financial year 2025 and up to the date of this report. The Company grew its EXO-NET customer base and delivered key development milestones across its exosome diagnostic, exosome therapeutic and SubB2M diagnostic pipeline. Our exosome diagnostic for screening ovarian cancer delivered outstanding performance for early-stage detection, our CAR-NKexosome therapeutic achieved in vitro cytotoxic efficacy in breast cancer cells and our neuCA15-3 breast cancer monitoring test showed disease specificity. These results further validate INOVIQ’s technology platforms and substantially de-risk our diagnostic and therapeutic pipeline for breast and ovarian cancers. 4 INOVIQ Limited Commercial › EXO-NET® revenue and customers grew across Europe, US and Asia via global partner Promega Corporation › NEURO-NET™ brainderived exosome isolation tool validated in Parkinson’s Disease and made available for collaborations › Promega developing combination EXO-NET exosome isolation and Maxwell RNA extraction products to expand product offering and provide automated solutions Review of Operations We are pleased to present the Group’s Annual Report for the financial year ended 30 June 2025 and provide an update on further strategic and operational progress since year end.
Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information 5 Annual Report 2025 Research and Development › EXO-OC™ Ovarian Cancer screening test achieved 77% sensitivity at >99.6% specificity for detecting ovarian cancer across all stages, and 100% sensitivity for early-stage I and II disease › EXO-OC data presented at ASCO 2025 and provisional patent application filed on 29 May 2025 to secure intellectual property rights protecting the biomarkers and combinations › CAR-NK-exosomes achieved 88% cell death in triple negative breast cancer and non-small cell lung cancer cells in vitro › Peter Mac engaged to further validate CAR-exosomes in Triple Negative Breast Cancer (TNBC) in vitro and in vivo studies › NeuCA15-3™ Breast Cancer monitoring test completes disease specificity testing and test being transferred to bead-based assay for commercialisation › Neu-CA15-3 diagnostic performance published in international peer reviewed journal Breast Cancer Research and Treatment › Capital raise of $9.4m completed in July 2024 › Cash of $6.5 million at 30 June 2025 to fund operations, pipeline development and commercial initiatives › Net loss of $6.9 million for the year ended 30 June 2025 › Research and Development Tax Refund of $1.27m recognised for the 2025 financial year › Mary Harney appointed Non-Executive Director, bringing deep understanding of applied life science research and experience in biopharmaceutical regulatory affairs and commercialisation › Dr Emma Ball appointed Chief Commercial Officer (CCO), bringing extensive business development and licensing experience in therapeutics and life sciences › Medical and Scientific Advisory Board established to provide expert guidance on INOVIQ’s diagnostic and therapeutic programs Financial Corporate
CANCER DIAGNOSTICS MARKET The global cancer burden encompassed 53.5 million people living with cancer1, 20.0 million new cases and 9.7 million deaths in 2022.2 The incidence of cancer is expected to reach 35 million new cases by 2050 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 lack sensitivity for early-stage 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.3 INOVIQ is developing non-invasive diagnostics using its proprietary exosome (liquid biopsies and companion diagnostics) and SubB2M (improves existing cancer biomarker tests) 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 ovarian and breast cancers. Ovarian cancer is the world’s deadliest gynaecological cancer with 314,000 cases and 207,000 deaths worldwide2, and a global diagnostic market expected to reach US$5.5 billion by 2030.4 Breast cancer is the most common cancer with 2.3 million cases and 685 million deaths worldwide2, and a global diagnostics market expected to reach US$8.5 billion by 2030.5 EXOSOMES MARKET FOR RESEARCH, DIAGNOSTIC AND THERAPEUTIC APPLICATIONS Exosomes (or small extracellular vesicles, EVs) 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 exosome research market was valued at US$177.4m in 2024 and is forecast to reach US$794.2m by 2030, growing at a CAGR of 28.7%.6 Another report valued the global exosome market for diagnostics and therapeutics at US$59 million in 2024 and is forecast to reach US$6.8 billion by 2032, growing at a CAGR of 81.2% as more diagnostics and therapeutics are commercialised.7 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 screening ovarian cancer, and progressing preclinicalstage exosome therapeutics for solid tumours. 1 The Global Cancer Observatory, GLOBOCAN 2022 World Fact Sheet 2 Bray, F et al. Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021. doi: 10.3322/caac.21834 3 SEER18 2010-2016 4 2024. Ovarian Cancer Diagnostics Market, 2024-2030. https://www.grandviewresearch.com/industry-analysis/ ovarian-cancer-diagnostics-market 5 2025. Breast Cancer Diagnostics Market, 2025-2030: https://www.grandviewresearch.com/industry-analysis/ breast-cancer-diagnostics-market 6 2025. Exosomes Market Size, Share and Trends Analysis Report, 2025-2030. https://www.grandviewresearch.com/ industry-analysis/exosomes-market 7 2024. Exosome Diagnostics and Therapeutics Market to 2032. MarketsandMarkets: https://www.marketsandmarkets. com/Market-Reports/exosome-diagnostics-therapeuticsmarket-198025144.html Extracellular Vesicle (EV) 6 INOVIQ Limited Review of Operations continued
PRODUCT PORTFOLIO INOVIQ’s product portfolio includes commercial exosome isolation products and an adjunct bladder cancer test, clinicalstage diagnostics for ovarian cancer screening and breast cancer monitoring, and a preclinical-stage CAR-exosome therapeutic program for solid tumours. Our pipeline priorities are our EXO-OC screening test for ovarian cancer and CAR-exosome therapy for triple negative breast cancer. Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information 7 Annual Report 2025 Research Tools Indication Use Discovery Verification Validation In-market Next Milestone EXO-NET Multiple Pan-EV Capture Sales Growth & Collaborations NEURO-NET Neurology Brain Derived-EV Capture Collaborations TEXO-NET Oncology Tumour Derived-EV Capture Validation data | 2H25 Diagnostics Indication Use Discovery Assay Development Clinical In-market Next Milestone EXO-OC Ovarian Cancer Screening Commence clinical validation | 2H25 neuCA15-3 Breast Cancer Monitoring Partnering | 2H25 hTERT ICC Bladder Cancer Adjunct to Cytology Therapeutics Indication Use Discovery Pre-clinical Clinical In-market Next Milestone EEV-001 Breast Cancer CAR-Exosome therapy In vivo data | 2H25 RUO RUO RUO LDT IVD-CLASS 1 US IVD
COMMERCIAL UPDATE Commercial activities during the year focused on EXONET customer engagement, expanding evaluations and collaborations, and promotion at international conferences. 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 diagnostics. EXO-NET offers speed, efficiency and scalability advantages over other exosome isolation methods. EXO-NET is commercially available worldwide through our distribution partner Promega Corporation. 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 affinity matrix-coated magnetic beads for processing up to 96, 60 or 15 samples. Promega grew the EXO-NET customer base to 60 by year-end across academic/government, pharmaceutical/ biotech, clinical laboratory/hospital and CRO customer types. Customer numbers were highest in Europe, followed by North America and Asia-Pacific. Applications were diverse including fundamental EV research, biomarker/target discovery and diagnostics research for Oncology, Neurology, Cardiac Disease, Transplant Rejection and Sepsis. Multiple conferences were attended during the year including GiVEX (Oct-24, Spain), AMP (Nov-24, Canada) and IMPACT Conference: Biomarkers in Psychiatry and Gynecology (Dec-24, Chile), ISEV (May-25, Europe) ASCO (Jun-25, USA), BIO International (Jun-25, USA) and AACR (Apr-25, USA). EXO-NET posters were presented showcasing the speed, specificity, reproducibility and scalability of EXO-NET for high-throughput EV isolation, biomarker discovery and diagnostics development. Joint research was undertaken by INOVIQ and Promega on Applications Development to provide validated data and Application Notes to support customer applications for urine-based workflows, flow cytometry of isolated EVs and miRNA/mRNA sequencing. Promega also invested in developing EXO-NET/RNA combination products that integrate with its Maxwell systems and consumables, providing flexible, scalable solutions for EV isolation and diagnostics. Launch of these combination products is expected in Q3 FY2026. Engagement with academia and industry is ongoing to secure collaborations and sales of EXO-NET, NEURONET and combination products. Multiple evaluations were progressed for biomarker discovery and diagnostic development across cancer, cardiology and neurological diseases. Promega continues to advance its EXO-NET roll-out from Early Access to full catalogue launch expected in early 2026. The first order from Promega was delivered and invoiced in August 2024 and the second order in May 2025. EXO-NET revenues achieved $253,261 during the year (2024: $201,863). New combination products and custom development services are expected to drive sales of EXO-NET over the next 12-months and underpin revenue growth. EXO-NET® 8 INOVIQ Limited Review of Operations continued
NEURO-NET® BRAIN-DERIVED EXOSOME CAPTURE NEURO-NET is a specific exosome capture tool designed for isolation of brain-derived exosomes for use in neurological applications. NEURO-NET has been analytically and clinically validated for isolation of brainderived EVs in Alzheimer’s Disease (AD) and Parkinson’s Disease (PD). NEURO-NET is available to academic and industry researchers for research collaborations. On 20 August 2024, INOVIQ announced that it had further validated its NEURO-NET™ technology for isolation of brain-derived exosomes in Parkinson’s Disease (PD). Initial analytical and clinical validation studies in PD showed that NEURO-NET enriched known protein biomarkers of neurodegenerative diseases by 5-8-fold and over 200 proteins were identified that were either decreased (blue) or increased (red) in PD patients when compared to normal healthy individuals (Figure 1, data obtained from 10 cases of PD and 10 healthy controls). INOVIQ also progressed discussions and evaluations with several academic groups, diagnostic and biopharma companies to assess NEURO-NET’s potential in diagnostic applications for brain cancer, neurodegenerative and neuropsychiatric disorders. Successful outcomes from these evaluations are anticipated to result in research collaborations and/or supply agreements for NEURO-NET. The next milestones for NEURO-NET include collecting further clinical validation data and fostering partnerships with both academic institutions and industry leaders in the field of neurological conditions. 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) for use as a clinical diagnostic by pathology laboratories for the detection of hTERT in cytopathology samples.8 The hTERT test is sold direct to laboratory customers in the US achieving revenues of $294,314 during the year (2024: $333,255). hTERT revenues are expected to remain flat in FY2026 due to the limited market size and increased competition from new products. Proteins present in NEURO-NET captured exosomes from Parkinson’s Disease and normal healthy individuals. 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 22 granted patents, 15 patents pending and 1 provisional patent application as at 30 June 2025, covering its Molecular NET, Exosome therapeutics, SubB2M, BARD1 and hTERT technologies and products across key jurisdictions including the United States, Europe, Asia, and Australia. Trademarks are also registered or pending for INOVIQ®, EXO-NET®, Sienna Cancer Diagnostics® and Acuris®. INOVIQ filed or advanced several patent applications to expand its exosome intellectual property (IP) portfolio during the period: › On 18 October 2024, INOVIQ filed international PCT application AU2024/051103 entitled ‘Extracellular vesicle compositions and uses thereof’ protecting its NEURO-NET technology for isolation of brain-derived exosomes. › On 29 May 2025, INOVIQ’s collaborator the University of Queensland filed Australian Provisional Patent Application 2025902121 entitled ‘Diagnostic signature’ to secure intellectual property rights covering various protein and RNA biomarker combinations and methods for the exosome ovarian cancer test. 8 Allison et al. Evaluation of Sienna Cancer Diagnostics hTERT Antibody on 500 Consecutive Urinary Tract Specimens. Acta Cytologica 2018. DOI: 10.1159/000489181 Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information 9 Annual Report 2025
Review of Operations continued EXOSOME DIAGNOSTICS The Exosome Ovarian Cancer Screening test (EXO-OC™ test) is a next-generation, exosomebased blood test in development for screening ovarian cancer in asymptomatic, average-risk women. EXO-OC uses proprietary EXO-NET® technology to isolate exosomes and combines multiple exosomal biomarkers in an AIenhanced algorithm to enable the early and accurate detection of ovarian cancer. Currently, there is no approved screening test to detect ovarian cancer early when treatment can be more effective and patient outcomes and survival improved. During the year, INOVIQ and the University of Queensland conducted a retrospective, blinded, case-control study to evaluate the performance of EXO-OC test in age-matched ovarian cancers (Stage I-IV), benign masses and healthy controls. Exosomes were isolated from blood samples using EXO-NET® on a fully-automated high-throughput robotic platform. The analysis was completed in two stages with the exosomal protein biomarkers measured using targeted mass spectrometry and miRNA biomarkers using RNA sequencing, and their diagnostic performance was confirmed using AI-enhanced machine learning modelling and ROC curve analysis. › On 3 December 2024, INOVIQ announced that its blood test for ovarian cancer screening had successfully completed an independent validation of its protein biomarkers and diagnostic performance, delivering accuracy of over 94% with sensitivity of 92% for all stages at a specificity of 96%, and 91% detection of Stage I alone. RESEARCH & DEVELOPMENT (R&D) PROGRESS INOVIQ pipeline products have the potential to deliver significant clinical and commercial benefits to patients, health systems and shareholders. R&D activities during FY25 focused on advancing the exosome program across our diagnostics and therapeutics pipeline, as well as adding to the SubB2M diagnostics data package. 10 INOVIQ Limited
› On 1 June 2025, a Poster titled Early detection of ovarian cancer: An accurate high-throughput extracellular vesicle test was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (ASCO poster and published abstract). › On 2 June 2025, INOVIQ announced game-changing results from its EXO-OC™ ovarian cancer test that demonstrated 77% sensitivity at >99.6% specificity for detection of ovarian cancer across all stages, meeting the clinically accepted performance criteria for effective population screening. Importantly, the test accurately detected 100% Stage I and II ovarian cancers, with no missed early-stage diagnoses. These miRNA biomarker results were achieved by INOVIQ working with leading computational scientist, Prof Amanda Barnard, to independently analyse the miRNA biomarker data and develop advanced AI machinelearning algorithms to enhance the detection of earlystage ovarian cancer (Stage I and II). 100% 100% 100% 100% 79% 50% 50% 77.4% controls benign Stage I Stage II Stage III Stage IV na overall percent speci city sensitivity The EXO-OC test can be run on fully-automated, high-throughput, instrument platforms suitable for clinical pathology laboratories worldwide. INOVIQ is currently engaging with potential clinical laboratory and diagnostic partners to expedite the development and commercialisation of the test, first as a Laboratory Developed Test (LDT) in late 2026 and then as a regulatory approved In Vitro Diagnostic (IVD) kit in the US, Europe and Asia Pacific from 2028. EXOSOME THERAPEUTICS – NEXT GENERATION CAR-EV THERAPY INOVIQ’s exosome therapeutics program uses chimeric antigen receptor (CAR)-exosomes that are released from genetically engineered immune cells. CARexosomes have 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. INOVIQ’s first CAR-NK-exosome therapy is in preclinical development for triple negative breast cancer (TNBC). There are no approved targeted therapeutics available for TNBC, with the current standard of care being chemotherapeutics. During the year, INOVIQ established its robust production process for therapeutic exosomes that target and kill breast cancer cells including establishing Master Cell Banks of engineered CAR-NK cell lines, optimising its proprietary EXO-ACE™ technology to isolate therapeutic exosomes, validating CAR expression on its CAR-NKexosomes and demonstrating in vitro cancer killing efficacy. › On 16 December 2024, INOVIQ announced that it had achieved in vitro proof-of-concept (POC) for its CARNK-exosomes demonstrating dose dependent cancer cell death and over 30% breast cancer cell death in vitro at the highest dose evaluated. › On 31 March 2025, INOVIQ announced that it has engaged Peter Mac to further validate its CARexosome therapy to treat solid tumours. INOVIQ signed a Master Service Agreement (MSA) with Peter Mac to provide contract research services under separate Statements of Work (SOW) to undertake in vitro and in vivo studies to support the development of its CAR exosome therapy. Initial in vitro studies are expected to be completed in Q3 CY25 and in vivo studies in Q4 CY25. › On 18 June 2025, INOVIQ announced a major milestone in its CAR-exosome therapeutic program where its optimised CAR-NK-exosomes demonstrated exceptional in vitro efficacy, killing 88% of triplenegative breast cancer (TNBC) and non-small cell lung cancer cells in vitro within 96 hours. In real-time xCELLigence assays, CAR-NK-EVs at a dose of 2.5 million EVs per cell achieved 87.8% cell death in TNBC cells and 87.9% in lung cancer cells. These data show the superior anti-proliferative and pro-death effects of CAR-NK-EVs in two cancer cell lines (in vitro), supporting their further development as a potential next-gen cell-free therapy for multiple cancer types. symptoms no symptoms Percent of samples correctly identified by EXO-OC Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information 11 Annual Report 2025
INOVIQ is advancing its CAR-NK-EVs to in vivo studies to assess anti-tumour efficacy in a TNBC mouse model, with initial results expected to be reported in Q4 CY2025. Following successful initial in vivo results, INOVIQ plans to conduct Investigational New Drug (IND) enabling studies with a US-based Contract Research Organization (CRO) to progress to human clinical studies. SUBB2M PROGRAM FOR CANCER MONITORING neuCA15-3 is a simple, accurate and affordable blood test in development for monitoring breast cancer in women. The assay uses a CA15-3 monoclonal antibody combined with INOVIQ’s SubB2M detection reagent to specifically identify CA15-3 produced by cancer cells. This enhances cancer detection and may reduce false positives. The test 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 also effective for monitoring breast cancer following treatment. During the year, INOVIQ completed disease specificity testing for its neuCA15-3 test, progressed the transfer program of its current research-grade ELISA to a beadbased assay, advanced discussions for an in-clinic study of the test for breast cancer monitoring and published data in an international peer reviewed journal. › On 5 December 2024, INOVIQ completed disease specificity testing for breast cancer. The neuCA15-3 test showed high specificity for breast cancer, with low false positives for non-cancer diseases. CA15-3 concentrations were measured in healthy individuals and patients with breast cancer or other conditions, including endometriosis, rheumatoid arthritis, Crohn’s disease, and type II diabetes. The test detected breast cancer with CA15-3 concentrations five times higher than in healthy individuals and was negative for 97.4% of non-breast cancer samples. An independent lab confirmed these results, showing the INOVIQ test’s superiority over the FDA-approved Roche Elecsys CA15-3 II test. › On 1 April 2025, INOVIQ announced its scientific paper titled ‘Improved breast cancer diagnosis using a CA15-3 capture antibody-lectin sandwich assay’ has been accepted for publication in the international peer reviewed journal Breast Cancer Research and Treatment. The published article is linked here. The paper describes the methods and results from case: control studies showing that INOVIQ’s neuCA15-3 test delivered superior diagnostic performance for breast cancer detection compared to the existing FDA-approved Roche Elecsys CA15-3 II test. The overall accuracy of the neuCA15-3 test was 81% compared to 55% for the comparator test. Additionally, the test had a sensitivity of 69% at 95% specificity for Stage I & II breast cancers, which compares favourably to mammography. The next steps to commercialise the neuCA15-3 test include completing transfer to a high-throughput instrument platform, additional in-clinic breast cancer monitoring study and securing a partner for commercialisation. Review of Operations continued The real-time xCELLigence assay demonstrated that CAR-NK-EVs exerted a significant cytotoxic effect on triple-negative breast cancer cells (Hs578T) compared to control treatments. Data from three independent experiments showed that treatment with 2.5 million CAR-NK-EVs/cell (orange line) resulted in 87.8% cell death in Hs578T cells within 96 hours. In contrast, EVs derived from HEK-293 cell (green line) conditioned medium did not induce cell death, confirming the specific cytolytic and antitumour activity of CAR-NK-EVs. 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 0 20 40 60 80 100 120 140 Cell Viability time (h) Breast Cancer Cells (Hs578T) Untreated control 2.5M CAR-NK-Exosomes 2.5M HEK-Exosomes 12 INOVIQ Limited
CORPORATE UPDATE MS MARY HARNEY APPOINTED NON-EXECUTIVE DIRECTOR On 3 September 2024, INOVIQ announced the appointment of Mary Harney as a Non-Executive Director effective 1 October 2024. Ms Harney is an experienced Non-Executive Director and Chief Executive and brings a deep understanding of applied life science research, in addition to experience in biopharmaceutical regulatory affairs and commercialisation. Ms Harney currently serves as Chair of private Australian biotech Oncology One Pty Ltd, a cancer drug discovery company. Ms Harney was previously Chair of Race Oncology (ASX: RAC) and a former Chair of Microbio Limited. DR EMMA BALL APPOINTED CHIEF COMMERCIAL OFFICER On 17 March 2025, INOVIQ announced the appointment of Dr Emma Ball BSc(Hons) PhD MBA GAICD as Chief Commercial Officer (CCO). Dr Ball commenced on 7 April 2025 and is responsible for providing commercial leadership across business development, licensing, marketing and sales to advance the commercialisation of INOVIQ technologies and products. She is an experienced biotechnology commercialisation executive with expertise in business development, licensing, and strategic partnerships across therapeutics, vaccines and diagnostics. Emma is currently Non-Executive Chair of BioMelbourne Network. Most recently, she was Global Head of Ecosystem Development at US-headquartered genomics and precision health leader, Illumina Inc (NASDAQ: ILMN), where she was responsible for strategic partnerships. Previously she held various leadership roles at CSL Limited (ASX: CSL) in business development and licensing, corporate strategy, commercial development and R&D program management. She trained originally as a molecular biologist and has a PhD from the University of Melbourne and an MBA from RMIT University. MEDICAL AND SCIENTIFIC ADVISORY BOARD ESTABLISHED On 10 February 2025, INOVIQ established its Medical and Scientific Advisory Board (MSAB) to provide worldclass research expertise, clinical insight and strategic advice to guide its diagnostic and therapeutic programs. The MSAB comprises internationally renowned clinical researchers and oncologists with expertise in exosome science, diagnostics, clinical trials and cancer treatment of haematological and solid tumours: › Professor H. Miles Prince AM: Leading Clinical Haematologist and Oncologist and Professor at both Melbourne and Monash universities. He is an NHMRC Investigator Fellow and has been principal investigator of over 100 clinical trials including targeted therapeutics (CAR-T therapy) for haematological conditions and cancers. › Professor Phillip K. Darcy: Group Leader of the Cancer Immunotherapy Laboratory at the Peter MacCallum Cancer Centre and NHMRC Principal Research Fellow, focused on novel T cell-based immunotherapy approaches for cancer in preclinical mouse models and clinical translation. › Professor Carlos Salomon: Director of the University of Queensland Centre for Extracellular Vesicle Nanomedicine, Head of the Translational Extracellular Vesicles in Obstetrics and Gynae-Oncology Group and NHMRC Investigator Fellow, specialising in exosome biology and its clinical translation to diagnostics and therapeutics for ovarian cancer and obstetrical syndromes. › Dr James McCracken: Leading Medical Oncologist specialising in breast cancer treatment at Epworth Healthcare and the Peter MacCallum Cancer Centre. His research interests include the field of liquid biopsies for cancer to personalise treatment and minimise toxicity. 2024 CAPITAL RAISE COMPLETION On 5 July 2024, INOVIQ successfully completed its share purchase plan (SPP) with applications totalling $7.293 million, exceeding the $2m target. Allocations to the maximum capacity of A$2.379m were accepted with a pro-rata scale-back. The SPP provided one free quoted option for every two new Shares issued at an exercise price of $1.00 expiring on 8 July 2026. A further $0.25m Director Placement (and 250,000 attaching Placement Options) was approved at an extraordinary general meeting held on 21 August 2024. 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. Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information 13 Annual Report 2025
Review of Operations continued FINANCIAL RESULTS The Group recorded a net loss from operating activities after income tax of $6,932,280 (2024: $6,554,350) and ended the financial year with a cash balance of $6,520,923 (2024: $9,233,192). Product revenues from sales of the hTERT test totalled $294,314 (2024: $333,255) and from EXO-NET totalled $253,261 (2024: $201,863). Income from other sources was $1,679,482 (2024: $1,283,025) including an accrual of $1,267,738 for the Research and Development Tax Incentive Refund for the 2025 financial year (2024: $1,017,344). The refund for 2025 is expected to be received in the coming months. No grant income was received in 2025 (2024: nil). Miscellaneous income added $411,744 (2024: $256,581). General and administration costs were $5,313,080 (2024: $5,158,586) with the following significant contributors: › Employee expenditure $2,890,233 (2024: $2,672,483) including non-cash share options expense of $824,563 (2024: $834,773); › Professional and legal fees $634,879 (2024: $612,005); › Amortisation of intangible assets $944,925 (2024: $947,514) for the hTERT and NETs intangible assets; and › ASX listing and share registry fees of $80,750 (2024: $134,137). Research and Development expenditure was $3,254,551 (2024: $2,699,591) including employee related expenditure of $1,312,059 (2024: $1,208,243) and $1,691,506 (2024: $1,251,410) paid to external contractors and suppliers. The majority of expenditure was incurred on the SubB2M and NETs programs. Sales and Marketing expenditure was $471,319 (2024: $433,303) of which employee related expenditure contributed $346,111 (2024: $272,181). 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 - $944,925 (2024: $947,514) for the hTERT and Molecular NETs intangible assets and $35,070 (2024: $28,385) related to granted patents; › depreciation of right-of-use assets (required by accounting standard AASB16 – Leases) - $193,576 (2024: $275,753); › depreciation of building improvements - $33,548 (2024: $33,548) and depreciation of plant and equipment - $172,992 (2024: $158,726); › share based payments expense of $824,563 (2024: $834,773); › lease liability interest expense, as required by AASB16, $21,734 (2024: $40,766). OUTLOOK AND PLANS INOVIQ’s mission is to transform lives through earlier cancer detection and more effective treatments, powered by world-class exosome technologies. The Company is strongly positioned with patented technology, a multi-product pipeline, strategic partners validating its technology, and an experienced leadership team to execute on strategy, deliver key milestones and grow shareholder value. INOVIQ expects to report data readouts across its exosome diagnostic and therapeutic programs, as well as commercial progress for its EXO-NET research tools and partnering activities over the next 12 months. Our FY26 priorities are: › Expanding our EXO-NET® business and growing revenues, › Advancing our EXO-OC™ ovarian cancer screening test toward commercialisation, › Progressing our CAR-exosome therapy into in vivo efficacy studies for breast cancer, and › Executing strategic partnerships to accelerate commercialisation of our diagnostic technologies. 14 INOVIQ Limited
16 Directors’ Report 29 Auditor’s Independence Declaration 30 Consolidated Statement of Comprehensive Income 31 Consolidated Statement of Financial Position 32 Consolidated Statement of Changes in Equity 33 Consolidated Statement of Cash Flows 34 Notes to the Financial Statements 62 Consolidated Entity Disclosure Statement 63 Directors’ Declaration 64 Corporate Governance Statement 65 Independent Auditor’s Report Contents Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information 15 Annual Report 2025
Directors’ Report 16 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 2025 and the independent auditor’s report thereon. PRINCIPAL ACTIVITIES The principal activities of the Group are the development and commercialisation of diagnostics and therapeutics for cancer. INOVIQ’s product portfolio includes commercial exosome isolation products and an adjunct bladder cancer test, clinical-stage diagnostics for breast and ovarian cancers, and a preclinical-stage CAR-exosome therapeutic program 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 2025 it had two operating wholly owned subsidiaries, Sienna Cancer Diagnostics Ltd (an Australian public company) and INOVIQ Inc (a US incorporated company). DIRECTORS The names and details of the directors of the Company in office during the year ended 30 June 2025 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 Director 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) 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.
Review of Operations Directors’ Report Chairman’s Letter CEO’s Report Financial Report Shareholder Information MR PHILIP POWELL BComm (Hons) ACA MAICD Non-Executive Director (appointed 17 June 2019) Mr Powell is a Chartered Accountant with extensive experience in investment banking, specialising in capital raisings, initial public offerings (IPOs), mergers and acquisitions and other successful corporate finance assignments across a diverse range of sectors including pharma, utilities, IT, financial services, food, and agriculture. He spent 10 years in senior financial roles at OAMPS Ltd, a former ASX-listed financial services group, and 10 years in audit with Arthur Andersen & Co in Melbourne, Sydney, and Los Angeles. Mr Powell is a former Non-Executive Director of RMA Global Ltd (ASX: RMY), PolyNovo Ltd (ASX: PNV) and Medical Developments International Ltd (ASX: MVP). Mr Powell is the Chair of the Company’s Audit & Risk Committee. Mr Powell has not been a director of any listed companies in the last three years other than those listed above. MS MARY HARNEY IDP-C INSEAD, BSc, BA (Fine Arts), MAICD FIML Non-Executive Director (appointed 1 October 2024) Ms Harney is an experienced Non-Executive Director and Chief Executive and brings a deep understanding of applied life science research, in addition to experience in biopharmaceutical regulatory affairs and commercialisation. Ms Harney is the Director of specialist consulting firm Mary Harney Advisory providing leadership, governance and strategic advice across innovation industries such as health, biotech and agriculture. Ms Harney currently serves as Chair of private Australian biotech Oncology One Pty Ltd, a cancer drug discovery company. Ms Harney was also previously the Chair of Race Oncology (ASX: RAC), and a former Chair of Microbio Limited. Ms Harney has not been a director of any listed companies in the last three years other than those listed above. INTERESTS IN THE SHARES AND OPTIONS OF THE COMPANY AND RELATED BODIES CORPORATE As at the date of issuing this report, the interests of the current directors in the shares of the Company were: Ordinary Shares ESS Options Listed Options Mr David Williams 5,179,337 6,450,000 90,000 Dr Geoffrey Cumming 237,414 250,000 30,000 Mr Max Johnston 804,310 250,000 100,000 Mr Philip Powell 584,630 250,000 30,000 Ms Mary Harney – 250,000 – EXECUTIVE MANAGEMENT AND COMPANY SECRETARY CHIEF EXECUTIVE OFFICER DR LEEARNE HINCH BSc BVMS MBA (appointed 7 November 2016) Dr Hinch is a seasoned biotechnology CEO and entrepreneur with a proven track record in corporate strategy, business management, capital raising, investor relations, M&A, business development and partnering. Leearne has successfully led INOVIQ’s transformation from a single-asset diagnostics company to a diversified biotech, through M&A, advancing its cancer diagnostics and therapeutics pipeline, securing a global commercial partner for its proprietary exosome isolation tools and building an experienced team. She previously established life sciences consulting firm Ingeneus Solutions Pty Ltd and has held past leadership roles as a biotechnology executive and consultant at Eustralis Pharmaceuticals Ltd, HealthLinx Ltd (ASX: HTX), OBJ Ltd (ASX: OBJ), Holista Colltech Ltd (ASX: HCT) and Chemeq Ltd (ASX: CMQ), where she gained extensive experience leading strategic, development and commercial programs across diagnostics, medical devices and therapeutics. She also worked for multinationals Virbac and Mars Petcare. Dr Hinch holds Bachelor of Science, Bachelor of Veterinary Medicine and Surgery and Master of Business Administration qualifications. 17 Annual Report 2025
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