Reviewof Operations 2 2022. Exosome ResearchMarket - Global Forecast to 2026. Markets&Markets. 3 2022. Exosomes Market Size, Share, Analysis Report byWorkflow, Biomolecule Type, Application and Region, Forecast 2022 - 2030. Acumen Research and Consulting. 4 Food and Drug Administration (FDA) 5 PreMarket Notification (510k) 6 PreMarket Approval (PMA) The global exosome research market was valued at US$144 million in 2021 and is expected to reach US$661 million by 2026, growing at a CAGR of 35.6%.2 North America is the largest geographic segment representing 41.5% of the market followed by Europe at 20%. The Kits and Reagents product segment in which INOVIQ’s EXO-NET research tools fit, was valued at US$71 million in 2021 and is forecast to reach US$311 million by 2026. The global exosomes market for diagnostics and therapeutics was valued at US$168 million in 2021 and is expected to reach US$2.3 billion by 2030, growing at a CAGR of 34% per annum.3 North America is the largest geographic segment. Market growth is driven by increased investment in exosome-based therapeutic R&D, rising incidence of cancer and higher prevalence of chronic inflammatory diseases. PRODUCT PORTFOLIO INOVIQ’s product portfolio includes a research tool for exosome capture, an adjunctive diagnostic test for use in bladder cancer detection, and a broad pipeline of diagnostic tests in development for detection and monitoring of breast, ovarian and other cancers based on our proprietary technologies. Our diagnostics pipeline includes SubB2M tests in development for monitoring breast and ovarian cancers and an exosome-based ovarian cancer screening test. The commercialisation strategy for INOVIQ’s diagnostic pipeline is to first launch its tests as laboratory developed tests (LDTs), followed by an FDA4 In Vitro Diagnostic (IVD) submission and clinical studies to support 510k clearance5 or PMA6 depending on the indication for use. Discussions with clinical and regulatory experts are ongoing as the Company advances its diagnostic development programs towards clinical development and commercialisation. PRODUCT INDICATION PLATFORM USE RESEARCH ASSAY DEVELOPMENT CLINICAL DEVELOPMENT REGISTRATION hTERT Bladder Cancer ICC Adjunct to cytology In-market EXO-NET-RUO Exosome Capture Device Research tool In-market Exosome-OC (UC) Ovarian Cancer Multiomic Screening (TBA) SubB2M-BCM Breast Cancer Immunoassay Monitoring 2023 SubB2M-OCM Ovarian Cancer Immunoassay Monitoring 2023 SubB2M-PCS Prostate Cancer Immunoassay Detection SubB2M-PaC Pancreatic Cancer Immunoassay Detection BARD1-Ovarian1 Ovarian Cancer Immunoassay Detection BARD1-Breast1 Breast Cancer Immunoassay Detection BARD1-Lung1 Lung Cancer Immunoassay Detection Products and pipeline *RUO = Research Use Only; ICC = Immunocytochemistry; 1. Adjunct to urine cytology to assist the detection of bladder cancer; 2 Umbrella Research & Option Agreement with UQ, 3. Progression subject to completion of review (ASX: 28/3/22) 17 | 9 AUGUST 2022 COMMERCIAL PROGRESS Commercial activities during the year focused on completing evaluations of the EXO-NET pan-exosome capture tool, establishing sales and logistics capability for US market launch of EXO-NET, and supporting our hTERT distributors. EXO-NET® exosome capture tools EXO-NET pan-exosome capture is a research use only product for the isolation of exosomes from blood and other body fluids with speed, purity and yield advantages over traditional exosome isolation methods. EXO-NET meets an unmet need for fast, precise and scalable isolation of exosomes for research and commercial applications. EXO-NET pan-exosome capture is a research tool in-market for the isolation of exosomes from body fluids including plasma, urine, and saliva. The product is offered for research use only (RUO) and is not registered for use in clinical diagnosis. EXONET RUO is supplied in 1mL vials containing EXO-NET coated magnetic beads for processing up to 50 samples. 1 BARD1 Autoantibody program currently on-hold pending review 10 INOVIQ Limited
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