INOVIQ Exosome Diagnostic Solutions

SubB2M/CA15-3 test | Breast Cancer monitoring Clinical-stage and progressing towards partner-ready by Dec 2023 to enable LDT commercialisation • #1 cancer in women For personal use only 9 Breast cancer • 2.3m new cases of breast cancer worldwide pa¹ • 7.8m survivors (5-year) 1 • Earlier and more accurate detection and monitoring tests required for breast cancer Development stage Completed Feasibility Unmet medical need Disruptive technology Intended use • US$4.2b global diagnostics market² • SubB2M is an engineered protein that specifically binds the pan-cancer biomarker Neu5Gc³ • Improved immunoassay for detection of Neu5Gc decorated CA15-3 • Increased sensitivity and specificity to detect cancer over existing assays • Aid in monitoring breast cancer treatment response and disease recurrence in women previously diagnosed with disease Assay development Completed Analytical validation (n=94) Completed Completed Clinical validation (n=483) Monitoring study H2 CY23 Go-to-market strategy •⚫LDT then IVD (510k/PMA process) • Partner with a CLIA-accredited laboratory 510k = FDA clearance for Class II device; CLIA = Clinical Laboratory Improvement Amendments (high-complexity tests); IVD = In Vitro Diagnostic; LDT = Laboratory Developed Test; 1. https://gco.iarc.fr/today/home; 2. https://www.grandviewresearch.com/industry-analysis/breast-cancer-diagnostics-market; 3 Neu5Gv = the sialic acid, N-glycolylneuraminic acid LDT partner ready Dec 2023 INOVIQ

View entire presentation