Genetic Signatures (GSS) Investor Presentation summary

Executive summary and strategic highlights

• Proprietary 3base® technology enables simplified, highly accurate syndromic molecular diagnostic testing for infectious diseases, with over 5 million patients tested globally and multiple products cleared in Australia and Europe.

• FDA clearance received for EasyScreen™ Gastrointestinal Parasite Detection Kit, the broadest molecular syndromic test for 8 GI parasites, targeting a US market of over 5.5 million tests annually and aiming for 40% market share within 5 years.

• US commercial rollout to begin immediately, leveraging existing reimbursement codes and targeting conversion of pre-qualified customer sites, with first US revenue expected early FY25.

• Appointment of Allison Rossiter, former MD of Roche Diagnostics Australia, as CEO from September 2024, supported by an experienced global team.

• $30m capital raising to fund US launch, R&D, and next-generation instrument development, with a post-raise pro-forma cash balance of A$50.3m.

Product and market opportunity

• EasyScreen™ GI Parasite Kit offers higher reliability, improved sensitivity and specificity, increased pathogen coverage, reduced patient burden, and faster turnaround compared to traditional methods.

• Estimated 9 million US patients seek medical attention for GI parasitic infections annually, with 5.5 million O&P tests performed; molecular testing expected to expand the addressable market.

• Four key customer segments targeted: large commercial reference labs, core labs/large hospitals, specialty reference labs, and independent hospitals, with a combined TAM of 5.5 million tests.

• Sales strategy focuses on converting customer experience sites, targeting high-throughput labs, and building clinical evidence to drive adoption.

• FDA clearance and regulatory changes are expected to accelerate adoption of cleared IVD molecular tests over traditional or lab-developed tests.

Operational readiness and growth initiatives

• US launch preparations include manufacturing in Australia, US warehousing, regulatory compliance, reimbursement coding, and a direct sales and field services team.

• Next Generation Instrument in development, aiming for high-throughput, fully automated sample-to-result workflow, consolidating multiple tests on a single platform.

• EMEA growth driven by direct sales in the UK and Germany, channel partnerships in Europe, Israel, and the Middle East, and a dedicated channel manager for global expansion.

• Robust product pipeline includes respiratory, gastrointestinal, sexual health, antimicrobial resistance, and other infectious disease panels, with ongoing R&D for new products.

• Significant news flow expected, including US contracts, Australian respiratory kit sales, and further expansion in UK/EMEA markets.