Oncosil Medical (OSL) AGM 2024 presentation summary

Commercialisation progress and market expansion

• Treated 200th patient with the targeted OncoSil™ brachytherapy device for pancreatic cancer, now approved in over 34 countries via CE Mark.

• Commercial ramp-up expected in FY25, with expanded market access through new delivery methods and chemotherapy combinations.

• Distribution agreements signed in the Middle East, Nordics, and Turkey; regulatory filings and commercial launches planned in LATAM, South Korea, and France.

• UKCA certificate received, removing post-market restrictions in the UK; MDR approval anticipated to accelerate EU market penetration.

• Market opportunity in existing geographies is $588M, expanding to $990M with near-term target markets.

Clinical outcomes and device benefits

• OncoSil™ plus chemotherapy shows median overall survival of 20.0 months vs. 13.0 months for chemotherapy alone.

• More than doubles surgical resection (28.6% vs. 12.1%) and downstaging rates (31.4% vs. 13.6%) compared to chemotherapy alone.

• Device delivers 98% of radiation within 81 days, targeting cancer cells with minimal damage to surrounding tissue.

• Established safety profile with no additional risk when combined with standard chemotherapy.

• Percutaneous delivery method expands access to interventional radiologists and outpatient settings.

Regulatory and operational milestones

• Second manufacturing facility in Sydney activated; first commercial production expected Q2 CY25.

• Cyclotek Sydney site validation on track for Q1 2025; ISO 13485 certification process underway.

• ANSTO contract finalized for increased reactor capacity to meet growing R&D and commercial supply.

• Innovative quartz ampoule design completed for improved irradiation and supply chain efficiency.

• Lighter, eco-friendly packaging developed by Nuclear Australia for final product shipment.