Oncosil Medical (OSL) Company presentation summary

Commercialisation progress and market opportunity

• Treated 200th patient with the targeted OncoSil™ brachytherapy device for pancreatic cancer as of October 2024.

• Device approved for sale in over 34 countries, with commercial ramp-up expected in FY25 and beyond.

• Market access expanding via new delivery methods, chemotherapy combinations, and label expansions.

• Addressable global market exceeds US$4.2bn, with no direct competition and a large patient population.

• Commercial opportunity in existing markets is US$588m, expanding to US$990m with new geographies.

Clinical impact and patient outcomes

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

• Surgical resection and downstaging rates more than doubled compared to chemotherapy alone.

• 90.5% local disease control at 16 weeks, with significant improvements in progression-free survival.

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

• 60% of resected patients in the PanCO study remained alive at 32 months median follow-up.

Regulatory and commercial milestones

• Received UKCA Certificate, removing post-market restrictions in the UK.

• MDR approval anticipated in Q4 2024, expected to accelerate EU market penetration.

• G-BA approval and conditional reimbursement secured in Germany, with public insurance coverage for trial participants.

• New distribution agreements in the Middle East, Nordics, and Turkey, with regulatory filings planned for LATAM and Asia.

• Second manufacturing facility in Sydney activated, with first commercial production targeted for Q2 CY25.