Medivir (MVIR) investor relations material

Key developments and strategic direction

• Advancing a liver-targeted treatment for advanced liver cancer, aiming to be the first approved option for second-line patients.

• Launching a fully guaranteed rights issue to fund a randomized phase II study with 80 patients, comparing Fostrox plus LENVIMA to LENVIMA alone.

• Early data show over 75% of patients experienced tumor shrinkage, with a median progression time of 10.9 months, outperforming LENVIMA monotherapy.

• The phase II study is set to begin patient enrollment in early 2026, with data expected by mid-2027, supporting a potential registrational program.

• Extending patent protection for the Fostrox and LENVIMA combination, with approvals in Europe and Japan and more expected.

Market opportunity and competitive landscape

• The second-line advanced liver cancer market is projected to exceed $2.5–3 billion annually, driven by rising fatty liver disease rates.

• No approved or funded second-line treatments currently exist, creating a significant unmet need.

• Most competitors focus on first-line immunotherapy combinations, with little development in second-line settings.

• Fostrox offers a novel mechanism, targeting tumor cells while sparing healthy liver tissue, minimizing side effects.

• The combination patent is strategically important, making it difficult for competitors to bypass.

Pipeline and asset management

• Remetinostat, a phase III-ready asset, was recently out-licensed, with further details to be discussed in a panel.

• Strategic focus remains on advancing Fostrox in liver cancer, while other assets are out-licensed to external partners.

• Dermatology-oncology partnerships for remetinostat do not alter the core strategic focus.

• The company leverages its expertise in prodrug solutions to enable oral administration and liver targeting.

• Ongoing collaborations with Korean research groups facilitate rapid study execution and access to high-prevalence patient populations.