Medivir (MVIR) Company presentation summary

Innovative treatment approach for advanced HCC

• Fostrox is the first oral, liver-targeted therapy designed specifically for advanced hepatocellular carcinoma (HCC), inducing DNA damage in tumor cells while sparing healthy liver tissue.

• The drug leverages a prodrug strategy for liver-guided delivery and tumor-selective payload, resulting in over 100-fold higher liver targeting compared to IV chemotherapy.

• Fostrox is rapidly activated by liver enzymes, ensuring minimal systemic exposure and selective tumor cell killing.

• The approach addresses the critical need for selective targeting in HCC, as most patients have impaired liver function.

Clinical efficacy and safety data

• In a phase 1b/2a study, fostrox combined with Lenvima achieved a median time to progression (TTP) of 10.9 months, substantially outperforming Lenvima monotherapy and other 2nd line HCC treatments.

• Objective response rate (ORR) was 24% and disease control rate (DCR) was 81%, with over 75% of patients experiencing tumor shrinkage.

• The combination showed a favorable tolerability profile, with stable neutrophil and platelet counts and no unexpected adverse events.

• Most adverse events were manageable and transient, with no treatment-related deaths or severe complications.

• Liver function remained stable during treatment, with no deterioration in liver enzymes or ALBI score.

Market opportunity and competitive landscape

• The 2nd line HCC market is projected to exceed $2.5 billion by 2030, driven by rising HCC incidence and improved first-line treatments.

• There are currently no approved 2nd line treatments for advanced HCC, positioning fostrox + Lenvima as a first-to-market opportunity.

• The competitive landscape in 2nd line HCC lacks novel mechanisms, with few ongoing studies and no clear standard of care.

• Fostrox + Lenvima data signals superiority over Lenvima monotherapy and immune-oncology combinations in 2nd line HCC.