Medivir (MVIR) Company presentation summary

Market opportunity and unmet need

• 2nd line hepatocellular carcinoma (HCC) market projected to exceed $2.5 billion by 2030, driven by rising HCC incidence and improved first-line treatments allowing more patients to reach second-line therapy.

• No approved or effective second-line treatments currently exist for advanced HCC, highlighting a significant unmet medical need and first-to-market potential.

• Fostrox + Lenvima is positioned at the forefront of the competitive landscape due to its novel mechanism and targeted approach.

Product profile and mechanism of action

• Fostrox is the first oral, liver-targeted treatment for advanced HCC, using a prodrug strategy to deliver a tumor-selective payload (troxacitabine) that induces DNA damage in tumor cells while sparing healthy liver tissue.

• The molecule is stable in the GI tract and blood, rapidly activated by liver enzymes, and achieves over 100-fold higher liver targeting compared to IV chemotherapy.

• Selective DNA damage is achieved due to higher proliferation rates in tumor cells versus healthy hepatocytes.

Clinical development and efficacy

• Phase 1b/2a study of fostrox + Lenvima in 2L/3L advanced HCC showed a median time to progression (TTP) of 10.9 months, substantially longer than Lenvima monotherapy or other 2L HCC treatments (typically 3.5–4.4 months).

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

• Patients benefitted regardless of prior therapy outcomes, and the longest duration of response was ongoing at 19.5 months.