Medivir (MVIR) Carnegie Småbolagsdag 2024 summary

Market opportunity and disease landscape

• 45% of US adults are obese, with over 25% having fatty liver disease, which increases liver cancer risk 17-fold.

• The global 2nd line HCC market is projected to grow from $2.8bn in 2024 to $4.0bn by 2030, driven by rising HCC incidence and improved first-line treatments.

• By 2030, HCC cases are expected to increase by 122% in the US and 82% in China, mainly due to fatty liver disease.

• Average treatment duration in 2nd line HCC is expected to rise to 10 months with fostrox + Lenvima.

Fostrox mechanism and clinical data

• Fostrox is an oral, liver-targeted prodrug that selectively kills tumor cells while sparing healthy liver cells.

• Combination of fostrox + Lenvima in 2nd/3rd line advanced HCC showed a median time to progression (TTP) of 10.9 months, outperforming other 2L HCC treatments.

• Overall response rate was 24% and disease control rate was 81% in the phase 1b/2a study.

• Stable liver function was maintained during treatment, as shown by ALT, AST, and ALBI score monitoring.

Competitive landscape and clinical development

• There are currently no approved 2nd line treatments for HCC after immunotherapy combinations, highlighting a weak competitive landscape.

• Fostrox + Lenvima targets a population with few treatment options and is positioned at the forefront of liver-targeted therapies.

• A global phase 2b study is planned, with first patient in (FPI) expected in H1 2025 and readout in H1 2027.

• The study aims for breakthrough therapy designation and accelerated approval, with primary endpoint of overall response rate.