Medivir (MVIR) DNB Carnegie Småbolagsdag 2025 summary

Market and disease landscape

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

• Fatty liver disease (MASLD/MASH) is projected to rise dramatically by 2050, doubling annual new liver cancer cases.

• The global 2nd line hepatocellular carcinoma (HCC) market is expected to grow from $2.8bn in 2024 to $4.0bn by 2030, driven by increased incidence and improved first-line treatments.

Product innovation and clinical data

• Fostrox is the first oral, liver-targeted treatment for advanced HCC, designed to selectively kill tumor cells while sparing healthy liver cells.

• Combination of fostrox + Lenvima targets the 2nd line HCC population, where no approved treatments currently exist.

• Phase 1b/2a study showed a median time to progression (TTP) of 10.9 months, an overall response rate (ORR) of 24%, and disease control rate (DCR) of 81%.

• Efficacy of fostrox + Lenvima is substantially better than current 2nd line HCC treatments, which typically show ORR <10% and PFS around 4 months.

Regulatory and commercial progress

• Patent protection for fostrox + Lenvima has been extended to 2041 in Japan, complementing approvals in the EU and Australia.

• IND approval obtained for the randomized global phase 2b FOcuS-2 study, comparing fostrox + Lenvima to Lenvima alone in 2nd line HCC.

• FOcuS-2 will enroll patients across 40 sites in 8-9 countries, with primary endpoint ORR and read-out expected in 2027.

• Study design is optimized for potential breakthrough therapy designation and accelerated approval.