Medivir AB (Nasdaq Stockholm: MVIR; 0GP7), the Swedish clinical-stage biopharmaceutical company developing therapies for high unmet medical need, has published its interim report for the nine months ended September 2026. The company reported a strengthened cash position of SEK 247.9 million following SEK 336 million raised through three capital raises since December 2025, providing funding it says is secured until at least 2030. Key highlights include continued recruitment in the FLEX-HCC phase 2 liver cancer study and a Notice of Allowance from the USPTO covering its fostrox plus lenvatinib combination patent, extending potential market exclusivity until at least April 2041.

Key Points

  • Medivir AB (0GP7), listed on the Small Cap segment of Nasdaq Stockholm under ticker MVIR
  • Cash and cash equivalents rose to SEK 247.9 million at period end, up from SEK 23.5 million in the comparable prior period
  • EBITDA for the nine-month period was SEK -45.8 million; Q3 EBITDA was SEK -15.9 million; nine-month net turnover was SEK 3.0 million
  • Investors will be watching patient recruitment progress in FLEX-HCC and selection of a formulation partner for MIV-711's Perthes disease study

FLEX-HCC Phase 2 Study Progresses at 12 South Korean Hospitals Under Professor Hong Jae Chon

Medivir's randomised phase 2 FLEX-HCC study, which compares fostrox combined with lenvatinib against lenvatinib monotherapy as a second-line treatment for advanced liver cancer, is described in the announcement as recruiting according to plan. The study is led by Professor Hong Jae Chon within the Korean Cancer Study Group and is conducted across 12 major hospitals in South Korea. Fostrox is a precision chemotherapy designed to selectively target liver cancer cells while minimising side effects. The announcement states the company sees a clear opportunity for fostrox to become the first approved second-line treatment for advanced liver cancer following first-line immunotherapy, citing a substantial unmet medical need among patients whose disease has progressed after immunotherapy.

USPTO Issues Notice of Allowance for Fostrox and Lenvatinib Combination Patent Until April 2041

On 20 July, Medivir received a Notice of Allowance from the US Patent and Trademark Office for the combination patent covering fostrox plus lenvatinib in hepatocellular carcinoma and liver metastases. Once formally granted, the patent will complement existing granted patents in the EU, Japan, Australia, and Canada, providing protection and market exclusivity until at least April 2041. The announcement indicates that this patent strengthens Medivir's commercial position in its key markets ahead of potential approval, representing a significant intellectual property milestone for a company whose lead oncology programme remains in phase 2 development.

MIV-711 Targets Osteogenesis Imperfecta and Perthes Disease, Both Carrying Orphan Drug Designations

Preparations for proof-of-concept studies with MIV-711 in Osteogenesis Imperfecta and Perthes disease are described as progressing well. Approximately 500,000 patients globally living with OI currently have no approved treatment, and the announcement estimates the market at a minimum of USD 2.5 billion. MIV-711 holds Orphan Drug Designation in both indications, as well as Rare Pediatric Disease Designation from the FDA for Perthes disease. For the Perthes study, Medivir has identified selection of a paediatric oral formulation partner as the remaining preparatory step before formulation work can begin, introducing a dependency on third-party engagement before this programme advances.

Out-Licensed Assets Include Remetinostat Partner Biossil, Which Raised USD 153 Million Led by OpenAI Startup Fund

Medivir's out-licensed portfolio generated several updates during and after the period. Biossil, which holds global development rights to remetinostat, raised USD 153 million in a financing round led by the OpenAI Startup Fund at end of September, and is now preparing its first clinical study. Under its agreement with Biossil, Medivir is entitled to milestone payments and royalties upon successful development. Additionally, Vetbiolix's study of MIV-701 in canine periodontitis has enrolled 40 of 45 planned dogs, and the MET-X project triggered a new milestone payment to partner Infex Therapeutics, of which Medivir is entitled to a share, though specific payment values were not disclosed in the announcement.