2025 was a transformative year for Medivir. In February, final results from the phase 1b/2a study of the fostrox + Lenvima combination in second- or third-line advanced hepatocellular carcinoma (HCC) were presented at the EASL Liver Cancer Summit in Paris. The combination demonstrated a median overall survival of 13.7 months — substantially better than previously reported outcomes in second-line advanced liver cancer. In addition, MIV-711 was granted Orphan Drug Designation by the FDA for the treatment of Osteogenesis Imperfecta, a rare disease for which no approved therapies currently exist.
 
During the year, a rights issue of approximately SEK 151 million was completed, followed by a directed share issue of SEK 45 million to Carl Bennet AB in the beginning of 2025, which secured the funding for the planned Phase 2 studies with fostrox in liver cancer and MIV-711 in Osteogenesis Imperfecta. Medivir also entered into an exclusive license agreement with Canadian-based Biossil, Inc. for remetinostat, with potential milestone payments of up to approximately USD 60 million. In addition, its partner Vetbiolix published groundbreaking clinical Proof-of-Concept results for VBX-1000 (MIV-701) in periodontal disease in dogs.
 
Jens Lindberg, CEO of Medivir, commented: "We have now secured funding for two programs with clear blockbuster potential, both addressing significant unmet medical needs. The randomized, placebo-controlled FLEX-HCC study will generate robust data on fostrox in combination with Lenvima in second-line hepatocellular carcinoma — a setting where no approved treatment options currently exist. At the same time, the directed share issue to Carl Bennet AB enables us to initiate the clinical development of MIV-711 for Osteogenesis Imperfecta, a strategically important new indication for Medivir. We believe both programs have the potential to deliver meaningful value for patients and shareholders alike."
 
The 2025 Annual Report describes the final study results for fostrox + Lenvima and the design of the planned randomized phase 2 FLEX-HCC study, which will be conducted in collaboration with the Korean Cancer Study Group at eight centers in Korea. It provides an overview of the development of MIV-711, including the regulatory advantages conferred by Orphan Drug Designation and the clinical development plan moving forward. The report also covers the out-licensed projects in Medivir's pipeline, including MIV-701, and the progress made during the year.
 
There has been a change in the Group's figures in the Annual Report, which were published in the Q4 report. The intangible assets and equity have been adjusted down by the amount corresponding to the value of MIV-711, as it was not a new project for the Group and should therefore not be included in the Group's financial statements, only in the subsidiary OsteoCat Therapeutics AB, which means that the sale of MIV-711 has still taken place from Medivir AB and the project is recorded in the subsidiary. The change has no impact on Medivir's cash flow, neither in 2025 nor going forward.
 
All of this and much more can be found in Medivir's 2025 Annual Report, published today on the company's website: https://www.medivir.com/investors/reports#FinancialReports2025