Medivir Reports 2025 Annual Results with Key Clinical and Financial Milestones
Medivir's 2025 Annual Report highlights FDA Orphan Drug Designation for MIV-711 in Osteogenesis Imperfecta and promising fostrox liver cancer data showing 13.7-month median survival. The company raised SEK 196 million to fund Phase 2 studies for both programs and reported year-end cash of SEK 119.2 million.
Medivir AB has published its 2025 Annual Report, highlighting a transformative year marked by significant clinical progress and strengthened financial positioning. The company reported key developments including Orphan Drug Designation for MIV-711 in Osteogenesis Imperfecta, promising clinical data for fostrox in liver cancer, and successful capital raises totaling approximately SEK 196 million.
In February 2025, final results from the phase 1b/2a study of the fostrox + Lenvima combination in second- or third-line advanced hepatocellular carcinoma 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. The planned randomized phase 2 FLEX-HCC study will be conducted in collaboration with the Korean Cancer Study Group at eight centers in Korea.
MIV-711 received Orphan Drug Designation from the FDA for the treatment of Osteogenesis Imperfecta, a rare disease for which no approved therapies currently exist. The designation provides important benefits, including market exclusivity following approval (seven years in the U.S.), regulatory support from the FDA, and reduced development costs. Osteogenesis Imperfecta is a rare and serious genetic disease that affects the body's ability to produce normal type I collagen, leading to brittle bones, skeletal deformities, and frequent fractures, affecting an estimated 500,000 patients globally.
During the year, Medivir completed a rights issue of approximately SEK 151 million before costs, followed by a directed share issue of SEK 45 million to Carl Bennet AB in the beginning of 2025, which secured funding for the planned Phase 2 studies with fostrox in liver cancer and MIV-711 in Osteogenesis Imperfecta. The company 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, as well as future royalty income on future net sales.
Medivir's partner Vetbiolix published groundbreaking clinical Proof-of-Concept results for VBX-1000 (MIV-701) in periodontal disease in dogs, and later announced that a randomized placebo-controlled study had been initiated to confirm the clinical benefit of VBX-1000.
Financially, for the full year January-December 2025, net turnover amounted to SEK 8.5 million, while the loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -60.1 million. Cash and cash equivalents at the end of the period amounted to SEK 119.2 million. For the fourth quarter, net turnover amounted to SEK 5.5 million, with EBITDA loss of SEK -12.0 million.
There has been a change in the Group's figures in the Annual Report, with intangible assets and equity 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. The change has no impact on Medivir's cash flow, neither in 2025 nor going forward.
The company's CEO stated that with a strengthened ownership base, a strong financial position, and two groundbreaking projects in clinical development, Medivir now has expanded opportunities to create long-term value. 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.