Medivir Reports Q2 2026: Fostrox Phase 2 FLEX-HCC Underway, MIV-711 Expanded into Perthes Disease
核心洞察
Medivir initiated FLEX-HCC, a randomized Phase 2 study of fostrox plus lenvatinib versus lenvatinib monotherapy in second-line advanced liver cancer, with the first patient enrolled in May 2026.
The Phase 1b/2a results for fostrox plus lenvatinib were published in Clinical Cancer Research, providing peer-reviewed confirmation of tumor-selective efficacy without impairing liver function.
A directed share issue of approximately SEK 140 million funds clinical development of MIV-711 in Perthes disease, expanding the candidate into a second rare bone indication alongside Osteogenesis Imperfecta (搜索).
Medivir AB reported its interim results for January–June 2026, marking what CEO Jens Lindberg described as "a clinical and financial turning point" for the company. The quarter saw the first patient enrolled in the FLEX-HCC Phase 2 study, publication of Phase 1b/2a data in a leading oncology journal, and a directed share issue that expands MIV-711 into a second rare bone indication.
FLEX-HCC Progresses with First Patient Enrolled
In May 2026, the first patient was included in FLEX-HCC, a randomized Phase 2 study comparing fostrox plus lenvatinib with lenvatinib monotherapy in the second-line treatment of advanced liver cancer. The study is led by Professor Hong Jae Chon within the Korean Cancer Study Group and is conducted at 12 major hospitals in South Korea.
According to the company, engagement among clinicians is high, and the study is developing in line with the plan to include all patients within 12 months. Lindberg emphasized the persistent unmet need in this setting, noting that "the IMbrave 251 study, presented at ASCO, missed its primary endpoint," which "underlines how substantial the unmet medical need still is after immunotherapy, and how promising the opportunity is for fostrox to become the first approved option in the second-line treatment of advanced liver cancer."
Phase 1b/2a Results Published in Clinical Cancer Research
In June, the Phase 1b/2a results for fostrox plus lenvatinib were published in Clinical Cancer Research. Medivir characterized this as "a peer-reviewed confirmation that the liver-targeted mechanism of action of fostrox delivers tumor-selective efficacy without impairing liver function."
Fostrox is described by the company as a precision chemotherapy designed to selectively target liver cancer cells while minimizing side effects.
MIV-711 Expanded into Perthes Disease
Through a directed share issue in June, Medivir is initiating clinical development of MIV-711 in Legg-Calvé-Perthes disease (搜索) (Perthes disease), a rare condition in which the femoral head degenerates in children. The company noted that there is no medical treatment for this disease, with bracing and surgery addressing only acute symptoms without changing the long-term prognosis.
MIV-711 has already been granted Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA in Perthes disease. Upon marketing approval in the U.S. and Europe, annual peak sales are estimated to reach approximately USD 1 billion five years after launch.
Osteogenesis Imperfecta Study Design Finalized
Preparations for the proof-of-concept study with MIV-711 in Osteogenesis Imperfecta (搜索) (OI) are progressing favorably. The study design has been finalized in close collaboration with the company's scientific expert council, and the first five investigator sites have already been identified.
Medivir highlighted the scale of the opportunity, stating that approximately 500,000 patients globally have no approved treatment, with the market estimated at least USD 2.5 billion.
Financing and Patent Protection Strengthened
The directed share issue announced in June was oversubscribed and brought in new institutional investors, including Cicero Fonder and Storebrand, alongside continued support from Carl Bennet, Hallberg Management, LINC and Nordea Småbolagsfond Norden. As a result, the company reports it now has financing in place for all three Phase 2 studies.
In July, Medivir received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the combination patent covering fostrox plus lenvatinib in hepatocellular carcinoma (搜索) (HCC) and liver metastases. Once granted, this provides protection and market exclusivity until at least April 2041, complementing approvals in the EU, Japan, Australia and Canada.
Financial Summary
For the April–June quarter, net turnover amounted to SEK 1.2 million (compared with SEK 1.5 million in the prior-year period). EBITDA amounted to SEK -21.2 million (versus SEK -22.5 million). Cash and cash equivalents at the end of the period amounted to SEK 253.5 million, up from SEK 38.2 million a year earlier.
For the January–June period, net turnover amounted to SEK 2.3 million (versus SEK 2.1 million), with EBITDA of SEK -29.9 million (versus SEK -35.1 million).
Outlook for the Second Half of 2026
Lindberg identified three clear value drivers for the remainder of the year: patient recruitment in FLEX-HCC, preparations for proof-of-concept studies with MIV-711 in both OI and Perthes disease, and results from Vetbiolix's study of MIV-701 in canine periodontitis, which could generate royalty revenues for Medivir without material development costs of its own.