"With funding secured until at least 2030, we are now focusing on the FLEX-HCC study with fostrox while preparing proof-of-concept studies with MIV-711"
July - September
Financial summary for the quarter
- Net turnover amounted to SEK 0.7 (0.9) million.
- Operating profit before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -15.9 (-12.9) million. Basic and diluted earnings per share amounted to SEK -0.03 (-0.13).
- Cash flow from operating activities amounted to SEK -14.7 (-14.1) million.
- Cash and cash equivalents at the end of the period amounted to SEK 247.9 (23.5) million.
Significant events during the quarter
- At the Extraordinary General Meeting on July 20, the Board's resolution to issue 6,097,560 ordinary shares to Hallberg Management AB (Tranche 2) was approved, completing the directed share issue of approximately SEK 140 million.
- On July 20, 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 (HCC) and liver metastases. Once granted, the patent provides protection and market exclusivity until at least April 2041.
January - September
Financial summary for the period
- Net turnover amounted to SEK 3.0 (3.0) million.
- Operating profit before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -45.8 (-48.0) million. Basic and diluted earnings per share amounted to SEK -0.08 (-0.45).
- Cash flow from operating activities amounted to SEK -46.1 (-67.0) million.
- Cash and cash equivalents at the end of the period amounted to SEK 247.9 (23.5) million.
Significant events after the period
- No significant events have occurred after the end of the period.
Conference call for investors, analysts and the media
The Interim Report January - September 2026 will be presented by Medivir's CEO, Jens Lindberg.
Time: Thursday, November 5, 2026, at 15.00 (CET).
To call in to the conference - Please register here!
If you wish to participate via webcast - Please use this link!
The conference call will also be streamed via a link on the website: www.medivir.com/investors/calendar.
The presentation will be available on Medivir's website after completion of the conference.
CEO's message
The third quarter has been characterized by focused execution. With the directed share issue in June/July, we have raised SEK 336 million before transaction costs through three capital raises since December 2025, with the support of both existing and new shareholders. We now have capital for all three phase 2 studies and are funded until at least 2030, giving us a solid foundation to advance the programs at full speed. FLEX-HCC is recruiting according to plan, and preparations for the proof-of-concept studies with MIV-711 in OI and Perthes disease are progressing well.
FLEX-HCC on track and strengthened patent protection in the U.S.
FLEX-HCC, the randomized phase 2 study comparing fostrox + lenvatinib with lenvatinib monotherapy in the second-line treatment of advanced liver cancer, continues to progress according to plan. 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. Engagement among the clinicians is high, and patient recruitment is proceeding according to plan. There is still a substantial unmet medical need among patients whose disease has progressed after immunotherapy, and we see a clear opportunity for fostrox to become the first approved second-line treatment for advanced liver cancer (following first-line immunotherapy).
In July, the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for the combination patent covering fostrox plus lenvatinib. Once granted, the patent will, together with granted patents in the EU, Japan, Australia and Canada, provide protection for fostrox in our key markets until at least April 2041.
MIV-711: two proof-of-concept studies in preparation
Preparations for the proof-of-concept study in Osteogenesis Imperfecta (OI) are progressing well. Approximately 500,000 patients globally currently have no approved treatment, and the market is estimated to be worth at least USD 2.5 billion.
In Perthes disease, there is currently no medical treatment at all, and a pediatric oral formulation is a prerequisite for the proof-of-concept study. Following a thorough evaluation, the remaining step is to select a partner before formulation work begins. As in OI, MIV-711 has Orphan Drug Designation in Perthes disease, as well as Rare Pediatric Disease Designation from the FDA. Developing MIV-711 in two rare bone diseases based on the same established safety profile significantly increases the value of the drug candidate.
Out-licensed projects taking important steps forward
Vetbiolix's study of MIV-701 in canine periodontitis is progressing well, and 40 of a total of 45 planned dogs have been enrolled to date. A positive outcome could pave the way for future royalty revenues to Medivir without material development costs of our own.
Biossil, which holds the global development rights to remetinostat, is now preparing its first clinical study with the drug candidate, with a manufacturing campaign of the drug product as a first step. At the end of September, Biossil raised USD 153 million in a financing round led by the OpenAI Startup Fund, strengthening the company's ability to advance its clinical programs, including remetinostat. Upon successful development, Medivir is entitled under the agreement to milestone payments and royalties.
Our out-licensed MET-X project is also moving forward. The project has advanced toward the planned phase 1 study in India, triggering a new milestone payment to our partner Infex Therapeutics, of which Medivir is entitled to a share.
Well positioned for continued value creation
With funding secured, we can focus fully on executing our projects. Our key value drivers going forward are patient recruitment in FLEX-HCC, the upcoming proof-of-concept studies with MIV-711 in OI and Perthes disease, and the results from Vetbiolix's study of MIV-701.
I would like to thank you, our shareholders, for your continued confidence, and I look forward to keeping you updated on Medivir's continued progress.
Jens Lindberg
Chief Executive Officer
This report has been subject to auditors' review.
For further information, please contact:
Jens Lindberg
Chief Executive Officer
Medivir AB
Phone: +46 725 311117
Email: jens.lindberg@medivir.com
About Medivir
Medivir develops innovative therapies targeting diseases with high unmet medical need. The company's drug candidates focus on indications where current treatment options are limited or non-existent, offering the potential to deliver meaningful improvements for patients. Medivir's two lead programs are fostrox, a precision chemotherapy designed to selectively target liver cancer cells while minimizing side effects, and MIV-711, aimed at treating Osteogenesis Imperfecta (Brittle bone disease) and Legg-Calvé-Perthes disease (Perthes disease). Both candidates have blockbuster potential, representing significant value creation opportunities Medivir's shareholders. Collaborations play a key role in Medivir's business model, with drug development conducted either in-house or in partnership. Medivir (Nasdaq Stockholm: MVIR) is listed on the Small Cap segment of Nasdaq Stockholm. More information is available at www.medivir.com
