"Following a transformative first quarter and strong external interest in our two key programs, we are well positioned to create long-term value for shareholders."
January - March
Financial summary for the quarter
· Net turnover amounted to SEK 1.0 (0.6) million.
· Earnings before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -8.8 (-12.6) million. Basic and diluted earnings per share amounted to SEK -0.02 (-0.12)
· Cash flow from operating activities amounted to SEK -13.0 (-26.8) million.
· Cash and cash equivalents at the end of the period amounted to SEK 149.1 (35.1) million.
Significant events during the quarter
· At the Extraordinary General Meeting held on January 14, it was resolved that Medivir's Board of Directors shall consist of four members without deputies. Uli Hacksell, Angelica Loskog, and Anna Törner were re-elected, and Anders Hallberg was newly elected as Board members, with Anders Hallberg appointed as Chairman of the Board.
· In January, the company's nomination committee was appointed ahead of the 2026 Annual General Meeting, consisting of Karl Tobieson (chairman), Anders Hallberg and Johan Claesson.
· In February, a directed share issue of SEK 45 million was made to Carl Bennet AB to enable clinical development of the drug candidate MIV-711 for the treatment of Osteogenesis Imperfecta.
· In February, Medivir's partner Vetbiolix announced that a randomized placebo-controlled study had been initiated to confirm the clinical benefit of VBX-1000 (MIV-701).
· Patrik Norgren, with more than 20 years of experience in financial leadership roles across both private and publicly listed companies, was appointed as new CFO and assumed his role at the end of March.
· At the end of March, Medivir established a Scientific Expert Council, with world-leading experts in Osteogenesis Imperfecta, to support the work of preparing and initiating a phase 2 proof-of-concept study.
Conference call for investors, analysts and the media
The Interim Report January - March 2026 will be presented by Medivir's CEO, Jens Lindberg.
Time: Tuesday, May 5, 2026, at 14.00 (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
For Medivir, the past quarter resulted in a strengthened financial position, enabling us to expand our project portfolio and initiate clinical development of our proprietary cathepsin K inhibitor, MIV-711, for the treatment of the brittle bone disease Osteogenesis Imperfecta. Separately, the planned randomized study of fostrox in second-line liver cancer is about to begin. In addition, our partner Vetbiolix initiated its study of VBX-1000 (MIV-701) in dogs with periodontitis during the first quarter and has already recruited 22 of 51 animals.
Osteogenesis Imperfecta - an indication with significant potential
The congenital brittle bone disease Osteogenesis Imperfecta represents a strategically important new indication for Medivir, with the potential to create significant value for both affected patients and our shareholders. Currently, there are no approved treatments for this population, which is estimated at approximately 500,000 patients globally. MIV-711 has the potential to open up a market of at least USD 2.5 billion, comparable to the market for fostrox in second-line advanced liver cancer.
In November 2025, Medivir received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration for the treatment of Osteogenesis Imperfecta. This designation provides several important benefits, including market exclusivity following approval (seven years in the U.S.), regulatory support from the FDA, and reduced development costs. We also see potential to obtain Rare Pediatric Disease Designation and eligibility for a Priority Review Voucher, further strengthening the commercial potential and development prospects for MIV-711.
To maximize the value of the project, the next step is to demonstrate clinical proof-of-concept. Our focus is now on finalizing the study design in close collaboration with the scientific expert council we established in March. This board consists of some of the world's leading specialists in Osteogenesis Imperfecta, and their combined expertise and clinical experience are critical to ensuring optimal clinical and scientific conditions for our study.
The FLEX-HCC study generates strong interest
The randomized FLEX-HCC study is designed to demonstrate that fostrox in combination with lenvatinib provides superior efficacy compared to lenvatinib monotherapy in the second-line treatment of advanced liver cancer. To date, the combination has shown promising results that exceed those previously reported for second-line treatment, including in terms of overall survival.
Fostrox's strong competitive position was reconfirmed at the ASCO Gastrointestinal Cancers Symposium in January 2026, where no competitors presented any meaningful advances in second-line liver cancer. We consider the unmet medical need addressable by fostrox to be significant, as this patient population currently lacks approved treatment options.
FLEX-HCC is a randomized, two-arm study with 40 patients per treatment arm. It is investigator-sponsored and conducted in collaboration with the Korean Cancer Study Group, a highly experienced academic consortium, under the leadership of Dr. Hong Jae Chon, Professor at CHA Bundang Hospital. The study has generated strong interest, and in April the Korean Cancer Study Group decided to expand the number of participating sites from 8 to 12 hospitals, including several of the most prominent hospitals in Korea.
Members of Medivir's management team and I have recently returned from Korea, where we visited most of the participating hospitals to ensure that optimal conditions for rapid patient recruitment are in place. We were struck by the interest and engagement in the study among the hospitals, and they all highlighted the potential of the fostrox + lenvatinib combination for patients in the second-line setting. Having had the opportunity to meet with Dr. Chon and his study team on site in Seoul, we continue to be impressed by their strong commitment and excellent preparations.
Rapid progress for MIV-701
Medivir's selective cathepsin K inhibitor MIV-701, developed for veterinary use, is licensed to the French biotech company Vetbiolix. In November 2025, strong clinical proof-of-concept results were published for VBX-1000 (MIV-701) in dogs with periodontitis, representing the first drug treatment to demonstrate disease-modifying effects. Currently, there are no approved drugs for the treatment of periodontitis in this patient population.
The ongoing study continues to progress rapidly, with 22 out of 51 dogs recruited to date. The results, which are intended to confirm the disease-modifying effect, are expected in the fourth quarter of 2026. If the results are positive, the company intends to evaluate potential partnering opportunities.
The licensing agreement with Vetbiolix provides Medivir with significant financial upside through future royalties on net sales, as well as a substantial share of potential partnership payments from collaborations with third parties. Provided that MIV-701 demonstrates clinically meaningful efficacy in treating periodontitis in dogs and receives market approval in all major markets, including the EU and the U.S., the project is assessed to have the potential to generate annual royalty revenues to Medivir of approximately SEK 700 million five years after global launch.
Strengthened finances create expanded opportunities
Through the directed share issue to Carl Bennet AB in February and the rights issue at the end of last year, Medivir has secured a significantly strengthened financial position. This enables the company to carry out Phase II studies for both fostrox in liver cancer and MIV-711 in Osteogenesis Imperfecta. Both programs address substantial unmet medical needs with clear blockbuster potential and are well positioned to create significant value-for both shareholders and affected patients.
We are also closely monitoring the development of our outlicensed drug candidates, particularly the ongoing study of MIV-701, which has the potential to become the first approved disease-modifying treatment for periodontitis in dogs.
I look forward to keeping you updated on the company's progress and the significant value-creating opportunities that lie ahead.
Jens Lindberg
Chief Executive Officer
This report has not been subject to auditors' review.
For additional information, please contact;
Jens Lindberg
Chief Executive Officer
Medivir AB
Phone: +46 8 5468 3100
Email: jens.lindberg@medivir.com
About Medivir
Medivir develops innovative therapies targeting areas of high unmet medical need. Its 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). Both candidates have blockbuster potential, representing significant value creation opportunities for Medivir's shareholders and affected patients. Collaborations and partnerships 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
