"With a strengthened ownership base, a strong financial position, and two groundbreaking projects in clinical development, we now have expanded opportunities to create long-term value"
October - December
Financial summary for the quarter
- Net turnover amounted to SEK 5.5 (1.0) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -12.0 (-26.2) million. Basic and diluted earnings per share amounted to SEK -0.19 (-0.23).
- Cash flow from operating activities amounted to SEK -6.3 (-29.4) million.
- Cash and cash equivalents at the end of the period amounted to SEK 119.2 (62.5) million.
Significant events during the quarter
- On October 23, an exclusive license agreement was entered with Canadian Biossil, Inc., providing Biossil global, exclusive rights for remetinostat - Medivirs topical HDAC inhibitor. The agreement entitles Medivir to compensation of up to approximately USD 60 million, as well as future royalty income on future net sales.
- On October 27, Medivir's selective cathepsin K inhibitor MIV-711 received Orphan Drug Designation (ODD) from the FDA for the treatment of Osteogenesis Imperfecta (OI).
- On October 28, Medivir's partner Vetbiolix announced the publication of landmark clinical Proof-of Concept study results for VBX-1000 (MIV-701).
- At the end of November, a rights issue was completed, raising approximately SEK 151 million before costs related to the rights issue.
January - December
Financial summary for the period
- Net turnover amounted to SEK 8.5 (3.5) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -60.1
(-124.6) million. Basic and diluted earnings per share amounted to SEK -0.66 (-1.08). - Cash flow from operating activities amounted to SEK -73.3 (-124.2) million.
- Cash and cash equivalents at the end of the period amounted to SEK 119.2 (62.5) million.
Significant events after the period
- 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, a directed share issue of SEK 45 million was carried out 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).
Conference call for investors, analysts and the media
The Year-End Report January - December 2025 will be presented by Medivir's CEO, Jens Lindberg.
Time: Wednesday, February 18, 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
Thanks to the directed share issue to Carl Bennet AB announced in February 2026, and the rights issue completed in December, Medivir has strengthened its financial position, enabling us to proceed with the planned randomized study of fostrox in second-line liver cancer, while simultaneously initiating the continued clinical development of MIV-711 for the bone disorder Osteogenesis Imperfecta, a strategically important new indication for Medivir with the potential to create significant value for both our shareholders and affected patients.
Orphan Drug Designation strengthens both development and market potential
It is extremely exciting that Medivir can now expand its clinical portfolio and advance clinical opportunities for our cathepsin K inhibitor MIV-711 for the treatment of Osteogenesis Imperfecta (OI). OI 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, often without preceding trauma. There are currently no approved drugs for treatment in a population estimated at approximately 500,000 patients globally.
In November, Medivir received Orphan Drug Designation (ODD) from the FDA for the treatment of OI. ODD provides important benefits, including market exclusivity following approval (seven years in the U.S.), regulatory support from the FDA, and reduced development costs. The designation may also enable faster review, thereby strengthening both the commercial potential and development conditions for MIV-711.
We see a future market opportunity for MIV-711 in OI comparable to that of fostrox in primary liver cancer. To maximize the project's value, the natural next step is to demonstrate clinical proof-of-concept- a goal that can now be accelerated thanks to the SEK 45 million investment in the directed share issue. In addition to supporting Medivir in realizing the market opportunity in OI, Carl Bennet AB-as a financially strong and long-term shareholder-will strengthen our position in partnership discussions and potential out-licensing of Medivir's drug candidates.
Further strengthening the potential of fostrox
Our conviction in fostrox's potential to make a real difference for patients with liver cancer remains strong. The next step is to conduct the randomized FLEX-HCC study to confirm the efficacy benefit of the combination fostrox + Lenvima compared with Lenvima monotherapy. Confirmatory data from this study will create significant value for both shareholders and patients in a population where there are currently no approved treatment options.
The study is a randomized, two-arm trial with 40 patients in each treatment arm, aiming to demonstrate that fostrox in combination with Lenvima is superior to Lenvima alone in second-line treatment of advanced liver cancer. The study will be investigator-sponsored and conducted in collaboration with Dr Chon, Professor at CHA Bundang Hospital in Korea and the Korean Cancer Study Group, a highly experienced academic consortium., The study has generated considerable interest within the Korean group, and the eight clinics participating in the study include the three largest and most influential hospitals in Korea.
Our study results with fostrox to date continue to exceed what has previously been demonstrated in the field. This was also confirmed at the ASCO GI Congress in January 2026, where no new advances in second-line liver cancer were presented from our competitors. The ambition of our development program with fostrox + Lenvima is to become the first approved treatment option.
Continued progress for MIV-701
Medivir's selective cathepsin K inhibitor MIV-701, developed for veterinary treatment, is licensed to the French biotech company Vetbiolix.
In November, 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.
There are currently no approved treatments, nor any other drug candidates in development, for the treatment of periodontitis. Vetbiolix has initiated a randomized, placebo-controlled study to confirm the disease-modifying effect of VBX-1000 (MIV-701) and, after just one month, has already enrolled 10 of a total of 51 dogs in the three-arm study. Results from the study are expected in the fourth quarter of 2026, after which the company intends to evaluate the possibility of entering into a partnering agreement.
Under the agreement with Vetbiolix, Medivir retains 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 periodontitis in dogs and obtains 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 for Medivir at a level equivalent to the company's current market capitalization five years after global launch.
The agreement is highly capital-efficient for Medivir as Vetbiolix (or its future partner), will finance all continued clinical development and future commercialization, giving Medivir an attractive, scalable revenue model with pure upside and no significant costs.
Out-licensing of remetinostat
At the end of October, we entered into an exclusive license agreement with the Canadian company Biossil, Inc., granting Biossil global and exclusive development rights to remetinostat. The drug candidate is a topical HDAC inhibitor in clinical phase that has shown positive phase 2 data in both basal cell carcinoma (BCC) and cutaneous T-cell lymphoma (CTCL). The agreement entitles Medivir to milestone-based payments of up to approximately USD 60 million, subject to successful development and regulatory approval, as well as future royalty revenues in the mid-single-digit percentage range on net sales.
After the end of the period, at the Extraordinary General Meeting held on January 14, 2026, 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 a Board member for the period until the next Annual General Meeting, with Anders Hallberg appointed as Chairman of the Board.
In conclusion, I can confirm that we have now secured the capital required to carry out our planned Phase 2 studies of fostrox in liver cancer and MIV-711 in Osteogenesis Imperfecta. Both programs address significant unmet medical needs in markets with clear blockbuster potential and therefore have the prerequisites to create substantial value for both shareholders and affected patients. At the same time, we are closely monitoring the development of our out-licensed drug candidates. As early as the fourth quarter, we expect clinical results from the ongoing study of MIV-701, which aims to confirm its potential as the first disease-modifying treatment for periodontal disease in dogs.
I would like to thank both existing and new shareholders who participated in the rights issue, as well as Carl Bennet AB for the confidence that has enabled Medivir's continued growth journey. I look forward to continuing to keep 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;
Magnus Christensen
Chief Financial Officer
Medivir AB
Phone: +46 8 5468 3100
Email: Magnus.Christensen@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
