"Fostrox + Lenvima has great potential to take the place as the first approved drug treatment in second-line liver cancer"
April - June
Financial summary for the quarter
- Net turnover amounted to SEK 1.5 (1.1) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -22.5 (-36.7) million. Basic and diluted earnings per share amounted to SEK -0.20 (-0.32).
- Cash flow from operating activities amounted to SEK -26.2 (-26.3) million.
- Cash and cash equivalents at the end of the period amounted to SEK 38.2 (126.7) million.
Significant events during the quarter
- Medivir's Annual General Meeting in May re-elected Uli Hacksell, Lennart Hansson, Bengt Westermark, Yilmaz Mahshid, Angelica Loskog and Anna Törner as members of the board of directors. Uli Hacksell was re-elected as chairman of the board of directors.
January - June
Financial summary for the period
- Net turnover amounted to SEK 2.1 (1.6) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -35.1 (-63.3) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.55).
- Cash flow from operating activities amounted to SEK -53.0 (-61.3) million.
- Cash and cash equivalents at the end of the period amounted to SEK 38.2 (126.7) million.
Significant events after the period
- In July, Medivir received Notice of Allowance for fostrox plus lenvatinib combination patent by Japan Patent Office.
Conference call for investors, analysts and the media
The Interim Report January - June 2025 will be presented by Medivir's CEO, Jens Lindberg.
Time: Thursday, August 21, 2025, 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
With the planned FOcuS-2 study, Medivir now faces an exciting and pivotal journey.
After presenting our final, very positive study data from the phase 1b/2a study with fostrox + Lenvima® in early 2025, preparations for the planned phase 2b study FOcuS-2 have been in focus during the second quarter. In connection with the largest and most important scientific conferences during the second quarter, including ASCO and ESMO GI, we have again been able to conclude that no other drug projects in second-line liver cancer have advanced to the point that they have stronger potential than fostrox + Lenvima to become the first approved option for these patients. Our study results remain better than what has previously been shown in second-line liver cancer.
Today, there are no approved treatments for liver cancer patients where immunotherapy has stopped working and who need a second-line alternative. The strength of fostrox is that it only targets tumor cells locally in the liver, without damaging healthy cells. The fact that the treatment does not damage the liver allows patients to continue treatment for a long time, which in itself contributes to prolonged clinical benefit. This is illustrated by the fact that the patient in the phase 1b/2a study who has been on treatment the longest, with maintained tumor control, has now been on treatment for a full three years. The study was completed in November 2024 and the remaining patients in the study are now treated in a compassionate use program.
Preparations for the planned, randomized phase 2b study FOcuS-2 are taking place in close collaboration with our collaboration partner Eisai. Within the framework of our collaboration agreement, a Joint Development Committee has been formed that is responsible for the planning and implementation of the study. Eisai is also providing Lenvima for the study. Medivir retains all rights to fostrox. The study is designed to enable breakthrough designation and support an accelerated market approval process. Interest in the study is considerable from investigators, clinicians as well as patients.
Our already strong IP protection has been further strengthened during the past quarter. In March, the European Patent Office granted Medivir's patent application for patent protection for the combination of fostroxacitabine bralpamide (fostrox) and lenvatinib (Lenvima) for the treatment of hepatocellular carcinoma (HCC) and liver metastases from other types of cancer. In early July, we were able to announce that the Japan Patent Office (JPO) had issued a Notice of Allowance for the company's patent application, a patent that was formally approved thereafter. Prior to this, an approval was also received from the Australian Patent Office (IP Australia). All of these patents provide protection and market exclusivity until April 2041.
On July 1st of this year, it was announced that IGM Biosciences will be acquired by Concentra Biosciences. Medivir has regained all rights to birinapant and we are currently investigating the best way forward for birinapant.
At Medivir's Annual General Meeting on May 7, all board members were re-elected; Uli Hacksell (Chairman), Lennart Hansson, Bengt Westermark, Yilmaz Mahshid, Angelica Loskog and Anna Törner as board members.
Thanks to the great confidence from Linc, our largest shareholder, we have during the quarter utilized the previously agreed loan facility of SEK 30 million. Medivir continues to evaluate the company's strategic alternatives to support the development of the planned phase 2b study.
I would like to conclude by emphasizing that we are now on an exciting and pivotal journey with the planned FOcuS-2 study. Our results show that there is clear potential for fostrox + Lenvima to become the first approved drug treatment for second-line liver cancer - a market worth ~$2.5 billion annually.
I look forward to continue keeping you informed of Medivir's exciting developments.
Jens Lindberg
Chief Executive Officer
This report has not been subject to auditors' review.
For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: magnus.christensen@medivir.com
About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a drug candidate designed to selectively treat cancer cells in the liver and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.
This information is information that Medivir AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-08-21 08:30 CEST.
