"With three Phase II studies funded, FLEX-HCC recruitment on track, and MIV-711 expanded into a second rare bone indication, Medivir is in its strongest position in many years"
April - June
Financial summary for the quarter
- Net turnover amounted to SEK 1.2 (1.5) million.
- Earnings before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -21.2 (-22.5) million. Basic and diluted earnings per share amounted to SEK -0.04 (-0.20).
- Cash flow from operating activities amounted to SEK -18.3 (-26.2) million.
- Cash and cash equivalents at the end of the period amounted to SEK 253.5 (38.2) million.
Significant events during the quarter
- At the Annual General Meeting on May 7, Anders Hallberg (Chairman), Angelica Loskog and Anna Törner were re-elected as board members. Kristian Tryggvason was newly elected.
- In May, the first patient was included in FLEX-HCC, the randomized phase 2 study of fostrox + lenvatinib compared with lenvatinib in second-line advanced liver cancer.
- In June, the phase 1b/2a results for fostrox + lenvatinib were published in Clinical Cancer Research.
- In June, the Board resolved on a directed share issue of approximately SEK 140 million, primarily to finance clinical development of MIV-711 in Legg-Calvé-Perthes disease (Perthes disease).
January - June
Financial summary for the period
- Net turnover amounted to SEK 2.3 (2.1) million.
- Earnings before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -29.9 (-35.1) million. Basic and diluted earnings per share amounted to SEK -0.06 (-0.32).
- Cash flow from operating activities amounted to SEK -31.3 (-53.0) million.
- Cash and cash equivalents at the end of the period amounted to SEK 253.5 (38.2) million.
Significant events after the period
- At the Extraordinary General Meeting on July 20, the issue of 6,097,560 ordinary shares to Hallberg Management AB (Tranche 2) was approved, completing the SEK 140 million directed share issue.
- In July, Medivir received a Notice of Allowance from the USPTO for the combination patent covering fostrox plus lenvatinib in hepatocellular carcinoma (HCC) and liver metastases. Once granted, it provides protection and market exclusivity until at least April 2041.
- As of July 31, 2026, Medivir had 626,487,237 shares in total, of which 624,037,074 were ordinary shares and 2,450,163 were C shares.
Conference call for investors, analysts and the media
The Interim Report January - June 2026 will be presented by Medivir's CEO, Jens Lindberg.
Time: Thursday, August 20, 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
The second quarter marks a clinical and financial turning point for Medivir. The phase 1b/2a results for fostrox + lenvatinib were published in one of oncology's most cited journals, while the first patient was included in the FLEX-HCC study. Through an oversubscribed directed share issue of approximately SEK 140 million, we are able to expand MIV-711 into a second rare bone indication (Perthes disease) - and secure the funding for all three phase 2 studies. With a strengthened financial base and three high-potential indications, Medivir is well positioned to create substantial value, for affected patients and for our shareholders.
FLEX-HCC progressing according to plan - the unmet medical need remains
In May, the first patient was included in FLEX-HCC, the randomized phase 2 study comparing fostrox + 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. Engagement among the clinicians is high, and the study is developing in line with the plan to include all patients within 12 months.
In June, the phase 1b/2a results for fostrox + lenvatinib were published in Clinical Cancer Research - a peer-reviewed confirmation that the liver-targeted mechanism of action of fostrox delivers tumor-selective efficacy without impairing liver function. The fact that the IMbrave 251 study, presented at ASCO, missed its primary endpoint 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.
Osteogenesis Imperfecta (OI) - study design finalized
Preparations for the proof-of-concept study with MIV-711 in OI are progressing favorably. The study design has been finalized in close collaboration with our scientific expert council, and feasibility work is well under way. Interest from investigator sites is strong, and the first five sites have already been identified.
The potential is substantial: approximately 500,000 patients globally have no approved treatment, and the market is estimated to at least USD 2.5 billion.
MIV-711 expanded into Perthes disease
Through the directed share issue in June, we are initiating the clinical development of MIV-711 in Perthes disease, a rare condition in which the femoral head degenerates in children. There is no medical treatment for this disease; bracing and surgery address only the 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, and upon marketing approval in the U.S. and Europe, annual peak sales are estimated to reach approximately USD 1 billion five years after launch. Building two rare bone indications on the same established safety profile multiplies the value within a single drug candidate.
Stronger organization, financing and patent protection
To ensure maximum momentum in the MIV-711 programs, we have recruited a highly experienced Clinical Operations Lead with responsibility for the operational leadership and clinical execution of the studies in both OI and Perthes disease.
The directed share issue announced in June was oversubscribed and brought in new institutional investors - Cicero Fonder and Storebrand - alongside continued support from Carl Bennet, Hallberg Management, LINC and Nordea Småbolagsfond Norden. As a result, we now have financing in place for all three phase 2 studies.
In July, we also received a Notice of Allowance from the U.S. Patent and Trademark Office for the combination patent covering fostrox plus lenvatinib. Once the patent is granted, we will - together with the approvals in the EU, Japan, Australia and Canada - have protection in our key markets until April 2041.
Value drivers in the second half of the year
We enter the second half of the year with three clear value drivers: patient recruitment in FLEX-HCC, the 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 our own.
I would like to thank new and existing shareholders for the confidence that makes all of this possible, and I look forward to keeping you updated on the company's progress and value-creating opportunities 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 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
This information is information that Medivir 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 2026-08-20 08:30 CEST.
