A Single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics Following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers

This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers

Start Date19 Jan 2018

Sponsor / Collaborator

Medivir AB

NCT03037489

/ CompletedPhase 2

An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).

Start Date01 Sep 2016

Sponsor / Collaborator

Medivir AB

NCT02705625

/ CompletedPhase 2

A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis

This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).

Start Date28 Jan 2016

Sponsor / Collaborator

Medivir AB

100 Clinical Results associated with MIV-711

100 Translational Medicine associated with MIV-711

100 Patents (Medical) associated with MIV-711

Literatures (Medical) associated with MIV-711

01 May 2022·Clinical and experimental rheumatologyQ3 · MEDICINE

Symptomatic and structural benefit of cathepsin K inhibition by MIV-711 in a subgroup with unilateral pain: post-hoc analysis of a randomised phase 2a clinical trial.

Q3 · MEDICINE

Article

Author: Byrjalsen, Inger ; Bowes, Mike A ; Öberg, Fredrik ; Conaghan, Philip G ; Andersen, Jeppe Ragnar ; Herder, Christina ; Bihlet, Asger Reinstrup

OBJECTIVES:

Osteoarthritis (OA) development programmes face challenges due to discordance between structural changes and symptoms. A novel cathepsin-K inhibitor, MIV-711, recently reported structural benefits, but did not demonstrate a significant difference from placebo in symptoms. Previous work suggests that pain from non-target joints may confound OA pain outcomes. We therefore conducted an exploratory analysis in participants with predominantly unilateral knee pain from the MIV-711-201 trial.

METHOSD:

Participants scoring below median contralateral knee NRS pain at baseline from the MIV-711-201 phase 2a clinical trial (n=119) were analysed by treatment group for differences in change from baseline in WOMAC pain, quantitative magnetic resonance imaging bone area and cartilage thickness with a repeated-measures mixed model adjusting for relevant co-variates.

RESULTS:

In the subgroup with unilateral knee pain, treatment with MIV-711 100 mg led to greater reduction in WOMAC pain compared to placebo (-5.0, 95% CI: -8.69 to -1.3, p=0.008), while 200 mg did not (-2.5, 95% CI: -6.5 to 1.6, p=0.23). MIV-711 treatment was associated with a reduced change in bone area compared to placebo (200 mg; -19.6 mm2 , 95% CI: -36.2 to -3.0, p=0.02, and 100 mg; -12.5 mm2 , 95% CI: -27.8 to 2.8, p=0.11,). No observed differences between treatment groups in cartilage thickness were found in this subgroup.

CONCLUSIONS:

In a subgroup with predominantly unilateral knee pain, significant reduction in OA pain by MIV-711 100 mg treatment was found, with concurrent beneficial structural effects, highlighting the importance of appropriate pain inclusion criteria in OA trials.

21 Jan 2020·Annals of internal medicineQ1 · MEDICINE

Disease-Modifying Effects of a Novel Cathepsin K Inhibitor in Osteoarthritis

Q1 · MEDICINE

Article

Author: Kingsbury, Sarah R. ; Guillard, Gwenael ; Bethell, Richard ; Jansson, Åsa ; Graham, Philippa ; Sjögren, Niclas ; Rizoska, Biljana ; Conaghan, Philip G. ; Brett, Alan ; Wadell, Cecilia ; Bowes, Michael A. ; Öhd, John

Background:

MIV-711 is a novel selective cathepsin K inhibitor with beneficial effects on bone and cartilage in preclinical osteoarthritis models.

Objective:

To evaluate the efficacy, safety, and tolerability of MIV-711 in participants with symptomatic, radiographic knee osteoarthritis.

Design:

26-week randomized, double-blind, placebo-controlled phase 2a study with a 26-week open-label safety extension substudy. (EudraCT: 2015-003230-26 and 2016-001096-73).

Setting:

Six European sites.

Participants:

244 participants with primary knee osteoarthritis, Kellgren-Lawrence grade 2 or 3, and pain score of 4 to 10 on a numerical rating scale (NRS).

Intervention:

MIV-711, 100 (n = 82) or 200 (n = 81) mg daily, or matched placebo (n = 77). Participants (46 who initially received 200 mg/d and 4 who received placebo) received 200 mg of MIV-711 daily during the extension substudy.

Measurements:

The primary outcome was change in NRS pain score. The key secondary outcome was change in bone area on magnetic resonance imaging (MRI). Other secondary end points included cartilage thickness on quantitative MRI and type I and II collagen C-telopeptide biomarkers. Outcomes were assessed over 26 weeks.

Results:

Changes in NRS pain scores with MIV-711 were not statistically significant (placebo, -1.4; MIV-711, 100 mg/d, -1.7; MIV-711, 200 mg/d, -1.5). MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels. Nine serious adverse events occurred in 6 participants (1 in the placebo group, 3 in the 100 mg group, and 2 in the 200 mg group); none were considered to be treatment-related.

Limitation:

The trial was relatively short.

Conclusion:

MIV-711 was not more effective than placebo for pain, but it significantly reduced bone and cartilage progression with a reassuring safety profile. This treatment may merit further evaluation as a disease-modifying osteoarthritis drug.

Primary Funding Source:

Medivir.

21 Jan 2020·Annals of internal medicineQ1 · MEDICINE

Structural Modification in Osteoarthritis: Dawn of a New Day?

Q1 · MEDICINE

Article

Author: Katz, Jeffrey N.

Editorials21 January 2020Structural Modification in Osteoarthritis: Dawn of a New Day?Jeffrey N. Katz, MD, MScJeffrey N. Katz, MD, MScBrigham and Women's Hospital, Harvard Medical School, and Harvard School of Public Health, Boston, Massachusetts (J.N.K.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-3809 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Osteoarthritis (OA) of the knee is a painful, disabling condition affecting more than 14 million people in the United States (1) and hundreds of millions worldwide. The pain of this condition arises from a series of pathologic processes involving articular cartilage, subchondral bone, synovium, meniscus, and other joint structures, ultimately leading to joint failure and pain-related functional limitations. Scientists around the world have worked to identify biological pathways underlying these destructive changes and to develop targeted therapies that address these pathways. These efforts have enhanced our understanding of the pathobiology of OA but have not yet succeeded in identifying a ...References1. Deshpande BR, Katz JN, Solomon DH, et al. Number of persons with symptomatic knee osteoarthritis in the US: impact of race and ethnicity, age, sex, and obesity. Arthritis Care Res (Hoboken). 2016;68:1743-50. [PMID: 27014966] doi:10.1002/acr.22897 CrossrefMedlineGoogle Scholar2. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27:1578-89. [PMID: 31278997] doi:10.1016/j.joca.2019.06.011 CrossrefMedlineGoogle Scholar3. Lindstrom E, Grabowska U, Jerling M, et al. MIV-711, a highly selective cathepsin K inhibitor, reduces biomarkers of bone resorption and cartilage degradation in healthy subjects. Osteoarthritis Cartilage. 2014;22 Suppl S197. doi:10.1016/j.joca.2014.02.376 CrossrefMedlineGoogle Scholar4. Conaghan PG, Bowes MA, Kingsbury SR, et al. Disease-modifying effects of a novel cathepsin K inhibitor in osteoarthritis. A randomized, placebo-controlled study. Ann Intern Med. 2020;172:86-95. doi:10.7326/M19-0675 LinkGoogle Scholar5. Hunter D, Nevitt M, Lynch J, et al; FNIH OA Biomarkers Consortium. Longitudinal validation of periarticular bone area and 3D shape as biomarkers for knee OA progression? Data from the FNIH OA Biomarkers Consortium. Ann Rheum Dis. 2016;75:1607-14. [PMID: 26483253] doi:10.1136/annrheumdis-2015-207602 CrossrefMedlineGoogle Scholar6. Hochberg MC, Guermazi A, Guehring H, et al. Effect of intra-articular sprifermin vs placebo on femorotibial joint cartilage thickness in patients with osteoarthritis: the FORWARD randomized clinical trial. JAMA. 2019;322:1360-70. [PMID: 31593273] doi:10.1001/jama.2019.14735 CrossrefMedlineGoogle Scholar7. Culvenor AG, Collins NJ, Guermazi A, et al. Early knee osteoarthritis is evident one year following anterior cruciate ligament reconstruction: a magnetic resonance imaging evaluation. Arthritis Rheumatol. 2015;67:946-55. [PMID: 25692959] doi:10.1002/art.39005 CrossrefMedlineGoogle Scholar8. U.S. Department of Health and Human Services; U.S. Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics. May 2014. Accessed at www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf on 9 December 2019. Google Scholar9. U.S. Department of Health and Human Services; U.S. Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health. Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment. Guidance for Industry. August 2018. Accessed at www.fda.gov/media/71132/download on 9 December 2019. Google Scholar Author, Article, and Disclosure InformationAffiliations: Brigham and Women's Hospital, Harvard Medical School, and Harvard School of Public Health, Boston, Massachusetts (J.N.K.)Acknowledgment: The author thanks Emma E. Williams, BA, for expert editorial assistance.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-3809.Corresponding Author: Jeffrey N. Katz, MD, MSc, Department of Orthopedic Surgery, Brigham and Women's Hospital, Hale 5016, 75 Francis Street, Boston, MA 02115; e-mail, [email protected]harvard.edu.This article was published at Annals.org on 31 December 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoDisease-Modifying Effects of a Novel Cathepsin K Inhibitor in Osteoarthritis Philip G. Conaghan , Michael A. Bowes , Sarah R. Kingsbury , Alan Brett , Gwenael Guillard , Biljana Rizoska , Niclas Sjögren , Philippa Graham , Åsa Jansson , Cecilia Wadell , Richard Bethell , and John Öhd Metrics 21 January 2020Volume 172, Issue 2Page: 147-148KeywordsAnterior cruciate ligamentArthralgiaBoneCartilageFood and Drug AdministrationKneesOsteoarthritisOsteocalcinRandomized trialsUrine ePublished: 31 December 2019 Issue Published: 21 January 2020 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

News (Medical) associated with MIV-711

20 Mar 2026

·www.medivir.com

Medivir creates Scientific Expert Council with world-leading Osteogenesis Imperfecta specialists

Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative medical treatments in areas of high unmet medical need, announced today the formation of a Scientific Expert Council as the company intensifies its plans for next phase of development with MIV-711 in Osteogenesis Imperfecta. In February, Medivir announced its intention to initiate clinical development of its proprietary drug candidate MIV-711 for the treatment of Osteogenesis Imperfecta (OI), a rare bone disease with significant unmet medical need and no approved disease-modifying therapies. This new and strategically important investment in MIV-711 for OI is supported by the directed share issue to Carl Bennet AB, which raised SEK 45 million. The program has the potential to address a market opportunity of at least USD 2.5 billion, comparable to fostrox in primary liver cancer. MIV-711 was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in November 2025, providing important benefits, including market exclusivity following approval. As the company accelerates preparations to initiate a clinical study in OI, with the objective of establishing clinical proof-of-concept, the Scientific Expert Council will work closely with Medivir to provide strategic guidance and expertise on study design and execution, while also helping lay the foundation for the next phase of clinical development. - “Having the possibility to learn about OI from a vastly experienced and highly renowned Scientific Expert Council ensures a vital foundation for designing and executing a clinical program in a rare disease. I am truly honored that we have been able to attract some of the world's leading experts in Osteogenesis Imperfecta to our Scientific Advisory Council, whose expertise and deep clinical knowledge will be critical in moving the clinical development of MIV-711 forward,” says Dr. Pia Baumann, Chief Medical Officer at Medivir. - “For patients living with Osteogenesis Imperfecta, the burden of recurrent fractures and progressive skeletal fragility remains profound, and current therapies fall short of addressing the underlying mechanisms that drive disease progression. There is a critical need for treatments that can directly influence bone remodeling and improve structural integrity, rather than simply managing symptoms. Cathepsin K inhibition represents a promising approach, targeting a key enzyme involved in excessive bone resorption, with the potential to strengthen bone and reduce fracture rates. Advancing this type of therapy could mark an important step toward meeting the significant unmet medical need faced by the OI community,” says Dr. Andreas Kindmark, Uppsala University Hospital. Members of Medivir’s Scientific Advisory Council: Dr. Marelise Eekhoff is an internist‑endocrinologist and professor at Amsterdam UMC, where she leads the center for rare bone disorders, including Osteogenesis Imperfecta, Fibrodysplasia Ossificans Progressiva, Genetic Osteoporosis, Fibrous Dysplasia/MAS, and Camurati‑Engelmann among others. She is a highly active researcher and has contributed extensively to scientific literature spanning rare skeletal diseases, pre‑ and clinical pathophysiology, treatment, and clinical management. She is responsible for a significant number of clinical studies. Dr. Richard Keen is a Consultant Rheumatologist and Director, Centre for Metabolic Bone Disease at Royal National Orthopaedic Hospital, Stanmore, UK. He specialises in clinical research and development of novel therapies for adults with rare metabolic bone conditions. He is the Chair of the UK Brittle Bone Society's Scientific Advisory Board. He has published over 60 scientific papers in peer-reviewed journals. Dr. Andreas Kindmark is an Associate Professor and Senior Consultant in Endocrinology at Uppsala University Hospital. He is clinically active at the Metabolic Diseases Clinic, specializing in the investigation of skeletal metabolic disorders, and is heading the Uppsala University Hospital units for National Highly Specialized care for Osteogenesis Imperfecta and for Skeletal Dysplasias. Dr Kindmark is also responsible for the Uppsala University Hospital DXA unit at the department of radiology. His research interests span from epidemiological studies, through effects of hereditary factors influencing bone metabolism, and he heads a research group working to identify genes and genetic variants affecting bone health. Dr. Bente Langdahl is a clinical professor, Department of Endocrinology and Internal medicine, Aarhus University Hospital, Denmark. She specializes in metabolic bone disorders with particular focus on Osteoporosis and Osteogenesis Imperfecta. She is head of the Clinical Bone Research Center at Aarhus University Hospital. She has authored more than 300 peer‑reviewed scientific papers, contributing extensively to the understanding of Osteoporosis, rare bone diseases including Osteogenesis Imperfecta and genetics of bone disorders. Dr. Oliver Semler is a pediatrician and professor at the University of Cologne, where he leads the department for rare skeletal diseases in childhood. His clinical and research work focuses on Osteogenesis Imperfecta and other skeletal dysplasias.A highly active researcher, he has contributed extensively to the scientific literature, with numerous publications spanning OI pathophysiology, treatment, and clinical management. For additional information, please contact; Jens Lindberg Chief Executive Officer Medivir AB Phone: +46 8 5468 3100 Email: jens.lindberg@medivir.com About Osteogenesis Imperfecta Osteogenesis imperfecta (OI), also known as brittle bone disease, is a rare and hereditary disorder characterised by fragile bones with a high susceptibility to fractures. The disease is caused by various genetic mutations that affect the structure or production of the bone matrix. The severity varies from mild to very severe forms. The most severe cases can involve repeated fractures, skeletal deformities, pain and short stature, and in the most severe form, children do not survive infancy. Globally, an estimated 500,000 people are affected, of whom around 135,000 are children. OI often requires lifelong treatment, with the aim of improving quality of life and reducing the risk of fractures. About MIV-711 MIV-711 is a potent and selective inhibitor of cathepsin K, the main protease involved in breaking down collagen in bone and cartilage. It has been shown to slow, stop or reverse the progressive degeneration of joints affected by osteoarthritis. By inhibiting cathepsin K and increased/excessive osteoclast activity, MIV-711 has the potential to counteract the excessive bone breakdown seen in patients with Osteogenesis Imperfecta (brittle bone disease). MIV-711 restores the balance between the breakdown of bone with mutated collagen and the formation of new bone with the aim of preventing fractures and bone deformities. 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 Attachments Press Release (PDF)

Orphan Drug

27 Feb 2026

·www.medivir.com

Number of shares and votes in Medivir AB on 27 February 2026

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the number of shares and votes in Medivir has changed during February 2026 as a result of the directed issue to Carl Bennet AB resolved on by Medivir on 5 February 2026. The issue has been previously announced through a separate press release. The new issue resulted in an increase of 90,000,000 ordinary shares. Today, the last trading day of the month, there are in total 541,121,383 shares in Medivir, of which 538,671,220 ordinary shares and 2,450,163 class C-shares, which together carry 538,916,236.3 votes. One ordinary share entitles to one (1) vote and one class C-share entitles to one tenth (1/10) of a vote. For additional information, please contact; Magnus Christensen Chief Financial Officer Medivir AB Phone: +46 8 5468 3100 Email: Magnus.Christensen@medivir.com This information is information that Medivir is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication at 2026-02-27 08:30 CET. 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 Attachments Press Release (PDF)

05 Feb 2026

·www.medivir.com

Medivir carries out a directed share issue of SEK 45 million to Carl Bennet AB

INSIDER INFORMATION: Stockholm —Medivir AB (Nasdaq Stockholm: MVIR) (“Medivir” or the “Company”), a pharmaceutical company focused on developing innovative treatments for diseases with significant unmet medical needs, today announced that the board of directors, based on the authorisation granted by the annual general meeting held on 7 May 2025, has resolved on a directed issue of 90,000,000 new ordinary shares, through which the Company will receive SEK 45 million before issue costs (the “Directed Share Issue”). The right to subscribe for shares in the Directed Share Issue is granted, with deviation from the shareholders' pre-emption rights, to Carl Bennet AB ("CBAB"). The subscription price in the Directed Share Issue amounts to SEK 0.50 per share, which represents a premium of 19,0 per cent compared to the closing price of the Company's share on 5 February 2026. The board's resolution on the Directed Share Issue entails a deviation from the shareholders' pre-emption rights. The reason for the deviation is that the Directed Share Issue to Carl Bennet AB is considered to be a time- and cost-effective way of providing the Company with additional capital. The Directed Share Issue enables the clinical development of the drug candidate MIV-711 for the treatment of Osteogenesis Imperfecta (brittle bone disease), a new and strategically important indication for Medivir that has the potential to create significant value, both for Medivir's shareholders and affected patients. The board of directors also believes that the Directed Share Issue will provide the Company with a financially strong and long-term owner, which will strengthen the Company's position in negotiations regarding partnerships and/or out-licensing of Medivir's drug candidates. Overall, the Directed Share Issue is considered to be positive for Medivir and its shareholders. Background and motive In December 2025, Medivir completed a rights issue (the "Rights Issue"), which resulted in the issue of 336,503,415 ordinary shares and proceeds totalling approximately SEK 151 million to the Company (before deduction of costs attributable to the Rights Issue). The subscription price in the Rights Issue was SEK 0.45 per share. The proceeds from the Rights Issue are primarily intended to be used to finance a randomised, controlled two-arm study of the Company's drug candidate Fostrox. Medivir is a development company and the Company's board of directors continuously evaluates various alternatives for financing the Company's operations. CBAB has expressed interest in investing in the Company and the board of directors has therefore entered into negotiations with CBAB. The board of directors deems that an additional capital injection is positive, as it will enable clinical development of the drug candidate MIV-711 for the treatment of Osteogenesis Imperfecta (brittle bone disease), a new and strategically important indication for Medivir. Medivir's drug candidate MIV-711 was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in November 2025. This designation provides important benefits, including market exclusivity after approval (seven years in the US), regulatory support from the FDA and reduced development costs. The status may also enable faster review, thereby strengthening both the commercial potential and development prospects for MIV-711. The board of directors considers that the drug candidate MIV-711 for the treatment of Osteogenesis Imperfecta has the potential to open up a market at least on par with that of Medivir's drug candidate Fostrox in primary liver cancer. The clinical development made possible by the Directed Share Issue therefore creates conditions for significant value creation for Medivir's shareholders. The Directed Share Issue can be carried out in a time and cost-effective manner, which means that Medivir can quickly benefit from a large part of the proceeds. The board of directors further deems that the Directed Share Issue will provide the Company with a financially strong and long-term investor, which strengthens the Company's negotiations regarding future partnerships and/or out-licensing of drug candidates. Overall, the Directed Share Issue is therefore considered to be positive for the Company and its shareholders. Considering that the Company has recently completed the Rights Issue, that a rights issue is time- and cost-consuming in relation to the limited size of the issue, that a rights issue would likely entail a discount in relation to the current market price, that guarantee costs are avoided through a directed share issue, and that one purpose of the Directed Share Issue is to provide the Company with a new strategic investor, the board of directors considers that a rights issue is not a suitable alternative to carrying out the Directed Share Issue. In an overall assessment and after careful consideration, the board of directors considers that it is justified and in the interest of the Company and the shareholders to deviate from the main rule regarding the shareholders' pre-emption rights. About Carl Bennet AB Carl Bennet AB is an owner company that contributes to the development and value creation of its holdings through long-term and active ownership. The company was founded in 1989 in connection with the acquisition of Getinge. Initially, the company was only the principal owner of Getinge AB, but over the years it has developed its ownership to also include the listed companies Arjo AB, Elanders AB and Lifco AB. Through its companies, the group operates globally in a number of different industries with market-leading positions. Healthcare, medical technology, dental, engineering and logistics are the main areas of operation. The group has a strong financial base with equity of approximately SEK 122 billion. During the 2025 financial year, the group's net sales amounted to approximately SEK 86 billion and profit before tax amounted to approximately SEK 10 billion. At the end of the year, the group had around 33,200 employees globally. Terms and conditions for the Directed Share Issue The Directed Share Issue is being carried out at a subscription price of SEK 0.50 and has been determined following negotiations with CBAB. The subscription price represents a premium of 19,0 per cent compared to the closing price of the Company's share on Nasdaq Stockholm on 5 February 2026 and a premium of 12.4 per cent compared to the volume-weighted average price (VWAP) of the Company's share during a period of five (5) trading days up to and including 5 February 2026. In determining the subscription price, the investor dialogues conducted in connection with the Rights Issue have also been considered. The board of directors' opinion is that the subscription price is in line with market conditions in this type of transaction and that the subscription price reflects demand and investor interest. The board of directors' assessment is therefore that the subscription price has been set on market terms. In connection with the Rights Issue, the Company undertook towards DNB Carnegie Investment Bank AB and Zonda Partners AB not to issue additional shares or other share-related instruments for a period of 90 days after the end of the subscription period. DNB Carnegie Investment Bank AB and Zonda Partners AB have consented to the Directed Share Issue but have not acted as advisors to the Company in connection with the Directed Share Issue. The Company's largest shareholders, Hallberg Management AB and Linc AB, support the Directed Share Issue. Dilution Through the Directed Share Issue, the number of outstanding shares will increase by 90,000,000 from 451,121,383 to 541,121,383 and the number of votes by 90,000,000 from 448,916,236 to 538,916,236.3. The share capital will increase by SEK 13,500,000 from SEK 67,668,207.45 to SEK 81,168,207.45. The Directed Share Issue entails a dilution for existing shareholders of approximately 16.63 per cent of the number of shares and approximately 16.70 per cent of the number of votes in the Company. Issue costs The costs for the Directed Share Issue are estimated to amount to approximately SEK 280,000. Advisors In connection with the Directed Share Issue, the Company has engaged Advokatfirman Lindahl KB as legal advisor. For additional information, please contact; Anders Hallberg Chairman of the Board, Medivir AB Telephone: +46 8 546 831 00 Email: anders.hallberg@medivir.se This information is information that Medivir is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-02-05 19:15 CET. About Osteogenesis Imperfecta Osteogenesis imperfecta (OI), also known as brittle bone disease, is a rare and hereditary disorder characterised by fragile bones with a high susceptibility to fractures. The disease is caused by various genetic mutations that affect the structure or production of the bone matrix. The severity varies from mild to very severe forms. The most severe cases can involve repeated fractures, skeletal deformities, pain and short stature, and in the most severe form, children do not survive infancy. Globally, an estimated 500,000 people are affected, of whom around 135,000 are children. OI often requires lifelong treatment, with the aim of improving quality of life and reducing the risk of fractures. About MIV-711 MIV-711 is a potent and selective inhibitor of cathepsin K, the main protease involved in breaking down collagen in bone and cartilage. It has been shown to slow, stop or reverse the progressive degeneration of joints affected by osteoarthritis. By inhibiting cathepsin K and increased/excessive osteoclast activity, MIV-711 has the potential to counteract the excessive bone breakdown seen in patients with Osteogenesis Imperfecta (brittle bone disease). MIV-711 restores the balance between the breakdown of bone with mutated collagen and the formation of new bone with the aim of preventing fractures and bone deformities. About Medivir Medivir develops innovative drugs with a focus on diseases where medical needs are significant. The company focuses on indication areas where available treatment methods are limited or lacking and where there is great potential to offer significant improvements to patients. Collaborations and partnerships are an important part of Medivir's business model, and drug development is conducted either in-house or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm, on the Small Cap list. Attachments Press Release (PDF)

AcquisitionOrphan Drug

100 Deals associated with MIV-711

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 2	Germany	Medivir AB	04 Dec 2015
Osteoarthritis, Knee	Phase 2	United Kingdom	Medivir AB	04 Dec 2015
Osteoarthritis	Phase 2	Sweden	Medivir AB	-
Osteogenesis Imperfecta	Phase 2	Sweden	Medivir AB	-
Legg-Calve-Perthes Disease	Preclinical	United States	Medivir AB	15 May 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02705625 (CTgov)	Phase 2	Osteoarthritis, Knee	244	Placebo	mhvgachdpf(tkbkeoslrb) = dtdjzcqfxo wqoiqurgqp (fwkjvtbrcp, 2.15) View more	-	17 Jun 2019
NCT03037489 (CTgov)	Phase 2	Osteoarthritis, Knee	50	MIV-711-201+MIV-711 (Group A)	twimxnbvyx = ksbwtznphh nvioamfimt (uurebrqeuo, vifcnknbiz - czvwvchtpx) View more	-	18 Mar 2019
NCT03037489 (CTgov)	Phase 2	Osteoarthritis, Knee	50	placebo+MIV-711 (Group B)	twimxnbvyx = msouulvbzu nvioamfimt (uurebrqeuo, wdoyrteonb - ociclqmfyt) View more	-	18 Mar 2019

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