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  • Medivir
    Medivir AB, Box 1086, SE-141 22 Huddinge, Sweden Visit: Lunastigen 5
    +46 8 5468 3100
    http://www.medivir.com
  • Jens Lindberg

    CEO


    +46 8 5468 3100
    http://www.medivir.com
  • Magnus Christensen

    CFO


    +46-73 125-0620
    http://www.medivir.com
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    Medivir to present mature clinical data for fostrox + Lenvima at ESMO Conference and to host a webcast on September 16

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, has previously announced that detailed and mature data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima® (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 16, 2024.   The abstract, titled “Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients with

    MEDIVIR AB – INTERIM REPORT JANUARY – JUNE 2024

    “Our study shows a superior profile with the combination of fostrox and Lenvima in advanced liver cancer”     April – June Financial summary for the quarter · Net turnover amounted to SEK 1.1 (2.0) million. · The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.7 (-26.3) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.47). · Cash flow from operating activities amounted to SEK -26.3 (-17.9) million. · Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million.

    Medivir to present updated clinical data for fostrox + Lenvima in HCC at ESMO Conference in September

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, is pleased to announce that updated data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima® (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 13-17, 2024.   The abstract, titled “Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients

    Number of shares and votes in Medivir AB on 28 June 2024

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the number of shares and votes in Medivir has changed during June 2024 as a result of the issue of 1,700,000 shares of series C and the reclassification of 114 587 shares of series C to ordinary shares which was carried out as a part of the implementation of the incentive program resolved by the general meeting on 7 May 2024. Both the issue and the reclassification have been previously announced through a separate press release.   Today, the last trading day of the month, there are in total 114,617,968 shares in

    Fostrox + Lenvima® holds promise of greatly improved outcomes for advanced liver cancer patients, reveals new data from Medivir at ESMO GI

    · New results from Medivir’s Phase 1b / 2a open label trial of fostrox + Lenvima® show great promise treating second-line hepatocellular carcinoma (HCC) patients, an extremely hard to treat population · Fostrox + Lenvima® achieved a 24% overall response rate (ORR) and estimated median time to progression (TTP) of 10.8 months1 (4.1 – NE) – with one patient still on treatment after 22 months · Results come despite very poor prognosis for most second-line HCC patients today, with just 5 – 10% responding to current standard of care treatment, and a typical TTP of only 3 - 4 months ·

    Medivir to present at Redeye Growth Day

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces that the company will participate at Redeye Growth Day, today May 30, 2024.   CEO Jens Lindberg will present updated data from the ongoing phase 1b/2a clinical study with fostroxacitabine bralpamide (fostrox) and the development plans moving forward at 09.40 CET. The presentation is live broadcasted and can be followed at the event page, where the replay and the presentations will be available

    Medivir´s licensee, Tango Therapeutics, has discontinued development of its TNG348 clinical program

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir’s licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has announced that the phase 1/2 clinical trial of TNG348, a novel USP1 inhibitor, is being terminated due to toxicity observed in the initial study cohorts.   TNG348 is a novel USP1 (ubiquitin-specific protease 1) inhibitor, for the treatment of BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers, and has

    Resolutions at the Annual General Meeting in Medivir on 7 May 2024

    Medivir Aktiebolag (publ) held its annual general meeting today on 7 May 2024. The annual general meeting was held by physical presence of shareholders and with the option for shareholders to exercise their voting rights by advance voting (postal voting). The annual general meeting in Medivir Aktiebolag (publ) resolved the following:   Approval of profit and loss accounts and balance sheets, and discharge from liability of the board members and the managing director The annual general meeting resolved to approve the profit and loss accounts and balance sheets for the financial year

    MEDIVIR AB – INTERIM REPORT JANUARY – MARCH 2024

    ”Preparations for the planned phase 2b study continue according to plan after the completed Type C meeting with the FDA, strengthened by the fact that the median time to progression with fostrox + Lenvima increased to 7 months”   January – MarchFinancial summary for the quarter · Net turnover amounted to SEK 0.5 (0.4) million. · The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.7 (-18.9) million. Basic and diluted earnings per share amounted to SEK -0.23 (-0.34) and SEK -0.23 (-0.34) respectively. · Cash flow from operating

    Medivir brings the Q1 webcast forward to 10 a.m. on April 30

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that the company will host the Q1 Quarterly Results webcast tomorrow, April 30, at 10 a.m. CET. The webcast is brought forward as Nasdaq Stockholm closes earlier.       For additional information, please contactMagnus Christensen, CFO, Medivir ABTelephone: +46 8 5468 3100E-mail: magnus.christensen@medivir.com         About Medivir Medivir develops innovative drugs with a focus

    FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that its selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) for the treatment of Legg-Calvé-Perthes Disease (LCPD).   The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age. Pediatric

    Medivir provides update from supportive Type C meeting with the FDA; preparations for enhanced phase 2b in HCC with fostrox + Lenvima continue

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today an update from a Type C meeting with the FDA, regarding the company’s plans for a global phase 2b study and opening of an IND for fostroxacitabine bralpamide (fostrox) in the US.   The key outcome of the Type C meeting was that Medivir’s preparations for the randomized phase 2b study, comparing fostrox + Lenvima® with Lenvima alone, continues with two key adjustments to the study design.   Firstly,

    Medivir’s partner Vetbiolix announces positive results from Proof-of-Concept study with VBX-1000, previously known as MIV-701

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that its partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a Proof-of-Concept clinical study in periodontal disease in dog with its drug candidate VBX-1000, previously known as MIV-701.   VBX-1000 (MIV-701) is the first specific cathepsin-K inhibitor, for the treatment of periodontal disease in dogs. During the early development of a selective cathepsin-K

    Medivir to present at Investing in Oncology Forum on April 10

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces that the company will participate at the Investing in Oncology Forum on April 10, 2024.   CEO Jens Lindberg will present Medivir with focus on data from the ongoing phase 1b/2a clinical study with fostroxacitabine bralpamide (fostrox) and how these data enable an acceleration of fostrox's development program.   Investing in Oncology Forum – hosted by Cord Communications and focusing on what

    Medivir 2023 Annual Report published

    Stockholm, Sweden - Medivir AB (Nasdaq Stockholm: MVIR) today announces that the Annual Report for 2023 now is available at the company’s website: www.medivir.com. In the fall of 2023, very promising data from the ongoing phase 1b/2a study with Medivir's spearhead project fostrox in combination with Lenvima[®] were presented. The combination has shown continued improved clinical benefit in patients with advanced primary liver cancer (HCC) and at ASCO-GI in January 2024, data were presented showing further increases in the proportion of patients achieving a clinically relevant reduction

    Medivir to present at Swiss Nordic Bio in Zürich on March 7

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces that the company will participate at the Swiss Nordic Bio conference on March 7, 2024.  CEO Jens Lindberg will present Medivir with focus on data from the ongoing phase 1b/2a clinical study with fostroxacitabine bralpamide (fostrox) and how these data enable an acceleration of fostrox's development program.   Swiss Nordic Bio aims to bring together biotech, pharma and life science investors from

    Medivir to present at the Life Science Day in Gothenburg on March 6

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces that the company will participate at the Life Science Day in Gothenburg on March 6, 2024.  CEO Jens Lindberg will present Medivir with focus on data from the ongoing Phase 1b/2a clinical trial with fostroxacitabine bralpamide (fostrox) and how these data enable an acceleration of fostrox's development program.   Medivir's presentation starts at 09.45 CET and can be viewed live on www.

    Medivir presents data that strengthens the fostrox/Lenvima combination in primary liver cancer at EASL Liver Cancer Summit

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that clinical pharmacokinetic (PK) data on dose linearity and systemic exposure from the first study with fostroxacitabine bralpamide (fostrox) (NCT03781934) will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit on February 23, 2024, in Rotterdam.   The abstract, titled “Population pharmacokinetic modeling of orally administered fostroxacitabine bralpamide (

    MEDIVIR AB – YEAR-END REPORT JANUARY – DECEMBER 2023

    “The clinical efficacy of fostrox in combination with Lenvima continues to improve with median time to progression having increased to over 6 months”October – December Financial summary for the quarter · Net turnover amounted to SEK 4.4 (2.3) million. · The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -20.1(-17.9) million. Basic and diluted earnings per share amounted to SEK -0.28 (-0.32) and SEK -0.28 (-0.32) respectively. · Cash flow from operating activities amounted to SEK -4.6 (-24.7) million. · Cash and cash equivalents at the

    Number of shares and votes in Medivir AB on 31 January 2024

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the number of shares and votes in Medivir has changed during January 2024 as a result of the rights issue resolved on by Medivir on 7 November 2023 and the directed issue to Hallberg Management AB resolved on by Medivir on 22 January 2024. Both issues have been previously announced through separate press releases. The new issues resulted in an increase of 48,664,647 ordinary shares respectively 7,547,170 ordinary shares, which entails an increase of 56,211,817 ordinary shares in total.   Today, the last

    Medivir announces the outcome of the directed share issue which was announced on 22 January 2024

    7,547,170 shares were issued, and all shares have been subscribed for by and allotted to Hallberg Management AB in accordance with the resolution regarding the share issue. The subscription price wasSEK 2.65 which means that Medivir receives issue proceeds of approximately SEK 20 million before deductions of costs related to the issue. For more information about the directed issue, see the separate press release published on 22 January 2024.   For additional information, please contact; Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100 E-mail: magnus.

    Medivir to present at the Redeye Fight Cancer Day

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces that the company will participate at the Redeye Fight Cancer Day, today January 24, 2024.   CEO Jens Lindberg will present the company and updated data from the ongoing phase 1b/2a clinical study with fostroxacitabine bralpamide (fostrox) at 15.20 CET. The presentation is live broadcasted and can be followed at the event page; https://www.redeye.se/events/966280/redeye-theme-fight-cancer-2

    Medivir invites to a conference call today on updated data at ASCO GI and the plans moving forward for fostrox in primary liver cancer (HCC)

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, invites to a conference call on the updated data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC). The data was presented at the ASCO (American Society of Clinical Oncology) GI (Gastrointestinal Cancers) Symposium in San Francisco on January 19. The conference call will be held today January 23, at 14.00 CET, to update on the results in the study and the plans moving forward, including

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