STOCKHOLM, November 3, 2022 /PRNewswire/ — Measures aimed at accelerating the pace of patient recruitment have borne fruit. The Fostrox study is now progressing as planned.

July – SeptemberQuarterly Financial Summary

  • The net turnover amounted to 1.1 (0.8) million SEK.
  • The loss before interest, taxes, depreciation and amortization (EBITDA) amounts to -13.9 (-11.7) million SEK. Basic and diluted earnings per share were -0.27 SEK (-0.24) and -0.27 SEK (-0.24) respectively.
  • Cash flow from operating activities was -19.7 (-20.0) million SEK.
  • Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million.

Highlights of the quarter

  • Fostroxacitabine bralpamide – the name given to MIV-818 by the World Health Organization (WHO) – has received official approval as a pharmaceutical name in the United States by the United States Adopted Names Council (USAN).

January – SeptemberFinancial summary for the period

  • Net turnover amounted to SEK 2.1 (11.6) million.
  • The loss before interest, taxes, depreciation and amortization (EBITDA) amounted to -66.9 (-36.0) million SEK. Basic and diluted earnings per share were -1.27 SEK (-0.75) and -1.27 SEK (-0.75) respectively.
  • Cash flow from operating activities amounted to SEK -77.1 (-43.3) million.
  • Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million.

Events after the end of the period

  • In October, the Nominating Committee was appointed ahead of the May 2023 AGM. The Nominating Committee consists of Karl Tobieson (Chairman), nominated by Linc AB, Richard Torgerson, nominated by Nordea Investment Funds, Anders Hallberg, nominated by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB.

Conference call for investors, analysts and mediaThe January – September 2022 interim report will be presented by Medivir CEO Jens Lindberg. Time: Thursday November 3, 2022, at 3:00 p.m. (CET).

Telephone numbers of participants from:Sweden +46 8 505 583 65Europe +44 33 3300 9269US +1 631 913 1422, PIN 19436682#

The conference call will also be broadcast via a link on the website: www.medivir.comThe presentation will be available on the Medivir website after the end of the conference. Message from the CEO Our measures to relaunch patient recruitment have been effective and the fotrox study is now progressing as planned.

Medivir’s top priority is the continued clinical development of our cutting-edge fostroxacitabine bralpamide (fostrox) project, for the treatment of hepatocellular carcinoma (HCC).

I described in our Q2 report that we saw slower-than-expected recruitment into the study in Q2, primarily in Europe. In order to increase the speed of recruitment, we have decided, for example, to activate additional study centers and to increase our presence in the trial centers already activated.

It is now very gratifying to see that the measures we have initiated to accelerate the recruitment of patients into the study have borne fruit. Today, a total of 14 centers are activated in the UK, Spain and South Korea and during the third quarter we saw an acceleration in the recruitment rate.

Fostrox has the potential to become the first oral, liver-targeting drug that can help patients with various liver cancers. Its unique mechanism of action in liver cancer allows interesting combination treatments with other drug alternatives for HCC.

Medivir’s strategy of combining fostrox with other treatments is well in line with the development within the HCC, a development where the enhanced clinical effect was achieved by combining different types of drugs.

Despite these advances, medical needs in liver cancer are still significant. Far from all patients benefit from existing treatment options, and therefore many combined studies are underway to find treatments that significantly improve outcomes for patients with HCC.

We are hopeful that fostrox with its liver-directed mechanism of action is an innovative combination concept that can contribute to more potent treatments and we have chosen to work in parallel with two combinations. Ultimately, we will choose the most attractive combination to proceed to phase 2b based on both the clinical results of the study and how the treatments are actually applied in cancer care.

Our preparations to open an Investigational New Drug (IND) in the United States in 2023 are progressing as planned.

The continued focus of our commercial development is based on our two clinical partnership projects, reminostat and MIV-711. The data packages of these two projects have been strengthened in 2021-2022 and we continue our dialogue with external parties with the ambition to find the best possible solution for each substance.

With respect to our licensed projects, IGM Bioscience’s clinical development work is progressing in the Phase I clinical study in solid tumors with birinapant in combination with IGM’s DR5 agonist IGM-8444 antibody. Three dose-escalation cohorts have been completed with no dose-limiting toxicity or clinically significant hepatotoxicity observed to date. Recruitment of patients into the fourth dose escalation cohort of the study is ongoing.

In summary, we see that the steps we have taken have paid off in recruiting patients for our ongoing fostrox combination study. We continue our work tirelessly so that fostrox can become an effective medicine against liver cancer that makes a real difference for patients and for care and therefore also for our shareholders. I look forward to keeping you informed of the continued development of Medivir.

jens lindbergChief executive officer

For more information, please contactMagnus Christensen, CFOTelephone: +46 (0)8 5468 3100E-mail: [email protected]

This report was reviewed by the statutory auditors. The information was submitted for publication at 08:30 CET on November 3, 2022.

The following files are available for download:

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SOURCE Medivir

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