HUDDINGE, Sweden, February 15, 2022 /PRNewswire/ —

October – December

Quarterly Financial Summary

  • Net sales amounted to SEK13.9 (1.5 million.
  • The loss before interest, taxes and amortization (EBITDA) amounts to -SEK23.5 (-10.6) million. Basic and diluted earnings per share amounted to SEK-0.44 (-0.46) and SEK-0.44 (-0.46) respectively.
  • Cash flow from operating activities amounted to -SEK5.4 (-1.0) million.
  • Cash and short-term investments at the end of the period amounted to SEK221.2 (70.0) million.

Highlights of the quarter

  • In October, the Board of Directors appointed jens lindberg as the new CEO of Medivir. jens lindberg has extensive experience in the pharmaceutical industry and the field of oncology. He comes from Sedana Medical where he served as vice president of business operations and interim CEO.
  • IGM Biosciences, Inc. has initiated its clinical study in solid cancers with birinapant (IGM-9427) in combination with the IGM DR5 agonist antibody IGM-8444. The purpose of this first clinical trial with the combination is to assess safety and tolerability.
  • In November, the results of an investigator-initiated phase II clinical trial of reminostat in patients with squamous cell carcinoma were published.
  • In December, it was announced that the first patient with hepatocellular carcinoma had started treatment with fostroxacitabine bralpamide (MIV-818) in the phase 1b / 2a combined study.

January – December

Financial summary for the period

  • Net sales amounted to SEK25.5 (13.9) million.
  • The loss before interest, taxes and amortization (EBITDA) amounts to -SEK59.5 (-38.5) million. Basic and diluted earnings per share amounted to -SEK1.20 (-1.75) and -SEK1.20 (-1.75) respectively.
  • Cash flow from operating activities amounted to -SEK 48.7 (-58.1) million.
  • Cash and short-term investments at the end of the period amounted to SEK221.2 (70.0) million.

Significant events after the end of the period

  • In January, it was announced that the WHO had selected fostroxacitabine bralpamide as the official generic name for patented drug candidate MIV-818, which is in clinical development for primary liver cancer.
  • jens lindberg took over as CEO of Medivir on January 24, 2022.

Conference call for investors, analysts and media

Year-end report January – December 2021 will be presented by the CEO of Medivir, jens lindberg.

Time: Tuesday, February 15, 2022at 2:00 p.m. (CET).

Telephone numbers of participants from:

Sweden + 46 8 566 427 06

Europe +44 33 3300 9032

USA +1 646 722 4956

The conference call will also be broadcast via a link on the website:

The presentation will be available on the Medivir website after the end of the conference.

Message from the CEO

At January 24, 2022, I took over the management of Medivir and after my first professional experience, I understand why the company has been so successful in achieving its business objectives in 2021. We have an extremely competent and experienced team who work with dedication with our two projects. fostroxacitabine bralpamide (MIV-818) and with the commercial development of our other assets. I hope I can contribute to strengthening our delivery capacity in the future. Under the leadership of the company’s former CEO, Yilmaz Mahshid, now a member of the Medivir Board of Directors, and our Chief Financial Officer Magnus Christensenwho has served as the company’s interim leader since May, Medivir has made significant progress in 2021.

Medivir’s drug development is focused on a very promising and proprietary clinical project, fostroxacitabine bralpamide (formerly MIV-818), with a clear therapeutic target, where unmet medical needs remain extremely high, despite recent clinical advances. Fostroxacitabine bralpamide has the potential to become the first oral, liver-targeting drug that can help patients with various liver cancers. Its unique mechanism of action means that it does not directly compete with other treatment options, but rather allows combination treatments with other drug alternatives in hepatocellular carcinoma (HCC). Liver cancer is the third leading cause of cancer-related death worldwide and HCC is the most common form of cancer that arises in the liver. The effect of today’s drugs is often limited and mortality remains high.

After the end of the year, MIV-818 received the official generic name fostroxacitabine bralpamide from the World Health Organization WHO, which we consider an important step towards a product for the treatment of HCC.

The clinical development program for fostroxacitabine bralpamide passed several milestones during the year. In April, it was announced that initial results from the monotherapy portion of the Phase Ib study were positive with a good safety and tolerability profile. They were then presented in more detail at the ESMO Congress in September and aroused great interest. In May, the design of the next stage, the phase 1b/2A combination study with fostroxacitabine bralpamide for liver cancer has been presented. Regulatory approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the study was obtained in late August, and from South Korea’s Ministry of Food and Drug Safety (MFDS) in November.

In December, the first patient with HCC received a dose in the phase 1b/2a combination study with fostroxacitabine bralpamide, which is given in combination with two other drugs, either Lenvima®, a tyrosine kinase inhibitor, or Keytruda®, an anti-PD-1 checkpoint inhibitor. Lenvima® and Keytruda® (approved in the United States) are currently approved as monotherapy treatments for HCC.

The licensing agreement with IGM Biosciences, Inc., which gives IGM worldwide and exclusive rights to develop birinapant, could potentially provide milestone payments up to a total of approximately $350 million as well as tiered royalties through “mid-teens”. At the time of signing January 2021Medivir received $1 millionand when IGM launched a phase I clinical trial in solid cancers with birinapant in combination with its own DR5 agonist antibody IGM-8444 in early November, it was followed by an additional clinical trial $1.5 million. Of course, we look forward to continued clinical development of birinapant by IGM.

Also for the reminostat, it is worth noting a number of advances made during the year. Positive results from the investigator-initiated Phase II clinical trial of reminostat in patients with squamous cell carcinoma were published in November in the scientific journal JAMA Dermatology. Promising results from the investigator-initiated phase II study with reminostat for basal cell carcinoma were published in August in the scientific journal Clinical Cancer Research. Thanks to a renegotiated multi-party agreement, Medivir was able to further strengthen the commercial development potential of reminostat in August.

Business development and collaborations are at the heart of Medivir’s success. Birinapant is a good example of this and we see opportunities for reminostat and MIV-711, but also in other smaller projects. In early 2021, a license agreement was concluded with Ubiquigent for the USP7 preclinical research program.

Thanks to the financing which was successfully completed at the beginning of the year and which enabled the company to 223 million Swedish crowns before transaction costs, we enter 2022 with resources and commercial development opportunities that offer good conditions to pursue the clinical development program of our cutting-edge fostroxacitabine bralpamide project. Our goal is to make it an effective medicine against liver cancer that makes a real difference for patients and for healthcare, and therefore also for our shareholders. I look forward to keeping you informed of the continued development of Medivir.

jens lindberg

Chief executive officer

For more information, please contact

Magnus ChristensenCFO, +46 (0)8 5468 3100
E-mail: [email protected]

This report has not been reviewed by the auditors.

The information was submitted for publication at 08:30 CET on February 15, 2022.

This information was brought to you by Cision—year-end-report-january—december-2021,c3506550

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SOURCE Medivir

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