MEDIVIR AB – INTERIM REPORT JANUARY – JUNE 2022

The clinical development of fostrox remains our focus 

April – June

Financial summary for the quarter

• Net turnover amounted to SEK 0.5 (0.9) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -21.5 (-17.1) million. Basic and diluted earnings per share amounted to SEK -0.42 (-0.31) and SEK -0.42 (-0.31) respectively.
• Cash flow from operating activities amounted to SEK -17.6 (-21.9) million.
• Cash and cash equivalents at the end of the period amounted to SEK 162.8 (247.8) million.

Significant events during the quarter

• At Medivir’s AGM on May 5, Uli Hacksell, Lennart Hansson, Bengt Westermark and Yilmaz Mahshid were re-elected and Anette Lindqvist was newly elected as board members in the company. Uli Hacksell was re-elected as chairman of the board. An van Es Johansson had declined re-election.

January – June

Financial summary for the period

• Net turnover amounted to SEK 1.0 (10.8) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -52.9
  (-24.3) million. Basic and diluted earnings per share amounted to SEK -1.00 (-0.51) and SEK -1.00 (-0.51) respectively.
• Cash flow from operating activities amounted to SEK -57.5 (-23.3) million.
• Cash and cash equivalents at the end of the period amounted to SEK 162.8 (247.8) million.

Significant events after the period

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

Conference call for investors, analysts and the media

The Interim Report January - June 2022 will be presented by Medivir’s CEO, Jens Lindberg.
 

Time: Friday, August 19, 2022, at 14.00 (CET).

Phone numbers for participants from:

Sweden + 46 8 566 426 93

Europe +44 33 3300 9031

US +1 646 722 4902

The conference call will also be streamed via a link on the website: www.medivir.com

The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message

Our steadfast determination is one of the most important factors enabling Medivir to deliver continued good results, both with fostrox and in the business development of our other assets.

The past quarter was above all characterized by the work to drive the clinical development of our cutting-edge project fostroxacitabine bralpamide (fostrox), for the treatment of hepatocellular carcinoma (HCC). Fostrox has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action in liver cancer enables attractive combination treatments with other drug alternatives for HCC.

In our currently ongoing phase 1b/2a combination study, fostrox is given in two different combinations, either with Lenvima®, a tyrosine kinase inhibitor, or with Keytruda®, an anti-PD-1 checkpoint inhibitor. The study is conducted at clinical trial centers in the UK, Spain and South Korea.             

During the second quarter, we have continued to focus on activating additional trial centers and on recruiting patients to the two arms in the study. We have now initiated 3 centers in the UK, 5 centers in Spain and 5 centers in South Korea. In addition, we intend to increase the number of investigators and centers primarily in South Korea. We are also working to open centers in additional countries. At the same time, we have intensified Medivir’s presence at the activated trial centers to ensure that investigators and other staff have a continued focus on our study.

Increased competition from other studies in our patient population and changes in second-line treatment, where we saw patients could receive Tecentriq® + Avastin® treatment also in second-line, have led to slower recruitment than planned in Europe in the second quarter. We are therefore in the process of broadening and simplifying the inclusion criteria, among other things by opening up to third-line patients if they do not have an overly advanced liver disease.

These measures, which include broadened inclusion criteria, an increased number of trial centers and investigators as well as an increased presence of our employees at the centers, create the conditions for the recruitment rate to increase during the second half of 2022.             

I would also like to mention that the name fostroxacitabine bralpamide that we received from the WHO has now also received formal approval as a drug name in the USA by the USAN Council. Furthermore, our work to open an Investigational New Drug (IND) in the USA in 2023 is progressing according to plan.

The continued focus for our business development lies on our two clinical projects for partnerships, remetinostat and MIV-711. Both projects come with very robust data packages. The data packages for these two projects have been strengthened during 2021–2022 and we continue our dialogue with external parties with the ambition of finding the best possible solution for each substance.

During the quarter, we have seen continued positive development of IGM Bioscience's clinical development work with birinapant. In the phase I clinical trial in solid tumors with birinapant in combination with IGM’s own DR5 agonist antibody IGM-8444, patient inclusion in the third dose escalation cohort has been completed. No dose-limiting toxicity or clinically significant hepatotoxicity has been observed to date. The patient recruitment for the fourth dose-escalation cohort of the study has been initiated. The agreement with IGM can potentially provide milestone payments up to a total of approximately USD 350 million as well as tiered royalties up to “mid-teens”.

Finally, in 2017, Medivir's MBLI program, aimed at addressing the threat of resistant bacteria, was out-licensed to AMR Centre in England. AMR, today INFEX Therapeutics, has in 2022 presented additional preclinical data and communicated its intention to initiate a phase 1 program in 2022/23. Several countries have developed innovative financial solutions for new antibiotics, which has increased the commercial opportunities for this type of pharmaceutical. Medivir is entitled to a share of potential future revenue.

I would also like to extend a warm welcome to Anette Lindqvist, who was elected as a new member of Medivir's board at the annual general meeting on May 5. I also want to thank An van Es Johansson, who declined re-election, for her efforts as a board member.

We are working with great enthusiasm to achieve the goal that our cutting-edge project fostrox can become an effective drug against liver cancer which would make a real difference for patients and for healthcare and thus also for our shareholders. We see that the measures we have taken in the clinical program have begun to yield results and look forward with confidence to the second half of the year and to keeping you informed about Medivir's continued development.

Jens Lindberg

Chief Executive Officer

For further information, please contact

Magnus Christensen, CFO

Phone: +46 (0)8 5468 3100

E-mail: magnus.christensen@medivir.com

This report has not been subject to auditors' review.

The information was submitted for publication at 08.30 CET on August 19, 2022.

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