MEDIVIR AB - INTERIM REPORT JANUARY - SEPTEMBER 2020

HUDDINGE, Sweden, Nov. 10, 2020 /PRNewswire/ --

Continued focus on MIV-818

July – September
Significant events during the quarter

• In July, a research collaboration was initiated with the Drug Discovery and Development Platform (DDD) at SciLifeLab on potential inhibitors of SARS CoV-2. Through the collaboration, DDD will get access to Medivir's unique proprietary protease-targeted compound library.

Financial summary for the quarter

• Net turnover amounted to SEK 1.1 (1.7) million.
• The profit before interest, tax, depreciation and amortization (EBITDA) amounted to SEK 5.2 (-22.0) million. Basic and diluted earnings per share amounted to SEK 0.19 (-0.95) and SEK 0.19 (-0.95) respectively.
• Cash flow from operating activities amounted to SEK -17.1 (-31.8) million.
• Liquid assets and short-term investments at the end of the period amounted to SEK 82.7 (158.5) million.

January - September
Financial summary

• Net turnover amounted to SEK 12.5 (7.3) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -27.9 (-88.6) million. Basic and diluted earnings per share amounted to SEK -1.30 (-3.76) and SEK -1.30 (-3.76) respectively.
• Cash flow from operating activities amounted to SEK -57.1 (-125.3) million.
• Liquid assets and short-term investments at the end of the period amounted to SEK 82.7 (158.5) million.

Significant events after the end of the quarter

• In October Dr. Tom Morris was appointed interim Chief Medical Officer. Dr. Morris will report to CEO Yilmaz Mahshid and be a member of Medivir's management team.

Conference call for investors, analysts and the media
The Interim Report January - September 2020 will be presented by Medivir's President & CEO, Yilmaz Mahshid.

Time: Tuesday, November 10, 2020, at 14.00 (CET).

Phone numbers for participants from:
Sweden + 46 8 566 427 04
Europe + 44 33 3300 9265
US + 1 833 249 84 05

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
I took office as CEO of Medivir at the end of the quarter and the time that has passed since then has truly been very stimulating and exciting. For me and my colleagues at Medivir, the focus is on the company's proprietary and wholly owned candidate drug for liver cancer, MIV-818. The ongoing phase Ib study has progressed according to plan during the autumn. However, we note that the pandemic has picked up again and this may impact our timeline for the study.

MIV-818 has the potential to become the first liver-directed, orally administered drug that can help patients with various cancers of the liver. Data from the Phase Ia study show that patients were exposed to acceptable troxacitabine levels outside of the liver, supporting the liver targeted effect of MIV-818.

The ongoing first part of the phase Ib study with MIV-818 in patients with advanced liver cancer is a classic dose-escalation study where the safety and tolerability profile is examined and the starting dose for the latter part of the study will be determined. We expect topline data from the ongoing study during the first quarter of 2021.

In the final part of the phase Ib study, MIV-818 will be administered in combination with standard treatment. We plan for the study to start towards the end of the first half of 2021 with topline data in the end of 2021.

Medivir's focused strategy builds on using our resources where they can create the greatest value. This means that practically all our resources are invested in driving MIV-818 forward towards efficacy data. As a consequence, we are currently pausing further development of our next candidate drug, MIV-828, a nucleotide-based prodrug for the treatment of blood cancer. For our other projects - remetinostat, birinapant and MIV-711 - we are searching for partnerships for further development.

In our collaborations with academic research, the two investigator-initiated phase II studies with remetinostat at Stanford University in the USA were completed during the quarter. This concerns the study with remetinostat for basal cell carcinoma (BCC), where promising preliminary data were presented last year. We look forward to seeing the final data when it is published. In the second study at Stanford University, with remetinostat against squamous cell carcinoma, four patients were recruited and then, in October, the study was terminated due to a shortage of GMP-manufactured drugs. We expect data on these four patients to be published in the future.

At the National Cancer Institute (NCI) in the USA, an ongoing investigator-initiated phase I study evaluates the safety and tolerability of Medivir's SMAC-mimetc birinapant combined with radiotherapy in patients with recurrent squamous cell carcinoma in the head and neck region.

I would like to take this opportunity to thank my predecessor Prof. Uli Hacksell for the work put into reshaping, sharpening and focusing Medivir. We will continue to focus on having as efficient organization as possible in order to be able to carry out our clinical development programs with continued cost control. During the quarter, we have for example renegotiated a lease agreement, which impacted earnings positively, and together with lower external costs we are reporting an operating profit of SEK 4.2 million.

An important strategic work is now underway on the best pathway for taking MIV-818 forward towards a potential market approval. I look forward to presenting the way forward during the first quarter of next year.

Yilmaz Mahshid
President & CEO
 
For further information, please contact
Yilmaz Mahshid, CEO, +46 (0) 8 5468 3100
Magnus Christensen, CFO, +46 (0)73-125 0620

This report has been subject to auditors' review.

The information in this report comprises the information that Medivir is obliged to disclose under the provisions of the Swedish Securities Markets Act.

The information was submitted for publication at 08.30 CET on 10 November 2020

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SOURCE Medivir