Medivir AB - Interim Report January - June 2018

HUDDINGE, Sweden, July 25, 2018 /PRNewswire/ --

Successful progression of clinical projects

April ? June
Significant events during the quarter

• Positive top-line results from the MIV-711 osteoarthritis phase IIa extension study. The study met the primary endpoint, demonstrating that MIV-711 200mg had an acceptable safety and tolerability profile.
• Preclinical data on MIV-818 were presented at the AACR Annual Meeting.
• The design of the ongoing phase I/II study of birinapant in combination with Keytruda®, including the planned phase II dose expansion cohorts, was presented at the 2018 American Society for Clinical Oncology annual meeting.
• Additional data from the phase II study of remetinostat in patients with early stage cutaneous T-cell lymphoma were presented during the International Investigative Dermatology meeting.
• Due to continued discussions with FDA to agree on the design of the planned pivotal phase III clinical study of remetinostat, study start will not be possible by end of 2018 as was previously expected.
• One class of shares outstanding as all series A shares have been converted to series B shares.

Financial summary

• Net turnover totaled SEK 2.8 million (9.5 m).
• The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -89.9 million (-90.9 m). Basic and diluted earnings per share were SEK -3.88 (-3.91) and -3.88 (-3.91) respectively.
• The cash flow from operating activities amounted to SEK -82.7 million (-82.1).
• Liquid assets and short-term investments totaled SEK 438.6 million (624.2 m) at the period end.

January - June
Financial summary

• Net turnover totaled SEK 7.3 million (27.3 m).
• The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -163.0 million (-171.8 m). Basic and diluted earnings per share were SEK -6.96 (-7.50) and -6.96 (-7.50) respectively.
• The cash flow from operating activities amounted to SEK -169.7 million (-206.0).
• Liquid assets and short-term investments totaled SEK 438.6 million (624.2 m) at the period end.

Conference call for investors, analysts and the media 
The Interim Report January ? June 2018 will be presented by Medivir's President & CEO, Christine Lind.
Time: Wednesday, 25 July 2018, at 14.00 (CET).

Phone numbers for participants from:
Sweden + 46-8-566-426-62
Europe + 44-20-3008 9804
US +1-855-753-2236

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 comments

During the second quarter of 2018, Medivir continued the rigorous development and advancement of our projects. The interest for these projects from the scientific community is truly great, which was further demonstrated this spring as all our clinical projects ? across the portfolio - had their day in the sun, being presented by our study investigators at important and well-respected scientific conferences.

On MIV-711, data from the initial phase IIa study demonstrating disease-modifying activity in patients with moderate knee osteoarthritis were presented by Dr. Philip Conaghan from the University of Leeds in the UK at the Osteoarthritis Research Society International (OARSI) World Congress in Liverpool in April.

Top-line results from the phase IIa extension study with MIV-711 in osteoarthritis were announced at the end of the second quarter. We were very pleased with these results demonstrating an acceptable safety and tolerability profile and sustained effects on clinical symptoms supporting the advancement into further studies of MIV-711 as a disease-modifying osteoarthritis treatment

The discussions with potential partners for MIV-711 for osteoarthritis disease modification continue, now strengthened by the results from this extension study.

On remetinostat, data from the phase II study in patients with early stage cutaneous T-cell lymphoma (CTCL) showing remetinostat's effect on reducing itching were presented by Dr. Madeleine Duvic from MD Anderson Cancer Center in the US at the International Investigative Dermatology (IID) meeting in Orlando in May.

We continue the dialogue with the FDA on the remetinostat phase III study design in order to ensure that we are able to initiate a pivotal study that, if successfully completed will bring the drug through approval and to patients with early-stage CTCL.

On birinapant, the design of the ongoing phase I/II study of birinapant in combination with Keytruda® in advanced cancer patients was presented by the study's lead investigator Professor Russell J. Schilder from Thomas Jefferson University Hospital in the US at the ASCO Annual Meeting in Chicago in June.

We are looking forward to the outcome of the phase I part of the phase I/II birinapant combination study with Keytruda® to enable us to further study in phase II birinapant's ability to improve patient responses in certain cancer types that are more likely to respond to birinapant.

In addition, MIV-818 further demonstrates the ability of our research organization to develop innovative new drug candidates. MIV-818 is our in-house discovered and developed nucleotide prodrug and is being developed for the treatment of hepatocellular carcinoma and other liver cancers. Preclinical efficacy data of MIV-818 in combination with sorafenib was presented by our own scientists at the annual meeting of the American Association for Cancer Research (AACR) in Chicago in April. This presentation focused on the preclinical efficacy data on MIV-818 in combination with sorafenib, the only agent currently approved in the USA as first-line treatment for advanced hepatocellular carcinoma.

We intend to advance MIV-818 into clinical studies specifically for liver cancer patients.

Rest assured that we will continue to develop our business the Medivir way: applying rigorous science to develop transformative drugs and thus create meaningful data and great partnerships. We will continuously keep you informed of the progress in each of our projects. It is my firm belief that with our expertise and thorough consistent execution, by continuing to put one foot in front of the other, we will get results that can make a true difference for patients and create value for our shareholders.

Christine Lind
President and CEO 

The information in this report comprises the information that Medivir AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 08.45 CET on 25 July 2018.

For further information, please contact:
Christine Lind,
President & CEO,
+46(0)8-5468-3100

or,

Erik Björk,
CFO,
+46(0)72-228-2831

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SOURCE Medivir