Medivir AB - Interim Report January - June 2019

STOCKHOLM, Aug. 28, 2019 /PRNewswire/ -- April – June

Significant events during the quarter

• Selective effect signal on liver cancer tissue in phase Ia study with MIV-818. The analysis shows an early indication that MIV-818 works as expected, i.e. the substance has the intended liver-directed effect.
• New data from the phase I study of birinapant in combination with Keytruda® presented at ASCO.
• Positive data from the investigator-initiated study evaluating the efficacy of remetinostat in basal cell carcinoma (BCC) patients presented at the SID annual meeting.
• New safety and efficacy data from the MIV-711 phase II open label extension study presented at the OARSI world congress.
• In April, Magnus Christensen was appointed as new CFO of Medivir. He joined the company and the management team on August 12.
• At Medivir's annual general meeting May 9, An van Es Johansson was newly elected as a member of the board of directors. Helena Levander was elected new Chairman of the Board. Anders Hallberg and Anna Malm Bernsten had both declined re-election. 

Financial summary

• Net turnover amounted to SEK 3.7 (2.8) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -12.5 (-89.9) million. Basic and diluted earnings per share amounted to SEK -0.51 (-3.77) SEK and SEK -0.51 (-3.77) respectively.
• Cash flow from operating activities amounted to SEK -35.5 (-82.1) million.
• Liquid assets and short-term investments totaled SEK 191.9 (438.6) million at the period end. 

January – June
Financial summary

• Net turnover amounted to SEK 5.7 (7.3) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -66.6 (-163.0) million. Basic and diluted earnings per share amounted to SEK -2.81 (-6.96) and SEK -2.81 (-6.96) respectively.
• Cash flow from operating activities amounted to SEK -91.8 (-169.7) million.
• Liquid assets and short-term investments totaled SEK 191.9 (438.6) million at the period end. 

Conference call for investors, analysts and the media
The Interim Report January - June 2019 will be presented by Medivir's President & CEO, Uli Hacksell.

Time: Wednesday, August 28 2019, at 14.00 (CET).

Phone numbers for participants from:
Sweden + 46 8 505 583 69
Europe + 44 33 3300 9268
US + 1 833 823 0586

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
During the second quarter we could conclude that our strategy and our focus on clinical development and business development are working well. That is evident in the clinical results and progress we presented during the period, but also in how we function as a very efficient and competent organization. The team has been strengthened with our new CFO, Magnus Christensen, who joined in August, and we have also strengthened our clinical ability and now have a very experienced clinical team in place. As previously communicated, the operational fixed costs will in Q3 amount to only one third of last year's level.

Let me summarize the status of our clinical portfolio.

Remetinostat is our topical HDAC inhibitor being developed for the treatment of mycosis fungoides, the most common form of cutaneous T-cell lymphoma, a rare form of blood cancer that occurs first in the skin.

Medivir has developed the phase III design based on the clarifications we received from the FDA at the end of last year. We are now looking for a partner for the continued development and commercialization of remetinostat.

The quarter provided an interesting example of the possibility of developing remetinostat for further indications. In our collaboration with Stanford University School of Medicine in California, remetinostat has been studied on basal cell cancer (BCC). At the Society for Investigative Dermatology (SID) annual meeting in Chicago, positive data from the investigator-initiated phase II study evaluating the efficacy of remetinostat in basal cell cancer patients were presented. The preliminary results indicate that remetinostat gel has potential as an effective and well-tolerated treatment of local tumors in BCC patients.

Birinapant is Medivir's SMAC mimetic that is being developed in combination with Merck's anti-PD-1 treatment Keytruda® (pembrolizumab) as a treatment for patients with colorectal cancer. The efficacy of the combination therapy is evaluated in an ongoing phase II study in patients with microsatellite stable (MSS) colorectal cancer, a cancer form in which treatment with Keytruda® alone very rarely gives effect. This study will evaluate preliminary efficacy as well as safety and tolerability. A futility analysis of the study is planned for Q4 2019.

New data from the phase I study of birinapant in combination with pembrolizumab (Keytruda®) was presented at an oral session on June 2nd at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. In two of the in total 19 patients a partial response was observed while seven patients achieved stable disease as best response. Two patients are still on treatment, one patient with MSS colorectal cancer has partial response after 80 weeks of treatment and one patient with osteosarcoma is in stable disease has been treated for 24 weeks. We are of course delighted to see these encouraging long-term data from the phase l study. The fact that these data were selected for an oral presentation at ASCO, a privilege given to few, also indicates a strong clinical interest in birinapant as combination therapy.

Under our agreement with Merck & Co, they provide Keytruda® to Medivir at no cost. Medivir retains all rights to birinapant as well as to the data generated.

MIV-818 is Medivir's internally developed nucleotide prodrug for the treatment of cancer in the liver. In an ongoing phase I study, the safety, tolerability and pharmacokinetics of MIV-818 are studied in patients with advanced cancer in the liver, including hepatocellular carcinoma (HCC), a fatal disease with very few available treatment options. In June, we were able to present encouraging results from an analysis of data from the first six patients treated with increasing HIV-818 doses in the phase Ia part of the study. Evaluated doses were shown to be well-tolerated by patients. An effect signal, measured as DNA damage, was observed in liver biopsies from tumor tissue in MIV-818 treated patients. In contrast to the tumor, normal liver tissue does not appear to have been affected by the treatment. This tumor-selective effect indicates that MIV-818 works as expected, i.e. the substance has the intended liver-directed effect. Based on the positive results from the first six patients, we have decided to proceed with the phase Ib part of the MIV-818 study, which is expected to start in Q4 2019.

We see these early results as a proof-of-concept for this proprietary project and we are very excited about the continued clinical development. There is a great potential to make a vital difference for patients currently without good treatment options.

For MIV-711, Medivir's cathepsin K inhibitor for the treatment of osteoarthritis, we were during the period able to present new data at the Osteoarthritis Research Society International (OARSI) World Congress. Data from the six months' open label extension demonstrated that MIV-711 has satisfactory safety and tolerability in knee osteoarthritis patients, and that the beneficial effects measured on bone and cartilage as well as other symptom measures in the placebo-controlled study were maintained during the second 6-month treatment period.

The FDA's new preliminary guidelines for the development of disease-modifying osteoarthritis treatments open for structural impact as treatment targets in clinical studies and for the possibility of obtaining so-called. "Accelerated approval" after phase III studies. Medivir continues to aim to establish a licensing or collaboration agreement for MIV-711.

At the Annual General Meeting on May 9, Medivir's Board of Directors received a fine new addition in the form of An van Es Johansson, who has valuable experience both in clinical development and business development. The long-time Board members Anders Hallberg and Anna Malm Bernsten had both declined re-election and Helena Levander was elected new Chairman of the Board after Anna. I would like to take this opportunity to extend my special thanks to Anna for her devoted and dedicated efforts.

In addition to our clinical portfolio development efforts, we work intensively with business development and with responding to the increased interest in our projects that we experienced during the first half of the year. We are pleased with the increasing attention we have received, not least by selecting the presentation at ASCO as an oral presentation. We also note that in addition to Carnegie and Kempen, both Wainwright and Redeye initiated analyst coverage of Medivir in the second quarter. It is important for Medivir to succeed in reaching out to potential partners in the industry, but also to generate interest and the right expectations from the stock market. These are important prerequisites for our drug candidates to develop in the right direction in order to improve the therapy for patients with major medical needs and thus ultimately create great value for our shareholders.

Uli Hacksell
President & CEO

For further information, please contact
Uli Hacksell, CEO, +46 (0) 8 5468 3100
Magnus Christensen, CFO, +46 (0)73-125 0620

The Interim Report has not been subject to auditors' review.

The information was submitted for publication, at 08.30 CET on 28 August 2019.

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SOURCE Medivir