Medivir AB - Interim Report January - September 2018

HUDDINGE, Sweden, Oct. 26, 2018 /PRNewswire/ -- Increased focus where we can create the most value

July – September

Significant events during the quarter

• Positive top-line joint structure outcomes were reported from the MIV-711 osteoarthritis phase II extension study (MIV-711-202). Treatment with MIV-711 over a total 12 months resulted in a continuing treatment effect on joint bone area growth and prevention of cartilage degradation.

• The first patient was enrolled and dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with basal cell carcinoma (BCC).

• Dr. Linda Basse was appointed as Chief Medical Officer effective October 1.

Financial summary

• Net turnover totaled SEK 3.0 million (5.1 m).

• The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -66.9 million (-78.3m). Basic and diluted earnings per share were SEK -2.93 (-3.94) and -2.93 (-3.94) respectively.

• The cash flow from operating activities amounted to SEK -78.4 million (-63.6 m).

• Liquid assets and short-term investments totaled SEK 357.1 million (557.8 m) at the period end.

January - September 

Financial summary

• Net turnover totaled SEK 10.3 million (32.4 m).

• The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -229.9 million (-250.1 m). Basic and diluted earnings per share were SEK -9.88 (-11.42) and -9.88 (-11.42) respectively.

• The cash flow from operating activities amounted to SEK -248.1 million (-269.6 m).

• Liquid assets and short-term investments totaled SEK 357.1 million (557.8 m) at the period end.

Significant events after the period end

• Phase Ia clinical study of MIV-818 started in patients with advanced liver cancer. The purpose of this first-in-human trial is to study the safety, tolerability and pharmacokinetics of MIV-818.

• Positive interim data on birinapant in combination with Keytruda®, in patients with advanced solid tumors who have exhausted available treatment options, were announced in October.

• Medivir announced its plans to concentrate its activities on clinical development. As a result, the board has appointed Dr. Uli Hacksell as the company's CEO. Dr. Hacksell, currently on the board of Medivir, succeeded Christine Lind as of October 15.

• On October 17 Medivir notifyed the Public Employment Office of potential employee redundancies impacting 60 positions, mainly within pre-clinical research and administration.

For further information, please contact

Uli Hacksell, CEO, +46(0)8-5468-3100

Erik Björk, CFO, +46(0)72-228-2831 

CEO's comments

I took office after the end of the quarter, but have closely followed the developments in Medivir since May this year as a board member. I would like to give a brief background to the focusing of the company's business that was communicated in connection with me becoming CEO. It is actually based on the positive development of our pharmaceutical projects in clinical phase. During the quarter, advancements continued with positive news for all of our clinical projects.

Our strong commitment to developing the value of Medivir's drug candidates has led us to concentrate the company's resources on clinical development. It was a difficult but necessary decision announced after the end of the quarter when we also gave notice to the Public Employment Office regarding potential redundancies of 60 positions. It was taken to ensure that our resources are used where we can create the greatest value. The measures are expected to reduce our running costs, excluding the costs of the clinical projects, by about two thirds.

Let me tell you about the development of Medivir's portfolio. At the end of the second quarter, we were able to present a good safety and tolerability profile in our phase II extension study with MIV-711 for the treatment of osteoarthritis. We could also show sustained effects on clinical symptoms based on the preliminary data. This was reinforced by the top-line results presented at the end of July, which showed that treatment with MIV-711 for a total of 12 months resulted in continued good effect on joint bone area growth. During the quarter, the FDA also published preliminary guidelines for the development of disease modifying osteoarthritis treatments. The new guidelines discuss structural changes as treatment goals in clinical trials, and how it could be used for so-called "accelerated approval", which can positively affect the value of MIV-711.

At the beginning of August, our collaboration with Stanford University School of Medicine in California resulted in the first patient being dosed with remetinostat gel 1% in its trial-initiated phase II clinical study with remetinostat in patients with basal cell cancer.

Dialogue with the FDA on the design of Medivir's planned phase III study with remetinostat continued during the quarter. We want to make possible the initiation of a pivotal study that, given good results, can result in market approval for the treatment of patients with early-stage cutaneous T-cell lymphoma.

MIV-818, our proprietary drug for liver cancer, took the final steps towards the clinic and on October 1, the first patient was dosed with MIV-818 in a phase Ia study. The purpose of this first in human trial is to study safety, tolerability and pharmacokinetics of MIV-818 in patients with advanced liver cancer, a fatal disease with very few available treatment options.

A few days later, on October 4, we presented positive safety data and an interesting effect signal after an interim phase I data analysis from the ongoing phase I/II study of birinapant in combination with Keytruda® on cancer patients in advanced stages. In addition to an excellent safety profile, no dose-limiting toxicity was observed in the first three patient groups, and the dose escalation has been continued to the highest planned dose level in the study.

The clinical projects have thus been pursued successfully. It is specifically to ensure our ability to develop and exploit the value contained in our clinical portfolio that we chose to concentrate the business and have taken both uncomfortable and heavy measures as it involves giving notice and reducing Medivir's research.

Medivir's research is of high quality and our employees are excellent. Therefore, we are investigating strategic alternatives for the valuable assets found in our early research.

Medivir is now restructuring into a significantly smaller organization. That we are reducing the running costs by two thirds says a lot. It will also require us to be more agile and flexible with the ability to work with outsourcing. In the proposed organization there is a high level of competence that also makes me confident we will manage to run the projects cost-effectively.

Finally, I would like to thank Christine Lind for her efforts and continued contributions in the near future.

Medivir's increased focus on clinical development gives us a positive path for the future. I look forward to sharing more information about our progress in the future.

Uli Hacksell

President and CEO 

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 26 October 2018.

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SOURCE Medivir