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Clinical studies progress according to plan

January – March
Significant events during the quarter

  • The phase II study of birinapant in combination with Keytruda® in colorectal cancer patients progresses according to plan. A futility analysis is planned to be conducted no later than the fourth quarter of 2019.
  • The phase Ia study of MIV-818 in patients with liver cancer is planned to be completed during the second quarter of 2019.
  • As a result of the restructuring of Medivir, there is no longer any preclinical research conducted in the company. The new organization focuses on clinical development and business development. The slimmed organization works well and efficiently in a more flexible way.
  • In February, it was announced that CFO Erik Björk decided to leave the company. Lotta Ferm was appointed interim CFO from March 1, 2019.

Financial summary

  • Net turnover amounted to SEK 2.0 (4.5) million.
  • The loss before interest, tax, depreciation and amortization (EBITDA totalled SEK -54.2 (-73.1) million. Basic and diluted earnings per share amounted to SEK -2.30 (-3.17) and SEK -2.30 (-3.17) respectively.
  • Cash flow from operating activities amounted to SEK -56.3 million (-87.1) million.
  • Liquid assets and short-term investments totaled SEK 228.6 million (522.6 m) at the period end.

Significant events after the period end

  • In April, Magnus Christensen was recruited as new CFO and he will assume his position in August 2019.

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

Time: Friday, May 3, 2019, at 14.00 (CET).

Phone numbers for participants from:
Sweden + 46 8 505 583 68
Europe + 44 33 3300 9267
US + 1 833 526 8381

The conference call will also be streamed via a link on the website:
The presentation will be available on Medivir’s website after completion of the conference.

For further information, please contact
Uli Hacksell, CEO, +46 (0) 8 5468 3100

Lotta Ferm, interim CFO, +46 (0) 73-125 17 13 

CEO’s comments

The first quarter of 2019 has run according to plan for Medivir. Following the transformative changes that were made last year, it is gratifying to note that the new organization is now working focused, efficiently and thoroughly with the company's clinical portfolio and business development. The changes that were made last year also enabled us to reduce the running costs in the business going forward. We estimate that our goal, that these costs will amount to one third of their previous level, will be reached in the third quarter.

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. We are now developing the phase III design based on the clarifications we received from the FDA at the end of last year. We intend to seek a partner for the continued development and commercialization of remetinostat.

In our collaboration with Stanford University School of Medicine in California, a trial-initiated phase II study with remetinostat in patients with basal cell cancer is ongoing.

Birinapant is Medivir's SMAC mimetic that is being developed in combination with MSD's anti-PD-1 treatment Keytruda® (pembrolizumab) for patients with solid tumors. The study, which is performed at several clinics, mainly in the United States, has an open single-arm design and is performed in two parts. The initial dose escalation part of the study (phase I) showed a positive safety profile and in addition, an interesting effect signal was noted on one of the patients with microsatellite-stable (MSS) colorectal cancer, a cancer form in which treatment with Keytruda® alone very rarely gives effect.

The inclusion of the first colorectal cancer patient in the phase II part of the study took place just before Christmas. This study evaluates preliminary efficacy as well as continued safety and tolerability of birinapant in combination with Keytruda® in patients with colorectal cancer. A futility analysis of the study is planned for Q4 2019.

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 nucleotide prodrug that is being developed for the treatment of liver cancer. In an ongoing phase I study, six patients have already been included. The purpose of this first-in-human study is to study safety, tolerability and pharmacokinetics of MIV-818 in patients with advanced cancer in the liver, a fatal disease with very few available treatment options. We expect the results from the first part of the phase I study to be available for analysis during Q2 2019.

At the end of last year, Medivir's proprietary substance MIV-828 was selected as candidate drug for the treatment of acute myeloid leukemia (AML) and other forms of blood cancer. MIV-828 is a nucleotide-based prodrug designed to overcome the resistance mechanisms that can inhibit the effects of nucleoside analogues currently used for the treatment of AML.

For MIV-711, Medivir's cathepsin K inhibitor for the treatment of osteoarthritis, we were able to present very positive phase II data last year. The FDA's new preliminary guidelines for the development of disease-modifying osteoarthritis treatments open up for structural influence as an endpoint in clinical studies and for the possibility of obtaining so-called "Accelerated approval". Medivir continues to aim at establishing a license or cooperation agreement for MIV-711.

The organization has quite recently recruited a new CFO, Magnus Christensen. He joins in August to a team with broad expertise and experience of both drug development and business development. Together, we work hard and diligently, developing our candidate drugs in the right direction in order to improve treatment for patients with great medical needs and thus ultimately create great values for our shareholders.

Uli Hacksell
President and CEO 

This report has not been subject to auditors' review.

The information was submitted for publication at 08.30 CET on 3 May 2019.