MEDIVIR AB – YEAR END REPORT JANUARY – DECEMBER 2019

Continued progress with our proprietary and wholly owned candidate drug MIV-818 for liver cancer

October – December
Significant events during the quarter

• Preclinical data showing that in addition to its direct effect on cancer cells, MIV-818 also modulates the anti-tumor immune response, presented at the AACR-NCI-EORTC conference in Boston.
• The ninth and final liver cancer patient was included in the phase Ia study with MIV-818. Based on safety and tolerability as well as pharmaco-kinetics and positive biomarker data, it was decided to initiate the phase Ib part of the study.
• In December, an investigator-initiated phase II clinical trial of remetinostat was started in patients with squamous cell carcinoma. The study is conducted at the Stanford University School of Medicine in the United States.
• The first patient was included in a phase I study evaluating the safety and tolerability of a combination of birinapant and radiation therapy in patients with recurrent Head and Neck Squamous Cell Carcinoma. The study is sponsored and funded as part of the National Cancer Institute's Cancer Treatment Evaluation Program.
• A futility analysis of the phase II combination study with birinapant and Keytruda® in colorectal cancer patients was performed. Medivir decided to end the study since the results of the analysis indicated that the study's goals were unlikely to be achieved.
• The first milestone payment for the candidate drug MIV-701 in veterinary medicine was received in October.

Financial summary for the quarter

• Net turnover amounted to SEK 1.4 (13.6) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -30.3 (-96.6) million. Basic and diluted earnings per share amounted to SEK -1.32 (-4.72) and SEK -1.32 (-4.72) respectively.
• Cash flow from operating activities amounted to SEK -22.6 (-72.4) million.
• Liquid assets and short-term investments at the end of the period amounted to SEK 134.6 (286.3) million.

January – December
Financial summary

• Net turnover amounted to SEK 8.7 (23.9) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -118.9 (-326.5) million. Basic and diluted earnings per share amounted to SEK -5.08 (-14.62) and SEK -5.08 (-14.62) respectively.
• Cash flow from operating activities amounted to SEK -148.5 (-320.5) million.
• Liquid assets and short-term investments at the end of the period amounted to SEK 134.6 (286.3) million.

Significant events after the end of the period

• The phase II study of MIV-711 in patients with osteoarthritis was published in Annals of Internal Medicine (DOI: 10.7326/M19-0675).

Conference call for investors, analysts and the media
The Year End Report January - December 2020 will be presented by Medivir’s President & CEO, Uli Hacksell. 

Time: Thursday, February 13, 2020, at 14.00 (CET).

Phone numbers for participants from:
Sweden + 46 8 505 583 52
Europe + 44 33 3300 9268
US + 1 833 5268 396

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
The reorganization and refocus that was initiated at the end of 2018 was successful. Today we are an agile and efficient development company with the ability to use our resources where we can create the greatest value. We continued to make progress with our proprietary and wholly owned candidate drug MIV-818 for liver cancer, and we entered 2020 with a clear and targeted focus on the continued clinical development of this exciting project.

MIV-818, our most important project, is the most advanced of a series of proprietary and wholly owned prodrug substances that we intend to develop for the treatment of various cancer indications.

MIV-818, which is developed for the treatment of liver cancer, has been designed to provide a targeted anti-tumor effect in the liver while minimizing side effects. MIV-818 has the potential to be the first liver cancer-targeted, orally administered drug that can help patients with this deadly disease, who lack good treatment options.

The ongoing phase I study is designed to study the safety, tolerability and pharmacokinetics of MIV-818 in patients with advanced liver cancer, and the data from patients in the phase Ia part of the study indicate that MIV-818 has the intended liver-targeted effect. MIV-818 was well tolerated and in addition, an efficacy signal was observed in liver biopsies from tumor tissue in patients treated with MIV-818. Unlike the tumor, normal liver tissue does not appear to have been affected by the treatment. These early clinical results in phase Ia constitute a proof-of-concept for this proprietary and wholly owned project. There is a very large potential here to make a life-changing difference for patients without good treatment options.

At the end of October, preclinical data were also presented at the AACR-NCI-EORTC conference in Boston showing that, in addition to its direct effect on cancer cells, MIV-818 also modulates the anti-tumor immune response.

In November, the ninth and final patient with liver cancer was included in the phase Ia study. Based on the very positive initial observations, we decided to initiate the phase Ib part of the study. We expect to be able to present topline data during the year. Based on the ongoing study, we will determine the recommended dose for the upcoming phase II study.

MIV-828 is the next candidate drug in our proprietary and wholly owned series of prodrugs. It is a nucleotide-based prodrug that has been optimized for the treatment of acute myeloid leukemia (AML) and other forms of blood cancer. Preclinical data indicate that MIV828 may offer patients with AML and other blood cancers a drug with good efficacy and tolerability. MIV828 is developed to be combined with other medications and exhibits synergistic anticancer activity in preclinical models.

We look forward to being able to initiate clinical studies on our own with MIV-828, but this will happen when we have ensured the financial resources required.

The fourth quarter offered both successes and one setback. Birinapant is Medivir's SMAC mimetic developed for the treatment of solid tumors. The futility analysis conducted by the independent safety committee for the phase II study of combination therapy with birinapant and pembrolizumab (Keytruda®) indicated that the study's goals would not be achieved. We therefore decided to end this colorectal cancer study.

In October, an investigator-initiated phase I study was started in which the safety and tolerability of a combination of birinapant and radiotherapy are evaluated in patients with recurrent squamous cell carcinoma in the head and neck region. Potential signs of treatment efficacy will also be studied. The study is sponsored and funded as part of the National Cancer Institute's Cancer Treatment Evaluation Program.

Remetinostat is our topical HDAC inhibitor that is developed to treat mycosis fungoides, the most common form of cutaneous T-cell lymphoma. Medivir has determined the design of a phase III study is searching a partner for the continued development and commercialization of remetinostat.

In an ongoing investigator-initiated study in collaboration with researchers at Stanford University, remetinostat is given to patients with basal cell cancer (BCC). The preliminary results, presented at last year’s SID conference, indicate that remetinostat has potential as an effective and well-tolerated treatment of local skin tumors in BCC patients.

In December 2019, the first patient was dosed with remetinostat in an investigator-initiated phase II clinical study on patients with squamous cell carcinoma. Also this study is being conducted at Stanford University.

For MIV-711, Medivir's cathepsin K inhibitor for the treatment of osteoarthritis, we have compiled a robust and comprehensive data package based on the data from the extension study presented before the summer. We continue to strive to reach a licensing or collaboration agreement for the continued development of MIV-711.

Our phase II study was recently published in the esteemed journal Annals of Internal Medicine. In an editorial in the same issue, the study was commented on in a positive way.

Medivir's most important task is to develop and realize the value of our candidate drugs. It was to ensure our ability to develop and exploit the values within our clinical portfolio that we chose to concentrate and focus our operations in 2019.

Our proprietary and wholly owned projects have great potential and I look forward to the development of these projects, especially MIV-818, during 2020.

Business development remains our focus when it comes to remetinostat, birinapant and MIV-711.

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

This report has not been subject to auditors' review.

The information was submitted for publication at 08.30 CET on 13 February 2020.

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