Momentum in several areas, not least the development of our cutting-edge project fostroxacitabine bralpamide
January – March
Financial summary for the quarter
- Net turnover amounted to SEK 0.5 (9.9) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -31.4 (-7.2) million. Basic and diluted earnings per share amounted to SEK -0.59 (-0.18) and SEK -0.59 (-0.18) respectively.
- Cash flow from operating activities amounted to SEK -39.9 (-1.5) million.
- Cash and cash equivalents at the end of the period amounted to SEK 180.8 (269.3) million.
Significant events during the quarter
- In January, it was announced that the WHO had selected fostroxacitabine bralpamide as the official generic name for the patented candidate drug MIV-818, which is in clinical development in primary liver cancer.
- Jens Lindberg assumed his position as CEO of Medivir on January 24, 2022.
- On February 3, additional data from the phase I study with fostroxacitabine bralpamide were presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit.
- In February, a subgroup analysis of Medivir's phase II study with MIV-711 for osteoarthritis was published, showing significantly reduced osteoarthritis-related pain.
Conference call for investors, analysts and the media
The Interim Report January - March 2022 will be presented by Medivir’s CEO, Jens Lindberg.
Time: Thursday, April 28, 2022, at 15.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 505 583 57
Europe +44 33 3300 9262
US +1 646 722 4902
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
I took on the role as CEO of Medivir at the end of January with confidence and enthusiasm. Medivir is going through an exciting transformation journey and today has a focused strategy with a clear priority for our cutting-edge project fostroxacitabine bralpamide (fostrox) while we create value through partnerships for our other projects. 2021 was an eventful year with clear momentum in several areas, not least in terms of development for fostrox. Our vision is to improve the lives of cancer patients through transformative drugs, and after my first months at work, I feel confident that we are well equipped to do just that. We have a unique "first-in-class" project in liver cancer, a dedicated and competent team and clear priorities, so it is with confidence that I look forward to an exciting 2022.
In January, our cutting-edge project MIV-818 received the official generic name fostroxacitabine bralpamide from the World Health Organization WHO, something we see as an important step towards a product for the treatment of HCC. Fostrox has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action means that it does not directly compete with other treatment options but instead enables attractive combination treatments with other drug alternatives in hepatocellular carcinoma (HCC). Liver cancer is the third leading cause of cancer-related deaths worldwide and HCC is the most common form of cancer that arises in the liver. The effect of today's medications is often limited and mortality remains at a high level.
In December, the first patient with HCC was dosed in our ongoing phase 1b/2a combination study with fostrox, at one of our clinical trial centers in the UK. Fostrox is given in two different combinations in the study, either with Lenvima®, a tyrosine kinase inhibitor, or with Keytruda®, an anti-PD-1 checkpoint inhibitor. Lenvima® and Keytruda® (approved in the USA) are currently approved as monotherapy for the treatment of HCC. During Q1, we have focused on initiating additional clinical trial centers in Spain and South Korea. Just over 40% of the centers are based in South Korea, which is of great importance for the future development of fostrox in Asia.
Additional biomarker data from the proof-of-concept demonstrated by fostrox in the completed phase I study were presented on February 3 at the European Association for the Study of the Liver (EASL) Liver Cancer Summit in an e-poster titled “Liver biopsy biomarkers in a phase 1 study of the prodrug MIV-818 demonstrates proof-of-concept for cancer in the liver”. These data confirm, among other things, that fostrox shows a tumor-selective effect in the liver by causing the desired DNA damage and cell death in tumor cells in the liver but not in normal or healthy liver cells.
In early November 2021, we announced that our collaboration partner, IGM Biosciences, Inc., had initiated a phase I clinical study in solid tumors with birinapant in combination with its own DR5 agonist antibody IGM-8444. IGM has also announced that the combination is completed without any limiting safety issues in the first dose group, and that recruitment in the next dose group is initiated. The licensing agreement with IGM can potentially provide milestone payments up to a total of approximately USD 350 million as well as tiered royalties up to "mid-teens”
The continued focus for our business development lies on our two clinical projects for partnerships, remetinostat, for different types of skin cancer, and MIV-711, for osteoarthritis. Both projects come with very robust data packages.
In 2021 the business development potential for remetinostat was significantly strengthened through the renegotiated multi-party agreement and additional positive data from investigator-initiated phase II studies. For MIV-711, which has the potential to become the first disease-modifying treatment for osteoarthritis, an article was published at the end of February this year in Clinical and Experimental Rheumatology 2022. The article shows that in the subgroup of patients with pain in only one knee in the phase IIa study with MIV-711, a statistically significant reduction in osteoarthritis-related pain was observed after treatment. This occurred in parallel with positive structural changes in the knee joint. These interesting results provide good guidance for further clinical trials with MIV-711.
Our business development opportunities are important, not least as they provide good conditions for progressing the clinical development program for our cutting-edge project, fostrox. Our goal is to develop an effective drug for liver cancer that makes a real difference for patients and for healthcare and thus also for our shareholders. I look forward to a continued eventful 2022.
Jens Lindberg
Chief Executive Officer
For further information, please contact
Magnus Christensen, CFO, +46 (0)8 5468 3100. E-mail: magnus.christensen@medivir.com
This report has not been subject to auditors' review.
The information was submitted for publication at 08.30 CET on April 28,