The measures to increase the pace of patient recruitment have yielded results. The Fostrox study is now progressing as expected.
July – September
Financial summary for the quarter
- Net turnover amounted to SEK 1.1 (0.8) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -13.9 (-11.7) million. Basic and diluted earnings per share amounted to SEK -0.27 (-0.24) and SEK -0.27 (-0.24) respectively.
- Cash flow from operating activities amounted to SEK -19.7 (-20.0) million.
- Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million.
Significant events during the quarter
- Fostroxacitabine bralpamide – the name given to MIV-818 by the World Health Organization (WHO) – received formal approval as a pharmaceutical name in the USA by the United States Adopted Names (USAN) Council.
January – September
Financial summary for the period
- Net turnover amounted to SEK 2.1 (11.6) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -66.9 (-36.0) million. Basic and diluted earnings per share amounted to SEK -1.27 (-0.75) and SEK -1.27 (-0.75) respectively.
- Cash flow from operating activities amounted to SEK -77.1 (-43.3) million.
- Cash and cash equivalents at the end of the period amounted to SEK 142.2 (225.9) million.
Events after the end of the period
- In October the nomination committee was appointed ahead of the AGM in May 2023. The Nomination Committee consists of Karl Tobieson (Chairman), appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB.
Conference call for investors, analysts and the media
The Interim Report January - September 2022 will be presented by Medivir’s CEO, Jens Lindberg.
Time: Thursday, November 3, 2022, at 15.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 505 583 65
Europe +44 33 3300 9269
US +1 631 913 1422, pin code 19436682#
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
Our measures to regain momentum in patient recruitment have been effective and the fostrox study is now progressing as expected.
Medivir's absolute focus is on the continued clinical development of our cutting-edge project fostroxacitabine bralpamide (fostrox), for the treatment of hepatocellular carcinoma (HCC).
I described in our Q2 report that we saw slower recruitment to the study than expected in the second quarter, mainly in Europe. In order to increase recruitment speed, we decided for example to activate additional study centers and increase our presence at already activated trial centers.
It is now very gratifying to state that the measures we initiated to speed up patient recruitment to the study have borne fruit. Today, a total of 14 centers are activated in the UK, Spain and South Korea and during Q3 we have seen an accelerated recruitment rate.
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 in liver cancer enables attractive combination treatments with other drug alternatives for HCC.
Medivir's strategy, to combine fostrox with other treatments, is well in line with the development within HCC, a development where improved clinical effect has been obtained by combining different types of medications.
Despite these advances, the medical needs in liver cancer are still significant. Far from all patients benefit from existing therapy options, and therefore many combination studies are underway to find treatments that significantlyimproves the outcome for HCC patients.
We have good hopes that fostrox with its liver-directed mechanism of action is an innovative combination concept that can contribute to more powerful treatments and we have chosen to work in parallel with two combinations. In the end, we will choose the most attractive combination to proceed with in phase 2b based both on the clinical results of the study and how the treatments are actually applied in cancer care.
Our preparations to open an Investigational New Drug (IND) in the USA in 2023 is progressing according to plan.
The continued focus for our business development lies on our two clinical projects for partnerships, remetinostat and MIV-711. The data packages for these two projects have been strengthened during 2021–2022 and we continue our dialogue with external parties with the ambition of finding the best possible solution for each substance.
Regarding our out-licensed projects, IGM Bioscience’s clinical development work is progressing in the phase I clinical study in solid tumors with birinapant in combination with IGM’s own DR5 agonist antibody IGM-8444. Three dose-escalation cohorts have been completed with no dose-limiting toxicity or clinically significant hepatotoxicity observed to date. Patient recruitment to the fourth dose escalation cohort in the study is ongoing.
In summary, we see that the measures we have taken have yielded results in patient recruitment for our ongoing combination study with fostrox. We continue our work tirelessly so that fostrox can become an effective drug against liver cancer that makes a real difference for patients and for care and thus also for our shareholders. I look forward to keeping you informed of Medivir's continued development.
Jens Lindberg
Chief Executive Officer
For further information, please contact
Magnus Christensen, CFO
Phone: +46 (0)8 5468 3100
E-mail: magnus.christensen@medivir.com
This report has been subject to auditors’ review.
The information was submitted for publication at 08.30 CET on November 3, 2022.