“Thanks to the strong interest from clinicians and patients, we were able to swiftly dose the first patients in the phase 2a part of the combination study with fostrox and Lenvima® in HCC after completed dose escalation”
January – March
Financial summary for the quarter
- Net turnover amounted to SEK 0.4 (0.5) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -18.9
(-31.4) million. Basic and diluted earnings per share amounted to SEK -0.34 (-0.59) and SEK -0.34 (-0.59) respectively. - Cash flow from operating activities amounted to SEK -16.1 (-39.9) million.
- Cash and cash equivalents at the end of the period amounted to SEK 100.8 (180.8) million.
Significant events during the quarter
- In January, Medivir's partner Infex Therapeutics received Qualified Infectious Disease Product (QIDP) designation from the FDA for MET-X.
- In February, it was announced that the recommended dose (RP2D) for the first combination arm of the phase 2a part of the fostrox study was established at 30 mg for fostrox in combination with Lenvima®.
- In February, Pia Baumann took over as CMO at Medivir.
- In March, it was announced that the first patient had been dosed in the phase 2a part of Medivir's study with fostrox in combination with Lenvima®.
- In March, it was announced that Medivir's nomination committee to the 2023 annual general meeting proposes a board consisting of current members Uli Hacksell, Lennart Hansson, Yilmaz Mahshid, Anette Lindqvist and Bengt Westermark. The nomination committee also proposes re-election of Uli Hacksell as chairman of the board.
Events after the end of the period
- In April, new data were presented showing synergistic anti-tumor effect of fostrox in triple combination with anti-PD1 and Lenvima® in non-clinical tumor models.
Conference call for investors, analysts and the media
The Interim Report January - March 2023 will be presented by Medivir’s CEO, Jens Lindberg.
Time: Thursday, April 27, 2023, at 15.00 (CET).
For dial-in numbers to the conference call, please see information on the website;
www.medivir.com/investors/calendar
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 first quarter of the year has been eventful in a very positive way for Medivir. In February, we were able to complete the dose escalation part and establish the recommended phase 2 dose for fostrox in combination with Lenvima® for patients with primary liver cancer. Shortly thereafter, the first patient was dosed in the phase 2a part of the combination study, where safety and signs of efficacy are further evaluated. We have also presented at the AACR in April new data on the synergistic anti-tumor effect of fostrox in triple combination with anti-PD1 and Lenvima® in non-clinical tumor models.
The strong interest from both patients and clinicians in Medivir's combination study with fostrox confirms the great medical need for more effective treatments for patients with hepatocellular carcinoma (HCC). The interest in participating in the study has been very large and enabled us to complete the dose escalation part and shortly afterwards start the treatment of the first patient with HCC in the phase 2a part of the combination study with fostrox and Lenvima®.
The preliminary results from the dose escalation part with fostrox in combination with Lenvima® were positive with a good safety and tolerability profile and no dose-limiting toxicity has been observed.
The results from the dose escalation and expansion phase will form the basis of the future development plan for fostrox. Lenvima® is today established as standard treatment for second-line HCC. This means that the combination of fostrox and Lenvima® has clear potential to contribute to more patients in the second line getting an increased clinical benefit from their treatment.
For the other combination arm where fostrox is given together with Keytruda®, the phase 1b part is still ongoing.
We have also, after the end of the quarter, presented new data describing the potential for fostrox to enhance anti-tumor activity in a triple combination with anti-PD-1 and kinase inhibitors in non-clinical tumor models. In order for more patients to get a satisfactory effect from their treatment, new combination options with different mechanisms of action will be critical. These new data show a synergistic anti-tumor effect when these three different treatments are combined. Fostrox, with its unique, liver-targeted approach, opens up completely new combinations with three different approaches to effectively treat HCC.
Pia Baumann has been in place since February as the new CMO at Medivir and her experiences will be very valuable for the continued clinical development of fostrox.
Medivir's clinical project birinapant is out-licensed to IGM Biosciences, which is running a phase I clinical trial in solid tumors with birinapant in combination with its own DR5 agonist antibody IGM-8444. During the quarter, the fourth dose-escalation cohort was completed and no dose-limiting toxicity has been observed to date. IGM has started the dosing of a fifth cohort in the study.
I would also like to mention our preclinical MBLI program aimed at addressing the threat of resistant bacteria. It is licensed to INFEX Therapeutics in England and MET-X, which is the name of the project, received QIDP classification by the FDA in January. INFEX has communicated its intention to initiate a phase 1 program in 2023.
In summary, an eventful quarter with the clinical development of fostrox in focus. We hope and believe that fostrox can become an effective treatment against liver cancer that makes a real difference for the patients and for the 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 not been subject to auditors' review.
The information was submitted for publication at 08.30 CET on April 27, 2023.