Positive MIV-818 data presented at ESMO. New positive data and renegotiated agreement for remetinostat
July – September
Financial summary for the quarter
- Net turnover amounted to SEK 0.8 (1.1) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -11.7 (5.2) million. Basic and diluted earnings per share amounted to SEK -0.26 (0.19) and SEK -0.26 (0.19) respectively.
- Cash flow from operating activities amounted to SEK -20.0 (-17.1) million.
- Liquid assets and short-term investments at the end of the period amounted to SEK 225.9 (82.7) million.
Significant events during the quarter
- In July, Malene Jensen was appointed Vice President Clinical Development. She took on her position in early September.
- In August, the positive results from the phase II study with remetinostat against basal cell carcinoma (BCC) were published in the scientific journal Clinical Cancer Research.
- In August, it was announced that Medivir, through a renegotiated multi-party agreement, strengthens the business development potential for remetinostat.
- End of August, Medivir received regulatory approval from the British UK Medicines & Healthcare products Regulatory Agency (MHRA) for the upcoming phase 1b/2a combination study with MIV-818 against liver cancer.
- At the ESMO Congress in September, the results from the completed dose escalation part of the phase 1b monotherapy study with MIV-818 were presented. Medivir presented the data at a conference call on the same day.
January - September
Financial summary for the period
- Net turnover amounted to SEK 11.6 (12.5) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.0 (-27.9) million. Basic and diluted earnings per share amounted to SEK -0.80 (-1.30) and SEK -0.80 (-1.30) respectively.
- Cash flow from operating activities amounted to SEK -43.3 (-57.1) million.
- Liquid assets and short-term investments at the end of the period amounted to SEK 225.9 (82.7) million.
Significant events after the end of the period
- In October, the Board of Directors appointed Jens Lindberg as new CEO of Medivir. Jens Lindberg has extensive experience from the pharmaceutical industry and the field of Oncology. He joins from Sedana Medical where he has been VP Commercial Operations and acting CEO.
Conference call for investors, analysts and the media
The Interim Report January - September 2021 will be presented by Medivir’s interim CEO, Magnus Christensen.
Time: Wednesday, November 3, 2021, at 15.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 505 583 69
Europe +44 33 3300 9032
US +1 646 722 4904
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 development strategy to reach the market remains unchanged and we have received the first approval for the upcoming phase 1b/2a combination study with MIV-818. Positive data from the dose escalation part of the monotherapy study presented at ESMO. New positive data and renegotiated agreement for remetinostat.
Despite a number of new treatments for hepatocellular carcinoma (HCC), the most common form of primary liver cancer, there is still a great need for pharmaceuticals with new mechanisms of action. Our candidate drug MIV-818 represents a new and unique mechanism that can be combined with the most common therapies for HCC. Among the drugs that are already approved or under development, the most common mechanisms are: stimulation of the immune system and blockage of the blood supply. We have therefore chosen to study MIV-818 in combination with two products representing these two different mechanisms, Keytruda® (anti-PD-1 checkpoint inhibitor) and Lenvima® (tyrosine kinase inhibitor). The goal is to develop a better therapy as second-line treatment for HCC patients.
The third quarter has been characterized by continued work to ensure the start of the next study in the MIV-818 clinical program. This spring, we announced positive data with a good safety and tolerability profile from the first part of the phase 1b study with MIV-818. These data were further strengthened in September when data from the final dose escalation part of the phase 1b study were presented at the leading scientific conference, ESMO.
A total of nine patients with various types of advanced cancer in the liver were included and evaluated. These patients had exhausted all possible approved treatments prior to being included in the study. The study evaluated safety and tolerability in patients with different types of cancer in the liver, and a positive sign of efficacy was that four patients with HCC showed stable liver disease over an extended period of time. Furthermore, liver biopsies from patients demonstrated delivery of MIV-818 to the liver, and a selective effect of MIV-818 on cancer cells.
The purpose of our next study in patients with HCC is to evaluate safety, tolerability and to also get an indication of the efficacy of MIV-818 in combination with two approved drugs.
At the end of August, we received regulatory approval from MHRA, the regulatory authority in UK, for the upcoming phase 1b/2a combination study with MIV-818. The study will include patients with hepatocellular carcinoma (HCC) who have progressed on, or are intolerant of, first line standard therapy. The study is an open-label phase 1b/2a study starting with a dose escalation part to establish the recommended phase 2 dose (RP2D).
Once the RP2D has been established for the combinations, further cohorts of up to 30 patients with HCC will be enrolled in the expansion part (phase 2a). The study will start in the UK and is planned later to include centers in Spain and South Korea. The first patient is expected to be enrolled before year-end and we look forward with optimism to conducting the study.
Medivir has two more drug development projects in the clinical development phase, remetinostat, and MIV-711. Medivir does not conduct clinical development of these projects on its own, but instead seeks partners for further development.
In August, positive results from a phase II study with remetinostat against Basal Cell Carcinoma (BCC) were published in the scientific journal Clinical Cancer Research. The study was conducted at the Stanford University School of Medicine in California, USA, and the results are very promising and provide further support for the potential of remetinostat as a treatment for a number of skin cancers in addition to cutaneous T-cell lymphoma (CTCL).
In August, the remetinostat agreement was renegotiated to create significantly improved conditions for a potential outlicensing or sale in our continued business development work.
Early this year, the global and exclusive rights to develop Medivir's project birinapant, were outlicensed to the American company IGM Biosciences. We are looking forward to the start of the clinical study with birinapant in combination with IGM's antibody IGM-8444 later this year.
In October, we announced that Jens Lindberg has been appointed new CEO of Medivir. Jens, who joins us from his role as VP Commercial Operations at Sedana Medical, has extensive experience from the pharmaceutical industry and the oncology area. We look forward to taking Medivir forward under Jens' leadership.
The further we advance the clinical program with MIV-818, the more I am impressed by the determination and commitment that prevails at Medivir. We are convinced that MIV-818 has the potential to become an effective drug for liver cancer. Our goal is that it would make a big difference for patients and for healthcare and thus also for the company's shareholders.
Magnus Christensen
Interim CEO and CFO
For further information, please contact
Magnus Christensen, interim CEO and CFO, +46 (0)8 5468 3100
E-mail: magnus.christensen@medivir.com
This report has been subject to auditors' review.
The information in this report comprises the information that Medivir is obliged to disclose under the provisions of the Swedish Securities Markets Act. The information was submitted for publication at 08.30 CET on November 3, 2021.