Medivir

July – September
Financial summary for the quarter

• Net turnover amounted to SEK 0.9 (0.8) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -35.1 (-23.4) million. Basic and diluted earnings per share amounted to SEK -0.30 (-0.42).
• Cash flow from operating activities amounted to SEK -33.4 (-21.0) million.
• Cash and cash equivalents at the end of the period amounted to SEK 92.6 (61.1) million.

 Significant events during the quarter

• At the ESMO Cancer Congress in Barcelona in September, Medivir presented updated clinical data from the phase 1b/2a study with fostrox in the second-line treatment of advanced liver cancer. Results showed a median time to progression (TTP) of 10.9 months[1], and an Objective Response Rate (ORR) of 24% with a median duration of response of 7.0 months (4.1 – 18.1).

January – September
Financial summary for the period

• Net turnover amounted to SEK 2.5 (3.2) million.
• The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -98.4 (-68.5) million. Basic and diluted earnings per share amounted to SEK -0.85 (-1.23).
• Cash flow from operating activities amounted to SEK -94.8 (-55.1) million.
• Cash and cash equivalents at the end of the period amounted to SEK 92.6 (61.1) million.

 Events after the end of the period

• In October, Medivir received a loan facility of SEK 30 million from Linc AB. The loan will only be used if necessary, as a secondary financing option. Priority will be given to other financing options such as issues or partnering agreements.
• In October, Medivir's nomination committee was appointed for the 2025 annual general meeting. The nomination committee consists of Karl Tobieson, appointed by Linc AB, Richard Torgerson, appointed by Nordea Funds AB, Anders Hallberg, appointed by Hallberg Management AB and Uli Hacksell, chairman of the board of Medivir AB.
• In October, the results of the phase 1 study, which showed proof-of-concept with fostrox monotherapy in liver cancer, were published in the Journal of Hepatocellular Carcinoma.
• In November, Medivir entered into a new collaboration and supply agreement with Eisai to evaluate fostrox in combination with Lenvima in a randomized phase 2b study in advanced liver cancer.

Conference call for investors, analysts and the media
The Interim Report January - September 2024 will be presented by Medivir’s CEO, Jens Lindberg.

Time: Wednesday, November 6, 2024, at 14.00 (CET).
 
To access the webcast and find information about the teleconference, please klick HERE!
 
The conference call will also be streamed via a link on the website; www.medivir.com/investors/calendar
The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message
Today, there are no approved drugs for the second-line treatment of advanced liver cancer. At the ESMO congress in Barcelona in September, we presented data indicating that the combination fostrox + Lenvima® is significantly better than the drugs used today in the second line, including Lenvima. These results position the fostrox + Lenvima combination at the forefront of becoming the first approved treatment for these patients. An opportunity strengthened by the collaboration agreement with Eisai.
 
Results from our ongoing phase 1b/2a study of fostrox + Lenvima in advanced liver cancer are very promising. The median time to progression (TTP) of 10.9 months[1] (4.1 – 18.1) is significantly longer than previously seen in second-line liver cancer and the combination shows an Objective Response Rate (ORR) of 24% with a median duration of response of 7.0 months. This should be viewed in relation to the dismal prognosis second-line liver cancer patients generally have, with a treatment response of 5 – 10%, and an expected median TTP of only 3 – 4 months.
 
The interest in our study results has increased as the data has matured and continuously demonstrated an improved clinical benefit. At ESMO in Barcelona, investigators from countries we had not previously had a dialogue with showed a strong interest in fostrox and the planned phase 2b study.
 
The use of first-line immunotherapy combinations has improved treatment outcomes and resulted in more patients being in a better condition to undergo second-line treatment. However, without access to approved therapies after immunotherapy, the need for new treatment options is substantial for these patients.
 
We have designed fostrox to target only tumor cells locally in the liver, without harming healthy cells. The tolerability profile in the study confirms the tumor-selective effect and enables patients to continue the treatment for a long time, which in itself contributes to prolonged clinical benefit. The targeted anti-tumor effect in the liver was also confirmed in the phase 1 study with fostrox monotherapy, which recently was published in the Journal of Hepatocellular Carcinoma.
 
It is thus with strong confidence that we continue preparations to start the planned phase 2b study where fostrox + Lenvima is compared with Lenvima alone in a randomized study to confirm the effectiveness of the combination.
 
We are very pleased with the collaboration and supply agreement with Eisai we entered into in November. In addition to Eisai contributing Lenvima to the study, we will, as part of the agreement, form a Joint Development Committee with Eisai for planning and execution of the study. The collaboration and engagement by Eisai further validate the ability of the combination to provide increased patient benefit.
 
Preparations are proceeding according to plan and we intend to open an IND in the US in the fourth quarter of 2024.
 
In October, Medivir received a loan facility of SEK 30 million from Linc AB. The loan will only be used if necessary, as a secondary financing option. Priority will be given to other financing options such as issues or partnering agreements.
 
There is a clear need and an obvious position for fostrox in the treatment landscape. The data presented indicate that fostrox + Lenvima could become the first approved drug therapy in second-line liver cancer - a market worth ~$2.5 billion annually. Preparations for the planned phase 2b study are progressing according to plan.
 
I look forward to continuing to keep you informed of Medivir's exciting developments.
  
Jens Lindberg
Chief Executive Officer
 
This report has been subject to auditors' review.