"We are now, within short, ready to initiate the phase 2b study - with the goal of making fostrox + Lenvima the first approved medical treatment for second-line liver cancer"
October - December
Financial summary for the quarter
- Net turnover amounted to SEK 1.0 (4.4) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.2 (-20.1) million. Basic and diluted earnings per share amounted to SEK -0.23 (-0.28).
- Cash flow from operating activities amounted to SEK -29.4 (-4.6) million.
- Cash and cash equivalents at the end of the period amounted to SEK 62.5 (169.5) million.
Significant events during the quarter
- 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 the planned randomized phase 2b study in advanced liver cancer.
- At the end of November, Medivir announced that the phase 1b/2a study with fostrox + Lenvima in advanced liver cancer had been completed and that the remaining patients in the study had been transferred to compassionate use.
- In December, the FDA approved Medivir's US Investigational New Drug Application (IND) to evaluate fostrox + Lenvima versus Lenvima + placebo in the planned phase 2b study in second-line advanced liver cancer.
January - December
Financial summary for the period
- Net turnover amounted to SEK 3.5 (7.6) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -124.6 (-88.7) million. Basic and diluted earnings per share amounted to SEK -1.08 (-1.48).
- Cash flow from operating activities amounted to SEK -124.2 (-59.7) million.
- Cash and cash equivalents at the end of the period amounted to SEK 62.5 (169.5) million.
Conference call for investors, analysts and the media
The Year-End Report January - December 2024 will be presented by Medivir's CEO, Jens Lindberg.
Time: Tuesday, February 18, 2025, 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
In September, we were able to present updated study results from Medivir's phase 1b/2a study with fostrox + Lenvima® in advanced liver cancer. After closing the study in November, we look forward to presenting final study data at the EASL Liver Cancer Summit in Paris in a couple of days. The update in September showed a median time to disease progression of 10.9 months and a response rate of 24% [1]. This is significantly better than what previously has been shown in second-line liver cancer, and it strengthens our belief that the combination fostrox + Lenvima can become the first approved option for these patients.
2024 has been a year in which we were able to follow how the strong results in the phase 1b/2a study gradually improved. We finished the study in November and the patients who remained in the study were transferred to compassionate use for continued treatment. We are excited about the good results we have reported so far, as there are currently no approved treatments for patients for whom immunotherapy has stopped working and who need a second-line alternative. The prognosis for second-line liver cancer patients is bleak as they generally have a treatment response of 5-10% and an expected time to progression (TTP) of only 3-4 months.
The study results have attracted a lot of attention, and there is great interest from the clinical expertise in our next step. The strength of the treatment lies largely in the fact that fostrox only targets tumor cells locally in the liver, without damaging healthy cells. The fact that the treatment does not damage the liver enables patients to continue treatment for a long time, which in itself contributes to prolonged clinical benefit.
The final results from the study, which will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit in Paris on February 20, 2025, are expected to further strengthen our starting point for the next big and decisive step - the planned phase 2b study in second-line advanced liver cancer. The preparations for the study have turned out well. The Type C meeting with the FDA in April yielded a positive outcome regarding the continued clinical development plan of fostrox. This summer we appointed a global CRO partner with a strong track record in oncology studies, particularly in HCC. Our cooperation and supply agreement with Eisai means that Medivir and Eisai form a Joint Development Committee with responsibility for the planning and implementation of the study. In addition, Eisai provides Lenvima to the study. Medivir retains all rights to fostrox. In December, the FDA approved Medivir's US Investigational New Drug Application (IND) to evaluate fostrox + Lenvima versus Lenvima + placebo in the planned randomized phase 2b study.
We are now working intensively on the preparations for the study with the aim of demonstrating improved efficacy with the combination of fostrox + Lenvima. The study will include patients with locally advanced or metastatic primary liver cancer who received an immunotherapy combination in the first line. The study is double-blind and patients will receive either fostrox + Lenvima or placebo + Lenvima and will be followed to evaluate the primary endpoint and survival for approximately 6 and 24 months, respectively. The first part of the study will also evaluate the optimized dose of fostrox.
To keep momentum in preparing the study, Medivir in October 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 funding options.
Medivir's partner Vetbiolix, a veterinary biotechnology company based in France, announced during the year positive results from a proof-of-concept clinical study in canine periodontitis with its candidate drug VBX-1000, formerly known as MIV-701. Vetbiolix has communicated its intention to initiate a phase 2/3 study to further strengthen the documentation of the effects of VBX-1000. In April, our partnering project, MIV-711, received Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes disease (LCPD), a rare hip disease that affects children aged 2-12 years.
We are now facing an exciting journey. Our results so far show that there is an obvious place for fostrox in the treatment landscape. That the need is great is underlined by the fact that approved treatments are currently lacking. Our presented data 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 and we are basically ready-to-go.
I look forward to continuing to keep you informed of Medivir's exciting developments.
Jens Lindberg
Chief Executive Officer
This report has not been subject to auditors' review.
For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: magnus.christensen@medivir.com
About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a drug candidate designed to selectively treat cancer cells in the liver and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.
1) Chon et al., ESMO 2024, Poster 9864
