"Final data from phase 2a study underscores potential for fostrox + Lenvima to become first approved option in second-line liver cancer"
January - March
Financial summary for the quarter
- Net turnover amounted to SEK 0.6 (0.5) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -12.6 (-26.7) million. Basic and diluted earnings per share amounted to SEK -0.12 (-0.23).
- Cash flow from operating activities amounted to SEK -26.8 (-35.0) million.
- Cash and cash equivalents at the end of the period amounted to SEK 35.1 (153.4) million.
Significant events during the quarter
- In February, final data from the phase 1b/2a study with fostrox + Lenvima in second- or third-line advanced liver cancer were presented at the EASL Liver Cancer Summit. The data showed a median overall survival (OS) of 13.7 months [1].
- In February, Medivir's partner Infex Therapeutics announced that a licensing agreement had been signed for clinical development of MET-X in India. MET-X originates from Medivir's Metallo Beta Lactamase (MBLI) program aimed at meeting the threat of resistant bacteria.
- In March, a European patent was obtained for fostrox plus lenvatinib for the treatment of hepatocellular carcinoma (HCC) and cancer metastases in the liver. The patent provides protection and market exclusivity until April 2041.
Conference call for investors, analysts and the media
The Interim Report January - March 2025 will be presented by Medivir's CEO, Jens Lindberg.
Time: Tuesday, April 29, 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
Medivir started off 2025 by presenting final, very positive study data from the phase 1b/2a study with fostrox + Lenvima® in advanced liver cancer at the EASL Liver Cancer Summit in Paris. Final data showed, among other things, a median overall survival (OS) of 13.7 months and a median time to disease progression of 10.9 months combined with an excellent safety and tolerability profile [1]. These study results are significantly better than what has previously been shown in second-line liver cancer and strengthen our belief that the combination fostrox + Lenvima has the potential to become the first approved option for these patients
Currently, there are no approved treatments for liver cancer patients who have failed immunotherapy and need a second-line option. The prognosis for second-line patients is bleak, with an overall response rate of 5-10% and a median time to progression (TTP) of only 3-4 months. It is therefore natural that our study results have attracted significant attention from clinical experts and that there is great interest in the next stage of development of fostrox. The strength of fostrox is that it only targets tumor cells locally in the liver, without damaging healthy cells. The fact that the treatment does not damage the liver allows patients to continue treatment for a long time, which in itself contributes to prolonged clinical benefit.
We continue to work with the preparations for the planned phase 2b study. Our interactions with the FDA were positive regarding our continued clinical development plan for fostrox. We have a global CRO partner with a strong track record in oncology studies, particularly in HCC. In addition, we have a collaboration and supply agreement with Eisai. This means that Medivir and Eisai will form a Joint Development Committee with responsibility for the planning and implementation of the study. Furthermore, Eisai provides Lenvima for 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. The study is designed to enable breakthrough designation and support an accelerated market approval process.
With the unique mechanism of action of fostrox, we also have very strong IP protection. This was further strengthened in March when the European Patent Office granted the company's application for patent protection for the combination of fostroxacitabine bralpamide (fostrox) and lenvatinib (Lenvima) for the treatment of hepatocellular carcinoma (HCC) and liver metastases from other types of cancer. The patent provides protection and market exclusivity until April 2041.
Even though fostrox is at the center, the level of activity remains high both in terms of our business development and in several of the projects that have been licensed out to our partners. In February, Medivir's partner Infex Therapeutics signed an exclusive licensing agreement for the Indian market with the pharmaceutical company Venus Remedies Ltd for the clinical development of MET-X, Infex's metallo-beta-lactamase inhibitor, targeting Gram-negative Enterobacteriaceae. MET-X originates from Medivir's Metallo Beta Lactamase program with the objective of addressing the threat of resistant bacteria, and Medivir is entitled to a share of potential future revenues.
In summary, we are now on an exciting and pivotal journey. Our results to date show that there is a clear place for fostrox in the treatment landscape. The need is significant, emphasized by the current lack of approved treatments. The potential for fostrox + Lenvima to become the first approved drug therapy for second-line liver cancer - a market worth ~$2.5 billion annually - is very strong.
I look forward to continue keeping 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) Evans et al., EASL Liver Cancer Summit, poster PO2-13.
