”Preparations for the planned phase 2b study continue according to plan after the completed Type C meeting with the FDA, strengthened by the fact that the median time to progression with fostrox + Lenvima increased to 7 months”
January – March
Financial summary for the quarter
- Net turnover amounted to SEK 0.5 (0.4) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.7 (-18.9) million. Basic and diluted earnings per share amounted to SEK -0.23 (-0.34) and SEK -0.23 (-0.34) respectively.
- Cash flow from operating activities amounted to SEK -35.0 (-16.1) million.
- Cash and cash equivalents at the end of the period amounted to SEK 153.4 (100.8) million
Significant events during the quarter
- In January Tango Therapeutics announced that it has dosed the first patient with TNG348, a new USP1-inhibitor from the preclinical USP1 program inlicensed from Medivir in 2020.
- Positive results from the ongoing phase 1b/2a study in advanced liver cancer (HCC) showing further improved response and time to progression were presented at the ASCO GI Symposium in San Francisco.
- In January, a directed issue to Hallberg Management AB was carried out amounting to approximately SEK 20 million before deduction of issuance costs.
- In February, a change in Medivir's nomination committee announced as Anders Hallberg, appointed by Healthinvest Partners, leaves the nomination committee and is replaced by Stefan Bengtsson, appointed by CA Fastigheter AB.
Events after the end of the period
- In April it was announced that Medivir's partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a proof-of-concept clinical trial in canine periodontitis with its drug candidate VBX-1000, formerly known as MIV-701.
- In April it was announced that Medivir has completed a so-called Type C meeting with the FDA and that the company's preparations for the planned phase 2b study are continuing as planned, with a couple of adjustments in study design with limited impact on the timeline and size of the study.
- In April MIV-711 was granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes disease (LCPD), an uncommon hip disorder affecting children aged 2-12 years.
Conference call for investors, analysts and the media
The Interim Report January - March 2024 will be presented by Medivir’s CEO, Jens Lindberg.
Time: Tuesday, April 30, 2024, at 10.00 (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
Our goal is that the combination of fostrox and Lenvima® shall become the first approved alternative in second-line for patients with primary liver cancer. Preparations for our planned phase 2b study continue after the Type C meeting with the FDA, strengthened by the fact that patients in the ongoing phase 1b/2a study continue to benefit from treatment with fostrox + Lenvima longer than expected and that the outcome continues to improve.
Medivir's proprietary candidate drug fostrox is a targeted, smart chemotherapy that selectively kills cancer cells in the liver. Fostrox + Lenvima constitutes a unique, potential combination of complementary medicines that is showing promising results in Medivir's ongoing phase 1b/2a study.
At the international ASCO-GI congress in San Francisco in January, results were presented for fostrox + Lenvima showing that the proportion of patients achieving a clinically relevant reduction in their liver tumor is greater than what would be expected with a second-line treatment. Data evaluated by investigators and local radiologists showed that the Objective Response Rate (ORR) was 25 percent (RECIST v1.1), a significantly higher rate than the 5–10 percent shown for second-line treatment of HCC in previous studies. The update also showed continued good tolerability without any new unexpected side effects.
As the patients remain on treatment longer than expected, the clinical efficacy has continued to improve.
At the time of writing, ~30 percent of patients remain on treatment in the study. The median time to progression has now increased further to 7 months, compared to 5 months at ASCO GI, significantly longer than previous studies in second-line HCC have shown. The patient who has benefited the longest remains on treatment after 20 months with continued partial response. The readout of the study as a whole is expected to be completed by the end of 2024, depending on how long the last patients continue to benefit from the treatment.
Our data has been met with great interest and the discussions with leading global experts, not least at ASCO GI, have confirmed what the combination fostrox + Lenvima could mean in the second-line treatment of HCC, where patients today are without any approved treatment alternative. With the increasingly exciting data from the study, the opportunity emerges to become the first approved drug treatment in a market worth ~$2.5 billion annually.
We have therefore put in a higher gear to ensure maximum speed forward in fostrox's development program to create the possibility of a so-called accelerated approval. Somewhat simplified, it can be described as a conditional regulatory approval that enables prescribing to patients where the data must later be substantiated in a follow-up confirmatory phase 3 study. This means an opportunity for fostrox to reach patients up to three years faster than would otherwise be the case. During the quarter, we also had a Type C meeting with the FDA to discuss the study design. The FDA provided clarifying guidance, which means we are now approaching the final study design for the planned Phase 2b study, which is proceeding as previously planned. Parallel to these measures, the discussions we are having with potential cooperation partners for fostrox continue.
Also, when it comes to the projects Medivir previously licensed out to partners, the development is exciting. In January, Tango Therapeutics initiated a phase 1/2 study and dosed the first patient with TNG348, a USP-1 inhibitor developed from the preclinical USP1 program in-licensed from Medivir in 2020. In April, our partner Vetbiolix, a veterinary biotech company based in France, could report positive results from a clinical Proof-of-Concept study in canine periodontitis disease with its drug candidate VBX-1000, formerly known as MIV-701 which was out-licensed to Vetbiolix in 2019.
In addition, our project for partnership MIV-711 was granted Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease from the FDA. Aside from that this creates opportunity for partnerships and future revenue, it also demonstrates the quality of Medivir's research.
The continued clinical development of fostrox is our focus and the promising data showing further improvement in clinical efficacy in second-line HCC reinforces our belief that fostrox can become an effective anti -cancer drug that makes a real difference to patients. There is a clear need and an obvious place for fostrox in the treatment landscape.
The goal is to become the first approved alternative in second-line for patients with primary liver cancer. 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 30, 2024