MEDIVIR AB "The clinical efficacy of fostrox in combination with Lenvima continues to improve with median time to progression having increased to over 6 months"
October - December
Financial summary for the quarter
- Net turnover amounted to
SEK 4.4 (2.3) million. -
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to
SEK -20.1
(-17.9) million. Basic and diluted earnings per share amounted toSEK -0.28 (-0.32) andSEK -0.28 (-0.32) respectively. -
Cash flow from operating activities amounted to
SEK -4.6 (-24.7) million. -
Cash and cash equivalents at the end of the period amounted to
SEK 169.5 (117.4) million.
Significant events during the quarter
- In October, data from an investigator evaluation showed continued promising tumor control with fostrox + Lenvima in HCC. All patients in the phase 2a study had dosed at least two treatment cycles.
-
In October, the Board of Directors announced that
Anette Lindqvist is leaving her position as Board Member ofMedivir AB due to personal reasons. -
In October the nomination committee was appointed ahead of the AGM in
May 2024 . The Nomination Committee consists of Karl Tobieson, appointed byLinc AB ,Richard Torgerson , appointed byNordea Investment Funds ,Anders Hallberg , appointed byHealthInvest Partners andUli Hacksell , Chairman of the Board,Medivir AB . - The Q3 report and the subsequent webcast included in-depth interim data from the 18 patients in the phase 1b/2a study who had a minimum follow-up of 12 weeks. These data continued to demonstrate clear patient benefit for the fostrox + Lenvima combination.
- In November it was announced that the company's interactions with the FDA regarding fostrox's clinical development plan had intensified with a first Type D meeting with a positive response regarding critical elements of the design for the planned phase 2b study.
- Late November it was announced that the development of an updated formulation of fostrox, suitable for commercial manufacture, had been finalized.
-
In December,
Medivir's partnerIGM Biosciences , communicated a strategic pipeline cost-saving prioritization that among other things affects IGM's DR-5-agonist, aplitabart, in combination with birinapant, which was licensed in fromMedivir in 2021. -
In December it was announced that
Medivir has signed an agreement with Lonza for the manufacture of fostrox drug substance for the planned phase 2b study. - In December it was announced that the durable clinical benefit in the ongoing phase 1b/2a study continues to improve, as data become more mature.
-
In December, a rights issue was carried out, through which the company received proceeds of approximately
SEK 129 before deduction of costs attributable to the rights issue.
January - December
Financial summary for the period
- Net turnover amounted to
SEK 7.6 (4.4) million. -
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to
SEK -88.7 (-84.8) million. Basic and diluted earnings per share amounted toSEK -1.48 (-1.59) andSEK -1.48 (-1.59) respectively. -
Cash flow from operating activities amounted to
SEK -59.7 (-101.8) million. -
Cash and cash equivalents at the end of the period amounted to
SEK 169.5 (117.4) million.
Events after the end of the period
- In January, a directed issue to
Hallberg Management AB was carried out amounting to approximatelySEK 20 million before deduction of issuance costs. -
In January, positive data from the ongoing phase 1b/2a study in advanced liver cancer (HCC) showing further improved response and time to progression was presented at the ASCO GI Symposium in
San Francisco . -
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
Conference call for investors, analysts and the media
The Year-End Report January -
Time:
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
CEO's message
Fostrox in combination with Lenvima continues to show improved efficacy for patients with advanced primary liver cancer (HCC). The data presented in
The unmet medical need in the treatment of advanced HCC is significant. Primary liver cancer is the third leading cause of cancer-related deaths. In today's treatment guidelines, an immunotherapy combination (Tecentriq®/Avastin®) is recommended as first-line treatment. However, when this combination has stopped working, there are no approved alternatives for second-line treatment. There is thus a large need for additional treatment options in second-line that attacks the tumor in different ways compared to what Tecentriq and Avastin does. Fostrox is an organ specific, so-called smart chemotherapy, that selectively kills cancer cells in the liver. Together with Lenvima, these two form a unique combination of complementary drugs that have shown promising interim results in an ongoing phase 1b/2a study, including a complete tumor response in one patient.
All patients in the study have now had at least 18 weeks of follow-up. The more mature and in-depth data we see from the study, the more convincing the clinical benefit for patients has become. Data from this study was presented at the
At the time of this quarterly report over 40% of patients remain on treatment in the study, and the clinical efficacy keeps improving. The median time to progression has increased further to 6.3 months, compared to 5.1 months at ASCO GI, significantly better than previous studies in second-line HCC. The patient who has benefited the longest remains on treatment after 18 months with partial response and continued shrinking tumor. Our data was met with great interest at ASCO GI, where we had the opportunity to discuss with leading global experts what the fostrox + Lenvima combination could mean for these patients. The discussions confirmed the great need that exists in the second-line treatment of HCC, where patients are today without any approved treatment alternative.
With these promising data, fostrox has the opportunity to become the first approved medicinal treatment in a market worth ~2.5 billion USD annually, through a so-called accelerated approval by the regulatory authorities.
We have therefore put in a higher gear in 2023 to ensure maximum momentum in fostrox's development program based on this possibility of accelerated approval. In Q4 2023 the development of an updated, commercially adapted formulation of fostrox was completed. In parallel, we have initiated the process with the FDA for a so-called Type C meeting to discuss the final study design of the planned registrational phase 2b study.
In conjunction with these measures, we can now also deepen our discussions with potential partners, in accordance with previously communicated plans.
We can also note that several of the projects that
For
I would like to thank old and new shareholders for the trust in our rights issue and for the capital injection that benefited us in the directed share issue. I look forward to keeping you informed of
Chief Executive Officer
For further information, please contact
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
https://news.cision.com/medivir/r/medivir-ab---year-end-report-january---december-2023,c3929041
https://mb.cision.com/Main/652/3929041/2606187.pdf
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