On October 26, 2023 Medivir reported Updated data show that the combination fostrox + Lenvima provides improved clinical efficacy compared to Lenvima study data alone in second-line HCC (Press release, Medivir, OCT 26, 2023, View Source;interim-report-january–september-2023-301969891.html [SID1234636395]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
July – September
Financial summary for the quarter
Net turnover amounted to SEK 0.8 (1.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -23.4 (-13.9) million. Basic and diluted earnings per share amounted to SEK -0.42 (-0.27) and SEK -0.42 (-0.27) respectively.
Cash flow from operating activities amounted to SEK -21.0 (-19.7) million.
Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.
Significant events during the quarter
In August, Medivir’s Scientific Advisory Council was formed, consisting of five world-leading experts in liver cancer.
In August, the 15th patient was included in the phase 2a study with fostrox in combination with Lenvima. Interim data from an investigator evaluation showed promising tumor control and good tolerability.
In September, Medivir reported promising interim data from an independent evaluation of the phase 1b dose-escalation arm of fostrox in combination with Lenvima, where, among others, one patient achieved a complete tumor response and two patients a partial tumor response, out of a total of six patients.
In September, Medivir, together with leading cancer experts, arranged a webinar on the treatment landscape and the unique treatment challenges in primary liver cancer (HCC).
In September, data on the additive efficacy of fostrox in combination with Lenvima or Nexavar in non-clinical tumor models were presented at the ILCA Annual Meeting.
In September, Medivir’s partner Tango Therapeutics received IND approval from the FDA to start a phase 1/2 clinical trial with TNG348. TNG348 is a USP-1 inhibitor developed by Tango Therapeutics from the preclinical USP1 program that was in-licensed from Medivir in 2020.
January – September
Financial summary for the period
Net turnover amounted to SEK 3.2 (2.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -68.5 (-66.9) million. Basic and diluted earnings per share amounted to SEK -1.23 (-1.27) and SEK -1.23 (-1.27) respectively.
Cash flow from operating activities amounted to SEK -55.1 (-77.1) million.
Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.
Events after the end of the period
In October, data from the fostrox + Lenvima combination was presented, showing continued promising tumor control in HCC from an investigator evaluation. All patients in the phase 2a study had dosed at least two treatment cycles at this timepoint.
In October, the Board of Directors announced that Anette Lindqvist is leaving her position as Board Member of Medivir 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 by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB.
This Q3 report and subsequent webcast presents in-depth interim data from the 18 patients in the phase 1b/2a study who have had minimum 12 weeks follow-up. These data continue to demonstrate clear patient benefit for the fostrox + Lenvima combination.
Conference call for investors, analysts and the media
The Interim Report January – September 2023 will be presented by Medivir’s CEO, Jens Lindberg.
Time: Friday, October 27, 2023, 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.