On April 30, 2024 Medivir reported 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 (Press release, Medivir, APR 30, 2024, View Source;interim-report-january–march-2024-302131228.html [SID1234642485]).
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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 in-licensed 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 (Free ASCO Whitepaper) 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 click 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.