On February 13, 2019 Medivir AB reported Year End Report January-December 2019 (Press release, Medivir, FEB 13, 2020, View Source [SID1234554328])
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Preclinical data showing that in addition to its direct effect on cancer cells, MIV-818 also modulates the anti-tumor immune response, presented at the AACR (Free AACR Whitepaper)-NCI-EORTC conference in Boston .
The ninth and final liver cancer patient was included in the phase Ia study with MIV-818. Based on safety and tolerability as well as pharmaco-kinetics and positive biomarker data, it was decided to initiate the phase Ib part of the study.
In December, an investigator-initiated phase II clinical trial of remetinostat was started in patients with squamous cell carcinoma. The study is conducted at the Stanford University School of Medicine in the United States.
The first patient was included in a phase I study evaluating the safety and tolerability of a combination of birinapant and radiation therapy in patients with recurrent Head and Neck Squamous Cell Carcinoma. The study is sponsored and funded as part of the National Cancer Institute’s Cancer Treatment Evaluation Program.
A futility analysis of the phase II combination study with birinapant and Keytruda in colorectal cancer patients was performed. Medivir decided to end the study since the results of the analysis indicated that the study’s goals were unlikely to be achieved.
The first milestone payment for the candidate drug MIV-701 in veterinary medicine was received in October.
Financial summary for the quarter
Net turnover amounted to SEK 1.4 (13.6) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -30.3 (-96.6) million. Basic and diluted earnings per share amounted to SEK -1.32 (-4.72) and SEK -1.32 (-4.72) respectively.
Cash flow from operating activities amounted to SEK -22.6 (-72.4) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 134.6 (286.3) million.
January – December
Financial summary
Net turnover amounted to SEK 8.7 (23.9) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -118.9 (-326.5) million. Basic and diluted earnings per share amounted to SEK -5.08 (-14.62) and SEK -5.08 (-14.62) respectively.
Cash flow from operating activities amounted to SEK -148.5 (-320.5) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 134.6 (286.3) million.
Significant events after the end of the period
The phase II study of MIV-711 in patients with osteoarthritis was published in Annals of Internal Medicine (DOI: 10.7326/M19-0675).
Conference call for investors, analysts and the media
The Year End Report January – December 2020 will be presented by Medivir’s President & CEO, Uli Hacksell.
Time: Thursday, February 13, 2020, at 14.00 (CET).
Phone numbers for participants from:
Sweden +46-8-505-583-52
Europe +44-33-3300-9268
US +1-833-5268-396
The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.
ombined with other medications and exhibits synergistic anticancer activity in preclinical models.