Bavarian Nordic Announces Interim Results for the First Three Months of 2016

GlobeNewswire

COPENHAGEN, Denmark, May 13, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results for the first three months of 2016. Below is a summary of business progress and financial performance for the period. The full interim report is attached as a PDF file and can be found on the company`s website, www.bavarian-nordic.com.

Key highlights from the report

  • Successfully completed a private placement of 2.77 million new shares in April, raising gross proceeds of DKK 665 million. The significantly strengthened cash preparedness will enable the accelerated development of key pipeline projects such as MVA-BN RSV and CV-301 cancer immunotherapy, as well as allow for potential expansion of manufacturing capabilities.

  • Results from the first Phase 1 study of the Ebola prime-boost vaccine regimen were published in JAMA in April, showing that the vaccine regimen produced an antibody response in 100 percent of healthy volunteers that was sustained 8 months following immunization, indicating potential for a durable response.

  • The first, planned interim analysis of Phase 3 study of PROSTVAC occurred in February, confirming that the study should continue without modification. The final analysis is still anticipated in 2017 with two more interim analyses occurring prior to that.

  • Two new Phase 2 clinical studies of PROSTVAC were initiated by the National Cancer Institute in the first quarter; a study investigating the combination of PROSTVAC and docetaxel in 38 patients with non-metastatic castration sensitive prostate cancer receiving androgen deprivation therapy, and a study investigating PROSTVAC in 80 patients with biochemically recurrent prostate cancer. Currently, eight Phase 2 & 3 clinical studies in more than 1,800 patients are ongoing, investigating PROSTVAC as single or combination therapy in various stages of prostate cancer.

  • In January, an End of Phase 2 meeting was held with the FDA to discuss the previously announced positive results of a Phase 2 study with IMVAMUNE. At this meeting, the agency accepted that immunogenicity could be bridged between the two formulations and that the proposed single Phase 3 lot consistency study is sufficient for approval of freeze-dried IMVAMUNE. Furthermore, based on the current safety database which includes data from a large Phase 3 lot-consistency and safety study, FDA agreed that all future trials involving MVA-BN would no longer require active cardiac monitoring.

  • At the request of certain health authorities, including BARDA and WHO, Bavarian Nordic has submitted proposals outlining a concept for utilization of MVA-BN in the development and manufacturing of vaccines in the fight against emerging infectious diseases, including Zika virus. Any future development in these areas would depend on funding availability.

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