Bavarian Nordic Announces First Half 2018 Results - Seite 2

Broadening our immunotherapy strategy

• Based on new findings in research, Bavarian Nordic plans to initiate two clinical studies during first half of 2019 evaluating the intravenous administration of BN-Brachyury and the intra-tumoral administration of CV301 in patients with solid tumors. Preclinical studies have shown that both approaches have significant advantages in either stimulating larger numbers of killer T cells with heightened killer activity against cancer cells, induction of inflammatory cytokines, stimulating natural killer (NK) cells; another arm of the immune system, or changing the immunosuppressive environment within tumors supporting improved T cell killing of cancer cells.
• These studies will evaluate the safety and certain immune parameters, and together with additional preclinical activities, will inform the further development of intravenous and intra-tumoral vaccination, including the potential for next-generation constructs with improved activity. 

Pipeline Developments

• Reported positive results from a Phase 2 extension study of our RSV vaccine, MVA-BN® RSV. The study revealed durable antibody and T cell responses against RSV one year post the original booster vaccination with MVA-BN RSV. These immune responses were significantly boosted following a further annual booster, particularly in the subjects with the weakest immunity at the baseline prior to the second vaccination. Results support an annual booster vaccination with MVA-BN RSV and will be important in discussions with the FDA concerning Phase 3 design later this year.
• Disclosed positive Phase 3 efficacy data for the IMVAMUNE® smallpox vaccine in comparison to ACAM2000, the replicating smallpox vaccine licensed in the U.S. The Company plans to file a BLA during 2018 and if approved, the Company would also be eligible to receive a Priority Review Voucher.
• Announced a partnership with the U.S. Department of Defense to develop a prophylactic vaccine against three separate strains of the equine encephalitis virus. The DoD will fund development of the MVA-BN® based vaccine, with total financial considerations potentially reaching USD $36 million.
• Our CV301 immunotherapy candidate has progressed into Phase 2 trials with the recent initiation of an investigator-led study in colorectal cancer evaluating the combination therapy of CV301, and Bristol Myers Squibb's checkpoint inhibitor, nivolumab (OPDIVO®). Two additional combination studies with other immune checkpoint inhibitors in patients with bladder and colorectal cancer are planned for initiation later this year, in-line with our strategy to seek rapid proof of concept for the combination of our platform and checkpoint inhibition.
• In line with our revised CV301 strategy to perform smaller studies with the potential for fast proof of concept, the Company will not be initiating the Phase 2 combination study of CV301 and pembrolizumab (KEYTRUDA®) in non-small cell lung cancer (NSCLC) as planned. The results of the Phase 1/1b combination study with nivolumab (OPDIVO®) or pembrolizumab (KEYTRUDA®) will be reported later this year. 
• BN-Brachyury for the treatment of chordoma, a rare bone cancer of the spine and base of the skull, received an orphan drug status with the FDA. Bavarian Nordic plans to initiate a Phase 2 study investigating BN-Brachyury in combination with radiation treatment in patients with chordoma in second half of 2018.
• A multi-company collaborative NCI-sponsored trial was initiated evaluating BN-Brachyury with multiple combinations of experimental immune modulating candidates (a bifunctional anti-PDL1-TGF-beta fusion protein; IL-15/IL-15R superagonist and an IDO inhibitor), initially in patients with multiple solid tumors and expanding into men with metastatic castrate-resistant prostate cancer (mCRPC).

Corporate

• Obtained a non-dilutive, currently undrawn EUR 30 million (USD $35 million) loan from the European Investment Bank (EIB), providing Bavarian Nordic with the financial flexibility to enhance its manufacturing capabilities, while continuing to focus on its research and development
• Based on the loan commitment by the EIB, Bavarian Nordic raised its 2018 year-end cash preparedness from approximately DKK 1,850 million (USD $289 million) to DKK 2,100 million (USD $329 million). 
• Henrik Juuel was appointed new CFO and Executive Vice President. He will join Bavarian Nordic in the fourth quarter of 2018.

Anticipated selected pipeline developments