Bavarian Nordic Announces First Half 2018 Results
- Positive RSV Phase 2 results recently confirmed the durability of broad vaccine responses after 1 year, which were rapidly increased following an annual booster vaccination.
- Compelling new research indicates a broader and more potent anti-tumor response after intra-tumoral and intravenous administration, which will broaden our strategy while we maintain our plans to evaluate CV301 in combination with checkpoint inhibitors in three indications. In-line with this strategy for CV301, the lung study will not continue into Phase 2.
- Financial results were in line with our expectations and outlook is maintained. Production and deliveries remain on track to fulfil full year guidance.
- Upgraded cash preparedness provides increased flexibility to execute on the Company's growth strategy.
- Revenue generated for the six months ending June 30, 2018 was DKK 98 million/USD 15 million (DKK 595 million/USD 93 million in the first six months of 2017).
- The income before interest and tax (EBIT) was a loss of DKK 280 million/USD 44 million (profit of DKK 99 million/USD 15 million in the first six months of 2017).
- As of June 30, 2018, the Group's cash preparedness was DKK 2,211 million/USD 346 million (DKK 2,604 million/USD 407 million as of December 31, 2017).
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.
- 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).
- 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.
- Filing of Biologics License Application (BLA) for liquid-frozen IMVAMUNE (H2, 2018)
- Initiation of a Phase 3 IMVAMUNE freeze-dried lot consistency study (H1, 2019)
- Anticipated FDA approval and award of a Priority Review Voucher (2019)
- Initiate discussions with the FDA on the regulatory pathway for approval (H2, 2018)
- Decide on the feasibility of a human challenge study (H2, 2018)
- Initiate Phase 1 study of MVA-BN HIV + AdVac (H2, 2018*)
- Initiate Phase 1 study of MVA-BN HPV + AdVac (H2, 2018*)
- Initiate Phase 2 study in combination with atezolizumab in bladder cancer (H2, 2018)
- Initiate Phase 2 study in combination with durvalumab in colorectal cancer (H2, 2018)
- Report clinical results of NSCLC combination Phase 1/1b (H2, 2018)
- Initiate a Phase 1 intra-tumoral administration in patients with solid tumors (H1, 2019)
- Report clinical results from Phase 1 study (H2, 2018)
- Initiate Phase 2 study in patients with chordoma (H2, 2018)
- Initiate Phase 1 intravenous administration (H1, 2019)
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Source: Bavarian Nordic A/S via GlobeNewswire