Bavarian Nordic plans to initiate Phase 3 trial of RSV vaccine candidate

• Bavarian Nordic (OTCPK:BVNRY) announces its commitment to initiate a Phase 3 clinical trial of its RSV vaccine candidate, MVA-BN RSV in H1 2022.
• The Phase 3 trial is expected to enroll up to 20,000 subjects and run over the course of one year, spanning multiple geographies.
• The total estimated cost of the study is ~$250M, including follow-up phases in 2023 and 2024. Bavarian Nordic plans to finance this through an equity capital raise of up to 10% of its registered share capital, which is expected to be launched in the near term.
• With the decision to initiate the Phase 3 trial in 2022, Bavarian Nordic will incur additional costs of ~DKK 30M already in 2021 and hence is adjusting the expected EBITDA guidance correspondingly to ~DKK 70M.
• In September 2021, the Company reported that MVA-BN RSV had met its primary endpoint in a Phase 2 human challenge study, demonstrating a statistically significant reduction in viral load in vaccinated versus control (placebo) treated volunteers. Further, the vaccine demonstrated an efficacy of up to 79% in preventing symptomatic RSV infections.