Bavarian Nordic Announces Interim Results for the First Nine Months of 2018

COPENHAGEN, Denmark, November 9, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results in line with guidance for the first nine months of 2018 and business progress for the third quarter of 2018.

Highlights

• A Biologics License Application for MVA-BN smallpox vaccine (formerly IMVAMUNE) was submitted to the U.S. Food and Drug Administration (FDA). Pending acceptance of the BLA, the Company anticipates approval of the vaccine during 2019 with subsequent filing for a Priority Review Voucher.
• IMVANEX smallpox vaccine was supplied to the Public Health England for vaccination of healthcare workers involved in first ever human cases of monkeypox in the U.K.
• Following the positive Phase 2 results for our RSV vaccine candidate, MVA-BN RSV, we have initiated discussions with the FDA, which will continue into 2019 with an aim to agree on the design of Phase 3, which we plan to initiate in 2020.
• Two studies of our cancer immunotherapy candidate, CV301, in combination with checkpoint inhibitors were initiated. This takes the total number of studies to three, which is in accordance with our strategy to seek rapid proof of concept for the combination of our platform and checkpoint inhibition in three indications. During 2019 we will further advance the potential of our platform by using other routes of administration, which are expected to provide an even broader and more potent anti-tumor response.
• A Phase 2 study of BN-Brachyury was initiated in patients with chordoma, a rare cancer in the bones of the skull base and spine with limited treatment options. The vaccine has received orphan drug designation from the FDA for the treatment of chordoma, and the study could potentially provide pivotal results for registration of the vaccine.
• Production and deliveries of MVA-BN smallpox vaccine remain on track to fulfil full year guidance.
• As planned, Henrik Juuel joined the Company in November as new Chief Financial Officer and member of the executive management.

"The recent BLA submission for our smallpox vaccine highlights the competences and strengths of Bavarian Nordic today, which we proudly apply to advance our technology to develop new vaccines to meet the unmet medical needs that remain in both infectious disease and oncology. We have seen strong progress in our pipeline over the past months with several new studies initiating, seeking proof-of-concept for our immuno-oncology platform across major solid tumor types, but also in rare and underserved cancers, such as chordoma. Following the positive Phase 2 data from our RSV program, we have also recently initiated discussions with the FDA on the design of Phase 3, anticipated to start in 2020. Meanwhile, we continue our successful operations with production of bulk vaccines and construction of our new fill/finish facility going according to plan, securing the foundation for future revenues and success for Bavarian Nordic," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.