Date: 04-Feb-2021

Dynavax Announces UK Government Exercise Option To Order Additional 40 Million Doses Of Valnevas SARS-CoV-2 Adjuvanted Vaccine Candidate, VLA2001

Dynavax Technologies, a biopharmaceutical company, announced Valneva SE has informed it that the UK Government exercised its option to order an additional 40 million doses of Valneva's SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. This option exercise triggers the reservation of additional quantities of Dynavax's advanced adjuvant CpG 1018 to support production of 40 million doses of Valneva's SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. In connection with its contract with the UK Government, Valneva has now reserved for delivery in 2021 CpG 1018 in quantities sufficient to support production of 100 million doses of VLA2001.

In September 2020, the companies announced a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant for use in VLA2001, to support Valneva's agreement with the UK government to provide up to 190 million doses of VLA2001 over a five-year period. Dynavax expects to supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase additional quantities of CpG 1018 to support the production of up to an additional 90 million doses of VLA2001 through 2025.

“Our commercial supply agreement with Valneva substantiates our strategy of leveraging CpG 1018 as an advanced vaccine adjuvant for use in the development of safe and effective vaccines, including against covid-19,” commented Ryan Spencer, chief executive officer of Dynavax, “Under this agreement, we are currently manufacturing, and scheduled to deliver, adjuvant for 100 million doses of VLA2001 which would generate CpG 1018 revenue of up to US$ 230 million in 2021, contingent on delivery of material and the continued success of the programme. We believe the emerging portfolio of CpG 1018 opportunities has the potential to drive the next leg of Dynavax growth, adding to the substantial opportunity of HEPLISAV-B, our US FDA approved adult hepatitis B vaccine.”

CpG 1018 is the adjuvant used in HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the US Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a Covid-19 vaccine.