Company: DVAX
Filing Date: 2025-02-20
Form Type: 10-K
Source: 0001029142-25-000049
Chunk: 7

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-02-20
Form: 10-K
Item: Item 1
Chunk 7
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•Deliver on our innovative and diversified pipeline leveraging CpG 1018 adjuvant with proven antigens;

•Build an adult vaccine portfolio of best-in-class products;

•Advance innovative pre-clinical and discovery efforts leveraging collaborations;

•Continue disciplined allocation of capital aligned with corporate strategy to deliver long-term value through internal and external innovation; and

•Pursue external opportunities with high synergy assets in vaccines, or other modalities in infectious diseases, to further leverage our expertise and capabilities. 

HEPLISAV-B [Hepatitis B Vaccine, (Recombinant), Adjuvanted]

Our first commercial product, HEPLISAV-B [Hepatitis B Vaccine, (Recombinant), Adjuvanted], is approved by the FDA, the European Commission and the UK Medicines and Healthcare products Regulatory Agency for prevention of infection caused by all known subtypes of HBV in adults aged 18 years and older. HEPLISAV-B combines CpG 1018 adjuvant, our proprietary TLR9 agonist adjuvant, and recombinant hepatitis B surface antigen (“rHBsAg” or “HBsAg”) that is manufactured by Dynavax GmbH, our wholly owned subsidiary, in Düsseldorf, Germany. HEPLISAV-B and each of the vaccines it directly competes against use rHBsAg to elicit an immune response to the virus. 

About Hepatitis B

Hepatitis B is a potentially life-threatening liver infection caused by HBV. It is a major global health problem. It can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer. The World Health Organization (“WHO”) and the CDC have set a goal to eliminate all viral hepatitis infections, including hepatitis B, globally by 2030, and are calling for a continued commitment to increase services to eliminate hepatitis. The WHO estimates that worldwide, approximately 254.0 million people were living with chronic hepatitis B in 2022, and that in the same year hepatitis B resulted in an estimated 1.1 million deaths primarily from liver cancer. In addition, the CDC estimated that in 2021 approximately 580,000 to 1.2 million people in the U.S. were living with HBV infection. There was a total of 2,045 new cases of acute hepatitis B reported to the CDC in 2021. However, after adjusting for under-ascertainment and under-reporting, the CDC estimated that 14,