Dynavax Receives Complete Response Letter from U.S. Food and Drug Administration for Biologics License Application for HEPLISAV-B - Seite 2

Conference Call Details
The Dynavax management team will host a conference call and webcast today, Monday, November 14, 2016, at 8:30 a.m. Eastern, to provide more information about the CRL. The live call can be accessed by phone by dialing [phone] (domestic) or [phone] (international) and specifying conference call code 19882810. A link to the live webcast may be accessed by visiting the "Investors" section of the Dynavax website or directly at (www.dynavax.com). A replay of the conference call may be accessed for one week following the call by dialing [phone] (domestic) or [phone], and the passcode is 19882810.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and can lead to cirrhosis of the liver, hepatocellular carcinoma and death. In the United States, the CDC estimates that approximately 20,000 hepatitis B infections continue to occur annually,(i) with the vast majority occurring in adults. There is no cure for hepatitis B, and disease prevention through effective vaccination is critical to reducing the spread of the disease. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. Results of a published Vaccine Safety Datalink study showed that 54 percent of adults completed the currently available three-dose hepatitis B vaccine series in one year. Those who do not complete the series may not be adequately protected against hepatitis B.

About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response. HEPLISAV-B is administered in two doses over one month.

In Phase 3 trials, HEPLISAV-B demonstrated higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. The investigational vaccine's safety profile is based on clinical trials that generated safety data from more than 14,000 participants. The most frequently reported local reaction was injection site pain. The most common systemic reactions were fatigue, headache and malaise, all of which were similar to an existing vaccine.

Dynavax has worldwide commercial rights to HEPLISAV-B.

About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information, visit www.dynavax.com.