Dynavax Receives Complete Response Letter from U.S. Food and Drug Administration for Biologics License Application for HEPLISAV-B - Seite 3

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the FDA's Complete Response Letter ("CRL") to the BLA for HEPLISAV-B, the Company's plans to respond to the CRL, plans and the ability to identify pharmaceutical or financial partners for the future development of HEPLISAV-B, plans to reduce spending on HEPLISAV-B, and the Company's focus on its oncology program, including SD-101. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether HEPLISAV-B may be approved by the FDA, the timing and ability for Dynavax to respond to the CRL, whether Dynavax will be able to find a pharmaceutical or financial partner for HEPLISAV-B, the timing of the FDA's review if Dynavax is able to respond to the CRL, and whether the issues identified in the CRL are resolvable with respect to questions involving the data or interpretation of the data submitted in support of the BLA; whether or not the FDA will require additional clinical trials, whether or not the FDA will identify additional issues after Dynavax responds to the CRL; whether there will be a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting and if so, whether it will impact the timing of FDA review or negatively impact the review and approval of the BLA; whether additional studies or manufacturing process enhancements will be required, or other issues will arise that will delay the BLA review or negatively impact the review and approval by the FDA; if approvable, whether the issues will negatively impact the potential scope of the label claims for HEPLISAV-B; initiation, enrollment and completion of pre-clinical studies and clinical trials of our other product candidates, including SD-101; the ability to successfully develop and commercialize SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; and other risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.