<SEC-DOCUMENT>0001193125-17-249857.txt : 20170807
<SEC-HEADER>0001193125-17-249857.hdr.sgml : 20170807
<ACCEPTANCE-DATETIME>20170807160232
ACCESSION NUMBER:		0001193125-17-249857
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20170803
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170807
DATE AS OF CHANGE:		20170807

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DYNAVAX TECHNOLOGIES CORP
		CENTRAL INDEX KEY:			0001029142
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				330728374
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-34207
		FILM NUMBER:		171011478

	BUSINESS ADDRESS:	
		STREET 1:		2929 SEVENTH STREET
		STREET 2:		SUITE 100
		CITY:			BERKELEY
		STATE:			CA
		ZIP:			94710
		BUSINESS PHONE:		5108485100

	MAIL ADDRESS:	
		STREET 1:		2929 SEVENTH STREET
		STREET 2:		SUITE 100
		CITY:			BERKELEY
		STATE:			CA
		ZIP:			94710
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d434848d8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML><HEAD>
<TITLE>Form 8-K</TITLE>
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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>Form 8-K
</B></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:14pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT REPORT </B></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) of the </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): August 3, 2017 </B></P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Dynavax Technologies Corporation </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission
File Number:&nbsp;001-34207 </B></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>33-0728374</B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>2929 Seventh Street, Suite 100 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Berkeley, CA 94710-2753 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices, including zip code) </B></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(510) 848-5100 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Registrant&#146;s telephone number, including area code) </B></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or former address, if changed since last report) </B></P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </TD></TR></TABLE>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this chapter). </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9744; </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section&nbsp;13(a) of the Exchange Act.&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>

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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01.</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Other Events </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On August&nbsp;3, 2017, Dynavax Technologies Corporation issued a press
release titled &#147;Dynavax Provides U.S. Regulatory Update on <FONT STYLE="white-space:nowrap">HEPLISAV-B&#153;</FONT> Following FDA Advisory Committee Meeting.&#148; A copy of the press release is attached hereto as Exhibit 99.1 and incorporated
herein by reference. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01.</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Financial Statements and Exhibits </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">(d) Exhibits. The following exhibit is filed
herewith: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Press Release, dated August&nbsp;3, 2017, titled &#147;Dynavax Provides U.S. Regulatory Update on <FONT STYLE="white-space:nowrap">HEPLISAV-B&#153;</FONT> Following FDA Advisory Committee Meeting&#148;</TD></TR>
</TABLE>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">Dynavax Technologies Corporation</TD></TR>
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<TD VALIGN="top">Date: August&nbsp;7, 2017</TD>
<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">By:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ STEVEN N. GERSTEN</P></TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">Steven N. Gersten</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">Vice President</TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>EXHIBIT INDEX </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; width:39.50pt; font-size:8pt; font-family:Times New Roman"><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP><FONT STYLE="white-space:nowrap">EX-99.1</FONT></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Press Release, August&nbsp;3, 2017, titled &#147;Dynavax Provides U.S. Regulatory Update on <FONT STYLE="white-space:nowrap">HEPLISAV-B&#153;</FONT> Following FDA Advisory Committee Meeting&#148;</TD></TR>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d434848dex991.htm
<DESCRIPTION>EX-99.1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<IMG SRC="g434848g0807234250752.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center"><B>Dynavax Provides U.S. Regulatory Update on <FONT STYLE="white-space:nowrap">HEPLISAV-B&#153;</FONT> Following FDA
Advisory Committee Meeting </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="center"><I>&#151;Conference call today at 4:30 p.m. EDT&#151; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>BERKELEY, Calif. &#150; August</B><B></B><B>&nbsp;3, 2017</B> <B>&#150;</B> Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and
Drug Administration (FDA) has requested more detailed information about the company&#146;s proposed post-marketing study for <FONT STYLE="white-space:nowrap">HEPLISAV-B&#153;</FONT> [Hepatitis B Vaccine, Recombinant (Adjuvanted)] based on feedback
received from the FDA&#146;s Vaccines and Related Biological Products Advisory Committee&nbsp;(VRBPAC) during a meeting on July&nbsp;28, 2017. The Advisory Committee voted 12 to 1 (with 3 abstentions) that the safety data for <FONT
STYLE="white-space:nowrap">HEPLISAV-B</FONT> support licensure for active immunization against hepatitis B infection in adults 18 years of age and older while also commenting on the design of Dynavax&#146;s proposed post-marketing study for <FONT
STYLE="white-space:nowrap">HEPLISAV-B.</FONT> Dynavax and the FDA have discussed the outcome of the VRBPAC meeting and have agreed that due to the feedback provided and the proximity to the scheduled Prescription Drug User Fee Act (PDUFA) date of
August&nbsp;10, 2017, more time is required to finalize key details of the post-marketing study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">&#147;Our conversation with the Agency was open and productive and
confirmed our mutual understanding of the VRBPAC&#146;s suggested requirements for the post-marketing study. We are working with our third-party providers to develop an appropriate study that addresses the advisory committee&#146;s feedback. We now
have clarity on the path forward and next steps required to complete the regulatory review of <FONT STYLE="white-space:nowrap">HEPLISAV-B,&#148;</FONT> said Eddie Gray, chief executive officer of Dynavax. &#147;We plan to respond to the request for
additional information expeditiously. We look forward to bringing this important vaccine to market to support the elimination of hepatitis B infection as a public health problem.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">As indicated in the FDA&#146;s request for additional information, and consistent with the discussion regarding myocardial infarction at the VRBPAC meeting, the
remaining details to address in the post-marketing study include: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Timeline for the final protocol submission, study completion and final report submission </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Timeliness of accruing patients into the study </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Time points for data review </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Measures to control for potential biases between study arms </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:ARIAL; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Updated statistical analysis plan </TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">In order to create sufficient time to complete this work under the existing
regulatory framework, the response to the information request will trigger a major amendment to the Biologics License Application (BLA). This will provide the FDA and Dynavax up to three months to agree on the post-marketing study prior to an
updated PDUFA date (expected to be no later than November&nbsp;10, 2017). The FDA and Dynavax have both committed to processing this final stage of the review in the most efficient manner possible by maintaining open channels of communication. This
timing does not impact the company&#146;s plans to launch <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> commercially in the United States in early 2018. </P>

<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Teleconference/Webcast Details </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Dynavax will conduct a live conference call today to provide additional context to investors and media. To participate in the call today, August&nbsp;3, at 4:30 p.m.
EDT, please dial (877) <FONT STYLE="white-space:nowrap">479-1857</FONT> from the U.S. and&nbsp;Canada&nbsp;or +1 (503) <FONT STYLE="white-space:nowrap">343-6309</FONT> internationally, and use the conference ID # 66006894. The live call is being
webcast and can be accessed in the &#147;Investors and Media&#148; section of the company&#146;s website at <U>www.dynavax.com</U>. A replay of the webcast will be available for 30 days following the live event. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About Hepatitis B </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">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 U.S., the number of reported cases of acute hepatitis B increased more than 20&nbsp;percent in
2015.<SUP STYLE="font-size:85%; vertical-align:top">i</SUP> After adjusting for under-reporting, the CDC estimated that 21,900 new HBV infections occurred in 2015. In addition to new cases of hepatitis B, chronic HBV infection remains a major public
health challenge. The CDC estimates that approximately 850,000 persons are living with HBV in the U.S. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT>
</B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> 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. In Phase 3 trials, <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> showed higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. 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 <FONT
STYLE="white-space:nowrap">HEPLISAV-B.</FONT> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>About Dynavax </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Dynavax is
a clinical-stage immunology company focused on leveraging the power of the body&#146;s innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax is developing product candidates for use in multiple cancer
indications, as a vaccine for the prevention of hepatitis B, and as a disease modifying therapy for asthma. Dynavax&#146;s lead product candidates are <FONT STYLE="white-space:nowrap">SD-101,</FONT> an investigational cancer immunotherapeutic
currently in Phase 1/2 studies, and <FONT STYLE="white-space:nowrap">HEPLISAV-B,</FONT> a Phase 3 investigational adult hepatitis B vaccine. For more information, visit www.dynavax.com. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Forward-Looking Statements </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">This release contains forward-looking statements
and estimates, including statements regarding <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> and FDA review. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including
whether the FDA will approve <FONT STYLE="white-space:nowrap">HEPLISAV-B,</FONT> notwithstanding the FDA Advisory Committee votes in favor of the safety and immunogenicity of <FONT STYLE="white-space:nowrap">HEPLISAV-B;</FONT> 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 decision whether to approve <FONT STYLE="white-space:nowrap">HEPLISAV-B;</FONT> the nature
and scope of the post-marketing study for <FONT STYLE="white-space:nowrap">HEPLISAV-B;</FONT> the final label claims and the nature of the label content for <FONT STYLE="white-space:nowrap">HEPLISAV-B;</FONT> and other risks detailed in the
&#147;Risk Factors&#148; section of our most recent current periodic report filed with the&nbsp;SEC. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information
on&nbsp;Dynavax&#146;s&nbsp;website at&nbsp;<U>www.dynavax.com</U>&nbsp;is not incorporated by reference in our current periodic reports with the&nbsp;SEC. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Contact: </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Ryan Spencer </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">VP, Corporate Strategy&nbsp;&amp; Communications </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">510.665.4618 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><U>rspencer@dynavax.com </U></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Media Contact: </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Leslie Bryant </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">WCG </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">562.505.9290 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><U>lbryant@w2ogroup.com </U></P>
<P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:10%">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><SUP STYLE="font-size:85%; vertical-align:top">i</SUP>
<U>https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm#Ref10</U>. Accessed July&nbsp;5, 2017. </P>
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