Dynavax (DVAX) Will Continue HEPLISAV-B Phase 3 Unchanged Following Third DSMB Review

July 9, 2015 9:06 AM EDT

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from HBV-23, the ongoing Phase 3 clinical study of HEPLISAV-B, Dynavax's investigational adult hepatitis B vaccine, has completed its third prespecified review and has recommended that the study continue unchanged.

The third DSMB review included safety data for all enrolled subjects collected through the data cut-off in June. As of the cut-off, all continuing subjects who had received the second immunization (which was the last active dose for HEPLISAV-B subjects) had reached at least 8 months of the requisite one year follow-up after the second immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the DSMB recommended continuing HBV-23 with no change to the study.

Over 2,200 subjects have completed their final study visit and all study visits for HBV-23 are expected to be completed by October 2015. Top line results are expected to be released by early 2016.

Separately, Dynavax announced that its cash, cash equivalents and marketable securities at June 30, 2015 were approximately $93.4 million, which does not include approximately $28.8 million in additional cash resulting from stock sales following the end of the quarter under the Company's at-the-market sales agreement ("ATM agreement"). The ATM agreement has concluded because the Company has reached $50 million of gross proceeds as specified in the ATM agreement. At July 8, 2015, the Company had approximately 31,400,000 shares of common stock outstanding and approximately 17,000 shares of preferred stock outstanding which are convertible into approximately 1,700,000 shares of common stock.


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. Dynavax has worldwide commercial rights to HEPLISAV-B.

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