Dynavax Technologies Corporation
DVAX today 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.
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