BERKELEY, CA--(Marketwired - November 05, 2014) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2014.
Dynavax had $130.6 million in cash, cash equivalents and marketable securities as of September 30, 2014, compared to $154.3 million at June 30, 2014. The net loss for the three months ended September 30, 2014 was $29.8 million compared to $24.8 million for the three months ended June 30, 2014. The net loss for the nine months ended September 30, 2014 was $68.4 million compared to $53.7 million for the nine months ended September 30, 2013. The increases in net loss are due primarily to increased operating expenses resulting from the phase 3 clinical trial of HEPLISAV-B™ that was initiated in April, 2014. Enrollment in this large safety and immunogenicity study (known as HBV-23) was completed in September, 2014 with more than 8,250 adults, including over 1,100 diabetic patients, enrolled in 40 sites across the U.S. All HBV-23 safety follow up visits are expected to be completed by October, 2015.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking" statements, including expectations for the conduct, timing and sufficiency of an additional clinical trial for HEPLISAV-B and plans to continue clinical development of AZD1419. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and review and approval of HEPLISAV-B and our process for its manufacture can occur without significant delay or additional studies; whether our studies and manufacturing efforts are sufficient to support registration for commercialization of HEPLISAV-B in either or both of the US and Europe; the timing for and costs of achieving the size of the safety database; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process, including whether a US or European licensure application will be approved; our ability to obtain additional financing to support the development and commercialization of HEPLISAV-B and our other operations; possible claims against us, including enjoining sales of HEPLISAV-B, based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, 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.
DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------ ------------------------
2014 2013 2014 2013
----------- ----------- ----------- -----------
Revenues:
Collaboration revenue $ 1,795 $ 1,110 $ 6,199 $ 3,349
Grant revenue 414 1,700 2,546 3,855
Service and license
revenue - 117 10 1,200
----------- ----------- ----------- -----------
Total revenues 2,209 2,927 8,755 8,404
Operating expenses:
Research and
development 28,072 11,770 64,942 38,739
General and
administrative 4,083 5,807 12,325 22,243
Unoccupied facility
expense 131 918 386 918
----------- ----------- ----------- -----------
Total operating expenses 32,286 18,495 77,653 61,900
----------- ----------- ----------- -----------
Loss from operations (30,077) (15,568) (68,898) (53,496)
Interest income 42 37 162 163
Interest expense - (24) - (83)
Other income (expense) 216 (120) 300 (248)
----------- ----------- ----------- -----------
Net loss $ (29,819) $ (15,675) $ (68,436) $ (53,664)
=========== =========== =========== ===========
Basic and diluted net
loss per share $ (0.11) $ (0.09) $ (0.26) $ (0.29)
=========== =========== =========== ===========
Shares used to compute
basic and diluted net
loss per share 262,908 183,022 262,883 182,960
=========== =========== =========== ===========
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
September 30, December 31,
2014 2013
---------------- ----------------
Assets
Cash, cash equivalents and marketable
securities $ 130,572 $ 189,376
Property and equipment, net 8,129 8,706
Goodwill 2,376 2,579
Other assets 5,819 3,961
---------------- ----------------
Total assets $ 146,896 $ 204,622
================ ================
Liabilities and stockholders'equity
Deferred revenues $ 6,499 $ 7,298
Other liabilities 18,821 11,030
---------------- ----------------
Total liabilities 25,320 18,328
Stockholders' equity 121,576 186,294
---------------- ----------------
Total liabilities and stockholders' equity $ 146,896 $ 204,622
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