SOURCE: Dynavax Technologies

Dynavax Technologies

November 05, 2014 06:00 ET

Dynavax Reports Third Quarter 2014 Financial Results

BERKELEY, CA--(Marketwired - Nov 5, 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-Bthat 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
 September 30,
   
    Nine Months Ended
 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
             
             

Contact Information

  • Contact:
    Michael Ostrach
    Chief Business and Principal Financial Officer
    510-665-7257
    Email Contact