Dynavax Technologies Corporation
Aug 2, 2017

Dynavax Reports Second Quarter 2017 Financial Results

BERKELEY, CA -- (Marketwired) -- 08/02/17 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June 30, 2017. Cash, cash equivalents and marketable securities were $127.0 million at June 30, 2017 compared to $81.4 million at December 31, 2016. The increase was primarily due to net proceeds of $88.2 million during the first half of 2017 from sales of common stock under an at-the-market sales agreement.

Additional Financial Results

The net loss for the three months ended June 30, 2017 was $20.3 million, or $0.41 per share, compared to $29.0 million, or $0.75 per share, for the same period in 2016. The net loss for the six months ended June 30, 2017 was $45.6 million, or $1.00 per share, compared to $56.0 million, or $1.46 per share, for the same period in 2016.

Research and development expenses for the quarter and six months ended June 30, 2017 were $14.8 million and $31.2 million, respectively, compared to $22.8 million and $42.8 million for the same periods in 2016. The decrease in the 2017 periods reflect reduced compensation and related personnel costs as a result of the January 2017 restructuring and cost reduction initiative. Additionally, the 2017 periods reflect lower costs related to HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] clinical and manufacturing activity partially offset by increased costs relating to seeking regulatory approval for HEPLISAV-B and the ongoing development of SD-101 and earlier stage oncology programs.

General and administrative expenses for the quarter and six months ended June 30, 2017 were $5.6 million and $12.1 million, respectively, compared to $9.2 million and $17.3 million for the same periods in 2016. The decrease in the 2017 periods reflect reduced compensation and related personnel costs as a result of the January 2017 restructuring and cost reduction initiative. Additionally, the 2016 periods included costs related to hiring of consultants for administrative and commercial development services for an anticipated commercial launch of HEPLISAV-B.

About HEPLISAV-B

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. In Phase 3 trials, HEPLISAV-B 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.

HEPLISAV-B is administered in two doses over one-month. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year1. Those who do not complete the series may not be adequately protected against hepatitis B.

Dynavax has worldwide commercial rights to HEPLISAV-B.

About SD-101

SD-101 is Dynavax's proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. SD-101 is being studied for its multiple anti-tumor activities in innate immune cells and activation of plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its safety and activity.

For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

1 Nelson, J. et al. American Journal of Public Health, "Compliance with Multiple-Dose Vaccine Schedules Among Older Children, Adolescents and Adults: Results from a Vaccine Safety Datalink Study." 2009. Vol. 99 No. S2.

About Dynavax

Dynavax is a clinical-stage immunology company focused on leveraging the power of the body'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's lead product candidates are SD-101, an investigational cancer immunotherapeutic currently in Phase 1/2 studies, and HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

Forward Looking Statements

This release contains forward-looking statements and estimates. 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 HEPLISAV-B, notwithstanding the FDA Advisory Committee votes in favor of the efficacy and safety of HEPLISAV-B; 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 HEPLISAV-B; the nature and scope of the post-marketing pharmacovigilance plan for HEPLISAV-B; the final label claims and the nature of the label content for HEPLISAV-B; whether the ACIP will recommend use of HEPLISAV-B and the timing of receiving a recommendation; whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials of SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize SD-101; whether or not Dynavax and parties with whom we are collaborating may reach any future agreement on further studies or a more extensive collaboration beyond the clinical trials contemplated under the existing agreements; and other risks detailed in the "Risk Factors" section of our most recent periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, 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  
   
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS  
   
(In thousands, except per share amounts)  
   
(Unaudited)  
   
  Three Months Ended     Six Months Ended  
  June 30,     June 30,  
  2017     2016     2017     2016  
Revenues:                      
  Collaboration revenue $ -     $ 1,683     $ -     $ 2,578  
  Grant revenue   105       88       253       127  
  Service and license revenue   -       876       -       884  
Total revenues   105       2,647       253       3,589  
                               
Operating expenses:                              
  Research and development   14,814       22,750       31,159       42,817  
  General and administrative   5,612       9,151       12,084       17,320  
  Restructuring   -       -       2,783       -  
Total operating expenses   20,426       31,901       46,026       60,137  
                               
Loss from operations   (20,321 )     (29,254 )     (45,773 )     (56,548 )
                               
Interest income   235       220       380       445  
Other income (expense), net   (232 )     48       (212 )     94  
Net loss $ (20,318 )   $ (28,986 )   $ (45,605 )   $ (56,009 )
Basic and diluted net loss per share $ (0.41 )   $ (0.75 )   $ (1.00 )   $ (1.46 )
Weighted average shares used to compute basic and diluted net loss per share   49,700       38,496       45,787       38,491  
                               
 
DYNAVAX TECHNOLOGIES CORPORATION
 
SELECTED BALANCE SHEET DATA
 
(In thousands)
 
(Unaudited)
 
  June 30,   December 31,
  2017   2016
Assets      
  Cash, cash equivalents and marketable securities $ 126,961   $ 81,415
  Property and equipment, net   16,751     17,174
  Goodwill   2,140     1,971
  Other assets   6,116     9,120
Total assets $ 151,968   $ 109,680
           
Liabilities and stockholders' equity          
  Other liabilities   11,441     20,479
  Total liabilities   11,441     20,479
  Stockholders' equity   140,527     89,201
Total liabilities and stockholders' equity $ 151,968   $ 109,680
           

Contact:
Ryan Spencer
VP, Corporate Strategy & Communications
510.665.4618
rspencer@dynavax.com

Source: Dynavax Technologies

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