Dynavax Reports First Quarter 2017 Financial Results
"In January we reduced operating cost, limited further investment in HEPLISAV-B [Hepatitis B Vaccine, (Recombinant) Adjuvanted] until after we have received approval, and focused our efforts on immuno-oncology," said
Research and development expenses were
General and administrative expenses were
As part of the
For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.
HEPLISAV-B™ [Hepatitis B Vaccine, (Recombinant) Adjuvanted] 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 year.1 Those who do not complete the series may not be adequately protected against hepatitis B.
Forward Looking Statements
This release contains forward-looking statements and estimates, including statements regarding estimated operating costs and anticipated cost reductions. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether anticipated operating costs projections will be achieved; whether HEPLISAV-B will be approved by the
1 Nelson, J. et al.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended|
|Service and license revenue||-||8|
|Research and development||16,345||20,067|
|General and administrative||6,472||8,169|
|Total operating expenses||25,600||28,236|
|Loss from operations||(25,452||)||(27,294||)|
|Other income, net||20||46|
|Basic and diluted net loss per share||$||(0.60||)||$||(0.70||)|
|Weighted average shares used to compute basic and diluted net loss per share||41,830||38,472|
|SELECTED BALANCE SHEET DATA|
|Cash, cash equivalents and marketable securities||$||85,356||$||81,415|
|Property and equipment, net||16,633||17,174|
|Liabilities and stockholders ' equity|
|Total liabilities and stockholders' equity||$||110,132||$||109,680|
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