Dynavax Reports Second Quarter 2017 Financial Results
Additional Financial Results
The net loss for the three months ended
Research and development expenses for the quarter and six months ended
General and administrative expenses for the quarter and six months ended
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.
For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.
1 Nelson, J. et al.
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
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|Service and license revenue||-||876||-||884|
|Research and development||14,814||22,750||31,159||42,817|
|General and administrative||5,612||9,151||12,084||17,320|
|Total operating expenses||20,426||31,901||46,026||60,137|
|Loss from operations||(20,321||)||(29,254||)||(45,773||)||(56,548||)|
|Other income (expense), net||(232||)||48||(212||)||94|
|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|
|SELECTED BALANCE SHEET DATA|
|Cash, cash equivalents and marketable securities||$||126,961||$||81,415|
|Property and equipment, net||16,751||17,174|
|Liabilities and stockholders' equity|
|Total liabilities and stockholders' equity||$||151,968||$||109,680|
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