Delaware
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33-0728374
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(State or other jurisdiction of
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(IRS Employer
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incorporation)
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Identification No.)
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The information with respect to Item 2.02 in this current report and its accompanying exhibit shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in Item 2.02 of this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
99.2 Press Release, dated October 27, 2011, titled "Dynavax Phase 3 Data in Chronic Kidney Disease Demonstrates Superiority of HEPLISAV(TM) vs Engerix-B(R)."
99.3 Press Release, dated October 27, 2011, titled "Dynavax Confirms HEPLISAV(TM) Submission Strategies with U.S. FDA and EMA."
Dynavax Technologies Corporation
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Date: October 31, 2011
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By:
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/s/ Jennifer Lew
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Jennifer Lew
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Vice President, Finance
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Exhibit No.
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Description
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EX-99.1
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Press Release, dated October 27, 2011, titled "Dynavax Reports Third Quarter 2011 Financial Results."
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EX-99.2
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Press Release, dated October 27, 2011, titled "Dynavax Phase 3 Data in Chronic Kidney Disease Demonstrates Superiority of HEPLISAV(TM) vs Engerix-B(R)."
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EX-99.3
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Press Release, dated October 27, 2011, titled "Dynavax Confirms HEPLISAV(TM) Submission Strategies with U.S. FDA and EMA."
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Exhibit 99.1 | ||
DYNAVAX | ||
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DYNAVAX TECHNOLOGIES | ||
2929 Seventh Street, Suite 100 | ||
Berkeley, CA 94710 | ||
Contacts: | ||
Jennifer Lew | Michael Ostrach | |
Vice President, Finance | Vice President and Chief Business Officer | |
510-665-7217 | 510-665-7257 | |
jlew@dynavax.com | mostrach@dynavax.com |
DYNAVAX REPORTS THIRD QUARTER 2011 FINANCIAL RESULTS
BERKELEY, CA October 27, 2011 Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2011, including $53.2 million in cash, cash equivalents and marketable securities at September 30, 2011. This amount does not include a total of $8.6 million, consisting of $6 million in previously announced payments from Dynavaxs collaborations with AstraZeneca and GlaxoSmithKline to be made after the close of the quarter and proceeds of $2.6 million from the sale of common stock to Aspire Capital received after the close of the third quarter.
Dynavax said that, based on developments to date and additional potential payments anticipated to be received or earned by year end under existing arrangements, it expects to end 2011 with approximately $50 million in cash, cash equivalents and marketable securities.
About Dynavax |
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAVTM, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements |
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements regarding our projected net cash usage and cash position. 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 approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; 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; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company 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
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if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
tables to follow |
DYNAVAX TECHNOLOGIES CORPORATION | ||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(In thousands, except per share amounts) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues: | ||||||||||||||||
Collaboration revenue | $ | 369 | $ | 10,402 | $ 7,098 | $ | 19,164 | |||||||||
Grant revenue | 658 | 1,218 | 2,437 | 2,697 | ||||||||||||
Service and license revenue | 147 | 29 | 652 | 323 | ||||||||||||
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Total revenues | 1,174 | 11,649 | 10,187 | 22,184 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 11,777 | 14,204 | 39,706 | 40,729 | ||||||||||||
General and administrative | 4,217 | 3,951 | 13,025 | 12,694 | ||||||||||||
Amortization of intangible assets | | 245 | 299 | 735 | ||||||||||||
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Total operating expenses | 15,994 | 18,400 | 53,030 | 54,158 | ||||||||||||
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Loss from operations | (14,820) | (6,751) | (42,843) | (31,974) | ||||||||||||
Interest income | 18 | 12 | 74 | 53 | ||||||||||||
Interest expense | (485) | (399) | (1,462) | (1,229) | ||||||||||||
Other income (expense) | 58 | 2,140 | (99) | (9,036) | ||||||||||||
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Net loss | $ | (15,229) | $ | (4,998) | $ (44,330) | $ (42,186) | ||||||||||
Basic and diluted net loss per share | $ | (0.12) | $ | (0.06) | $ (0.37) | $ (0.57) | ||||||||||
Shares used to compute basic net loss per share | 124,069 | 86,826 | 119,244 | 74,519 | ||||||||||||
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DYNAVAX TECHNOLOGIES CORPORATION | ||||||||||||||||
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES | ||||||||||||||||
(In thousands) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
GAAP revenues | $ | 1,174 | $ | 11,649 | $ | 10,187 | $ | 22,184 | ||||||||
LESS: | ||||||||||||||||
Deferred revenue from collaborations | | 10,000 | | 10,000 | ||||||||||||
Pro forma revenues (1) | $ | 1,174 | $ | 1,649 | $ | 10,187 | $ | 12,184 | ||||||||
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(1) | These pro forma amounts are intended to illustrate the Companys revenues excluding certain items for which cash was received in a prior period. Management of the Company believes the pro forma results are a more useful measure of the Companys revenues because it provides investors the ability to evaluate the Companys operations in the manner that management uses to assess the continued progress of operating programs. These pro forma results are not in accordance with, or an alternative for, generally accepted accounting principles and may be different from pro forma measures used by other companies. |
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
(In thousands) (Unaudited)
Three Months Ended | Nine Months Ended | |||||||
September 30, | September 30, | |||||||
2011 | 2010 | 2011 | 2010 | |||||
GAAP operating expenses | $ 15,994 | $ 18,400 | $ 53,030 | $ 54,158 | ||||
LESS: | ||||||||
Stock-based compensation expense | 1,287 | 586 | 3,934 | 1,552 | ||||
Amortization of intangible assets | | 245 | 299 | 735 | ||||
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Pro forma operating expenses (2) | $ 14,707 | $ 17,569 | $ 48,797 | $ 51,871 |
(2) | These pro forma amounts are intended to illustrate the Companys operating expenses excluding certain non-cash charges in accordance with the financial statements that management uses to evaluate the Companys operations. These pro forma results are not in accordance with, or an alternative for, generally accepted accounting principles and may be different from pro forma measures used by other companies. |
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DYNAVAX TECHNOLOGIES CORPORATION | ||||||||
SELECTED BALANCE SHEET DATA | ||||||||
(In thousands) | ||||||||
(Unaudited) | ||||||||
September 30, | December 31, | |||||||
2011 | 2010 | |||||||
Assets | ||||||||
Cash and cash equivalents and marketable securities | $ | 53,221 | $ | 72,154 | ||||
Property and equipment, net | 6,127 | 6,404 | ||||||
Goodwill | 2,312 | 2,312 | ||||||
Other intangible assets, net | | 299 | ||||||
Other assets | 3,059 | 3,080 | ||||||
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Total assets | $ | 64,719 | $ | 84,249 | ||||
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Liabilities and stockholders equity | ||||||||
Accounts payable | $ | 1,313 | $ | 2,329 | ||||
Accrued and other liabilities | 8,823 | 11,786 | ||||||
Current portion of deferred revenue | 1,429 | 1,429 | ||||||
Noncurrent portion of deferred revenue | 4,583 | 5,655 | ||||||
Long-term note payable to Holdings | 12,342 | 10,939 | ||||||
Stockholders equity | 36,229 | 52,111 | ||||||
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Total liabilities and stockholders equity | $ | 64,719 | $ | 84,249 | ||||
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# # # |
Exhibit 99.2 |
DYNAVAX |
DYNAVAX TECHNOLOGIES 2929 Seventh Street, Suite 100 Berkeley, CA 94710 |
Contact: Michael Ostrach Vice President and Chief Business Officer 510-665-7257 mostrach@dynavax.com |
DYNAVAX PHASE 3 DATA IN CHRONIC KIDNEY DISEASE DEMONSTRATES SUPERIORITY OF HEPLISAV VS ENGERIX-B®
Detailed Phase 3 Data to Be Presented at Kidney Week
Berkeley, CA October 27, 2011 Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the company has unblinded its Phase 3 primary endpoint immunogenicity data in subjects with chronic kidney disease and that the data achieved statistical significance demonstrating both the superiority and non-inferiority of HEPLISAV as compared to Engerix-B. A partial safety analysis also showed a similar safety profile for the two vaccines, with the incidence of post-injection reactions and adverse events similar in both groups. This Phase 3 multi-center trial evaluated 507 subjects with chronic kidney disease, as defined by a modified intent-to-treat analysis, and compared three doses of HEPLISAV given at months 0, 1 and 6 with eight doses of Engerix-B given as double-doses at months 0, 1, 2 and 6. Detailed results of the trial will be presented in November at the American Society of Nephrology Kidney Week meeting in Philadelphia.
Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "The demonstrated superiority of HEPLISAV in chronic kidney disease patients who are at high risk of HBV infection and hypo-responsive to hepatitis B vaccine adds to the growing body of evidence of HEPLISAVs advantages in a well known hypo-responsive patient population already being vaccinated against hepatitis B infection. These results, with three doses of HEPLISAV compared to eight doses of Engerix-B, provide the data necessary to support an indication and specific treatment regimen for HEPLISAV in persons with chronic kidney disease.
The observer-blinded trial was conducted among 507 patients 18-75 years of age with chronic kidney disease (GFR 45 mL/min/1.73 m2). Subjects were recruited at 69 sites in the U.S., Canada, and Germany and were randomized 1:1 to receive HEPLISAV or Engerix-B. The primary objective was to determine if HEPLISAV is non-inferior to Engerix-B by comparing seroprotection rates (anti-HBs 10mIU/mL) one month after the last dose of vaccine (Month 7) and if non-inferior, to determine if HEPLISAV was superior to Engerix-B.
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Engerix-B® is a registered trademark of GlaxoSmithKline |
The Advisory Committee on Immunization Practices (ACIP) and other public health authorities recommend vaccination for all persons with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis, and home dialysis patients. Specific regimens or formulations are recommended for both of the currently available hepatitis B vaccines due to the hypo-responsiveness of chronic kidney disease patients. For immunocompromised persons, including dialysis patients, it is also recommended that additional vaccine be administered as needed to retain seroprotective levels of antibody against hepatitis B.
There are 750,000 persons with end-stage kidney disease in the United States and the five major European markets and an annual incidence of 150,000 new diagnoses and entry onto dialysis. Dialysis patients typically receive dialysis treatments, vaccination and monitoring of antibody levels through a network of dialysis centers that include approximately 5,000 sites in the United States.
About HEPLISAV |
HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3 trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax |
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-Looking Statements |
This press release contains "forward-looking statements," including those relating to the timing of presentation of results and the data necessary to support an indication and regimen for chronic kidney disease, that are subject to a number of risks and uncertainties. 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 approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our studies can support registration for commercialization of HEPLISAV; 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 the outcome of pre-filing discussions with regulatory authorities; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company 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 the Company's current periodic reports with the SEC.
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Exhibit 99.3 |
DYNAVAX |
DYNAVAX TECHNOLOGIES 2929 Seventh Street, Suite 100 Berkeley, CA 94710 |
Contact: Michael Ostrach Vice President and Chief Business Officer 510-665-7257 mostrach@dynavax.com |
DYNAVAX CONFIRMS HEPLISAV SUBMISSION STRATEGIES WITH U.S. FDA AND EMA
Berkeley, CA October 27 Dynavax Technologies Corporation (NASDAQ: DVAX) today said that the U.S. Food and Drug Administration (FDA) had concurred with the companys plan to submit a Biologics License Application (BLA) for HEPLISAV for persons over 40 years of age, followed by a supplemental BLA for licensure of a specific regimen for vaccinating chronic kidney disease (CKD) patients against hepatitis B infection at the time the initial application is approved. Dynavax also updated its timeline for the companys first BLA submission saying it expected to submit in the first quarter of 2012.
Dynavax also said that the European Medicines Agency (EMA) has advised the company it could submit the primary endpoint immunogenicity data and associated safety data for the over-40 population as well as the CKD indication as part of the initial Marketing Authorization Application (MAA) and that the outstanding CKD data can be submitted in the course of the applications review. Dynavax confirmed its plan to submit the MAA for European approval after the submission of its BLA in the U.S.
About HEPLISAV |
HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3 trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax |
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
more |
Forward-Looking Statements |
This press release contains "forward-looking statements," including those relating to our plans for the HEPLISAV BLA and MAA and the timing of the submissions, that are subject to a number of risks and uncertainties. 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 approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our studies can support registration for commercialization of HEPLISAV; 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 the outcome of pre-filing discussions with regulatory authorities; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company 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 the Company's current periodic reports with the SEC.
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