Full Press Release Details
BERKELEY, CA--(Marketwire - March 16, 2010) - Dynavax Technologies Corporation (NASDAQ: DVAX) today said that its large-scale Phase 3 study of HEPLISAV is
fully enrolled, with immunization of subjects proceeding in accordance with
the pre-specified safety monitoring plan. Dynavax indicated that it expects
immunization of all 2,000 subjects with HEPLISAV in the lot-to-lot
consistency study will be completed in the near future, an achievement that
creates the opportunity to submit a BLA in the third quarter of 2011,
approximately six months earlier than previously projected.
According to Dino Dina, M.D., President and CEO, "The accelerated
enrollment and immunization of subjects for the safety and consistency
study of HEPLISAV is an important accomplishment that we expect will
facilitate the successful conclusion of several ongoing financing
discussions. Clearly, this is our highest priority to ensure the success of
Dynavax separately reported $36.7 million in unrestricted cash and cash
equivalents at December 31, 2009. This compares to $46.4 million at
September 30, 2009, of which $21.7 million were investments held by
Symphony Dynamo, Inc. (SDI). The $9.7 million burn for the fourth quarter
primarily reflected intensified activities relating to the initiation of
the two Phase 3 multi-center trials for HEPLISAV in the U.S., Canada and
Germany. The year-end 2009 results do not include a $4.0 million payment
due from Merck as announced this week. The results do not reflect a
separate $1.8 million payment from AstraZeneca representing a reimbursement
adjustment for 2009 and prior periods.
Today Dynavax filed its annual report on Form 10-K for the fiscal year
ended December 31, 2009 with the Securities and Exchange Commission (SEC).
As a result of the Company's current financial position, Dynavax's
independent registered public accounting firm has included a statement
regarding the Company's ability to continue as a going concern in its
unqualified opinion contained in the Form 10-K. This announcement is being
made in compliance with NASDAQ Marketplace Rule 4350(b)(1)(B), which
requires separate disclosure of a recent audit opinion that contains "going
concern" explanatory language. Management's plan to address the Company's
liquidity requirements and a more detailed discussion of the financial
results is provided in the Form 10-K.
The tables included as part of this press release provide a reconciliation
of GAAP revenues and operating expenses to pro forma revenues and operating
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine
candidate is being evaluated in two Phase 3 studies that are directed
toward fulfilling licensure requirements in U.S., Canada and Europe. In a
completed pivotal Phase 3 trial, 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 Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six
months to achieve full immunogenicity in healthy patient populations.
Because compliance with this vaccine regimen is low, new vaccines are
needed to provide increased protection in a shorter timeframe. Furthermore,
currently available vaccines do not fully address the needs of several
patient populations, including those with chronic kidney disease, HIV or
chronic liver disease. In particular, patients with comprised immune
systems require both rapid and enhanced protection, either because they are
less responsive to conventional vaccine regimens or because they are at
high risk of infection.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical
company, discovers and develops novel products to prevent and treat
infectious diseases. The Company's lead product candidate is HEPLISAV, an
investigational adult hepatitis B vaccine designed to enhance protection
more rapidly and 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 relating to
clinical trial status, BLA submission and financing. 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 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)
Three Months Ended Twelve Months Ended
December 31, December 31,
-------------------- --------------------
--------- --------- --------- ---------
Collaboration revenue $ 1,455 $ 10,231 $ 35,534 $ 31,666
Grant revenue 556 972 3,477 2,999
Service and license revenue 178 742 1,307 2,429
--------- --------- --------- ---------
Total revenues 2,189 11,945 40,318 37,094
Research and development(1) 9,506 6,249 38,708 44,771
General and administrative(2) 4,052 3,559 15,745 15,463
Amortization of intangible
assets 245 245 980 980