e424b5
The information
in this prospectus supplement and the accompanying prospectus is
not complete and may be changed. This prospectus supplement and
the accompanying prospectus are not an offer to sell these
securities and are not soliciting an offer to buy these
securities in any state where the offer or sale is not
permitted.
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Filed Pursuant To Rule 424(b)(5)
Registration Statement No. 333-127930
Subject to Completion
Prospectus Supplement dated
October 3, 2005
PROSPECTUS SUPPLEMENT
(To Prospectus dated October 3, 2005)
4,000,000 Shares
Common Stock
We are offering 4,000,000 shares of our common stock.
Our common stock is listed on The Nasdaq National Market under
the symbol DVAX. The last reported sale price of our
common stock on The Nasdaq National Market on September 30,
2005 was $6.70 per share.
Investing in our common stock involves risks. See Risk
Factors beginning on page S-6 of this prospectus
supplement.
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The underwriters may also purchase up to an additional
600,000 shares from us at the public offering price, less
the underwriting discount, within 30 days from the date of
this prospectus supplement to cover any overallotments. If the
overallotment option is exercised in full, we will receive
additional proceeds, before expenses, of
$ .
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus supplement or the
prospectus to which it relates is truthful or complete. Any
representation to the contrary is a criminal offense.
The shares will be ready for delivery on or
about ,
2005.
Bear, Stearns & Co. Inc.
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CIBC World Markets |
Pacific Growth Equities, LLC |
The date of this prospectus supplement
is ,
2005.
TABLE OF CONTENTS
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Prospectus |
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You should rely only on the information contained in this
prospectus supplement or contained in or incorporated by
reference in the accompanying prospectus to which we have
referred you. We have not authorized anyone to provide you with
information that is different. The information contained in this
prospectus supplement and contained, or incorporated by
reference, in the accompanying prospectus is accurate only as of
the respective dates thereof, regardless of the time of delivery
of this prospectus supplement and the accompanying prospectus or
of any sale of common stock. It is important for you to read and
consider all information contained in this prospectus supplement
and the accompanying prospectus, including the documents
incorporated by reference therein, in making your investment
decision. You should also read and consider the information in
the documents to which we have referred you under the caption
Where You Can Find More Information About Dynavax And This
Offering in the prospectus.
We are offering to sell, and are seeking offers to buy, the
common stock only in jurisdictions where offers and sales are
permitted. The distribution of this prospectus supplement and
the accompanying prospectus and the offering of the common stock
in certain jurisdictions may be restricted by law. Persons
outside the United States who come into possession of this
prospectus supplement and the accompanying prospectus must
inform themselves about and observe any restrictions relating to
the offering of the common stock and the distribution of this
prospectus supplement and the accompanying prospectus outside
the United States. This prospectus supplement and the
accompanying prospectus do not constitute, and may not be used
in connection with, an offer to sell, or a solicitation of an
offer to buy, any securities offered by this prospectus
supplement and the accompanying prospectus by any person in any
jurisdiction in which it is unlawful for such person to make
such an offer or solicitation.
i
ABOUT THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is this prospectus
supplement, which describes the specific terms of this offering
and also adds to and updates information contained in the
accompanying prospectus and the documents incorporated by
reference in the prospectus. The second part is the accompanying
prospectus, which gives more general information, some of which
may not apply to this offering.
If the description of this offering varies between this
prospectus supplement and the accompanying prospectus, you
should rely on the information contained in this prospectus
supplement; provided that if any statement in one of these
documents is inconsistent with a statement in another document
having a later date for example, a document
incorporated by reference in the accompanying
prospectus the statement in the document having the
later date modifies or supersedes the earlier statement.
We further note that the representations, warranties and
covenants made by us in any agreement that is filed as an
exhibit to any document that is incorporated by reference in the
accompanying prospectus were made solely for the benefit of the
parties to such agreement, including, in some cases, for the
purpose of allocating risk among the parties to such agreements,
and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties or
covenants were accurate only as of the date when made.
Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current
state of our affairs.
Unless we have indicated otherwise, or the context otherwise
requires, references in this prospectus supplement and the
accompanying prospectus to Dynavax, we,
us and our refer to Dynavax Technologies
Corporation.
Dynavax Technologies is a registered trademark of Dynavax
Technologies Corporation. We have also filed trademark
registrations for TOLAMBA and HEPLISAV. This prospectus
supplement and the accompanying prospectus also includes
trademarks, trade names and service marks of other companies.
Use by us of other parties trademarks, trade names or
service marks is not intended to and does not imply a
relationship with, or endorsement or sponsorship of us by, these
other parties.
ii
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights selected information contained
elsewhere or incorporated by reference in this prospectus
supplement and the accompanying prospectus. This summary may not
contain all the information that you should consider before
investing in our common stock. You should read the entire
prospectus supplement and the accompanying prospectus carefully,
including Risk Factors contained in this prospectus
supplement and the financial statements incorporated by
reference in the accompanying prospectus, before making an
investment decision. This prospectus supplement may add to,
update or change information in the accompanying prospectus.
Except where we state otherwise, the information we present in
this prospectus supplement assumes no exercise of the
underwriters overallotment option.
About Dynavax Technologies Corporation
We discover, develop and intend to commercialize innovative
products to treat and prevent allergies, infectious diseases,
cancer and chronic inflammatory diseases. Our clinical
development programs are based on immunostimulatory sequences
(ISS), which are short DNA sequences that we believe enhance the
ability of the immune system to fight disease and control
chronic inflammation. ISS are agonists of toll-like receptor-9
(TLR-9), which plays a key role in regulating immune system
responses. Depending on the indication for which ISS is being
explored as a therapy, we can administer ISS in different ways:
ISS linked to allergens, ISS linked to or combined with antigens
and ISS delivered alone. Our most advanced clinical programs are
TOLAMBA, a ragweed allergy immunotherapeutic, and HEPLISAV, a
hepatitis B (HBV) vaccine. We have completed Phase II
trials of TOLAMBA, and are currently completing a two-year
Phase IIb clinical trial. In 2005, we initiated a clinical
trial in ragweed allergic children designed to support our
pivotal Phase III program. In 2005, we initiated the first
of two large-scale, pivotal Phase III clinical trials of
HEPLISAV, and anticipate initiating the second pivotal
Phase III trial in 2006. We also have ongoing programs in
cancer and asthma.
Lead Product Candidates
Our lead product candidates, which are based on our proprietary
ISS, address large market segments and we believe they provide
significant advantages over current therapies. Our lead product
candidates include:
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TOLAMBA: Immunotherapeutic for Ragweed Allergy |
TOLAMBA is a novel injectable product candidate to treat ragweed
allergy that consists of ISS linked to the purified major
allergen of ragweed, called Amb a 1.
We believe that allergy represents a major market opportunity
for enhanced immunotherapy offerings. The worldwide allergy
therapies market is a multi-billion dollar market with
symptomatic treatments making up the vast majority of this
market. Our strategy is to develop product candidates based on
our proprietary ISS technology that address different types of
allergies across different markets. Ragweed allergy, the
indication for TOLAMBA, is the most common allergy in the United
States, representing approximately 30 million of the
40 million allergics in the United States. A significant
proportion of ragweed allergy sufferers have moderate to severe
symptoms and represent a target population for pharmacotherapy
and conventional immunotherapy. In addition to the health
problems directly associated with allergies, many sufferers also
develop additional health problems and it is estimated that a
significant percentage of those who suffer from allergic
rhinitis progress to asthma. Asthma is highly prevalent in
children and there is a need for a safer and more effective
therapy to prevent the allergic march from allergy
to asthma.
Current allergy immunotherapy regimens present significant
compliance challenges since they typically require 60 to 90
injections over a period of up to five years. Unlike the most
commonly-used medicines for seasonal allergic rhinitis, TOLAMBA
targets the underlying cause of seasonal allergic rhinitis
caused by ragweed and offers a more convenient six-week
treatment regimen and potentially longer-lasting therapeutic
results. In previously completed clinical trials, TOLAMBA has
demonstrated the ability to reduce allergy symptoms and the use
of allergy medications while improving quality of life.
S-1
Our clinical and regulatory strategy for TOLAMBA is to
demonstrate safety and efficacy in a broad age range of allergy
sufferers. We anticipate having final results from the
Phase IIb clinical trial in the first quarter of 2006. The
primary endpoint of this 462 patient trial is reduction in
nasal symptom scores after the second ragweed season. Pending
the final results of the Phase IIb study and the outcome of
discussions with the U.S. Food and Drug Administration
(FDA), we plan to initiate a large-scale pivotal Phase III
clinical trial in early 2006. In June 2005, we initiated a
Phase III clinical trial of TOLAMBA in ragweed allergic
children, aged 6-15 years, designed to support the pivotal
Phase III trial.
We plan to conduct a pivotal Phase III trial in
approximately 800-1000 subjects. The endpoint of this trial is
reduction in nasal symptom scores. We anticipate that the trial
will be designed with a two-year primary endpoint. Subject to
FDA approval of the pivotal Phase III trial design,
including a one-year interim analysis yielding positive interim
results, we could be in a position to apply for registration in
late 2007. Positive results from the ongoing trial with ragweed
allergic children could be part of our filing as well. Positive
data from this pediatric trial could enable us to establish
efficacy in an additional target population, and may allow us to
expand the potential labeling for TOLAMBA, should it receive
marketing approval from the FDA.
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HEPLISAV: Enhanced Hepatitis B Vaccine |
HEPLISAV combines our proprietary ISS co-administered with HBV
surface antigen (HBsAg), designed to significantly enhance the
level, speed and longevity of protection against hepatitis B
infection.
Hepatitis B is a common chronic infectious disease with an
estimated 350 million chronic carriers worldwide. HBV is a
major cause of acute and chronic viral hepatitis, with effects
ranging from asymptomatic infection to liver failures, cancer
and death. Vaccination is critical to managing the spread of the
disease. Annual sales of hepatitis B vaccines in 2003 were
approximately $1 billion globally. Current vaccination
regimens require three doses over a six-month period. Compliance
with the current vaccination regimen is a significant challenge,
as many patients fail to receive all three doses. According to a
survey of U.S. adolescents and adults published by the
Centers for Disease Control, only 30% of those patients who
began vaccine therapy received the third dose. Consequently, an
unacceptably large number of individuals who start the
vaccination regimen remain susceptible to infection. In
addition, certain populations are particularly in need of
vaccination due to their high risk of HBV infection, including
people with compromised immune systems, such as people
undergoing kidney dialysis, HIV-positive and hepatitis C
virus-positive subjects, as well as professionals facing an
occupational risk of HBV infection.
In clinical trials to date, HEPLISAV has demonstrated superior
seroprotection compared to GlaxoSmithKlines Engerix-B, the
current leading HBV vaccine. Results have shown that HEPLISAV
has been able to reduce both the time and number of injections
required to achieve a protective hepatitis B antibody response.
We believe this is due to the potent immune-enhancing properties
of ISS.
Statistically significant results from a double-blind
Phase II clinical trial in healthy adults (aged 18 to
28 years) conducted in 2004 showed that HEPLISAV induced a
more robust and durable antibody response than Engerix-B.
Results from this trial demonstrated that protective antibody
responses were achieved faster (two vaccinations over two months
compared to three over six months) and were maintained longer
with HEPLISAV than with Engerix-B. Recipients of HEPLISAV more
rapidly achieved seroprotection after each dose when compared to
Engerix-B (79% and 100% seroprotection one month after one and
two doses administered over one month, respectively, compared to
12% and 64% for the Engerix-B-treated group). The 100%
seroprotection achieved by the HEPLISAV-treated group after only
two doses was sustained more than one year later. The Engerix-B
treated group required three doses to achieve 98%
seroprotection, which fell to 90% six months later.
Earlier this year, we completed a Phase IIb trial in
Singapore in subjects aged 40 to 70 years who are more
difficult to immunize with conventional vaccines. Results from
the final analysis of the Phase IIb trial showed that our
vaccine demonstrated statistically significant superiority in
protective antibody response and robustness of protective effect
after three vaccinations when compared to GlaxoSmithKlines
Engerix-B vaccine.
S-2
We intend to present the full results from this clinical trial
in December 2005 at the 45th Annual Interscience Conference
on Antimicrobial Agents and Chemotherapy (ICAAC) in
Washington, DC.
In June 2005, we initiated the first of two large-scale,
double-blind pivotal Phase III clinical trials. The first
Phase III trial is being conducted in an older, more
difficult to immunize population, and will enroll more than 400
seronegative adults, aged 40 to 70 years, at study sites in
Asia. The primary endpoint is seroprotection four weeks after
the third vaccination (administered at month seven). We expect
to have results from this trial in the second half of 2006. In
the first half of 2006, we anticipate initiating a second
pivotal Phase III trial in Canada and Europe. This trial
will enroll approximately 400 seronegative subjects, aged 15 to
39 years. The primary endpoint will be seroprotection four
weeks after the second vaccination. We are also planning to
conduct trials in other target populations, including dialysis
patients, and, potentially, HIV-positive and hepatitis C
virus-positive subjects, in Canada and Europe, and potentially
in the United States.
We believe that HEPLISAV could represent a potential new
standard of care with respect to HBV vaccines, especially for
populations that are at high risk. We plan to focus our
commercial efforts on target populations for whom the clinical
need for an enhanced vaccine is greatest and where we believe we
can achieve a significant commercial return. Our clinical
strategy is to demonstrate superior safety and efficacy in
sufficient numbers of subjects and in multiple geographies where
the vaccine can potentially be used. We expect our registration
strategy will target selected markets where we believe we can
achieve significant market share with competitive pricing.
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Potential for Therapeutic Franchises |
We believe that our first-generation programs are the
cornerstones of our strategy to build commercially valuable and
therapeutically important franchises in cancer, inflammation,
allergy immunotherapy and enhanced vaccines.
Cancer. We are evaluating the potential of ISS to enhance
the effect of monoclonal antibodies in cancer therapies. This
strategy has been shown to be effective in preclinical models
using various anticancer monoclonal antibodies. We have
conducted an open-label Phase I, dose-escalation trial of
ISS in combination with Rituximab in 20 patients with
Non-Hodgkins lymphoma (NHL). Results of this study showed
dose dependent pharmacological activity without significant
toxicity.
A follow-up Phase II trial of ISS with Rituximab in NHL is
currently underway in 30 patients with histologically
confirmed CD20+, B-cell follicular NHL who have received at
least one previous treatment regimen for lymphoma. The primary
objective is to assess the proportion of patients who are alive
and without disease progression one year after initiating
Rituximab therapy. Mechanistic studies will be performed to
characterize the enhancement of antitumor activity by ISS.
Asthma. We have an inhaled therapeutic product candidate
for treatment of asthma, which has completed a Phase IIa
trial. We intend to perform additional preclinical work to
optimize the route of administration and regimen for the asthma
clinical program.
Allergy. Our strategy is to establish an ISS-based
franchise in seasonal allergy immunotherapy. As TOLAMBA
progresses through clinical development, we intend to produce
similar ISS-allergen linked product candidates for the treatment
of other major allergies, including peanut, grass and cedar tree
allergies. These programs are currently in the preclinical stage
of development.
Vaccines. We believe ISS based vaccines have the
potential to confer higher levels of immunity more quickly and
effectively than currently available vaccines. We are currently
developing ISS based anthrax and influenza vaccines. These
programs are currently in the preclinical stage of development.
S-3
Our Strategy
Our goal is to become a leading immunotherapy company focused on
discovering, developing and commercializing novel vaccines and
treatments for allergies, infectious diseases, cancer and
chronic inflammatory diseases. The key elements of our business
strategy include:
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Advancing our lead product candidates through development,
regulatory approval and into commercialization; |
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Continuing to implement our franchise-building strategy by
leveraging our ISS technology to advance our product portfolio
focused on allergies, infectious diseases, cancer, and chronic
inflammatory diseases; |
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Continuing the development of our proprietary technologies to
support advancement of next generation product
candidates; and |
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Selectively establishing corporate collaborations with global
pharmaceutical and biotechnology companies to assist in the
development and commercialization of our products while
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Corporate Information
We were incorporated in California in August 1996 under the name
Double Helix Corporation, and we changed our name to Dynavax
Technologies Corporation in September 1996. We reincorporated in
Delaware in 2001. Our principal offices are located at 2929
Seventh Street, Suite 100, Berkeley, California 94710-2753.
Our telephone number is (510) 848-5100. Our Internet
address is www.dynavax.com. The information on our
website is not incorporated by reference into this prospectus
supplement, and you should not consider it part of this
prospectus supplement or the accompanying prospectus.
S-4
THE OFFERING
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Common stock offered by Dynavax |
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4,000,000 shares |
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Common stock to be outstanding after this offering |
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28,757,438 shares |
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Use of proceeds |
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We intend to use the net proceeds from this offering for general
corporate purposes, including clinical trials, research and
development expenses and general and administrative expenses. |
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The Nasdaq National Market symbol |
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DVAX |
The number of shares of our common stock to be outstanding
immediately after this offering is based on the number of shares
outstanding as of September 15, 2005, which was
24,757,438 shares. This number does not include:
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an aggregate of 2,477,195 shares of common stock issuable
upon the exercise of options outstanding as of
September 15, 2005 at a weighted average exercise price of
$4.40 per share; |
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an additional 2,957,981 shares of common stock reserved for
issuance as of September 15, 2005 under our 2004 Stock
Incentive Plan; |
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461,308 shares of common stock available for issuance under
our 2004 Employee Stock Purchase Plan as of September 15,
2005; and |
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84,411 shares of common stock issuable upon the exercise of
an outstanding warrant at an exercise price of $6.18 per
share. |
Unless otherwise stated, the information contained in this
prospectus supplement assumes no exercise of the
underwriters overallotment option.
S-5
RISK FACTORS
You should carefully consider the risks described below
before making an investment decision. You should also refer to
the other information in this prospectus supplement and the
accompanying prospectus, including our financial statements and
the related notes incorporated by reference in the accompanying
prospectus. The risks and uncertainties described below are not
the only risks and uncertainties we face. Additional risks and
uncertainties not presently known to us or that we currently
deem immaterial also may impair our business operations. If any
of the following risks actually occur, our business, results of
operations and financial condition could suffer. In that event
the trading price of our common stock could decline, and you may
lose all or part of your investment in our common stock. The
risks discussed below also include forward-looking statements
and our actual results may differ substantially from those
discussed in these forward-looking statements.
Risks Related to Our Business
We have incurred substantial losses since inception and do
not have any commercial products that generate revenue.
We have experienced significant operating losses in each year
since our inception in August 1996. To date, our revenue has
resulted from a collaboration agreement with UCB Farchim, S.A.,
(UCB) and government and private agency grants. The UCB
collaboration agreement ended in March 2005. The grants are
subject to annual review based on the achievement of milestones
and other factors and will terminate in January 2007 at the
latest. Our accumulated deficit was $98.8 million as of
June 30, 2005, and we anticipate that we will incur
substantial additional operating losses for the foreseeable
future. These losses have been, and will continue to be,
principally the result of the various costs associated with our
research and development activities. We expect our losses to
increase primarily as a consequence of our continuing product
development efforts.
We do not have any products that generate revenue. We began a
Phase IIb trial for TOLAMBA, an immunotherapy for ragweed
allergy, and a Phase IIb trial for HEPLISAV, both in 2004.
In 2005, we initiated a trial of TOLAMBA in ragweed allergic
children designed to support our pivotal Phase III program
and initiated a pivotal Phase III trial for HEPLISAV. These
and our other product candidates may never be commercialized,
and we may never generate product-related revenue. Our ability
to generate product revenue depends upon:
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demonstrating in clinical trials that our product candidates are
safe and effective, in particular, in the planned Phase III
trials for TOLAMBA, the current Phase III trial of
HEPLISAV, the planned additional Phase III trials in
HEPLISAV; |
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obtaining regulatory approvals for our product candidates in the
United States and international markets; |
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entering into collaborative relationships on commercially
reasonable terms for the development, manufacturing, sales and
marketing of our product candidates, and then successfully
managing these relationships; and |
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obtaining commercial acceptance of our products, in particular
TOLAMBA and HEPLISAV. |
If we are unable to generate revenues or achieve profitability,
we may be required to significantly reduce or discontinue our
operations or raise additional capital under adverse
circumstances.
If we are unable to secure additional funding, we will have
to reduce or discontinue operations.
We believe our existing capital resources will be adequate to
satisfy our capital needs for at least the next twelve months.
Because of the significant time and resources it will take to
develop our product candidates, potentially commercialize them
and generate revenues, we may require substantial additional
capital resources in order to continue our operations, and any
such funding may not cover our costs of operations. In the
S-6
event we change our development plans or clinical programs, we
may need additional capital sooner than we currently anticipate.
We expect capital outlays and operating expenditures to increase
over the next several years as we expand our operations. We may
be unable to obtain additional capital from financing sources or
from agreements with collaborators on acceptable terms, or at
all. If at any time sufficient capital is not available, we may
be required to delay, reduce the scope of, or eliminate some or
all of our research, preclinical or clinical programs or
discontinue our operations.
All of our product candidates are unproven, and our success
depends on our product candidates being approved through
uncertain and time-consuming regulatory processes. Failure to
prove our products safe and effective in clinical trials and
obtain regulatory approvals could require us to discontinue
operations.
None of our product candidates has been proven safe and
effective in clinical trials or approved for sale in the United
States or any foreign market. Any product candidate we develop
is subject to extensive regulation by federal, state and local
governmental authorities in the United States, including the
FDA, and by foreign regulatory agencies. Our success is
primarily dependent on our ability to obtain regulatory approval
for TOLAMBA, our ragweed allergy product candidate, and
HEPLISAV, our hepatitis B vaccine product candidate. Approval
processes in the United States and in other countries are
uncertain, take many years and require the expenditure of
substantial resources. Product development failure can occur at
any stage of clinical trials and as a result of many factors,
many of which are not under our control.
We will need to demonstrate in clinical trials that each product
candidate is safe and effective before we can obtain the
necessary approvals from the FDA and foreign regulatory
agencies. We initiated a two-year, multi-site Phase IIb
trial in the first quarter of 2004 in the United States for
TOLAMBA. We currently expect data from this trial in the early
part of 2006; however, we cannot guarantee that results from
this trial will be positive. If we do not obtain positive data
from this trial, and pending the outcome of discussions with the
FDA, we may be delayed or prevented from initiating our planned
pivotal Phase III trial for TOLAMBA in early 2006. We
initiated a trial of TOLAMBA in ragweed allergic children
designed to support our pivotal Phase III program. We have
initiated a pivotal Phase III trial for HEPLISAV in Asia.
We anticipate initiating a second pivotal Phase III trial
for HEPLISAV in Canada and Europe in the first half of 2006. The
FDA or foreign regulatory agencies may require us to conduct
additional clinical trials prior to approval in their
jurisdictions.
Many new drug candidates, including many drug candidates that
have completed Phase III clinical trials, have shown
promising results in early clinical trials and subsequently
failed to establish sufficient safety and efficacy to obtain
regulatory approval. Despite the time and money expended,
regulatory approvals are never guaranteed. Failure to complete
clinical trials and prove that our products are safe and
effective would have a material adverse effect on our ability to
eventually generate revenues and could require us to reduce the
scope of or discontinue our operations.
Our clinical trials may be suspended, delayed or terminated
at any time. Even short delays in the commencement and progress
of our trials may lead to substantial delays in the regulatory
approval process for our product candidates, which will impair
our ability to generate revenues.
We may suspend or terminate clinical trials at any time for
various reasons, including regulatory actions by the FDA or
foreign regulatory agencies, actions by institutional review
boards, failure to comply with good clinical practice
requirements and concerns regarding health risks to test
subjects. In addition, our ability to conduct clinical trials
for some of our product candidates, notably TOLAMBA, is limited
due to the seasonal nature of ragweed allergy. Even a small
delay in a trial for any product candidate could require us to
delay commencement of the trial until the next appropriate
season, which could result in a delay of an entire year. For
example, if we are unable to initiate our Phase III program
for TOLAMBA by mid 2006, we will not obtain the necessary data
to permit us to file for registration in late 2007. Accordingly,
the earliest we would
S-7
be able to file for registration is late 2008. Consequently, we
may experience additional delays in obtaining regulatory
approval for these product candidates.
Suspension, termination or unanticipated delays of our clinical
trials for TOLAMBA or HEPLISAV may:
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adversely affect our ability to commercialize or market any
product candidates we may develop; |
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impose significant additional costs on us; |
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potentially diminish any competitive advantages that we may
attain; |
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adversely affect our ability to enter into collaborations,
receive milestone payments or royalties from potential
collaborators; |
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cause us to abandon the development of the affected product
candidate; or |
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limit our ability to obtain additional financing on acceptable
terms, if at all. |
If third parties successfully assert that we have infringed
their patents and proprietary rights or challenge the validity
of our patents and proprietary rights, we may become involved in
intellectual property disputes and litigation that would be
costly, time consuming, and delay or prevent development or
commercialization of our product candidates.
We may be exposed to future litigation by third parties based on
claims that our product candidates, proprietary technologies or
the licenses on which we rely, infringe their intellectual
property rights, or we may be required to enter into litigation
to enforce patents issued or licensed to us or to determine the
scope or validity of another partys proprietary rights. If
we become involved in any litigation, interference or other
administrative proceedings related to our intellectual property
or the intellectual property of others, we will incur
substantial expenses and it will divert the efforts of our
technical and management personnel. Others may succeed in
challenging the validity of our issued and pending claims.
Two of our potential competitors relative to HEPLISAV, Merck and
GlaxoSmithKline, are exclusive licensees of broad patents
covering hepatitis B surface antigen. In addition, the Institute
Pasteur also owns or has exclusive licenses to patents covering
hepatitis B surface antigen. While some of these patents have
expired or will soon expire outside of the United States, they
remain in force in the United States and are likely to be in
force when we commercialize HEPLISAV or a similar product in the
United States. To the extent we were to commercialize HEPLISAV
in the United States, Merck and/or GlaxoSmithKline or the
Institute Pasteur may bring claims against us.
If we are unsuccessful in defending or prosecuting our issued
and pending claims or in defending potential claims against us,
for example, as may arise to the extent we were to commercialize
HEPLISAV or any similar product candidate in the United States,
we could be required to pay substantial damages and we may be
unable to commercialize our product candidates or use our
proprietary technologies unless we obtain a license from these
or other third parties. A license may require us to pay
substantial royalties, require us to grant a cross-license to
our technology or may not be available to us on acceptable terms
or on any terms. In addition, we may be required to redesign our
technology so it does not infringe a third partys patents,
which may not be possible or could require substantial funds and
time. Any of these outcomes may require us to change our
business strategy and could reduce the value of our business.
Another of our potential competitors, Coley Pharmaceutical Group
(Coley), has issued U.S. patent claims, as well as patent
claims pending with the U.S. Patent and Trademark Office,
that, if held to be valid, could require us to obtain a license
in order to commercialize one or more of our formulations of ISS
in the United States, including TOLAMBA and HEPLISAV. In
December 2003 the U.S. Patent and Trademark Office declared
an interference to resolve first-to-invent disputes between a
patent application filed by the Regents of the University of
California, which is exclusively licensed to us, and an issued
U.S. patent owned by Coley relating to immunostimulatory
DNA sequences. The declaration of interference named the Regents
of the University of California as senior party, indicating that
a patent application filed by the Regents of the University of
California and licensed to us was filed prior to a patent
application owned by Coley that led to an issued
U.S. patent. The interference provides the first forum to
challenge the validity and priority of certain of Coleys
patents. On March 10, 2005, the U.S. Patent and
Trademark Office issued a decision in the interference which did
not address the merits of the case, but dismissed it on a legal
technicality related to
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the timing of Dynavaxs filing of its claims and request
for interference. Dynavax has appealed this non-final decision.
If we prevail in the appeal, we will be able to continue the
interference to address the merits of the case. If we prevail in
the interference proceeding, it would establish our founders as
the inventors of the inventions in dispute. However, even a
favorable outcome in the interference would not prevent Coley
from asserting its other patents or patent claims, that were not
the subject of the interference, against our ISS products, which
could harm our ability to commercialize those products. If we do
not prevail in the interference proceeding, we may not be able
to obtain patent protection on the subject matter of the
interference, which would have a material adverse impact on our
business. In addition, if Coley prevails in the interference, it
may seek to enforce its rights under issued claims, including,
for example, by suing us for patent infringement. Consequently,
we may need to obtain a license to issued and/or pending claims
held by Coley by paying cash, granting royalties on sales of our
products or offering rights to our own proprietary technologies.
Such a license may not be available to us on acceptable terms,
if at all.
If we receive regulatory approval for our product candidates,
we will be subject to ongoing FDA and foreign regulatory
obligations and continued regulatory review, which may be costly
and subject us to various enforcement actions.
Any regulatory approvals that we receive for our product
candidates are likely to contain requirements for post-marketing
follow-up studies, which may be costly. Product approvals, once
granted, may be modified, resulting in limitations on our
labeling indications or marketing claims, or withdrawn
completely if problems occur after commercialization. Thus, even
if we receive FDA and other regulatory approvals, our product
candidates may later exhibit qualities that limit or prevent
their widespread use or that force us to withdraw those products
from the market.
In addition, we or our contract manufacturers will be required
to adhere to federal regulations setting forth current good
manufacturing practice. The regulations require that our product
candidates be manufactured and our records maintained in a
prescribed manner with respect to manufacturing, testing and
quality control activities. Furthermore, we or our contract
manufacturers must pass a pre-approval inspection of
manufacturing facilities by the FDA and foreign regulatory
agencies before obtaining marketing approval and will be subject
to periodic inspection by the FDA and corresponding foreign
regulatory agencies under reciprocal agreements with the FDA.
Further, to the extent that we contract with third parties for
the manufacture of our products, our ability to control
third-party compliance with FDA requirements will be limited to
contractual remedies and rights of inspection.
Failure to comply with regulatory requirements could prevent or
delay marketing approval or require the expenditure of money or
other resources to correct. Failure to comply with applicable
requirements may also result in warning letters, fines,
injunctions, civil penalties, recall or seizure of products,
total or partial suspension of production, refusal of the
government to renew marketing applications and criminal
prosecution, any of which could be harmful to our ability to
generate revenues and our stock price.
Our product candidates in clinical trials rely on a single
lead ISS compound, 1018 ISS, and most of our earlier stage
programs rely on ISS-based technology. Serious adverse safety
data relating to either 1018 ISS or other ISS-based technology
may require us to reduce the scope of or discontinue our
operations.
Our product candidates in clinical trials are based on 1018 ISS,
and substantially all of our research and development programs
use ISS-based technology. If any of our product candidates in
clinical trials produce serious adverse safety data, we may be
required to delay or discontinue all of our clinical trials. In
addition, as all of our clinical product candidates contain 1018
ISS, potential collaborators may also be reluctant to establish
collaborations for our products in distinct therapeutic areas
due to the common safety risk across therapeutic areas. If
adverse safety data are found to apply to our ISS-based
technology as a whole, we may be required to discontinue our
operations.
A key part of our business strategy is to establish
collaborative relationships to commercialize and fund
development of our product candidates. We may be unsuccessful in
establishing and managing
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collaborative relationships, which may significantly limit
our ability to develop and commercialize our products
successfully, if at all.
We will need to establish collaborative relationships to obtain
domestic and international sales, marketing and distribution
capabilities for our product candidates. We also intend to enter
into collaborative relationships to provide funding to support
our research and development programs. We have established a
collaborative relationship with Berna Biotech for HEPLISAV, a
prophylactic vaccine, and for hepatitis B therapeutic product
candidates. Our collaboration agreement with UCB for TOLAMBA and
for grass allergy immunotherapy ended in March 2005. Future
collaboration revenue will depend on our ability to enter into
new collaborative relationships.
The process of establishing collaborative relationships is
difficult, time-consuming and involves significant uncertainty.
Moreover, even if we do establish collaborative relationships,
our collaborators may seek to renegotiate or terminate their
relationships with us due to unsatisfactory clinical results, a
change in business strategy, a change of control or other
reasons. If any collaborator fails to fulfill its
responsibilities in a timely manner, or at all, our research,
clinical development or commercialization efforts related to
that collaboration could be delayed or terminated, or it may be
necessary for us to assume responsibility for expenses or
activities that would otherwise have been the responsibility of
our collaborator. If we are unable to establish and maintain
collaborative relationships on acceptable terms, we may have to
delay or discontinue further development of one or more of our
product candidates, undertake development and commercialization
activities at our own expense or find alternative sources of
capital.
We rely on third parties to supply component materials
necessary for our clinical product candidates and manufacture
product candidates for our clinical trials. Loss of these
suppliers or manufacturers, or failure to replace them may delay
our clinical trials and research and development efforts and may
result in additional costs, which would preclude us from
producing our product candidates on commercially reasonable
terms.
We rely on a number of third parties for the multiple steps
involved in the manufacturing process of our product candidates,
including, for example, the manufacture of the antigens and ISS,
the component materials that are necessary for our product
candidates, the combination of the antigens and ISS, and the
fill and finish. Termination or interruption of these
relationships may occur due to circumstances that are outside
our control, resulting in higher cost or delays in our product
development efforts.
We and these third parties are required to comply with
applicable current FDA good manufacturing practice regulations
and similar requirements in Canada and other foreign countries.
If one of these parties fails to maintain compliance with these
regulations, the production of our product candidates could be
interrupted, resulting in delays and additional costs.
Additionally, these third parties must pass a preapproval
inspection before we can obtain regulatory approval for any of
our product candidates.
In particular, we have relied on a single supplier to produce
our ISS for clinical trials. ISS is a critical component of both
of TOLAMBA and HEPLISAV. To date, we have manufactured only
small quantities of ISS ourselves for research purposes. If we
were unable to maintain or replace our existing source for ISS,
we would have to establish an in-house ISS manufacturing
capability, incurring increased capital and operating costs and
delays in commercializing our product candidates. We or other
third parties may not be able to produce ISS at a cost, quantity
and quality that are available from our current third-party
supplier.
In addition, we do not currently have a contract manufacturer
for TOLAMBA or sufficient TOLAMBA to supply our potential
commercial needs. We are currently manufacturing supplies of
TOLAMBA for the second year of our current Phase III
clinical trial in ragweed allergic children. We intend to enter
into manufacturing agreements with one or more commercial-scale
contract manufacturers to produce additional supplies of TOLAMBA
as required for new clinical trials and commercialization. If we
are unable to complete such agreements, we would have to
establish an internal commercial scale manufacturing capability
for TOLAMBA, incurring increased capital and operating costs,
delays in the commercial development of TOLAMBA and higher
manufacturing costs than we have experienced to date.
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We have or intend to contract with one or more third parties
to conduct our clinical trials for TOLAMBA and HEPLISAV. If
these third parties do not carry out their contractual
obligations or meet expected deadlines, our planned clinical
trials may be delayed and we may fail to obtain the regulatory
approvals necessary to commercialize TOLAMBA or HEPLISAV.
We are unable to independently conduct our planned clinical
trials for TOLAMBA or HEPLISAV, and we have or intend to
contract with third party contract research organizations to
manage and conduct these trials. If these third parties do not
carry out their contractual duties or obligations or meet
expected deadlines, if the third parties need to be replaced or
if the quality or accuracy of the clinical data they obtain is
compromised due to failure to adhere to our clinical protocols
or for other reasons, our planned clinical trials may be
extended, delayed or terminated. Any extension, delay or
termination of our trials would delay our ability to
commercialize TOLAMBA or HEPLISAV and generate revenues.
If any products we develop are not accepted by the market or
if regulatory agencies limit our labeling indications or
marketing claims, we may be unable to generate significant
revenues, if any.
We do not anticipate that any of our product candidates will be
commercially available until 2008 at the earliest, if at all.
Furthermore, even if we obtain regulatory approval for our
product candidates and are able to successfully commercialize
them, our product candidates may not gain market acceptance
among physicians, patients, health care payors and the medical
community. The FDA or other regulatory agencies could limit the
labeling indication for which our product candidates may be
marketed or could otherwise constrain our marketing claims,
reducing our or our collaborators ability to market the
benefits of our products to particular patient populations. If
we are unable to successfully market any approved product
candidates, or are limited in our marketing efforts by
regulatory limits on labeling indications or marketing claims,
our ability to generate revenues could be significantly impaired.
In particular, treatment with TOLAMBA, if approved, will require
a series of injections, and we expect that some of the patients
that currently take oral or inhaled pharmaceutical products to
treat their allergies would not consider using our product. We
believe that market acceptance of TOLAMBA will also depend on
our ability to offer competitive pricing, increased efficacy and
improved ease of use as compared to existing or potential new
allergy treatments.
We may seek partners for purposes of commercialization of
HEPLISAV in selected markets worldwide in addition to or as a
replacement for our current collaborative partner, Berna
Biotech. Berna Biotech has an exclusive option to commercialize
HEPLISAV and therapeutic product candidates. Marketing
challenges vary by market and could limit or delay acceptance in
any particular country. We believe that market acceptance of
HEPLISAV will depend on our ability to offer increased efficacy
and improved ease of use as compared to existing or potential
new hepatitis B vaccine products.
We face uncertainty related to coverage, pricing and
reimbursement and the practices of third party payors, which may
make it difficult or impossible to sell our product candidates
on commercially reasonable terms.
In both domestic and foreign markets, our ability to generate
revenues from the sales of any approved product candidates in
excess of the costs of producing the product candidates will
depend in part on the availability of reimbursement from third
party payors. Existing laws affecting the pricing and coverage
of pharmaceuticals and other medical products by government
programs and other third party payors may change before any of
our product candidates are approved for marketing. In addition,
third party payors are increasingly challenging the price and
cost-effectiveness of medical products and services. Significant
uncertainty therefore exists as to coverage and reimbursement
levels for newly approved health care products, including
pharmaceuticals. Because we intend to offer products, if
approved, that involve new technologies and new approaches to
treating disease, the willingness of third party payors to
reimburse for our products is particularly uncertain. We will
have to charge a price for our products that is sufficiently
high to enable us to recover the considerable capital resources
we have spent and will continue to spend on product development.
Adequate third-party reimbursement may not be available to
enable us to maintain price levels sufficient to
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realize a return on our investment in product development. If it
becomes apparent, due to changes in coverage or pricing of
pharmaceuticals in our market or a lack of reimbursement, that
it will be difficult, if not impossible, for us to generate
revenues in excess of costs, we will need to alter our business
strategy significantly. This could result in significant
unanticipated costs, harm our future prospects and reduce our
stock price.
Many of our competitors have greater financial resources and
expertise than we do. If we are unable to successfully compete
with existing or potential competitors despite these
disadvantages we may be unable to generate revenues and our
business will be harmed.
We compete with many companies and institutions, including
pharmaceutical companies, biotechnology companies, academic
institutions and research organizations, in developing
alternative therapies to treat or prevent allergy, infectious
diseases, asthma and cancer, as well as those focusing more
generally on the immune system. Competitors may develop more
effective, more affordable or more convenient products or may
achieve earlier patent protection or commercialization of their
products. These competitive products may render our product
candidates obsolete or limit our ability to generate revenues
from our product candidates. Many of the companies developing
competing technologies and products have significantly greater
financial resources and expertise in research and development,
manufacturing, preclinical and clinical testing, obtaining
regulatory approvals and marketing than we do.
TOLAMBA, if approved, will compete directly with conventional
allergy shots and indirectly with antihistamines,
corticosteroids and anti-leukotriene agents, used to treat
seasonal allergy symptoms, including those produced by
GlaxoSmithKline Plc, Merck & Co., Inc. and AstraZeneca
Plc. Since our TOLAMBA ragweed allergy treatment would require a
series of injections, we expect that some patients that
currently take oral or inhaled pharmaceutical products to treat
their allergies would not consider our product.
HEPLISAV, if approved, will compete with existing vaccines
produced by GlaxoSmithKline Plc and Merck & Co., Inc.,
among others.
Existing and potential competitors may also compete with us for
qualified scientific and management personnel, as well as for
technology that would be advantageous to our business. If we are
unable to compete with existing and potential competitors we may
not be able to obtain financing, sell our product candidates or
generate revenues.
We depend on key employees in a competitive market for
skilled personnel, and the loss of the services of any of our
key employees would affect our ability to develop and
commercialize our product candidates and achieve our
objectives.
We are highly dependent on the principal members of our
management, operations and scientific staff, including our Chief
Executive Officer, Dino Dina. We experience intense competition
for qualified personnel. Our future success also depends in part
on the continued service of our executive management team, key
scientific and management personnel and our ability to recruit,
train and retain essential scientific personnel for our drug
discovery and development programs, including those who will be
responsible for overseeing our preclinical testing and clinical
trials as well as for the establishment of collaborations with
other companies. If we lose the services of any of these people,
our research and product development goals, including the
identification and establishment of key collaborations,
operations and marketing efforts could be delayed or curtailed.
We intend to develop, seek regulatory approval for and market
our product candidates outside the United States, requiring a
significant commitment of resources. Failure to successfully
manage our international operations could result in significant
unanticipated costs and delays in regulatory approval or
commercialization of HEPLISAV and therapeutic product
candidates.
We plan to introduce HEPLISAV initially in various markets
outside the United States. Developing, seeking regulatory
approval for and marketing our product candidates outside the
United States could impose
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substantial burdens on our resources and divert
managements attention from domestic operations. We may
also conduct operations in other foreign jurisdictions.
International operations are subject to risk, including:
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the difficulty of managing geographically distant operations,
including recruiting and retaining qualified employees, locating
adequate facilities and establishing useful business support
relationships in the local community; |
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compliance with varying international regulatory requirements; |
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securing international distribution, marketing and sales
capabilities; |
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adequate protection of our intellectual property rights; |
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difficulties and costs associated with complying with a wide
variety of complex international laws and treaties; |
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legal uncertainties and potential timing delays associated with
tariffs, export licenses and other trade barriers; |
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adverse tax consequences; |
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the fluctuation of conversion rates between foreign currencies
and the U.S. dollar; and |
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geopolitical risks. |
If we are unable to successfully manage our international
operations, we may incur significant unanticipated costs and
delays in regulatory approval or commercialization of HEPLISAV
and therapeutic product candidates, as well as other product
candidates that we may choose to commercialize internationally,
which would impair our ability to generate revenues.
We use hazardous materials in our business. Any claims or
liabilities relating to improper handling, storage or disposal
of these materials could be time consuming and costly to
resolve.
Our research and product development activities involve the
controlled storage, use and disposal of hazardous and
radioactive materials and biological waste. We are subject to
federal, state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of these materials
and certain waste products. We are currently in compliance with
all government permits that are required for the storage, use
and disposal of these materials. However, we cannot eliminate
the risk of accidental contamination or injury to persons or
property from these materials. In the event of an accident
related to hazardous materials, we could be held liable for
damages, cleanup costs or penalized with fines, and this
liability could exceed the limits of our insurance policies and
exhaust our internal resources. We may have to incur significant
costs to comply with future environmental laws and regulations.
We face product liability exposure, which, if not covered by
insurance, could result in significant financial liability.
While we have not experienced any product liability claims to
date, the use of any of our product candidates in clinical
trials and the sale of any approved products will subject us to
potential product liability claims and may raise questions about
a products safety and efficacy. As a result, we could
experience a delay in our ability to commercialize one or more
of our product candidates or reduced sales of any approved
product candidates. In addition, a product liability claim may
exceed the limits of our insurance policies and exhaust our
internal resources. We have obtained limited product liability
insurance coverage in the amount of $1 million for each
occurrence for clinical trials with umbrella coverage of an
additional $4 million. This coverage may not be adequate or
may not continue to be available in sufficient amounts, at an
acceptable cost or at all. We also may not be able to obtain
commercially reasonable product liability insurance for any
product approved for marketing in the future. A product
liability claim, product recalls or other claims, as
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well as any claims for uninsured liabilities or in excess of
insured liabilities, would divert our managements
attention from our business and could result in significant
financial liability.
If the combination of patents, trade secrets and contractual
provisions that we rely on to protect our intellectual property
is inadequate, the value of our product candidates will
decrease.
Our success depends on our ability to:
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obtain and protect commercially valuable patents or the rights
to patents both domestically and abroad; |
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operate without infringing upon the proprietary rights of
others; and |
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prevent others from successfully challenging or infringing our
proprietary rights. |
We will be able to protect our proprietary rights from
unauthorized use only to the extent that these rights are
covered by valid and enforceable patents or are effectively
maintained as trade secrets. We try to protect our proprietary
rights by filing and prosecuting United States and foreign
patent applications. However, in certain cases such protection
may be limited, depending in part on existing patents held by
third parties, which may only allow us to obtain relatively
narrow patent protection. In the United States, legal standards
relating to the validity and scope of patent claims in the
biopharmaceutical field can be highly uncertain, are still
evolving and involve complex legal and factual questions for
which important legal principles remain unresolved.
The biopharmaceutical patent environment outside the United
States is even more uncertain. We may be particularly affected
by this uncertainty, given that several of our product
candidates may initially address market opportunities outside
the United States. For example, we expect to market HEPLISAV, if
approved, in various foreign countries with high incidences of
hepatitis B, including Canada, Europe and selected markets in
Asia, where we may only be able to obtain limited patent
protection.
The risks and uncertainties that we face with respect to our
patents and other proprietary rights include the following:
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we might not have been the first to make the inventions covered
by each of our pending patent applications and issued patents; |
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we might not have been the first to file patent applications for
these inventions; |
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the pending patent applications we have filed or to which we
have exclusive rights may not result in issued patents or may
take longer than we expect to result in issued patents; |
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the claims of any patents that are issued may not provide
meaningful protection; |
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our issued patents may not provide a basis for commercially
viable products or may not be valid or enforceable; |
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we might not be able to develop additional proprietary
technologies that are patentable; |
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the patents licensed or issued to us or our collaborators may
not provide a competitive advantage; |
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patents issued to other companies, universities or research
institutions may harm our ability to do business; |
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other companies, universities or research institutions may
independently develop similar or alternative technologies or
duplicate our technologies and commercialize discoveries that we
attempt to patent; and |
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other companies, universities or research institutions may
design around technologies we have licensed, patented or
developed. |
We also rely on trade secret protection and confidentiality
agreements to protect our interests in proprietary know-how that
is not patentable and for processes for which patents are
difficult to enforce. We
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cannot be certain that we will be able to protect our trade
secrets adequately. Any leak of confidential data into the
public domain or to third parties could allow our competitors to
learn our trade secrets. If we are unable to adequately obtain
or enforce proprietary rights we may be unable to commercialize
our products, enter into collaborations, generate revenues or
maintain any advantage we may have with respect to existing or
potential competitors.
We rely on our licenses from the Regents of the University of
California. Impairment of these licenses or our inability to
maintain them would severely harm our business.
Our success depends upon our license arrangements with the
Regents of the University of California. These licenses are
critical to our research and product development efforts. Our
dependence on these licenses subjects us to numerous risks, such
as disputes regarding the invention and corresponding ownership
rights in inventions and know-how resulting from the joint
creation or use of intellectual property by us and the Regents
of the University of California, or scientific collaborators.
Additionally, our agreements with the Regents of the University
of California generally contain diligence or milestone-based
termination provisions. Our failure to meet any obligations
pursuant to these provisions could allow the Regents of the
University of California to terminate any of these licensing
agreements or convert them to non-exclusive licenses. In
addition, our license agreements with the Regents of the
University of California may be terminated or may expire by
their terms, and we may not be able to maintain the exclusivity
of these licenses. If we cannot maintain licenses that are
advantageous or necessary to the development or the
commercialization of our product candidates, we may be required
to expend significant time and resources to develop or license
similar technology.
We will need to implement additional finance and accounting
systems, procedures and controls as we grow our business and
organization and to satisfy new reporting requirements.
As a public company, we are required to comply with the
Sarbanes-Oxley Act of 2002 and the related rules and regulations
of the SEC, including expanded disclosures and accelerated
reporting requirements and more complex accounting rules.
Compliance with Section 404 of the Sarbanes-Oxley Act of
2002 and other requirements will increase our costs and require
additional management resources. We may need to continue to
implement additional finance and accounting systems, procedures
and controls as we grow our business and organization and to
comply with new reporting requirements. Compliance with
Section 404 will apply in 2005, and Section 404
reporting will first occur in our Form 10-K for our fiscal
year ending December 31, 2005. There can be no assurance
that we will be able to complete a favorable assessment as to
the adequacy of our internal control reporting.
The adoption of Statement of Financial Accounting Standard
No. 123R and changes to existing accounting pronouncements,
rules or practices may affect how we conduct our business and
affect our reported financial results.
On December 16, 2004, the Financial Accounting Standards
Board issued Financial Accounting Standard (FAS) No. 123R
(revised 2004), Share-Based Payment which will
require us to measure compensation costs for all stock-based
compensation at fair value. We will adopt FAS No. 123R as
of January 1, 2006. Adoption of FAS No. 123R will
have a material impact on our financial statements, as we will
be required to record compensation expense in our statement of
operations for stock option grants and stock purchases under our
employee stock purchase plan, rather than disclose the impact on
our net loss within our footnotes, as is our current practice.
The impact of adoption of FAS No. 123R cannot be predicted
at this time because it will depend on levels of share-based
payments granted in the future. Changes to existing rules,
current practices, or future changes, if any, may adversely
affect our reported financial results or the way we conduct our
business.
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Risks Relating to this Offering
Our stock price is subject to volatility, and your investment
may suffer a decline in value.
The market prices for securities of biopharmaceutical companies
have in the past been, and are likely to continue in the future
to be, very volatile. The market price of our common stock is
subject to substantial volatility depending upon many factors,
many of which are beyond our control, including:
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progress or results of any of our clinical trials, in particular
any announcements regarding the progress or results of our
planned Phase III trials for TOLAMBA and HEPLISAV; |
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progress of regulatory approval of our product candidates, in
particular TOLAMBA and HEPLISAV, and compliance with ongoing
regulatory requirements; |
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our ability to establish collaborations for the development and
commercialization of our product candidates; |
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market acceptance of our product candidates; |
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our ability to raise additional capital to fund our operations,
whether through the issuance of equity securities or debt; |
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technological innovations, new commercial products or drug
discovery efforts and preclinical and clinical activities by us
or our competitors; |
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changes in our intellectual property portfolio or developments
or disputes concerning the proprietary rights of our products or
product candidates; |
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our ability to obtain component materials and successfully enter
into manufacturing relationships for our product candidates or
establish manufacturing capacity on our own; |
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our ability to form strategic partnerships or joint ventures; |
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maintenance of our existing licensing agreements with the
Regents of the University of California; |
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changes in government regulations; |
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issuance of new or changed securities analysts reports or
recommendations; |
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general economic conditions and other external factors; |
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actual or anticipated fluctuations in our quarterly financial
and operating results; and |
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degree of trading liquidity in our common stock. |
One or more of these factors could cause a decline in the price
of our common stock. In addition, securities class action
litigation has often been brought against a company following a
decline in the market price of its securities. This risk is
especially relevant for us because we have experienced greater
than average stock price volatility, as have other biotechnology
companies in recent years. We may in the future be the target of
similar litigation. Securities litigation could result in
substantial costs, and divert managements attention and
resources, which could harm our business, operating results and
financial conditions.
This offering will cause dilution in net tangible book
value.
Purchasers in this offering will experience immediate and
substantial dilution in net tangible book value of
$3.85 per share (based upon an assumed public offering
price of $6.70 per share). Additional dilution is likely to
occur upon the exercise of options or warrants granted by us. To
the extent we raise additional capital by issuing equity
securities, our stockholders may experience additional
substantial dilution.
S-16
We have broad discretion in how we use the net proceeds of
this offering, and we may not use these proceeds effectively or
in ways with which you agree.
We have broad discretion in how we use the net proceeds of this
offering, and we may not use these proceeds effectively or in
ways with which you agree. Our management will have broad
discretion as to the application of the net proceeds of this
offering and could use them for purposes other than those
contemplated at the time of this offering. Our stockholders may
not agree with the manner in which our management chooses to
allocate and spend the net proceeds. Moreover, our management
may use the net proceeds for corporate purposes that may not
increase the market price of our common stock.
Anti-takeover provisions of our certificate of incorporation,
bylaws and Delaware law may prevent or frustrate a change in
control, even if an acquisition would be beneficial to our
stockholders, which could affect our stock price adversely and
prevent attempts by our stockholders to replace or remove our
current management.
Provisions of our certificate of incorporation and bylaws may
delay or prevent a change in control, discourage bids at a
premium over the market price of our common stock and adversely
affect the market price of our common stock and the voting or
other rights of the holders of our common stock. These
provisions include:
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authorizing our Board of Directors to issue additional preferred
stock with voting rights to be determined by the Board of
Directors; |
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limiting the persons who can call special meetings of
stockholders; |
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prohibiting stockholder actions by written consent; |
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creating a classified board of directors pursuant to which our
directors are elected for staggered three year terms; |
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providing that a supermajority vote of our stockholders is
required for amendment to certain provisions of our certificate
of incorporation and bylaws; and |
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establishing advance notice requirements for nominations for
election to our Board of Directors or for proposing matters that
can be acted on by stockholders at stockholder meetings. |
In addition, we are subject to the provisions of the Delaware
corporation law that, in general, prohibit any business
combination with a beneficial owner of 15% or more of our common
stock for five years unless the holders acquisition of our
stock was approved in advance by our Board of Directors.
S-17
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying prospectus,
including the documents incorporated therein by reference,
contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
This Act provides a safe harbor for forward-looking
statements to encourage companies to provide prospective
information about themselves so long as they identify these
statements as forward-looking and provide meaningful cautionary
statements identifying important factors that could cause actual
results to differ from the projected results. In some cases, you
can identify forward-looking statements by terminology such as
anticipate, believe,
continue, could, estimate,
expect, intend, may,
might, plan, potential,
predict, should or will or
the negative of those terms or comparable terminology. These
statements are only current predictions and are subject to known
and unknown risks, uncertainties, and other factors that may
cause our or our industrys actual results, levels of
activity, performance or achievements to be materially different
from those anticipated by the forward-looking statements.
Forward-looking statements include, but are not limited to,
statements about:
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The safety and efficacy of our clinical development programs; |
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The initiation and timing of our clinical trials; |
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The commercialization opportunities for our product candidates; |
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Our estimates regarding anticipated capital requirements and our
needs for additional financing; |
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The commercial launch of any of our product candidates; and |
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Our expectations regarding licensing and strategic
collaborations. |
Forward-looking statements involve risks and uncertainties, such
as our objectives, forecasts, expectations and intentions. From
time to time, we also may provide oral or written
forward-looking statements in other materials we release to the
public. Any or all forward-looking statements in this prospectus
supplement, in the accompanying prospectus, in the documents
incorporated herein by reference and in any other public
statements we make may turn out to be wrong. Forward-looking
statements reflect our current expectations and are inherently
uncertain. Inaccurate assumptions we might make and known or
unknown risks and uncertainties can affect the accuracy of our
forward-looking statements. Consequently, no forward-looking
statement can be guaranteed and our actual results may differ
materially. We undertake no obligation to publicly update any
forward-looking statements, whether as a result of new
information, future events or otherwise.
S-18
USE OF PROCEEDS
We expect to receive approximately $24.9 million in net
proceeds from the sale of the 4,000,000 shares of common
stock offered by us in this offering (approximately
$28.7 million if the underwriters exercise their
overallotment option in full), based on an assumed public
offering price of $6.70 per share, after deducting the
underwriting discounts and commissions and estimated offering
expenses payable by us.
We intend to use the net proceeds from this offering for general
corporate purposes, including clinical trials, research and
development expenses and general and administrative expenses.
We have not determined the amounts we plan to spend on any of
the areas listed above or the timing of these expenditures. As a
result, our management will have broad discretion to allocate
the net proceeds from this offering. Pending application of the
net proceeds as described above, we intend to temporarily invest
the proceeds in short-term interest bearing instruments.
S-19
PRICE RANGE OF COMMON STOCK
Our common stock has been quoted on The Nasdaq National Market
under the symbol DVAX since our initial public
offering on February 19, 2004. The following table shows
the high and low per share prices of our common stock for the
periods indicated.
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High | |
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Low | |
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2004
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First Quarter
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$ |
9.98 |
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$ |
7.10 |
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Second Quarter
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9.35 |
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5.14 |
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Third Quarter
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6.87 |
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4.02 |
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Fourth Quarter
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8.80 |
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4.75 |
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2005
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First Quarter
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$ |
8.48 |
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$ |
4.50 |
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Second Quarter
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4.97 |
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3.44 |
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Third Quarter
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7.00 |
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4.61 |
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On September 30, 2005, the last reported sale price of our
common stock on The Nasdaq National Market was $6.70 per
share. On September 15, 2005, there were 113 holders of
record of our common stock.
DIVIDEND POLICY
We have never declared or paid cash dividends on our capital
stock. We currently intend to retain our future earnings, if
any, for use in our business and therefore do not anticipate
paying cash dividends in the foreseeable future. Payment of
future dividends, if any, will be at the discretion of our Board
of Directors after taking into account various factors,
including our financial condition, operating results, current
and anticipated cash needs and plans for expansion.
S-20
DILUTION
Our net tangible book value as of June 30, 2005 was
approximately $57,150,000, or approximately $2.31 per share
of common stock. Net tangible book value per share represents
total tangible assets less total liabilities, divided by the
number of shares of common stock outstanding. Dilution in net
tangible book value per share represents the difference between
the amount per share paid by purchasers of common stock in this
offering and the net tangible book value per share of our common
stock immediately after the offering. After giving effect to our
sale of shares of common stock in this offering at an assumed
public offering price of $6.70 per share and after
deduction of the underwriting discounts and commissions and
estimated offering expenses payable by us, our net tangible book
value as of June 30, 2005 would have been approximately
$82,042,00, or $2.85 per share. This represents an
immediate increase in net tangible book value of $0.54 per
share to existing stockholders and an immediate dilution in net
tangible book value of $3.85 per share to purchasers of
common stock in this offering.
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Assumed public offering price per share
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$ |
6.70 |
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Net tangible book value per share as of June 30, 2005
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$ |
2.31 |
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Increase per share attributable to new investors
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0.54 |
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Net tangible book value per share after the offering
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2.85 |
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Dilution per share to new investors
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$ |
3.85 |
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The number of shares in the table above assumes no exercise of
the underwriters overallotment option and excludes:
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an aggregate of 2,477,195 shares of common stock issuable
upon the exercise of options outstanding as of
September 15, 2005 at a weighted average exercise price of
$4.40 per share; |
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an additional 2,957,981 shares of common stock reserved for
issuance as of September 15, 2005 under our 2004 Stock
Incentive Plan; |
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461,308 shares of common stock available for issuance under
our 2004 Employee Stock Purchase Plan as of September 15,
2005; and |
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84,411 shares of common stock issuable upon the exercise of
an outstanding warrant at an exercise price of $6.18 per
share. |
From July 1, 2005 through September 15, 2005, no
shares of our common stock were issued upon exercise of options
and 9,621 shares of our common stock were purchased under
our 2004 Employee Stock Purchase Plan. We issued options to
purchase 61,950 shares of our common stock at a
weighted exercise price of $6.31, and options to
purchase 7,812 shares of our common stock were
cancelled and returned for issuance under our 2004 Stock
Incentive Plan.
S-21
CAPITALIZATION
The following table sets forth our capitalization as of
June 30, 2005:
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on an actual basis; and |
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on an as adjusted basis to reflect the sale of the
4,000,000 shares of common stock offered by us at an
assumed public offering price of $6.70 per share, less the
underwriting discounts, commissions and estimated offering
expenses payable by us. |
You should read the information in this table together with
Managements Discussion and Analysis of Financial
Condition and Results of Operations and our financial
statements and the accompanying notes incorporated by reference
in the accompanying prospectus.
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June 30, 2005 | |
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As | |
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Adjusted | |
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(Unaudited) | |
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(In thousands) | |
Shareholders equity:
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Preferred stock: $0.001 par value; 5,000,000 shares
authorized and no shares issued and outstanding at June 30,
2005
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$ |
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$ |
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Common stock: $0.001 par value; 100,000,000 shares
authorized at June 30, 2005; 24,747,817 shares issued
and outstanding at June 30, 2005
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25 |
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29 |
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Additional paid-in capital
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159,126 |
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184,014 |
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Deferred stock compensation
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(2,693 |
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(2,693 |
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Notes receivable from stockholders
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(339 |
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(339 |
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Accumulated other comprehensive loss:
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Unrealized loss on marketable securities available-for-sale
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(120 |
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(120 |
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Cumulative translation adjustment
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(4 |
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(4 |
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Accumulated deficit
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(98,845 |
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(98,845 |
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Total shareholders equity
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57,150 |
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82,042 |
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Total capitalization
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$ |
57,150 |
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$ |
82,042 |
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The number of shares in the table above excludes:
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an aggregate of 2,477,195 shares of common stock issuable
upon the exercise of options outstanding as of
September 15, 2005 at a weighted average exercise price of
$4.40 per share; |
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an additional 2,957,981 shares of common stock reserved for
issuance as of September 15, 2005 under our 2004 Stock
Incentive Plan; |
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461,308 shares of common stock available for issuance under
our 2004 Employee Stock Purchase Plan as of September 15,
2005; and |
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84,411 shares of common stock issuable upon the exercise of
an outstanding warrant at an exercise price of $6.18 per
share. |
From July 1, 2005 through September 15, 2005, no
shares of our common stock were issued upon exercise of options
and 9,621 shares of our common stock were purchased under
our 2004 Employee Stock Purchase Plan. During this same period,
we issued options to purchase 61,950 shares of our
common stock at a weighted exercise price of $6.31, and options
to purchase 7,812 shares of our common stock were
cancelled and returned for issuance under our 2004 Stock
Incentive Plan.
S-22
UNDERWRITING
Under the terms and subject to the conditions contained in an
underwriting agreement dated as of the date of this prospectus
supplement, the underwriters named below have severally agreed
to purchase and we have agreed to sell to them, severally, the
respective number of shares of common stock set forth opposite
their names below:
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Number | |
Underwriter |
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of Shares | |
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Bear, Stearns & Co. Inc.
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CIBC World Markets Corp.
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Pacific Growth Equities, LLC
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Total
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4,000,000 |
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The underwriters are offering the shares of common stock subject
to their acceptance of the shares from us and subject to prior
sale. The underwriting agreement provides that the obligations
of the several underwriters to pay for and accept delivery of
the shares of common stock offered by this prospectus supplement
and the accompanying prospectus are subject to the approval of
legal matters by their counsel and to other conditions. The
underwriters are obligated to take and pay for all of the shares
of common stock offered by this prospectus supplement if any
such shares are taken. However, the underwriters are not
required to take or pay for the shares covered by the
underwriters overallotment described below.
The underwriters initially propose to offer part of the shares
of common stock directly to the public at the public offering
price listed on the cover page of this prospectus supplement and
part to certain dealers at a price that represents a concession
not in excess of
$ per
share less than the public offering price. After the initial
offering of the shares of common stock, the offering price and
other selling terms may from time to time be varied by the
underwriters. The total price to the public will be
$ ,
the total underwriting discount will be
$ and
the total gross proceeds to us will be
$ .
We have granted to the underwriters an option, exercisable for
30 days from the date of this prospectus supplement, to
purchase up to 600,000 additional shares of common stock at the
public offering price set forth on the cover page of this
prospectus supplement, less the underwriting discount. The
underwriters may exercise this option solely for the purpose of
covering overallotments, if any, made in connection with the
offering of the shares of common stock offered by this
prospectus supplement. To the extent that the option is
exercised, each underwriter will become obligated, subject to
certain conditions, to purchase about the same percentage of the
additional shares of our common stock as the number listed
opposite the underwriters name in the preceding table
bears to the total number of shares of our common stock listed
opposite the names of all underwriters in the preceding table.
If the overallotment option is exercised in full, the total
price to the public would be
$ ,
the total underwriting discount would be
$ and
the total proceeds to us would be
$ .
The estimated offering expenses payable by us are approximately
$ ,
not including the underwriting discount, which includes legal,
accounting and printing costs and various other fees associated
with registering and listing the common stock.
We and each of our executive officers and directors and entities
related to Care Capital and Interwest Partners, have agreed not
to sell or transfer any common stock for 90 days after the
date of this prospectus supplement without first obtaining the
written consent of Bear, Stearns & Co. Specifically, we
and these other individuals and entities have agreed not to
directly or indirectly:
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offer, sell, agree to offer of sell, solicit offers to purchase,
grant any call option or purchase any put option with respect
to, pledge, borrow or otherwise dispose of any shares of common
stock or any securities convertible into or exercisable or
exchangeable for common stock or file any registration statement
with respect to any of the foregoing; or |
S-23
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Otherwise enter into any swap, derivative or other transaction
or arrangement that transfer to another, in whole or in part,
any economic consequence of ownership of the common stock,
whether any such swap or transaction described above is to be
settled by delivery of common stock or such other securities, in
cash or otherwise. |
Notwithstanding the foregoing, if (1) during the last
17 days of the 90-day period after the date of this
prospectus supplement, we issue an earnings release or publicly
announce material news or if a material event relating to us
occurs or (2) prior to the expiration of the 90-day period
after the date of this prospectus supplement, we announce that
we will release earnings during the 16-day period beginning on
the last day of the 90-day period, the above restrictions will
continue to apply to our executive officers and directors until
the expiration of the 18-day period beginning on the issuance of
the earnings release or the occurrence of the material news or
material event.
This lockup provision applies to common stock and to securities
convertible into or exchangeable or exercisable for common stock
owned now or acquired later by the person executing the
agreement or for which the person executing the agreement later
acquires the power of disposition, subject to certain exceptions
set forth in the agreement. Bear Stearns in its sole discretion
may release any of the securities subject to lock-up agreements
at any time without notice.
In order to facilitate the offering of the common stock, the
underwriters may engage in transactions that stabilize, maintain
or otherwise affect the price of the common stock. Specifically,
the underwriters may sell more shares than they are obligated to
purchase under the underwriting agreement, creating a short
position. A short sale is covered if the short position is no
greater than the number of shares available for purchase by the
underwriters under the overallotment option. The underwriters
can close out a covered short sale by exercising the
overallotment option or purchasing shares in the open market. In
determining the source of shares to close out a covered short
sale, the underwriters will consider, among other things, the
open market price of shares compared to the price available
under the overallotment option. The underwriters may also sell
shares in excess of the overallotment option, creating a naked
short position. The underwriters must close out any naked short
position by purchasing shares in the open market. A naked short
position is more likely to be created if the underwriters are
concerned that there may be downward pressure on the price of
the common stock in the open market after pricing this offering
that could adversely affect investors who purchase shares in
this offering. In addition, in order to cover any overallotments
or to stabilize the price of our common stock, the underwriters
may bid for, and purchase, shares of our common stock in the
open market. Finally, the underwriting syndicate may reclaim
selling concessions allowed to an underwriter or a dealer for
distributing our common stock in this offering, if the syndicate
repurchases previously distributed shares of our common stock to
cover syndicate short positions, in stabilization transactions
or otherwise. Any of these activities may raise or maintain the
market price of the common stock above independent market levels
or prevent or retard a decline in the market price of the common
stock. The underwriters are not required to engage in these
activities, and may end any of these activities at any time.
From time to time, Bear, Stearns & Co. Inc., CIBC World
Markets Corp. and Pacific Growth Equities, LLC and their
affiliates have provided, and may in the future provide,
investment banking, commercial banking and financial advisory
services to us, for which they have in the past received, and
may in the future receive, customary fees.
We and the underwriters have agreed to indemnify each other
against certain liabilities, including liabilities under the
Securities Act of 1933, as amended.
S-24
LEGAL MATTERS
Certain legal matters are being passed upon for us by
Morrison & Foerster LLP, San Francisco,
California. Latham & Watkins LLP, Menlo Park,
California will pass upon certain legal matters for the
underwriters.
EXPERTS
The consolidated financial statements of Dynavax Technologies
Corporation incorporated by reference in Dynavax Technologies
Corporations Annual Report (Form 10-K) for the year
ended December 31, 2004, have been audited by
Ernst & Young LLP, independent registered public
accounting firm, as set forth in their report thereon,
incorporated by reference therein, and incorporated herein by
reference. Such consolidated financial statements are
incorporated herein by reference in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
S-25
PROSPECTUS
$75,000,000
Common Stock
We may offer and sell from time to time shares of our common
stock in one or more offerings in amounts, at prices and on the
terms that we will determine at the time of offering, with an
aggregate initial offering price of up to $75,000,000. Each time
we sell common stock, we will provide specific terms of the
securities offered in a supplement to this prospectus. The
prospectus supplement may also add, update or change information
contained in this prospectus. You should read this prospectus
and the applicable prospectus supplement carefully before you
invest in any securities. This prospectus may not be used to
consummate a sale of securities unless accompanied by the
applicable prospectus supplement.
We will sell these securities directly to our stockholders or to
purchasers or through agents on our behalf or through
underwriters or dealers as designated from time to time. If any
agents or underwriters are involved in the sale of any of these
securities, the applicable prospectus supplement will provide
the names of the agents or underwriters and any applicable fees,
commissions or discounts.
Our common stock trades on the Nasdaq National Market under the
trading symbol DVAX. On September 30, 2005 the
last reported sale price of our common stock was $6.70 per
share. We recommend that you obtain current market quotations
for our common stock prior to making an investment decision.
Investing in our common stock involves risks. See Risk
Factors beginning on page 2.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is October 3, 2005.
TABLE OF CONTENTS
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Page | |
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OVERVIEW
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1 |
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RISK FACTORS
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2 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
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2 |
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USE OF PROCEEDS
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2 |
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PLAN OF DISTRIBUTION
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3 |
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LEGAL MATTERS
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4 |
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EXPERTS
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4 |
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WHERE YOU CAN FIND MORE INFORMATION ABOUT DYNAVAX AND THIS
OFFERING
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5 |
|
You should rely only on the information contained in or
incorporated by reference in this prospectus. We have not
authorized anyone to provide you with different information. We
are not making an offer of these securities in any state where
the offer is not permitted. You should assume that the
information in this prospectus is accurate only as of the date
on the front of the document and that any information we have
incorporated by reference is accurate only as of the date of the
document incorporated by reference, regardless of the time of
delivery of this prospectus or any sale of our common stock.
OVERVIEW
We discover, develop and intend to commercialize innovative
products to treat and prevent allergies, infectious diseases and
chronic inflammatory diseases using versatile, proprietary
approaches that alter immune system responses in highly specific
ways. Our clinical development programs are based on
immunostimulatory sequences (ISS), which are short DNA sequences
that we believe enhance the ability of the immune system to
fight disease and control chronic inflammation. The most
advanced clinical programs in Dynavaxs ISS-based pipeline
are a ragweed allergy immunotherapeutic and a hepatitis B
vaccine.
We have developed a novel injectable product candidate to treat
ragweed allergy that we call AIC (Amb a1 ISS Conjugate). AIC has
completed Phase II trials, and is currently completing a
two-year Phase IIb clinical trial. At the end of 2004, we
reported that the one-year interim analysis of this
Phase IIb trial showed a clear positive trend relative to
the trials major endpoint of nasal symptom scores, as well
as other secondary endpoints, following the 2004 ragweed season.
We intend to complete the Phase IIb clinical trial. In
2005, we initiated a clinical trial in ragweed allergic children
designed to support our Phase III pivotal program. Pending
the outcome of discussions with the U.S. Food and Drug
Administration (FDA) and the results of the Phase IIb
study, we plan to initiate a pivotal Phase III clinical
program in early 2006.
We have developed a product candidate for hepatitis B
prophylaxis. A Phase IIb trial in subjects aged 40-70 who
are more difficult to immunize with conventional vaccines has
been conducted in Singapore. All patients in the trial have been
treated and the final data analysis is being completed. In June
2005, the Company reported that top-line data from this trial
showed that Dynavaxs vaccine demonstrated statistically
significant superiority in protective antibody response and
robustness of protective effect after three vaccinations when
compared to GlaxoSmithKlines Engerix-B® vaccine. The
primary endpoint of the ongoing Phase IIb trial is
seroprotection four weeks after administration of the third
dose. Results from an earlier interim analysis of this
Phase IIb trial showed that our vaccine demonstrated
statistically significant superiority in protective antibody
response and robustness of protective effect after two
vaccinations when compared to GlaxoSmithKlines Engerix-B
vaccine. Results from a Phase II clinical trial in healthy
adults aged 18-39 conducted in 2004 showed that our vaccine
induced a more robust and durable antibody response than
Engerix-B. In June 2005, we initiated a pivotal Phase III
trial in the older, more difficult to immunize population in
Asia. We anticipate initiating a second pivotal Phase III
trial in younger adults in Canada and Europe in early 2006. We
believe that strategic opportunities for our vaccine exist in
selected countries worldwide. Our initial commercialization
strategies will likely target these markets and focus on
high-value, underserved populations. These populations include
pre-hemodialysis patients, HIV and HCV positive patients, other
populations with compromised immune systems as well as
professionals in healthcare and law enforcement for whom
achieving seroprotection quickly is critical.
We have an inhaled therapeutic product candidate for treatment
of asthma that has shown preliminary safety and pharmacology in
a Phase IIa clinical trial. We intend to perform additional
preclinical work to optimize the route of administration and
regimen for the asthma clinical program and have postponed
additional clinical trials in asthma. We have a cancer therapy
that is currently in a Phase II clinical trial.
Other Information
We were incorporated in California in August 1996 under the name
Double Helix Corporation, and we changed our name to Dynavax
Technologies Corporation in September 1996. We reincorporated in
Delaware in 2001. Our principal offices are located at 2929
Seventh Street, Suite 100, Berkeley, California 94710-2753.
Our telephone number is (510) 848-5100. Our Internet
address is www.dynavax.com. We do not incorporate the
information on our website into this prospectus, and you should
not consider it part of this prospectus.
Dynavax Technologies is a registered trademark of Dynavax
Technologies Corporation. Each of the other trademarks, trade
names or service marks appearing in this prospectus belongs to
its respective holder.
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RISK FACTORS
You should carefully consider the specific risks set forth under
the caption Risk Factors in the applicable
prospectus supplement, under the caption Risk
Factors under Item 2 of Part I of our
Form 10-Q for the quarter ended June 30, 2005, which
is incorporated by reference in this prospectus, and any
subsequent report that is incorporated by reference into this
prospectus, before making an investment decision.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
The statements in this prospectus and the documents incorporated
by reference contain forward-looking statements which are
subject to a number of risks and uncertainties. All statements
that are not historical facts are forward-looking statements,
including statements about our business strategy, our future
research and development, our preclinical and clinical product
development efforts, the timing of the introduction of our
products, the effect of GAAP accounting pronouncements,
uncertainty regarding our future operating results and our
profitability, anticipated sources of funds and all plans,
objectives, expectations and intentions. These statements appear
in a number of places and can be identified by the use of
forward-looking terminology such as may,
will, should, expect,
plan, anticipate, believe,
estimate, predict, future,
intend, or certain or the negative of
these terms or other variations or comparable terminology, or by
discussions of strategy.
Our actual results may differ materially from the results
expressed or implied by these forward-looking statements because
of the risk factors and other factors disclosed in this
prospectus and documents incorporated by reference. The risk
factors may not be all of the factors that could cause actual
results to vary materially from the forward-looking statements.
The forward-looking statements made or incorporated in this
prospectus relate only to circumstances as of the date on which
the statements are made. Readers should not place undue reliance
on these forward-looking statements and are cautioned that any
such forward-looking statements are not guarantees of future
performance. We assume no obligation to update any
forward-looking statements.
USE OF PROCEEDS
Unless otherwise provided in the applicable prospectus
supplement, we intend to use the net proceeds from the sale of
the common stock under this prospectus for general corporate
purposes, including clinical trials, research and development
expenses, general and administrative expenses, and potential
acquisitions of companies, products and technologies that
complement our business. We will set forth in the prospectus
supplement our intended use for the net proceeds received from
the sale of any securities. Pending the application of the net
proceeds, we intend to invest the net proceeds generally in
short-term, investment grade, interest bearing securities.
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PLAN OF DISTRIBUTION
We may sell the securities from time to time pursuant to
underwritten public offerings, negotiated transactions, block
trades or a combination of these methods. We may sell the
securities (1) through underwriters or dealers,
(2) through agents and/or (3) directly to one or more
purchasers. We may distribute the securities from time to time
in one or more transactions:
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at market prices prevailing at the time of sale; |
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at prices related to such prevailing market prices; or |
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at negotiated prices. |
We may solicit directly offers to purchase the securities being
offered by this prospectus. We may also designate agents to
solicit offers to purchase the securities from time to time. We
will name in a prospectus supplement any agent involved in the
offer or sale of our securities.
If we utilize a dealer in the sale of the securities being
offered by this prospectus, we will sell the securities to the
dealer, as principal. The dealer may then resell the securities
to the public at varying prices to be determined by the dealer
at the time of resale.
If we utilize an underwriter in the sale of the securities being
offered by this prospectus, we will execute an underwriting
agreement with the underwriter at the time of sale and we will
provide the name of any underwriter in the prospectus supplement
that the underwriter will use to make resales of the securities
to the public. In connection with the sale of the securities,
we, or the purchasers of securities for whom the underwriter may
act as agent, may compensate the underwriter in the form of
underwriting discounts or commissions. The underwriter may sell
the securities to or through dealers, and the underwriter may
compensate those dealers in the form of discounts, concessions
or commissions.
We will provide in the applicable prospectus supplement any
compensation we pay to underwriters, dealers or agents in
connection with the offering of the securities, and any
discounts, concessions or commissions allowed by underwriters to
participating dealers. Underwriters, dealers and agents
participating in the distribution of the securities may be
deemed to be underwriters within the meaning of the Securities
Act of 1933, and any discounts and commissions received by them
and any profit realized by them on resale of the securities may
be deemed to be underwriting discounts and commissions. We may
enter into agreements to indemnify underwriters, dealers and
agents against civil liabilities, including liabilities under
the Securities Act, or to contribute to payments they may be
required to make in respect thereof.
We may authorize underwriters, dealers or agents to solicit
offers by certain purchasers to purchase the common stock from
us at the public offering price set forth in the prospectus
supplement. These purchases will be subject only to those
conditions set forth in the prospectus supplement, and the
prospectus supplement will set forth any commissions we pay for
solicitation of these purchases.
To facilitate the offering of securities, certain persons
participating in the offering may engage in transactions that
stabilize, maintain or otherwise affect the price of the
securities. This may include over-allotments or short sales of
the securities, which involves the sale by persons participating
in the offering of more securities than we sold to them. In
these circumstances, these persons would cover such
over-allotments or short positions by making purchases in the
open market or by exercising their over-allotment option. In
addition, these persons may stabilize or maintain the price of
the securities by bidding for or purchasing securities in the
open market or by imposing penalty bids, whereby selling
concessions allowed to dealers participating in the offering may
be reclaimed if securities sold by them are repurchased in
connection with stabilization transactions. The effect of these
transactions may be to stabilize or maintain the market price of
the securities at a level above that which might otherwise
prevail in the open market. These transactions may be
discontinued at any time.
The underwriters, dealers and agents may engage in transactions
with us, or perform services for us, in the ordinary course of
business.
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To the extent required, this prospectus may be amended or
supplemented from time to time to describe a specific plan of
distribution.
LEGAL MATTERS
Morrison & Foerster LLP will pass upon the validity of
the common stock offered by this prospectus for us.
EXPERTS
The consolidated financial statements of Dynavax Technologies
Corporation incorporated by reference in Dynavax Technologies
Corporations Annual Report (Form 10-K) for the year
ended December 31, 2004, have been audited by
Ernst & Young LLP, independent registered public
accounting firm, as set forth in their report thereon,
incorporated by reference therein, and incorporated herein by
reference. Such consolidated financial statements are
incorporated herein by reference in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
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WHERE YOU CAN FIND MORE INFORMATION ABOUT DYNAVAX AND THIS
OFFERING
We are a reporting company and we file annual, quarterly and
current reports, proxy statements and other information with the
SEC. We have filed with the SEC a registration statement on
Form S-3 under the Securities Act to register the shares of
common stock offered by this prospectus. However, this
prospectus does not contain all of the information contained in
the registration statement and the exhibits and schedules to the
registration statement. For further information with respect to
us and the securities offered under this prospectus, we refer
you to the registration statement and the exhibits and schedules
filed as a part of the registration statement. You may read and
copy the registration statement, as well as our reports, proxy
statements and other information, at the SECs public
reference rooms at 100 F Street, N.E., in Washington, DC, 20549.
You can request copies of these documents by contacting the SEC
and paying a fee for the copying cost. Please call the SEC at
1-800-SEC-0330 for further information about the operation of
the public reference rooms. Our SEC filings are also available
at the SECs website at www.sec.gov. In addition,
you can read and copy our SEC filings at the office of The
National Association of Securities Dealers, Inc. at
1735 K Street, N.W., Washington, D.C. 20006.
The SEC allows us to incorporate by reference the
information contained in documents that we file with them, which
means that we can disclose important information to you by
referring to those documents. The information incorporated by
reference is considered to be part of this prospectus.
Information in this prospectus modifies or supersedes
information incorporated by reference that we filed with the SEC
prior to the date of this prospectus, and information that we
file later with the SEC also will automatically update and
supersede this information. We incorporate by reference the
documents listed below, any filings we will make with the SEC
under Sections 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934, as amended, after the date we filed the
registration statement of which this prospectus is a part and
before the effective date of the registration statement and any
future filings we will make with the SEC under those sections.
The following documents filed with the SEC are incorporated by
reference in this prospectus:
1. Our annual report on Form 10-K for the year ended
December 31, 2004, filed on March 18, 2005;
2. Our quarterly reports on Form 10-Q for the periods
ended March 31, 2005, filed on May 9, 2005, and
June 30, 2005, filed on August 9, 2005;
3. Our current reports on Form 8-K filed on
January 5, 2005, January 26, 2005, March 18,
2005, April 18, 2005, August 19, 2005 and
August 23, 2005; and
4. The description of our common stock set forth in the
registration statement on Form S-1 (Registration
No. 333-109965) filed on February 5, 2004.
We will furnish without charge to you, on written or oral
request, a copy of any or all of the documents incorporated by
reference, including exhibits to these documents. You should
direct any requests for documents to Jane M.
Green, Ph.D., Vice President, Corporate Communications,
2929 Seventh Street, Suite 100, Berkeley, CA
94710-2753, (510) 848-5100.
5
4,000,000
Common Stock
PROSPECTUS SUPPLEMENT
,
2005
Bear, Stearns & Co. Inc.
CIBC World Markets
Pacific Growth Equities, LLC