e424b4
Filed pursuant to
Rule 424(b)(4)
File No.333-147455
PROSPECTUS
1,850,000 Shares
DYNAVAX TECHNOLOGIES CORPORATION
Common Stock
This prospectus relates to the disposition from time to time of up to 1,850,000 shares of our
Common Stock, which includes 1,300,000 shares of our Common Stock issuable upon the exercise of
warrants and an additional 550,000 shares of our Common Stock that may be issued upon the
redemption of those warrants following certain major transactions, events of default and upon the
occurrence of certain events. We are not selling any Common Stock under this prospectus and will
not receive any of the proceeds from the sale of shares by the selling stockholders.
The selling stockholders may sell the shares of Common Stock described in this prospectus in a
number of different ways and at varying prices. We provide more information about how the selling
stockholders may sell their shares of Common Stock in the section entitled Plan of Distribution
on page 12. We will not be paying any underwriting discounts or commissions in this offering.
The Common Stock is traded on the Nasdaq Global Market under the symbol DVAX. On December
3, 2007, the reported closing price of the Common Stock was $4.43 per share.
An investment in the shares offered hereby involves a high degrees of risk. See Risk Factors
beginning on page 2 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is December
5, 2007.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
You should rely only on the information contained or incorporated by reference in this
prospectus. We have not, and the selling stockholders have not, authorized anyone to provide you
with information different from that contained in this prospectus. The selling stockholders are
offering to sell, and seeking offers to buy, shares of our Common Stock only in jurisdictions where
it is lawful to do so. The information in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or any sale of our Common Stock.
PROSPECTUS SUMMARY
Dynavax Technologies Corporation
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative
TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and
chronic inflammatory diseases using versatile, proprietary approaches that alter immune system
responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or
ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease
and control chronic inflammation.
Our product candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3 partnered with
Merck & Co. Inc.; TOLAMBA(TM), a ragweed allergy immunotherapy in Phase 2; a therapy for
non-Hodgkins lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a
therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with
AstraZeneca. The National Institutes of Health (NIH) partially funds our preclinical work on a
vaccine for influenza. Symphony Dynamo, Inc. (SDI) funds our colorectal cancer trials and our
preclinical hepatitis C therapeutic program, and the selling stockholders (as defined in the
selling stockholders table on page 11) have committed funding for our allergy programs.
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, HEPLISAV and TOLAMBA are registered trademarks of Dynavax Technologies
Corporation. Each of the other trademarks, trade names or service marks appearing in this
prospectus belongs to its respective holder. For further information regarding us and our financial
information, you should refer to our recent filings with the Securities and Exchange Commission, or
SEC. See Where You Can Find More Information and Incorporation of Certain Documents by
Reference.
1
RISK FACTORS
Various statements in this Quarterly Report on Form 10-Q are forward-looking statements
concerning our future products, timing of development activities, expenses, revenues, liquidity and
cash needs, as well as our plans and strategies. These forward-looking statements are based on
current expectations and we assume no obligation to update this information. Numerous factors could
cause our actual results to differ significantly from the results described in these
forward-looking statements, including the following risk factors.
We have incurred substantial losses since inception and do not have any commercial products that
generate significant revenue.
We have experienced significant net losses in each year since our inception. Our accumulated
deficit was $215.8 million as of September 30, 2007. To date, our revenue has resulted from
collaboration agreements, services and license fees from customers of Dynavax Europe, and
government and private agency grants. The grants are subject to annual review based on the
achievement of milestones and other factors and are scheduled to terminate in 2009. We anticipate
that we will incur substantial additional net losses for the foreseeable future as the result of
our investment in research and development activities.
We do not have any products that generate significant revenue. Clinical trials for certain of
our product candidates are ongoing. These and our other product candidates may never be
commercialized, and we may never achieve profitability. Our ability to generate revenue depends
upon:
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demonstrating in clinical trials that our product candidates are safe and
effective, in particular, in the current and planned trials for our product
candidates; |
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obtaining regulatory approvals for our product candidates; and |
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entering into and maintaining successful collaborative relationships. |
If we are unable to generate significant revenues or achieve profitability, we may be required
to reduce or discontinue our current and planned operations or raise additional capital on less
favorable terms.
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
and commercialize our product candidates, we will require substantial additional capital resources
in order to continue our operations, and any such funding may not allow us to continue operations
as currently planned. We expect capital outlays and operating expenditures to increase over the
next several years as we expand our operations, and any change in plans may increase these outlays
and expenditures. We may be unable to obtain additional capital on acceptable terms, or at all and
we may be required to delay, reduce the scope of, or eliminate some or all of our programs, or
discontinue our operations.
The success of our TLR9 product candidates depends on achieving successful clinical results and
regulatory approval. Failure to obtain regulatory approvals could require us to discontinue
operations.
None of our TLR9 product candidates have been approved for sale. 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 our most advanced TLR9 product
candidates. Approval processes in the United States and in other countries are uncertain, take many
years and require the expenditure of substantial resources.
We will need to demonstrate in clinical trials that a product candidate is safe and effective
before we can obtain the necessary approvals from the FDA and foreign regulatory agencies. If we
identify any safety issues associated with our product candidates, we may be restricted from
initiating further trials for those products. Moreover, we may not see sufficient signs of efficacy
in those studies. The FDA or foreign regulatory agencies may require us to conduct additional
clinical trials prior to approval.
Many new drug candidates, including many drug candidates that have completed Phase 3 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 uncertain. Failure to successfully complete clinical trials and show that
our products are safe and effective would have a material adverse effect on our business and
results of operations.
Our clinical trials may be extended, 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
2.
will impair our ability to generate
revenues.
We may extend, 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, concerns regarding health risks
to test subjects or inadequate supply of the product candidate. In addition, our ability to conduct
clinical trials for some of our product candidates is limited due to the seasonal nature. Even a
small delay in a trial for any product candidate could require us to delay commencement of the
trial until the target population is available for testing, which could result in a delay of an
entire year.
Our registration and commercial timelines depend on results of the current and planned
clinical trials and further discussions with the FDA. Any extension, suspension, termination or
unanticipated delays of our clinical trials could:
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adversely affect our ability to timely and successfully commercialize or market
these product candidates; |
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result in significant additional costs; |
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potentially diminish any competitive advantages for those products; |
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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 we receive regulatory approval for our product candidates, we will be subject to ongoing FDA and
foreign regulatory obligations and continued regulatory review.
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 based on data from subsequent studies or long-term use. As a result,
limitations on labeling indications or marketing claims, or withdrawal from the market may be
required if problems occur after commercialization.
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 most advanced 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 most advanced product candidates in clinical trials are based on our 1018 ISS compound,
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 ISS, a common safety risk across therapeutic areas may hinder our ability to
enter into potential collaborations and if adverse safety data are found to apply to our ISS-based
technology as a whole, we may be required to significantly reduce or discontinue our operations.
We rely on third parties and our facility in Düsseldorf, Germany to supply materials necessary to
manufacture our clinical product candidates for our clinical trials and for fulfilling our
manufacturing obligations under our collaboration with Merck. Loss of these suppliers or key
employees in Düsseldorf, or failure to timely replace them may delay our clinical trials and
research and development efforts and may result in additional costs, delays or significantly higher
costs in manufacturing our product candidates or breach of our obligations under our Merck
collaboration.
3.
We rely on a number of third parties and our facility in Düsseldorf for the multiple steps
involved in the manufacturing process of our product candidates, including, for example, ISS, a key
component material that is 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 of our control, resulting in higher cost or delays in our product
development efforts.
We and these third parties are required to comply with applicable FDA current good
manufacturing practice regulations and other international regulatory requirements. 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 and our manufacturing facility must undergo a pre-approval inspection before we can
obtain marketing authorization for any of our product candidates.
We have relied on a single supplier to produce our ISS for clinical trials. 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 internal ISS
manufacturing capability which would result in increased capital and operating costs and delays in
developing and 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.
We currently utilize our facility in Düsseldorf to manufacture the hepatitis B surface antigen
for HEPLISAV, which is part of our collaboration with Merck & Co., Inc, or Merck. We are obligated
to manufacture, on behalf of Merck, HEPLISAV for clinical development and commercial quantities of
hepatitis B surface antigen until such time as we can effect the appropriate technology transfer to
Merck. Accordingly, we will have to allocate the entire capacity of our Düsseldorf facility to meet
our obligations under the Merck collaboration. Moreover, in order to meet our commercial supply
obligations to Merck, we expect to have to establish commercial-scale manufacturing capability for
HEPLISAV, which will involve increased capital and operating costs and the assumption of risks
associated with the construction, validation and operation of a new commercial manufacturing
facility as well as the continued operation of our existing facility. There can be no assurance
that we can successfully meet our supply obligations to Merck and maintain our internal product
candidate timelines and, if we undertake the establishment of a new commercial manufacturing
facility, that we can finance the capital costs and ongoing expenses that we would need to
undertake until or if HEPLISAV achieves commercial success. There also can be no assurance that the
cost of meeting our supply obligation to Merck will be covered by the negotiated supply price.
We rely on contract research organizations to conduct our clinical trials. If these third parties
do not fulfill 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
our product candidates.
We rely on third parties to conduct our clinical trials. If these third parties do not perform
their obligations or meet expected deadlines our planned clinical trials may be extended, delayed or terminated. Any extension, delay
or termination of our clinical trials would delay our ability to commercialize our products and
could have a material adverse effect on our business and operations.
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.
Even if we obtain regulatory approval for our product candidates and are able to successfully
commercialize them, our products 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 limit
marketing efforts for our products. If we are unable to successfully market any approved product
candidates, or marketing efforts are restricted by regulatory limits, our ability to generate
revenues could be significantly impaired.
A key part of our business strategy is to establish collaborative relationships to commercialize
and fund development of our product candidates. We may not succeed in establishing and maintaining
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. 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
4.
one or more of our product candidates, undertake development and
commercialization activities at our own expense or find alternative sources of capital.
In October 2007, we entered into a collaborative arrangement with Merck in which we and Merck
will further develop and commercialize HEPLISAV. Pursuant to the terms of the collaboration, we are
obligated to complete ongoing clinical studies, manufacture and supply on behalf of Merck, and
conduct technology transfer with respect to our existing HEPLISAV development program. Although we
will be reimbursed for specified development efforts and the delivery of clinical material to Merck
in the further development and commercialization of HEPLISAV, Merck controls the development and
commercialization plans for the product. There can be no assurance that we will successfully and
timely fulfill our obligations under the collaboration, that Merck may not develop or market a
potentially competitive product, or that HEPLISAV, even if successfully developed, can achieve
commercial success sufficient for us to achieve all of the milestones and royalties contemplated
under the collaborative arrangement.
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 pharmaceutical companies, biotechnology companies, academic institutions and
research organizations, in developing therapies to treat or prevent infectious diseases, allergy,
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.
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 successfully, we may not be able to obtain financing, enter into
collaborative arrangements, 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, Dr. 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 key personnel, our research and product development goals, including the identification and
establishment of key collaborations, operations and marketing efforts could be delayed or
curtailed.
We may 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 our product candidates.
We may introduce certain of our product candidates in various markets outside the United
States. Developing, seeking regulatory approval for and marketing our product candidates outside
the United States could impose substantial burdens on our resources and divert managements
attention from domestic operations. 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, laws and treaties; |
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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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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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regional and geopolitical risks. |
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If we are unable to successfully manage our international operations, we may incur significant
unanticipated costs and delays in regulatory approval or commercialization of our product
candidates, which would impair our ability to generate revenues.
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 current research and development efforts depend upon our license arrangements with the
Regents of the University of California, or UC. Our dependence on these licenses subjects us to
numerous risks, such as disputes regarding the creation or use of intellectual property by us and
UC, or scientific collaborators. Additionally, our agreements with UC generally contain diligence
or milestone-based termination provisions. Our failure to meet any obligations pursuant to these
provisions could allow UC to terminate our agreements or convert exclusive to non-exclusive
licenses. In addition, our license agreements with UC 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.
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 or proprietary technologies 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 our or another partys proprietary rights, including a challenge as to the
validity of our issued and pending claims. We are involved in various interference and other
administrative proceedings related to our intellectual property which has caused us to incur
certain legal expenses. If we become involved in any litigation and/or other significant
interference proceedings related to our intellectual property or the intellectual property of others, we will
incur substantial additional expenses and it will divert the efforts of our technical and
management personnel.
If we or our collaborators are unsuccessful in defending or prosecuting our issued and pending
claims or in defending potential claims against our products, for example, as may arise in the
commercialization of HEPLISAV or any similar product candidate in the United States, we or our
collaborator could be required to pay substantial damages or be unable to commercialize our product
candidates or use our proprietary technologies without a license from such third party. A license
may require the payment of substantial fees or royalties, require a grant of a cross-license to our
technology or may not be available on acceptable terms, if at all. 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 could require us to
change our business strategy and could materially impact our business and operations.
One of our potential competitors, Coley, has issued U.S. patent claims, as well as patent
claims pending with the U.S. Patent and Trademark Office, or PTO, that may be asserted against our
ISS products. We may need to obtain a license to one or more of these patent claims held by Coley
by paying fees or royalties or offering rights to our own proprietary technologies in order to
commercialize one or more of our formulations of ISS in the U.S. other than with respect to
HEPLISAV. Such a license may not be available to us on acceptable terms, if at all, which could
preclude or limit our ability to commercialize our products.
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
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this uncertainty since several of our product candidates may initially address market opportunities
outside the United States, 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 receive an issued patent for any of our patent applications or for any
patent applications that we have exclusively licensed; |
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the pending patent applications we have filed or to which we have exclusive rights
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 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 parties may limit our intellectual property protection or
harm our ability to do business; |
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other parties 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 parties 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 cannot be certain that we will be able to protect our trade secrets
adequately. Any disclosure of confidential data in 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.
Our TLR9 allergy program, including the development of TOLAMBA, relies on debt funding that is
accessible only on the achievement of specified development milestones. We may not be able to
achieve the milestones in a timely manner and as a result may not receive or have access to
sufficient funding to continue further development of TOLAMBA. Even if we achieve such milestones,
we will be obligated to repay up to $30 million in July 2010 and we may not have sufficient funds
to pay such amounts upon maturity.
In July 2007, we entered into a funding arrangement with the selling stockholders to
support our further development of our allergy product programs, including TOLAMBA. Our continued
access to the funding is dependent upon our successful achievement of specified milestones in a
timely manner. There can be no assurance that TOLAMBA will be entered into planned clinical studies
or successfully achieve the planned end points, and failure to successfully further develop TOLAMBA
according to our current clinical plans may result in the termination of further development
efforts. Moreover, even if we achieve the planned clinical results, we will be required to issue an
additional warrants to purchase up to 3,000,000 shares of our Common Stock and repay outstanding
loans to the selling stockholders. We may be required to enter into a financing arrangement or
license arrangement with one or more third parties, or some combination of these in order to repay
the loan at maturity. There can be no assurance that any financing or licensing arrangement will be
available or even if available, that the terms would be favorable to us and our stockholders.
We have licensed some of our development and commercialization rights to certain of our development
programs in connection with our Symphony Dynamo funding arrangement and will not receive any future
royalties or revenues with respect to this intellectual property unless we exercise an option to
repurchase some or all of the programs in the future. We may not obtain sufficient clinical data in
order to determine whether we should exercise our option prior to the expiration of the development
period, and even if we decide to exercise, we may not have the financial resources to exercise our
option in a timely manner.
In April 2006, we granted an exclusive license to the intellectual property for certain
ISS compounds for cancer, hepatitis B and hepatitis C therapeutics to Symphony Dynamo, Inc., or
SDI, in consideration for a commitment from Symphony Capital Partners, LP and certain of its
affiliates, or Symphony, and its co-investors to provide $50 million of committed capital to
advance these programs. As part of the arrangement, we received an option granting us the exclusive
right, but not the obligation, to acquire certain or all of the programs at specified points in
time at specified prices during the term of the five-year development period. The development
programs under the arrangement are jointly managed by SDI and us, and there can be no assurance
that we will agree on various decisions that will enable us to successfully develop the potential
products, or even if we are in agreement on the development plans, that the development efforts
will result in sufficient clinical data to make a fully informed decision with respect to the
exercise of our option. If we do not exercise the purchase option prior to its expiration, then our
rights in and with respect to the SDI programs will
7.
terminate and we will no longer have rights to any of the programs licensed to SDI under the
arrangement. In April 2007, we exercised our option for the hepatitis B program. The exercise of
this program option triggers a payment obligation of $15 million to Symphony upon the expiration of
the SDI collaboration in 2011 if the purchase option for all programs is not exercised.
If we elect to exercise the purchase option, we will be required to make a substantial
payment, which at our election may be paid partially in shares of our common stock. As a result, in
order to exercise the option, we will be required to make a substantial payment of cash and
possibly issue a substantial number of shares of our common stock. We do not currently have the
resources to exercise the option and we may be required to enter into a financing arrangement or
license arrangement with one or more third parties, or some combination of these in order to
exercise the option, even if we paid a portion of the purchase price with our common stock. There
can be no assurance that any financing or licensing arrangement will be available or even if
available, that the terms would be favorable to us and our stockholders. In addition, the exercise
of the purchase option will likely require us to record a significant charge to earnings and may
adversely impact future operating results.
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 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.
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 achieve profitability will depend in
part on the negotiation of a favorable price or the availability of appropriate 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. 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 our
considerable investment in product development. Adequate third-party reimbursement may not be
available to enable us to maintain price levels sufficient to achieve profitability and could harm
our future prospects and reduce our stock price.
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.
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 or regulatory efforts, in
particular any announcements regarding the progress or results of our planned trials; |
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our ability to establish and maintain collaborations for the development and
commercialization of our product candidates; |
8.
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our ability to raise additional capital to fund our operations; |
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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 enter into and maintain collaborations; |
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maintenance of our existing exclusive licensing agreements with the Regents of the
University of California; |
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changes in government regulations, general economic conditions, industry
announcements; |
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issuance of new or changed securities analysts reports or recommendations; |
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actual or anticipated fluctuations in our quarterly financial and operating results;
and |
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volume of trading 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.
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.
We will continue to implement additional financial and accounting systems, procedures or controls
as we grow our business and organization and to satisfy new reporting requirements.
We are required to comply with the Sarbanes-Oxley Act of 2002 and the related rules and
regulations of the SEC. Compliance with Section 404 of the Sarbanes-Oxley Act of 2002, or Section
404, and other requirements may 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.
Specifically, we have integrated the operations, technologies, products and personnel of Dynavax
Europe into our operations and Dynavax Europes operations will be required to be included in our
assessment of internal controls over financial reporting under Section 404 by the end of 2007.
There can
9.
be no assurance that we will be able to maintain a favorable assessment as to the adequacy of our
internal control over financial reporting. If we are unable to reach an unqualified assessment, or our independent auditors are
unable to issue an unqualified attestation as to the effectiveness of our internal controls over
financial reporting, investors could lose confidence in the reliability of our financial reporting
which could harm our business and could impact the price of our common stock.
INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the information that we incorporate by reference, contains various
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended,
or the Exchange Act. These statements relate to future events or our future financial performance
and involve known and unknown risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ materially from any future
results, levels of activity, performance or achievements expressed or implied by these
forward-looking statements. In some cases, you can identify forward-looking statements by
terminology such as anticipates, believes, continue estimates, expects, intends, may,
plans, potential, predicts, should, will, or the negative of these terms or other
comparable terminology. These forward-looking statements may also use different phrases.
Discussions containing these forward-looking statements may be found, among other places, in
Business and Managements Discussion and Analysis of Financial Condition and Results of
Operations incorporated by reference from our most recent annual report on Form 10-K and in our
most recent quarterly report on Form 10-Q subsequent to the filing of our most recent annual report
on Form 10-K with the SEC, as well as any amendments thereto reflected in subsequent filings with
the SEC. We may not actually achieve the plans, intentions or expectations disclosed in our
forward-looking statements and you should not place undue reliance on our forward-looking
statements. Actual results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make. Forward-looking statements
include, but are not limited to, statements about:
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our expectations with respect to the clinical development and timing of clinical
development of our product candidates, our clinical trials and the regulatory approval
process; |
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the commercialization of our TOLAMBA and HEPLISAV products; |
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our expectations with respect to our collaborations and programs funded by third
parties; |
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our expectations with regard to our ability to retain, obtain and protect necessary
intellectual property to commercialize our products; and |
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our expectations regarding our capital requirements, how long our current financial
resources will last, and our needs for additional financing. |
Such forward-looking statements involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or achievements to differ materially from
any future results, performance or achievements expressed or implied by such forward-looking
statements. These risks include those risks discussed under the heading Risk Factors and
elsewhere in this prospectus. Because the factors referred to above could cause actual results or
outcomes to differ materially from those expressed in any forward-looking statements made by us or
on our behalf, you should not place undue reliance on any forward-looking statements. New factors
emerge from time to time, and it is not possible for us to predict which factors will arise. In
addition, we cannot assess the impact of each factor on our business or the extent to which any
factor, or combination of factors, may cause actual results to differ materially from those
contained in any forward-looking statements. Further, any forward-looking statement speaks only as
of the date on which it is made, and, except as required by law, we undertake no obligation to
publicly revise our forward-looking statements to reflect events or circumstances that arise after
the date of this prospectus or the date of documents incorporated by reference in this prospectus
that include forward-looking statements. You should read this prospectus and the documents that we
reference and have filed as exhibits to the registration statement of which this prospectus is a
part with the understanding that we cannot guarantee future results, levels of activity,
performance or achievements.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of shares of our Common Stock by the
selling stockholders pursuant to this prospectus. A portion of the shares covered by this
prospectus are issuable upon exercise of warrants to purchase our Common Stock. Upon any exercise
of the warrants for cash, the selling stockholders would pay us the exercise price of the warrants.
The cash exercise price of the warrants is $5.75 per share of our Common Stock. Under certain
conditions set forth in the warrants, the warrants are
10
exercisable on a cashless basis. If the warrants are exercised on a cashless basis, we would
not receive any cash payment from the selling stockholders upon any exercise of the warrants.
SELLING STOCKHOLDERS
On July 18, 2007, we entered into a loan agreement with the selling stockholders that provided
for us to receive up to $30,000,000 of loans over a three-year period, subject to our satisfaction
of specific milestones and agreed to issue to those stockholders warrants to purchase up to
5,550,000 shares of our Common Stock at a premium to the then current trading price following the
achievement of certain milestones. In connection with the execution of the agreement we issued
warrants to the selling stockholders to purchase an aggregate of 1,250,000 shares of our Common
Stock at $5.13 per share and filed a registration statement on August 31, 2007. Upon completion of
a milestone on October 18, 2007, we issued warrants to purchase an additional 1,300,000 shares of
our Common Stock at a price of $5.75 per share. We agreed to file a registration statement with
respect to each issuance, of which this prospectus is a part, with the Securities and Exchange
Commission to register the disposition of any Common Stock issued pursuant to the warrants and to
use our best efforts to keep the registration statement effective until the earlier of (a) such
time as all of the shares registered hereunder may be sold without restrictions under the
Securities Act as determined in the reasonable opinion of counsel to the selling stockholders, and
(b) such time as all such shares registered hereunder have been sold by the selling stockholders.
Additional information on our transaction with the selling stockholders is contained in our current
report on Form 8-K, filed with the SEC on July 24, 2007, incorporated by reference herein.
The following table sets forth:
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the name of each of the selling stockholders; |
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the number of shares of our Common Stock owned by each such selling stockholder prior
to this offering; |
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the number of shares of our Common Stock being offered pursuant to this prospectus; |
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the number of shares of our Common Stock owned upon completion of this offering; and |
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the percentage (if one percent or more) of Common Stock owned by each such selling
stockholder after this offering. |
This table is prepared based on information supplied to us by the selling stockholders and
reflects holdings as of November 14, 2007. As used in this prospectus, the term selling
stockholder includes each of the selling stockholders listed below, and any donees, pledges,
transferees or other successors in interest selling shares received after the date of this
prospectus from a selling stockholder as a gift, pledge, or other non-sale related transfer. The
number of shares in the column Shares of Common Stock Being Offered plus 550,000 of the shares
referred to in footnote (1) to the table represent all of the shares that selling stockholders may
offer under this prospectus. The selling stockholder may sell some, all or none of its shares. We
do not know how long the selling stockholders will hold the shares before selling them, and we
currently have no agreements, arrangements or understandings with the selling stockholders
regarding the sale of any of the shares.
Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC
under the Securities Exchange Act. As of November 14, 2007, 39,764,520 shares of our Common Stock
were outstanding.
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Shares of |
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Shares of |
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Common |
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Shares of |
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Common |
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Stock Owned |
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Common |
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Stock Owned |
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% of |
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Stock Being |
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After |
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Common |
Name of Selling Stockholder(1)(2) |
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Offering(3) |
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Offered(7) |
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Offering(8) |
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Stock |
Deerfield Special Situations Fund International Limited |
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1,134,926 |
(4) |
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136,890 |
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998,036 |
(9) |
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2.5 |
% |
Deerfield Special Situations Fund, L.P. |
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589,904 |
(5) |
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79,690 |
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510,214 |
(10) |
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1.3 |
% |
Deerfield Private Design Fund, L.P. |
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801,210 |
(6) |
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408,460 |
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392,750 |
(6) |
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1.0 |
% |
Deerfield Private Design International, L.P. |
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1,323,960 |
(6) |
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674,960 |
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649,000 |
(6) |
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1.6 |
% |
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(1) |
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In addition to the shares of Common Stock listed, these selling stockholders may offer up to
an aggregate of 1,080,000 shares of Common Stock that are issuable upon redemption of warrants
following certain major transactions or events of default and upon the occurrence of certain
events. The resale of an aggregate of 550,000 of these shares is being registered under the
registration statement of which this prospectus is a part and the resale of the balance of
these shares is registered under another registration statement. |
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James E. Flynn has the power to vote or dispose of the shares held by the selling
stockholders. |
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Includes shares of Common Stock issuable upon exercise of warrants. For the
purposes hereof, we assume the issuance of all such shares pursuant to a cash exercise. |
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Includes 268,515 shares of Common Stock issuable upon the exercise of warrants held by the
selling stockholder and 866,411 shares of Common Stock owned by the selling stockholder. |
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(5) |
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Includes 156,315 shares of Common Stock issuable upon the exercise of warrants held by the
selling stockholder and 433,589 shares of Common Stock owned by the selling stockholder. |
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(6) |
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Represents shares of Common Stock issuable upon the exercise of warrants held by these
selling stockholders |
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(7) |
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Represents shares of Common Stock issuable upon the exercise of warrants held by these
selling stockholders. The disposition of these shares is being registered under the
registration statement of which this prospectus is a part and, for the purposes hereof, we
assume the issuance of all such shares pursuant to a cash exercise. |
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The resale of these shares is registered under another registration statement. |
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(9) |
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Includes 131,625 shares of Common Stock issuable upon the exercise of warrants held by the
selling stockholder and 866,411 shares of Common Stock owned by the selling stockholder. |
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(10) |
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Includes 76,625 shares of Common Stock issuable upon the exercise of warrants held by the
selling stockholder and 433,589 shares of Common Stock owned by the selling stockholder. |
PLAN OF DISTRIBUTION
We are registering the shares of Common Stock issuable upon exercise of the warrants to permit
the resale of these shares of Common Stock by the holders thereof from time to time after the date
of this prospectus. We will not receive any of the proceeds from the sale by the selling
stockholders of the shares of Common Stock. We will bear all fees and expenses incident to our
obligation to register the shares of Common Stock.
The selling stockholders may sell all or a portion of the shares of Common Stock beneficially
owned by them and offered hereby from time to time directly or through one or more underwriters,
broker-dealers or agents. If the shares of Common Stock are sold through underwriters or
broker-dealers, the selling stockholders will be responsible for underwriting discounts or
commissions or agents commissions. We will file a prospectus supplement if the selling
stockholders engage one or more underwriters. The shares of Common Stock may be sold in one or more
transactions at fixed prices, at prevailing market prices at the time of the sale, at varying
prices determined at the time of sale, or at negotiated prices. These sales may be executed in
transactions, which may involve crosses or block transactions:
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on any national securities exchange or quotation service on which the securities may be
listed or quoted at the time of sale; |
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in the over-the-counter market; |
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in transactions otherwise than on these exchanges or systems or in the over-the-counter
market; |
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through the writing of options, whether such options are listed on an options exchange
or otherwise; |
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involving ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers; |
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involving block trades in which the broker-dealer will attempt to sell the shares as
agent but may position and resell a portion of the block as principal to facilitate the
transaction; |
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involving purchases by a broker-dealer as principal and resale by the broker-dealer for
its account; |
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in an exchange distribution in accordance with the rules of the applicable exchange; |
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in privately negotiated transactions; |
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through the settlement of short sales; |
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where broker-dealers may agree with the selling stockholders to sell a specified number
of such shares at a stipulated price per share; |
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in a combination of any such methods of sale; and |
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through any other method permitted pursuant to applicable law. |
The selling stockholders may also sell shares under Rule 144 under the Securities Act, if
available, rather than under this prospectus, provided the sale meets the criteria and conforms to
the requirements of such Rule.
If the selling stockholders effect such transactions by selling shares of Common Stock to or
through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may
receive commissions in the form of discounts, concessions or commissions from the selling
stockholders or commissions from purchasers of the shares of Common Stock for whom they may act as
agent or to
12.
whom they may sell as principal (which discounts, concessions or commissions as to particular
underwriters, broker-dealers or agents may be in excess of those customary in the types of
transactions involved). In connection with sales of the shares of Common Stock or otherwise, the
selling stockholders may enter into hedging transactions with broker-dealers, which may in turn
engage in short sales of the shares of Common Stock in the course of hedging in positions they
assume. The selling stockholders may also sell shares of Common Stock short and deliver shares of
Common Stock covered by this prospectus to close out short positions. The selling stockholders may
also loan or pledge shares of Common Stock to broker-dealers that in turn may sell such shares.
The selling stockholders may pledge or grant a security interest in some or all of the
warrants or shares of Common Stock owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer and sell the shares of Common Stock
from time to time pursuant to this prospectus or any supplement to this prospectus under Rule 424
or other applicable provision of the Securities Act modifying and superseding, if necessary, the
list of selling stockholders to include the pledgee, transferee or other successors in interest as
selling stockholders under this prospectus. The selling stockholders also may transfer and donate
the shares of Common Stock in other circumstances in which case the transferees, donees, pledgees
or other successors in interest will be the selling stockholders for purposes of this prospectus.
We will file a prospectus supplement naming the new selling stockholders if the shares are
transferred, donated or pledged.
The selling stockholders and any broker-dealer participating in the distribution of the shares
of Common Stock may be deemed to be underwriters within the meaning of the Securities Act, and
any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be
deemed to be underwriting commissions or discounts under the Securities Act. At the time a
particular offering of the shares of Common Stock is made, a prospectus supplement, if required,
may be distributed which will set forth the aggregate amount of shares of Common Stock being
offered and the terms of the offering, including the name or names of any broker-dealers or agents,
any discounts, commissions and other terms constituting compensation from the selling stockholders
and any discounts, commissions or concessions allowed or reallowed or paid to broker-dealers.
Under the securities laws of some states, the shares of Common Stock may be sold in such
states only through registered or licensed brokers or dealers. In addition, in some states the
shares of Common Stock may not be sold unless such shares have been registered or qualified for
sale in such state or an exemption from registration or qualification is available and is complied
with.
The selling stockholders and any other person participating in such distribution will be
subject to applicable provisions of the Exchange Act and the rules and regulations thereunder,
including, without limitation, Regulation M of the Exchange Act, which may limit the timing of
purchases and sales of any of the shares of Common Stock by the selling stockholders and any other
participating person. Regulation M may also restrict the ability of any person engaged in the
distribution of the shares of Common Stock to engage in market-making activities with respect to
the shares of Common Stock. All of the foregoing may affect the marketability of the shares of
Common Stock and the ability of any person or entity to engage in market-making activities with
respect to the shares of Common Stock.
We will pay all expenses of the registration of the shares of Common Stock pursuant to a
registration rights agreement we entered into with the selling stockholders in connection with the
issuance of the warrants, including, without limitation, Securities and Exchange Commission filing
fees and expenses of compliance with state securities or blue sky laws; provided, however, that
the selling stockholders will pay all underwriting discounts and selling commissions, if any. We
will indemnify the selling stockholders against liabilities, including some liabilities under the
Securities Act, in accordance with the registration rights agreement, or the selling stockholders
will be entitled to contribution. We may be indemnified by the selling stockholders against civil
liabilities, including liabilities under the Securities Act, that may arise from any written
information furnished to us by the selling stockholders specifically for use in this prospectus, in
accordance with the registration rights agreement, or we may be entitled to contribution.
Once sold under the shelf registration statement, of which this prospectus forms a part, the
shares of Common Stock will be freely tradable in the hands of persons other than our affiliates.
LEGAL MATTERS
The validity of the securities being offered hereby will be passed upon by Cooley Godward
Kronish llp, Palo Alto, California.
EXPERTS
The consolidated financial statements of Dynavax Technologies Corporation appearing in Dynavax
Technologies Corporations Annual Report on Form 10-K for the year ended December 31, 2006, and
Dynavax Technologies Corporation managements assessment of the effectiveness of internal control
over financial reporting as of December 31, 2006 included therein, have been audited by Ernst &
Young LLP, independent registered public accounting firm, as set forth in their reports thereon
included therein,
13.
and incorporated herein by reference. Such consolidated financial statements and managements
assessment have been incorporated herein by reference in reliance upon such reports given on the
authority of such firm as experts in accounting and auditing.
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, D.C. 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 Financial
Industry Regulatory Authority 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 Exchange Act 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.
We incorporate by reference the documents listed below and any documents that we file in the
future with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of
this prospectus and before the completion of the offering (other than current reports furnished
under Item 9 or Item 12 of Form 8-K):
1. Our Annual Report on Form 10-K for the year ended December 31, 2006, filed with the SEC on
March 16, 2007;
2. Our Quarterly Reports on Form 10-Q for the period ended March 31, 2007, filed with the SEC
on May 2, 2007, for the period ended June 30, 2007, filed with the SEC on August 3, 2007 and for
the period ended September 30, 2007, filed with the SEC on November 6, 2007;
3. Our Current Reports on Form 8-K filed with the SEC on July 3, 2007, July 24, 2007, August
2, 2007 and November 7, 2007;
4. Our Definitive Proxy Statement on Form 14A filed with the SEC on April 26, 2007; and
5. The description of our Common Stock set forth in Registration Statement on Form S-1
(Registration No. 333-109965) filed with the SEC 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 Michael Ostrach, Secretary, 2929 Seventh Street, Suite 100, Berkeley, CA
94710-2753, (510) 848-5100.
14.
WE HAVE NOT AUTHORIZED ANY DEALER, SALESPERSON OR OTHER PERSON TO GIVE ANY INFORMATION OR
REPRESENT ANYTHING NOT CONTAINED IN THIS PROSPECTUS. YOU SHOULD RELY ONLY ON THE INFORMATION
PROVIDED OR INCORPORATED BY REFERENCE IN THIS PROSPECTUS. YOU SHOULD NOT RELY ON ANY UNAUTHORIZED
INFORMATION. THIS PROSPECTUS DOES NOT OFFER TO SELL ANY SHARES IN ANY JURISDICTION IN WHICH IT IS
UNLAWFUL. THE INFORMATION IN THIS PROSPECTUS IS CURRENT AS OF THE DATE ON THE COVER.
1,850,000 SHARES
DYNAVAX TECHNOLOGIES CORPORATION
COMMON STOCK
PROSPECTUS
DECEMBER 5, 2007
15.