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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of
report (Date of earliest event reported): April 18, 2006
DYNAVAX TECHNOLOGIES CORPORATION
(Exact name of Registrant as Specified in its Charter)
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Delaware |
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000-50577 |
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33-0728374 |
(State or Other Jurisdiction
of Incorporation)
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(Commission File
Number)
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(IRS Employer
Identification No.) |
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2929 Seventh Street, Suite 100, Berkeley, CA |
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94710 |
(Address of Principal Executive Offices)
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(Zip Code) |
Registrants telephone number, including area code: (510) 848-5100
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N/A |
(Former Name or Former Address, if Changed Since Last Report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement.
On April 19, 2006, the Company announced that it entered into a series of related agreements
with Symphony Capital Partners, LP, Symphony Dynamo Holdings LLC and Symphony Dynamo, Inc.,
consisting of the following:
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Purchase Option Agreement; |
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Warrant Purchase Agreement; |
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Warrant to purchase 2,000,000 shares of the Companys common stock; |
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Registration Rights Agreement; |
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Research & Development Agreement; |
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Amended & Restated Research and Development Agreement; |
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Technology License Agreement; |
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Novated and Restated Technology License Agreement; |
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Confidentiality Agreement; and |
Pursuant to these agreements the investors capitalized Symphony Dynamo, Inc. in order to fund
commitments to the Company for $20 million in funding upon signing and $30 million in additional
capital not later than the first anniversary following closing. The funding will be used to support clinical
development of certain of the Companys specified ImmunoStimulatory Sequences, or ISS-based,
cancer, hepatitis B and hepatitis C therapeutic programs (the Programs). The intellectual
property for the programs under development in these therapeutic areas was licensed exclusively
under the Technology License Agreement with Symphony Dynamo Holdings LLC and Symphony Dynamo, Inc.
In consideration for the issuance of a five-year warrant to purchase 2,000,000 shares of the
Companys common stock at a price of $7.32 per share, subject to adjustment under certain
circumstances to $5.86 per share, the Purchase Option Agreement provides for the exclusive right,
but not the obligation of the Company to repurchase certain or all of the Programs at specified
points in the future during the five-year term at specified prices. If the Company exercises its
right to acquire all of the Programs at any time beginning no earlier than one year after the
closing date of the transaction or when certain minimum funding level balances are reached, the
purchase price provides for a compounded annual rate of return of 27% to Symphony Capital,
calculated as of the time of exercise and subject to a minimum purchase price. The purchase price
is payable in cash or a combination of cash and shares of the Companys common stock, at the
Companys sole discretion. The Company also has an option to separately purchase either the
hepatitis B or hepatitis C program during the first year of the arrangement. If the Company does not exercise
its exclusive right with respect to the purchase of some or all of the Programs licensed under the
arrangement, rights to the Programs at the end of the development period will remain with Symphony
Dynamo, Inc.
The implementation of the development plan during the five-year development period will be led
by the Company with support from RRD International LLC, the clinical development partner of
Symphony Capital Partners, LP. Funds for the arrangement will be dedicated to the Companys cancer
product candidate, currently in a Phase 2 clinical trial in Non-Hodgkins lymphoma, and its
hepatitis B and hepatitis C therapeutic product candidates. The arrangement will governed by a
board of directors comprised of one Company representative, two representatives from Symphony
Capital Partners, LP and two independent directors.
On April 19, 2006 the Company filed a press release describing this transaction. A copy of
this press release is attached as Exhibit 99.1 to this Form 8-K.
Item 2.01 Completion of Acquisition or Disposition of Assets.
The
information set forth in Item 1.01 is incorporated herein by reference.
Item 3.02 Unregistered Sales of Equity Securities.
The information set forth in Item 1.01 is incorporated herein by reference.
The warrant was issued only to an accredited investor, as such term is defined in Rule 501 of
Regulation D promulgated under the Securities Act of 1933, as amended (the Securities Act). The
warrant has not been registered under the Securities Act or any state securities laws. Dynavax
relied on the exemption from the
registration requirements of the Securities Act set forth in
Section 4(2) thereof and the rules and regulations promulgated thereunder. Dynavax has agreed to
file a registration statement for the resale of the shares of common stock underlying the warrant.
Neither this current report on Form 8-K nor any of the exhibits attached hereto is an offer to sell
or the solicitation of an offer to buy shares of common stock or other securities of Dynavax.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release of the Registrant, dated April 19, 2006.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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Dynavax Technologies Corporation
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Date: April 24, 2006 |
By: |
/s/ Timothy G. Henn
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Timothy G. Henn |
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Chief Accounting Officer and Vice President, Finance
and Administration |
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exv99w1
Exhibit 99.1
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2929 Seventh Street, Suite 100
Berkeley, CA 94710
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Contact:
Dynavax Technologies Corporation
Jane M. Green, PhD
Vice President, Corporate Communications
Phone (510) 665-4630
Email: jgreen@dvax.com
DYNAVAX TO ADVANCE CANCER, HEPATITIS B
AND HEPATITIS C THERAPY PROGRAMS WITH $50 MILLION FUNDING
Collaborative Financing from Symphony Capital Partners, LP Designed to
Advance Next-Generation TLR-Agonist Pipeline
Berkeley, CA April 19, 2006 Dynavax Technologies Corporation (NASDAQ:DVAX) announced an
agreement with Symphony Capital Partners, LP and its co-investors to provide $50 million of
committed capital to advance Dynavaxs ISS-based cancer, hepatitis B and hepatitis C therapeutic
programs through clinical development.
Under the terms of the agreement, Symphony Capital, a private equity fund, has established Symphony
Dynamo, Inc., which will be capitalized initially with $20 million and an additional $30 million
within one year following closing to fund Dynavaxs identified development programs in cancer and
hepatitis therapeutics. Dynavax has granted a license to the intellectual property for the ISS
compounds selected for the Symphony Dynamo programs. Through a purchase option, Dynavax retains the
exclusive right, but not the obligation, to acquire certain of the programs at specified points in
time, or the entire set of funded programs at specified prices during the term of the development
period. The term of the agreement is up to five years. The implementation of the development plans
will be led by Dynavax with support from RRD International, LLC, Symphony Capitals clinical
development partner, to provide additional clinical development and regulatory capabilities for the
advancement of Dynavaxs cancer, hepatitis B and hepatitis C therapeutic programs.
We believe that this collaborative financing arrangement is timely and opportune, and fulfills key
strategic goals for our company. It will enable us to continue to focus critical resources on
advancing our lead programs in ragweed allergy and hepatitis B vaccines and provide additional
minimally dilutive funding for investment in our early-stage, second-generation programs. This
approach should allow us to build additional value in our pipeline and expand our partnering
opportunities, all in a risk-reduced manner, said Dino Dina, MD, president and chief executive
officer.
Continued Dr. Dina: We can now invest more robustly in our cancer and hepatitis therapeutics
pipeline, optimize the potential of our second-generation ISS-based technology, and accelerate
creation of a new set of partnering assets. With TOLAMBA and HEPLISAV having achieved
proof-of-concept and advancing through late-stage clinical trials and potentially toward
registration, we believe now is the right time to invest in our cancer, hepatitis B and hepatitis C
therapeutic programs. This financing strategy is consistent with our overall corporate strategy to
have a steady stream of product opportunities moving into and through the clinic, to advance
next-generation programs that represent attractive therapeutic and commercial opportunities, and to
generate a meaningful return on investment for our shareholders.
Financial Terms
Funds from the arrangement will be dedicated to Dynavaxs cancer product candidate, currently in a
Phase 2 trial in Non-Hodgkins lymphoma and anticipated to advance into clinical trials in solid
tumors in 2006, and its hepatitis B and C therapeutic product candidates, which are anticipated to
enter the clinic in 2007.
Symphony Dynamo will be capitalized initially with $20 million and an additional $30 million within
one year following closing. Dynavax will issue to Symphony Dynamo investors warrants to purchase
two million shares of Dynavax common stock at $7.32 per share, representing a 25% premium over the
recent 60-day trading range average of $5.86 per share. The term of the warrants is five years and
the exercise price is subject to reduction to $5.86 per share under certain circumstances.
Dynavax will have an exclusive option, exercisable at its sole discretion, to acquire all of the
programs through the purchase of all of the equity in Symphony Dynamo, exercisable at any time
beginning one year after the closing date of the transaction and ending either five years after the
closing date or at a time when the funding balance remaining in Symphony Dynamo reaches a certain
minimum level. The purchase price is based on a compounded annual rate of return of 27% calculated
as of the time of exercise. The purchase option exercise price is payable in cash or a combination
of cash and shares of Dynavax common stock,
at Dynavaxs sole discretion. Dynavax also has an option to purchase either the hepatitis B or
hepatitis C program during the first year of the agreement.
Dynavax plans to consolidate the results of operations of Symphony Dynamo into its financial
statements in the second quarter of 2006. To the extent that Dynavax contributes existing internal
resources to the Symphony Dynamo programs as planned, the company currently estimates that the
transaction may have a positive impact on both Dynavaxs use of cash and the timing of future
capital requirements.
Symphony Dynamo will be governed by a board of directors, comprised of one Dynavax representative,
Dino Dina, MD, two representatives from Symphony Capital Partners, Harri Taranto and Mark Kessel,
and two independent directors, one of whom is Ann Arvin, MD, the Lucile Salter Packard Professor of
Pediatrics, Associate Dean of Research, Professor of Microbiology & Immunology and Chief of
Pediatric Infectious Diseases at Stanford University School of Medicine.
JMP Securities LLC served as advisor to Dynavax in this transaction.
Conference Call Today
Dynavax will hold a conference call to discuss the Symphony Dynamo transaction today at 4:30 pm
Eastern /1:30 pm Pacific. To access the live call, please dial 866.543.6403 (US) or 617.213.8896
(international), passcode 90694187. Interested parties may listen to the webcast live at
http://www.dynavax.com by clicking on the Events tab under the heading, Investors. The webcast
is also being distributed over CCBNs Investor Distribution Network to both institutional and
individual investors. Individual investors can listen to the call through CCBNs individual
investor center at http://www.fulldisclosure.com or by visiting any of the investor sites in
CCBNs Individual Investor Network. Institutional investors can access the call via CCBNs
password-protected event management site, StreetEvents, at http://www.streetevents.com. A
telephonic replay will be available through April 24, 2006 by dialing 888.286.8010, access code
67463566. International callers can dial 617.801.6888, access code 67463566.
About Symphony Capital Partners, LP
Symphony Capital is a New York-based private equity firm that invests in development stage
biopharmaceutical programs. Symphony has the most experienced team for project-specific financings
and has $315 million in private equity capital dedicated to invest exclusively in the type of
collaboration undertaken with Dynavax. Symphony Capital Partners is the lead investor in Symphony
Dynamo. Additional information about Symphony is available at www.symphonycapital.com.
About RRD International, LLC
RRD International, LLC (RRD) is an innovative product development company dedicated to supporting
the global regulatory, preclinical and clinical needs of biotechnology, pharmaceutical and medical
device companies. RRD provides comprehensive strategic planning and operational support from
program inception to product approval including the design, management and execution of clinical
trials. RRDs team of highly experienced drug and device developers has a substantial record of
favorable FDA interactions and outcomes. Through its customized and flexible business approach,
RRD offers a unique risk-sharing model, enabling its goals and interests to be aligned with a
partner companys success. Additional information about RRD is available at www.rrdintl.com.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends 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, or ISS, which are short
DNA sequences that enhance the ability of the immune system to fight disease and control chronic
inflammation. Dynavaxs pipeline includes: TOLAMBA, a ragweed allergy immunotherapeutic, that
has completed a large-scale Phase 2/3 clinical trial, and is in a supportive clinical trial in
ragweed allergic children; HEPLISAV, a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma
immunotherapeutic that has shown preliminary safety and pharmacologic activity in a Phase 2a
clinical trial.
Dynavax cautions you that statements included in this press release that are not a description of
historical facts are forward-looking statements, including without limitation all statements
regarding the agreement with Symphony Capital Partners, LP and its investors to provide $50 million
of committed capital to advance Dynavaxs ISS-based cancer, hepatitis B and hepatitis C therapeutic
programs through clinical development; expectations that this agreement will build value in
Dynavaxs pipeline, accelerate the advancement of promising, early-stage development programs, will
be minimally dilutive, reduce risk and provide a return on investment to shareholders; statements
related to plans to advance its clinical programs in ragweed allergy, hepatitis B, hepatitis C and
cancer and the commercial opportunities for those programs. Words such as believes,
anticipates, plans, expects, intend, will, slated, goal and similar expressions are
intended to identify forward-looking statements. The inclusion of forward-looking statements should
not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual
results may differ materially from those set forth in this release due to the risks and
uncertainties inherent in Dynavaxs business including, without limitation, risks
relating to: plans to advance its cancer, hepatitis B and hepatitis C programs into clinical
development and the therapeutic and commercial potential of these programs; and other risks
detailed in the Risk Factors section of Dynavaxs
Annual Report on Form 10-K filed on March 16,
2006. You are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. All forward-looking statements are qualified in their entirety by
this cautionary statement and Dynavax undertakes no obligation to revise or update this news
release to reflect events or circumstances after the date hereof.