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): July 28, 2017
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
Commission
File
Number: 001-34207
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Delaware
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33-0728374
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(State or other jurisdiction
of incorporation)
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(IRS Employer
Identification No.)
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2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code) (510)
848-5100
(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:
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the Registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an emerging
growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
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Item 5.03.
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Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
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On
July 31, 2017, the stockholders of the Company approved an amendment to the Company’s Sixth Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock, par value $0.001
from 69,500,000 shares to 139,000,000 shares. The increase in authorized shares was effected pursuant to a Certificate of Amendment to the Sixth Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”), filed with
the Secretary of State of the State of Delaware on July 31, 2017. A copy of the Certificate of Amendment is attached as Exhibit 3.1 to this Current Report on Form
8-K
and is incorporated into this Item
5.03 by reference.
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Item 5.07.
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Submission of Matters to a Vote of Security Holders
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On July 31, 2017, the Company
held its Special Meeting of Stockholders (the “Special Meeting”), at the Company’s executive office in Berkeley, California. A total of 54,747,656 shares of the Company’s common stock were entitled to vote as of June 30,
2017, the record date for the Special Meeting. There were 43,316,072 shares present in person or by proxy at the Special Meeting, at which the stockholders were asked to vote on two (2) proposals. Set forth below are the matters acted upon by
the stockholders, and the final voting results of each such proposal. The proposals are described in detail in the Company’s Proxy Statement for a Special Meeting of Stockholders.
Proposal 1. Amend the Company’s Sixth Amended and Restated Certificate of Incorporation.
The stockholders approved to amend the Company’s Sixth Amended and Restated Certificate of Incorporation, as amended, to increase the
authorized number of shares of common stock from 69,500,000 to 139,000,000. The votes were as follows:
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For
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Against
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Abstain
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35,935,589
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6,888,876
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491,607
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Proposal 2. Authorize an adjournment of the meeting, if necessary, to solicit additional proxies if there are
not sufficient votes in favor of Proposal 1.
The stockholders approved to authorize an adjournment, if necessary, to solicit additional
proxies if there are not sufficient votes I favor of Proposal 1. The votes were as follows:
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For
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Against
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Abstain
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35,058,281
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7,918,240
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339,551
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On July 28, 2017, Dynavax Technologies Corporation issued a press
release titled “Dynavax Announces FDA Advisory Committee Vote in Favor of
HEPLISAV-B™.”
A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
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Item 9.01.
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Financial Statements and Exhibits
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(d) Exhibits. The following exhibits are filed
herewith:
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3.1
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Certificate of Amendment to the Sixth Amended and Restated Certificate of Incorporation.
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99.1
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Press Release, dated July 28, 2017, titled “Dynavax Announces FDA Advisory Committee Vote in Favor of
HEPLISAV-B™”
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, 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: July 31, 2017
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By:
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/s/ STEVEN N. GERSTEN
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Steven N. Gersten
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Vice President
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EXHIBIT INDEX
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Exhibit
No.
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Description
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EX-3.1
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Certificate of Amendment to the Sixth Amended and Restated Certificate of Incorporation.
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EX-99.1
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Press Release, dated July 28, 2017, titled “Dynavax Announces FDA Advisory Committee Vote in Favor of
HEPLISAV-B™”
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Exhibit 3.1
CERTIFICATE OF AMENDMENT OF THE
SIXTH AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF
DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
, a corporation organized and existing under and by virtue of the General Corporation Law of the State
of Delaware (the “
Corporation
”), hereby certifies that:
FIRST
: The name of the Corporation
is
DYNAVAX TECHNOLOGIES CORPORATION
SECOND
: The Corporation was originally incorporated under the same name and the
original Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on November 6, 2000.
THIRD
: The Board of Directors of the Corporation, acting in accordance with the provisions of Sections 141 and 242 of the General
Corporation Law of the State of Delaware, adopted resolutions to amend its Sixth Amended and Restated Certificate of Incorporation as follows:
1. Article IV shall be amended and restated to read in its entirety as follows:
“The Corporation is authorized to issue two classes of stock to be designated, respectively, Common Stock and Preferred Stock. The
Corporation shall be authorized to issue 139,000,000 shares of Common Stock at $0.001 par value, and 5,000,000 shares of Preferred Stock at $0.001 par value. The Preferred Stock may be issued from time to time in one or more series pursuant to a
resolution or resolutions providing for such issue duly adopted by the Board of Directors (authority to do so being hereby expressly vested in the Board). The rights, preferences, privileges and restrictions granted to or imposed upon the Preferred
Stock or any series of Preferred Stock will be determined or altered by the Board of Directors. The Board of Directors shall have the authority to fix or alter the number of shares of any series of Preferred Stock and the designation of any such
series of Preferred Stock. The Board of Directors, within the limits and restrictions stated in any resolution or resolutions of the Board of Directors originally fixing the number of shares constituting any series, may increase or decrease (but not
below the number of shares in any such series then outstanding), the number of shares of any series subsequent to the issue of shares of that series.”
FOURTH:
Thereafter pursuant to a resolution of the Board of Directors, this Certificate of Amendment was submitted to the
stockholders of the Corporation for their approval, and was duly adopted at the Special Meeting of Stockholders held on July 31, 2017 in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware.
IN WITNESS WHEREOF
, the Corporation has caused this Certificate of Amendment to be signed by its Chief Executive Officer this 31st
day of July, 2017.
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DYNAVAX TECHNOLOGIES CORPORATION
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By:
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/s/ Eddie Gray
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Eddie Gray, Chief Executive Officer
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Exhibit 99.1
Dynavax Announces FDA Advisory Committee
Vote in Favor of
HEPLISAV-B
™
BERKELEY, Calif. – July
28, 2017
–
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S.
Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that the safety data for
HEPLISAV-B
[Hepatitis B Vaccine, Recombinant
(Adjuvanted)] support licensure for immunization against hepatitis B infection in adults 18 years of age and older. Three members of the panel abstained. Additionally, the Committee provided commentary on the design of Dynavax’s proposed
post-marketing pharmacovigilance plan for
HEPLISAV-B.
The FDA did not ask this VRBPAC panel to vote on the immunogenicity of
HEPLISAV-B.
A prior VRBPAC panel voted 13 to
1 that the data from Phase 3 clinical trials supports the immunogenicity of
HEPLISAV-B.
“We are encouraged
by the committee’s positive vote in favor of
HEPLISAV-B,
which we believe will become an important new tool in the fight against hepatitis B infection if approved by the FDA,” said Eddie Gray, chief
executive officer of Dynavax. “Clinical studies of
HEPLISAV-B
have shown that the vaccine provides increased rates of seroprotection. In addition, the
two-dose
regimen offers the potential to increase patient compliance, which physicians and advocates agree is essential to preventing more cases of hepatitis B and achieving the public health goal of eradication. We look forward to completing our ongoing
discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review.”
The incidence of hepatitis B in the U.S. is
increasing
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and there is no cure for the disease. Therefore, disease prevention through effective vaccination is critical to reducing its spread. Currently marketed hepatitis B vaccines are
administered in three doses over a
six-month
schedule. The
HEPLISAV-B
regimen is two doses over one month. Results of a published Vaccine Safety Datalink study showed
that only 54 percent of adults completed the currently available three-dose hepatitis B vaccine series in one year.
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Those who do not complete the series may not be adequately protected
against hepatitis B.
The FDA is not bound by the committee’s recommendation but takes its advice into consideration when reviewing marketing
applications.
HEPLISAV-B
has a Prescription Drug User Fee Act (PDUFA) date of August 10, 2017. If the FDA approves
HEPLISAV-B,
Dynavax will seek a recommendation
from the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) during its October 2017 meeting. Dynavax plans to launch the vaccine commercially in the U.S. in early 2018 on its own or through a
commercial partner.
About Hepatitis B
Hepatitis B
is a viral disease of the liver that can become chronic and can lead to cirrhosis of the liver, hepatocellular carcinoma and death. In the U.S., the number of reported cases of acute hepatitis B increased more than 20 percent in 2015.
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After adjusting for under-reporting, the CDC estimated that 21,900 new hepatitis B virus infections occurred in 2015. In addition to new cases of hepatitis B, chronic HBV infection remains a major
public health challenge. The CDC estimates that approximately 850,000 persons are living with hepatitis B virus in the U.S.
About
HEPLISAV-B
HEPLISAV-B
is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary
Toll-like Receptor 9 agonist to enhance the immune response. In Phase 3 trials,
HEPLISAV-B
showed higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. The most
frequently reported local reaction was injection site pain. The most common systemic reactions were fatigue, headache and malaise, all of which were similar to an existing vaccine. Dynavax has worldwide commercial rights to
HEPLISAV-B.
About Dynavax
Dynavax is a clinical-stage immunology company focused on leveraging the power of the body’s innate and adaptive immune responses through toll-like
receptor (TLR) stimulation. Dynavax is developing product candidates for use in multiple cancer indications, as a vaccine for the prevention of hepatitis B and as a disease modifying therapy for asthma. Dynavax’s lead product candidates are
SD-101,
an investigational cancer immunotherapeutic currently in Phase 1/2 studies, and
HEPLISAV-B,
a Phase 3 investigational adult hepatitis B vaccine. For more information,
visit www.dynavax.com.
Forward-Looking Statements
This press release contains “forward-looking” statements, including statements regarding
HEPLISAV-B
and FDA
review. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the FDA will find the response to the Complete Response Letter (CRL) to be satisfactory to support
approval; whether the FDA will require additional information or studies; whether the FDA will identify additional issues following review of Dynavax’s response to the CRL; whether the FDA will decide not to approve
HEPLISAV-B
despite a positive recommendation of the Vaccines and Related Biological Products Advisory Committee; whether the FDA will delay approval of
HEPLISAV-B;
whether
additional manufacturing process enhancements will be required or other issues will arise that will negatively impact the review and approval by the FDA; whether the issues will negatively impact the potential scope of the label for
HEPLISAV-B;
the nature and scope of any post-marketing study that the FDA will require; whether the Centers for Disease Control and Prevention’s Advisory Committee on Immunization will provide a recommendation
for
HEPLISAV-B
if approved by the FDA; and other risks detailed in the “Risk Factors” section of our most recent current periodic report filed with the SEC. We do not undertake any obligation to
update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
Contact:
Ryan Spencer
VP, Corporate Strategy & Communications
510.665.4618
rspencer@dynavax.com
Media Contact:
Leslie Bryant, WCG
562.505.9290
lbryant@w2ogroup.com
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i
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https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm#Ref10. Accessed July 5, 2017.
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ii
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Nelson JC, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents and adults: Results from a Vaccine Safety Datalink study. Am J Public Health. 2009;99(S2); S389-S397.
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iii
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https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm#Ref10. Accessed July 5, 2017.
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