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): August 5, 2016
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.) |
2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(Address of principal executive offices, including zip code)
(510) 848-5100
(Registrant’s telephone number, including area code)
(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:
¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition
On August 5, 2016, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its financial results for the quarter ended June 30, 2016. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
The information with respect to item 2.02 in this current report and its accompanying Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information with respect to item 2.02 in this current report and in accompanying Exhibit 99.1 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01. Other Events
On August 5, 2016, Dynavax issued a press release titled “Dynavax Announces FDA Advisory Committee Meeting To Review HEPLISAV-B.” A copy of the press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits. Exhibit 99.1 is furnished and Exhibit 99.2 is filed herewith:
99.1 Press Release, dated August 5, 2016, titled "Dynavax Reports Second Quarter 2016 Financial Results"
99.2 Press Release, dated August 5, 2016, titled "Dynavax Announces FDA Advisory Committee Meeting To Review HEPLISAV-B"
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: August 8, 2016 |
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By: |
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/s/ DAVID JOHNSON |
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David Johnson |
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Vice President |
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Exhibit No. |
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Description |
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EX-99.1 |
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Press Release, dated August 5, 2016, titled “Dynavax Reports Second Quarter 2016 Financial Results” |
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EX-99.2 |
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Press Release, dated August 5, 2016, titled “Dynavax Announces FDA Advisory Committee Meeting To Review HEPLISAV-B” |
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Exhibit 99.1
DYNAVAX REPORTS SECOND QUARTER 2016
FINANCIAL RESULTS
BERKELEY, CA – August 5, 2016 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter and six months ended June 30, 2016.
The Company had $139.0 million in cash, cash equivalents and marketable securities as of June 30, 2016, compared to $196.1 million at December 31, 2015. The net loss for the second quarter of 2016 was $29.0 million, or $0.75 per basic and diluted share, compared to $23.6 million, or $0.80 per basic and diluted share, for the second quarter of 2015.
Recent Progress
During the quarter, the U.S. Food and Drug Administration (FDA) established December 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date for its review of the Biologics License Application (BLA) for HEPLISAV-B™, the company's investigational vaccine for immunization against hepatitis B infection in adults 18 years of age and older. In August, the FDA informed the Company that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to discuss HEPLISAV-B at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date.
Preparations for launch of HEPLISAV-B are continuing, including pre-commercial activities, manufacturing of launch inventory and continued infrastructure spending related to implementation of commercial development and information technology systems and capabilities and related increases in headcount.
In June, we reported additional details from the HBV-23 pivotal Phase 3 HEPLISAV-B trial at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA).
We presented encouraging additional data from Part 1 of the Phase 1/2 study evaluating our lead immunotherapy product candidate, SD-101, in lymphoma patients in April at the American Association for Cancer Research (AACR) Annual Meeting. Recently our collaborator, Merck, initiated a Phase 1 study of SD-101 in combination with its immunomodulator MK-1966 in cancer patients.
Financials
Total revenues for the second quarter of 2016 were $2.6 million compared to $1.6 million for the same period in 2015. Revenue primarily reflects research and development revenues from our collaboration with AstraZeneca.
Research and development expenses for the second quarter of 2016 were $22.8 million compared to $19.7 for the same period in 2015. This $3.1 million increase was primarily due to an increase in employee headcount and regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B, partially offset by a reduction in outside services expense associated with the completion of HBV-23 in the fourth quarter of 2015.
General and administrative expenses for the second quarter of 2016 were $9.2 million compared to $5.1 for the same period in 2015. This $4.1 million increase reflects expenses related to preparation for the commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development.
The net loss for the second quarter of 2016 was $29.0 million, or $0.75 per basic and diluted share, compared to $23.6 million, or $0.80 per basic and diluted share, for the same period in 2015.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, uses TLR biology to discover and develop novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information visit www.dynavax.com.
Forward Looking Statements
This release contains forward-looking statements, including statements regarding anticipated approval and launch of HEPLISAV-B. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether there will be the need for additional studies, further manufacturing enhancements or other activities, or other issues will arise that will negatively impact the review, duration of review and approval of the BLA by the FDA; whether we will successfully launch the product, possible claims against us, including enjoining sales of HEPLISAV-B based on the patent rights of others, and the potential size and value of approved indications addressable with HEPLISAV-B; initiation and completion of pre-clinical studies and clinical trials of our other product candidates, including SD-101, in a timely manner; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; our ability to execute on our commercial strategies; whether our financial resources will be adequate without the need to obtain additional financing and other risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available.
DYNAVAX TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2016 |
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2015 |
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2016 |
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2015 |
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Revenues: |
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Collaboration revenue |
$ |
1,683 |
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$ |
930 |
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$ |
2,578 |
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$ |
1,401 |
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Grant revenue |
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88 |
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101 |
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127 |
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249 |
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Service and license revenue |
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876 |
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519 |
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884 |
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527 |
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Total revenues |
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2,647 |
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1,550 |
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3,589 |
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2,177 |
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Operating expenses: |
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Research and development |
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22,750 |
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19,686 |
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42,817 |
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41,906 |
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General and administrative |
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9,151 |
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5,098 |
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17,320 |
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9,957 |
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Total operating expenses |
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31,901 |
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24,784 |
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60,137 |
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51,863 |
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Loss from operations |
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(29,254 |
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(23,234 |
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(56,548 |
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(49,686 |
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Interest income |
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220 |
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18 |
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445 |
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45 |
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Interest expense |
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- |
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(263 |
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- |
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(510 |
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Other income (expense), net |
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48 |
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(112 |
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94 |
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343 |
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Net loss |
$ |
(28,986 |
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$ |
(23,591 |
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$ |
(56,009 |
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$ |
(49,808 |
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Basic and diluted net loss per share |
$ |
(0.75 |
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$ |
(0.80 |
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$ |
(1.46 |
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$ |
(1.70 |
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Weighted average shares used to compute basic and diluted net loss per share |
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38,496 |
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29,335 |
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38,491 |
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29,230 |
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DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
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June 30, |
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December 31, |
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2016 |
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2015 |
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Assets |
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Cash, cash equivalents and marketable securities |
$ |
138,989 |
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$ |
196,125 |
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Property and equipment, net |
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17,448 |
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13,804 |
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Goodwill |
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2,080 |
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2,043 |
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Other assets |
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9,096 |
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4,661 |
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Total assets |
$ |
167,613 |
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$ |
216,633 |
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Liabilities and stockholders’ equity |
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Deferred revenues |
$ |
- |
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$ |
2,654 |
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Other liabilities |
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28,843 |
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26,900 |
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Total liabilities |
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28,843 |
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29,554 |
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Stockholders’ equity |
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138,770 |
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187,079 |
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Total liabilities and stockholders’ equity |
$ |
167,613 |
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$ |
216,633 |
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# # #
Exhibit 99.2
DYNΛVAX
INNOVATING IMMUNOLOGY
Dynavax Announces FDA Advisory Committee Meeting
To Review HEPLISAV-B
--Advisory Committee Meeting Scheduled for November 16, 2016--
BERKELEY, Calif. – August 5, 2016 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date. HEPLISAV-B, the company’s vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older, is currently under FDA review, with a December 15, 2016 Prescription Drug User Fee Act (PDUFA) action date.
“The upcoming VRBPAC meeting is the next step towards our goal of obtaining regulatory approval for HEPLISAV-B and we are prepared for it,” said Eddie Gray, chief executive officer of Dynavax. “The company looks forward to discussing HEPLISAV-B with the advisory committee and continuing to work closely with the FDA through the review process.”
The VRBPAC reviews and evaluates data regarding the safety, efficacy, and appropriate use of vaccines and related biological products that are intended for use in the prevention, treatment, or diagnosis of human diseases.
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 CDC estimates that approximately 20,000 hepatitis B infections continue to occur annually, with the vast majority occurring in adults. There is no cure for hepatitis B, and disease prevention through effective vaccination is critical to reducing the spread of the disease. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. Results of a published Vaccine Safety Datalink study showed that 54 percent of adults completed the currently available three-dose hepatitis B vaccine series in one year. Those who do not complete the series may not be adequately protected against hepatitis B.
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. HEPLISAV-B is administered in two doses over one month.
In Phase 3 trials, HEPLISAV-B demonstrated higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. It also demonstrated a similar safety profile to the existing vaccine.
The investigational vaccine's safety profile is based on clinical trials that generated safety data from more than 14,000 participants. 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, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. 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 there will be changes in the data or interpretation; whether the final study results will be deemed satisfactory by the FDA; whether additional studies or manufacturing process enhancements will be required or other issues will arise that will delay the BLA review or negatively impact the review and approval by the FDA; initiation, enrollment and completion of pre-clinical studies and clinical trials of our other product candidates, including SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; and other risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. 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:
Katie Hogan
WCG
415.658.9745
khogan@wcgworld.com
Contact:
Michael Ostrach
Chief Financial Officer, Dynavax
510.229.2907
mostrach@dynavax.com