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 20, 2011
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
Commission File Number: 001-34207
| Delaware | 33-0728374 | |
| (State or other jurisdiction of incorporation) |
(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 July 20, 2011, Dynavax Technologies Corporation (“Dynavax”) issued a press release announcing its financial results for the second quarter ended June 30, 2011. 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 shall not be deemed to be “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 contained in Item 2.02 of this current report and in the accompanying exhibit 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 July 20, 2011, Dynavax issued a press release titled “Dynavax Phase 3 Demonstrates Superiority and Safety of HEPLISAV™ vs. Engerix-B®.” A copy of the press release is attached as Exhibit 99.2 to this current report and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibit
| Exhibit No. |
Description | |
| 99.1 |
Press Release, dated July 20, 2011, titled “Dynavax Reports Second Quarter 2011 Financial Results.” | |
| 99.2 |
Press Release, dated July 20, 2011, titled “Dynavax Phase 3 Demonstrates Superiority and Safety of HEPLISAV™ vs. Engerix-B®.” | |
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.
| DYNAVAX TECHNOLOGIES CORPORATION | ||||||
| Date: July 20, 2011 | By: | /s/ Michael S. Ostrach | ||||
| Michael S. Ostrach Vice President | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 |
Press Release, dated July 20, 2011, titled “Dynavax Reports Second Quarter 2011 Financial Results.” | |
| 99.2 |
Press Release, dated July 20, 2011, titled “Dynavax Phase 3 Demonstrates Superiority and Safety of HEPLISAV™ vs. Engerix-B®.” | |
Exhibit 99.1
| ||
| 2929 Seventh Street, Suite 100 | ||
| Berkeley, CA 94710 | ||
| Contacts: | ||
| Jennifer Lew | Michael Ostrach | |
| Vice President, Finance | Vice President and Chief Business Officer | |
| 510-665-7217 | 510-665-7257 | |
| jlew@dynavax.com | mostrach@dynavax.com | |
DYNAVAX REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
BERKELEY, CA – July 20, 2011 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June 30, 2011. Cash, cash equivalents and marketable securities were $61.7 million at June 30, 2011, compared to $53.2 million at March 31, 2011 and $72.2 million at December 31, 2010. During the second quarter, the Company raised approximately $18.7 million through its At-the-Market common stock purchase agreement with Aspire Capital and received a $6 million milestone payment from GlaxoSmithKline from the initiation of a Phase 1 trial in the partnered lupus program.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAVTM, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
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DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Revenues: |
||||||||||||||||
| Collaboration revenue |
$ | 6,363 | $ | 1,341 | $ | 6,729 | $ | 8,762 | ||||||||
| Grant revenue |
890 | 617 | 1,779 | 1,479 | ||||||||||||
| Service and license revenue |
16 | 233 | 505 | 294 | ||||||||||||
| Total revenues |
7,269 | 2,191 | 9,013 | 10,535 | ||||||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
13,257 | 14,045 | 27,929 | 26,525 | ||||||||||||
| General and administrative |
4,054 | 4,173 | 8,808 | 8,743 | ||||||||||||
| Amortization of intangible assets |
54 | 245 | 299 | 490 | ||||||||||||
| Total operating expenses |
17,365 | 18,463 | 37,036 | 35,758 | ||||||||||||
| Loss from operations |
(10,096 | ) | (16,272 | ) | (28,023 | ) | (25,223 | ) | ||||||||
| Interest income |
23 | 39 | 56 | 41 | ||||||||||||
| Interest expense |
(487 | ) | (431 | ) | (977 | ) | (830 | ) | ||||||||
| Other expense |
(75 | ) | (11,340 | ) | (157 | ) | (11,176 | ) | ||||||||
| Net loss |
$ | (10,635 | ) | $ | (28,004 | ) | $ | (29,101 | ) | $ | (37,188 | ) | ||||
| Basic and diluted net loss per share |
$ | (0.09 | ) | $ | (0.34 | ) | $ | (0.25 | ) | $ | (0.54 | ) | ||||
| Shares used to compute basic and diluted net loss per share |
117,864 | 82,012 | 116,801 | 68,264 | ||||||||||||
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DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING
EXPENSES
(In thousands)
(Unaudited)
| Three Months
Ended June 30, |
Six Months
Ended June 30, |
|||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| GAAP operating expenses |
$ | 17,365 | $ | 18,463 | $ | 37,036 | $ | 35,758 | ||||||||
| LESS: Stock-based compensation expense |
1,167 | 425 | 2,647 | 966 | ||||||||||||
| Amortization of intangible assets |
54 | 245 | 299 | 490 | ||||||||||||
| Pro forma operating expenses(1) |
$ | 16,144 | $ | 17,793 | $ | 34,090 | $ | 34,302 | ||||||||
| (1) | These pro forma amounts are intended to illustrate the Company’s operating expenses excluding certain non-cash charges in accordance with the financial statements that management uses to evaluate the Company’s operations. These pro forma results are not in accordance with, or an alternative for, generally accepted accounting principles and may be different from pro forma measures used by other companies. |
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DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
| June 30, 2011 |
December 31, 2010 |
|||||||
| Assets |
||||||||
| Cash and cash equivalents and marketable securities |
$ | 61,724 | $ | 72,154 | ||||
| Property and equipment, net |
6,570 | 6,404 | ||||||
| Goodwill |
2,312 | 2,312 | ||||||
| Other intangible assets, net |
— | 299 | ||||||
| Other assets |
3,824 | 3,080 | ||||||
| Total assets |
$ | 74,430 | $ | 84,249 | ||||
| Liabilities and stockholders’ equity |
||||||||
| Accounts payable |
$ | 1,742 | $ | 2,329 | ||||
| Accrued liabilities |
7,755 | 10,943 | ||||||
| Current portion of deferred revenue |
1,429 | 1,429 | ||||||
| Noncurrent portion of deferred revenue |
4,940 | 5,655 | ||||||
| Long-term note payable to Holdings |
11,874 | 10,939 | ||||||
| Long-term contingent liability to Holdings |
860 | 843 | ||||||
| Total stockholders’ equity |
45,830 | 52,111 | ||||||
| Total liabilities and stockholders’ equity |
$ | 74,430 | $ | 84,249 | ||||
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Exhibit 99.2
|
| ||
| 2929 Seventh Street, Suite 100 | ||
| Berkeley, CA 94710 |
| Contact: |
| Michael Ostrach |
| Vice President and Chief Business Officer |
| 510-665-7257 mostrach@dynavax.com |
DYNAVAX PHASE 3 DEMONSTRATES SUPERIORITY AND SAFETY OF HEPLISAV™ vs.
ENGERIX-B®
Berkeley, CA – July 20, 2011 – Dynavax Technologies Corporation (NASDAQ: DVAX) today said that top-line data from its Phase 3 trial comparing HEPLISAV, an investigational hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine, Engerix-B, demonstrated non-inferiority, superiority and the safety of HEPLISAV. The study evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month compared to a three-dose regimen of Engerix-B administered at 0, 1 and 6 months. The trial studied 2,449 healthy adults 40 to 70 years of age, randomized to HEPLISAV or Engerix-B in a 4:1 ratio. Data supporting the consistency of three consecutively manufactured lots of HEPLISAV have been submitted to the Food and Drug Administration (FDA), and Dynavax expects confirmation of its analysis shortly.
Immunogenicity data demonstrated:
| • | At the primary endpoint, 8 weeks post the last dose of vaccine, 12 weeks for HEPLISAV and 32 weeks for Engerix-B, the seroprotection rate (SPR) was 90% for HEPLISAV and 70% for Engerix-B, demonstrating the non-inferiority and superiority of HEPLISAV to Engerix-B. |
| • | The peak SPR for HEPLISAV occurred at 24 weeks and was 95%. The peak SPR for Engerix-B occurred at 28 weeks and was 73%. |
| • | At the final visit, week 52, 48 weeks after the last dose of HEPLISAV and 28 weeks after the last dose of Engerix-B, the SPRs were 92% for HEPLISAV and 59% for Engerix-B. |
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Engerix-B® is a registered trademark of GlaxoSmithKline
Dynavax also reported that the trial’s safety data showed HEPLISAV to be safe and well tolerated, and similar to Engerix-B. Careful safety evaluation over the 12 month duration of trial demonstrated:
| • | 50% of HEPLISAV subjects and 53% of Engerix-B subjects experienced an adverse event. |
| • | 7% of HEPLISAV subjects and 6% of Engerix-B subjects experienced possibly related adverse events. |
| • | 4% of HEPLISAV subjects and 5% of Engerix-B subjects experienced a serious adverse event. |
| • | 3 new onset autoimmune adverse events were confirmed by the Safety Evaluation and Adjudication Committee (SEAC), none of which were serious adverse events. All three occurred in the HEPLISAV group, consistent with the 4:1 randomization. |
| • | There were no cases of ANCA-associated vasculitis or Wegener’s Granulomatosis. |
With respect to the consistency analysis of three consecutively manufactured lots of HEPLISAV, Dynavax concluded that the study had demonstrated consistency based on the complete immunogenicity data demonstrated by the three vaccine lots over the six months following second immunization.
| • | By Geometric Mean Antibody Concentration (GMC), the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks, the pre-specified primary endpoint. The GMC of one HEPLISAV lot was slightly higher than the other two lots, which resulted in not meeting the consistency criteria at week 8. |
| • | By SPR, the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks. |
| • | At all of these timepoints, each lot of HEPLISAV was superior to Engerix-B. |
Dynavax said it had submitted these data and its analysis supporting lot-to-lot consistency to the FDA and expects confirmation from the agency in the near future.
“These results confirm and expand the superiority of HEPLISAV vs. Engerix-B in this hyporesponsive population of persons age 40 and above. HEPLISAV again demonstrated the rapid onset of seroprotection and superior peak protection compared to Engerix-B. A new finding in this trial is the superior duration of HEPLISAV to Engerix-B. Based on the results of intensive safety monitoring over 12 months, we have again demonstrated that HEPLISAV has a similar safety profile to Engerix-B, generally considered to be a very safe vaccine. Finally, we believe the consistency of the peak immune response of three lots of HEPLISAV was clearly demonstrated in this trial,” commented Tyler Martin, M.D., President and Chief Medical Officer.
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Dynavax said it will present complete results from the Phase 3 trial in an oral presentation at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on Sunday, September 18, 2011 in Chicago, IL.
Webcast and Conference Call Today
Dynavax will host a conference call and webcast a discussion of the HEPLISAV Phase 3 top-line data along with the company’s second quarter 2011 financial results on Wednesday, July 20, 2011 at 9:00 a.m. Eastern Daylight Time / 6:00 a.m. Pacific Daylight Time. To join the Conference Call, please dial 1-877-280-7280. International callers can dial 1-707-287-9365. A telephonic replay of the discussion will be available 90 minutes after its conclusion and through August 3, 2011 by dialing 1-855-859-2056, access code: 85190076. International callers can dial 1-404-537-3406, access code: 85190076. The webcast can be accessed on Dynavax’s website at http://investors.dynavax.com/events.cfm. A webcast replay of the discussion will be available on Dynavax’s website, 90 minutes after its conclusion and through August 3, 2011.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company’s lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties, including statements regarding our expectation of confirmation in the near future by the FDA of our assessment of lot-to-lot consistency. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including the FDA’s assessment of the data from this study and any requests it may make to conduct additional studies, whether successful clinical and regulatory development and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company’s ability to obtain
– more –
additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the “Risk Factors” section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in the Company’s current periodic reports with the SEC.
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