SECURITIES AND EXCHANGE COMMISSION
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, 2004
DYNAVAX TECHNOLOGIES CORPORATION
Commission File Number: 000-1029142
Delaware | 33-0728374 | |
(State or Other Jurisdiction of Incorporation) | (I.R.S. Employer Identification No.) |
717 Potter Street, Suite 100
Berkeley, CA 94710-2722
(Address of Principal Executive Offices including zip code)
(510) 848-5100
(Registrants Telephone Number, Including Area Code)
Item 7. Financial Statements and Exhibits. | ||||||||
Item 12. Results of Operations and Financial Condition. | ||||||||
SIGNATURES | ||||||||
EXHIBIT 99.1 |
Item 7. Financial Statements and Exhibits.
c. Exhibits
Exhibit No. |
Description |
|
99.1
|
Press release of Dynavax Technologies Corporation, dated August 5, 2004. |
Item 12. Results of Operations and Financial Condition.
On August 5, 2004, the Company issued a press release relating to the Companys earnings for the second quarter of fiscal year 2004. A copy of the press release is attached as Exhibit 99.1.
The information in this report (including Exhibit 99.1) is being furnished pursuant to Item 12 and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
2
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: August 5, 2004 | By: | /s/ Dino Dina | ||
Dino Dina, M.D. | ||||
President, Chief Executive Officer and Acting Chief Financial Officer | ||||
3
Exhibit 99.1
Contact:
Dynavax Technologies Corporation
Dino Dina, M.D.
President and Chief Executive Officer
Phone (510) 848-5100
DYNAVAX REPORTS 2004 SECOND QUARTER RESULTS
Berkeley, California, August 5, 2004 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases, today reported financial results for the quarter and six months ended June 30, 2004.
Dynavax reported a net loss of $2.9 million for the quarter ended June 30, 2004, or $0.12 per basic and diluted share, compared to a net loss of $4.0 million, or $2.23 per basic and diluted share for the same period in 2003. As of June 30, 2004, cash and cash equivalents totaled $74.0 million.
Revenue for the second quarter ended June 30, 2004 was $5.5 million, compared to $96,000 for the same period in 2003. The increase in revenue is due primarily to the Companys collaborative agreement with UCB Pharma in ragweed and grass allergies, which was initiated in 2004, and biodefense grants awarded by the National Institute of Allergy and Infectious Diseases.
Total operating expenses were $8.6 million for the second quarter ended June 30, 2004, compared to $4.2 million for the same period in 2003. The increase in operating expenses is primarily due to increased clinical trial activities in the Companys ragweed allergy, hepatitis B vaccine, and asthma programs, as well as preclinical work associated with government grants for biodefense programs. This increase also reflects higher compensation and benefits associated primarily with the expanding of our management team and higher expenditures for consulting and professional services.
For the six months ended June 30, 2004, total revenues were $8.7 million compared to $96,000 in the comparable period of 2003. The increase in revenues is due primarily to the collaborative agreement with UCB in ragweed and grass allergies, initiated in the first quarter of 2004, and biodefense grants awarded by the National Institute of Allergy and Infectious Diseases.
Operating expenses for the six months ended June 30, 2004 totaled $15.8 million as compared to $9.0 million in the comparable period of 2003. The increase in operating expenses is primarily due to increased clinical trial activities in the Companys ragweed allergy, hepatitis B vaccine, and asthma programs, as well as preclinical work associated with government grants for biodefense programs. This increase also reflects higher compensation and benefits associated primarily with the expanding of our management team and higher expenditures for consulting and professional services.
We made solid progress on all fronts, said Dino Dina, M.D., President and Chief Executive Officer of Dynavax Technologies. We met several important milestones in our clinical development programs, including full enrollment of our Phase II/III AIC trial for ragweed allergy, initiation of a Phase II/III trial of our hepatitis B prophylactic vaccine candidate, and the successful completion of immunizations in a Phase I pediatric trial of AIC for ragweed allergy. In addition, we have been effective in containing expenditures and maintaining a strong balance sheet.
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.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are 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, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to control expenses and maintain a strong financial position; and other risks detailed in the Risk Factors section of Dynavaxs Annual Report on Form 10-K filed on March 30, 2004, and in the section titled Additional Factors That May Affect Future Results within Dynavaxs quarterly report on Form 10-Q filed on May 12, 2004. 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 an obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Dynavax Technologies Corporation
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, |
June 30, |
|||||||||||||||
2004 |
2003 |
2004 |
2003 |
|||||||||||||
Revenues: |
||||||||||||||||
Collaboration revenue |
$ | 5,131 | $ | | $ | 7,875 | $ | | ||||||||
Grant revenue |
361 | 96 | 822 | 96 | ||||||||||||
Total revenues |
5,492 | 96 | 8,697 | 96 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
6,510 | 2,947 | 11,781 | 6,593 | ||||||||||||
General and administrative |
2,077 | 1,214 | 3,996 | 2,417 | ||||||||||||
Total operating expenses |
8,587 | 4,161 | 15,777 | 9,010 | ||||||||||||
Loss from operations |
(3,095 | ) | (4,065 | ) | (7,080 | ) | (8,914 | ) | ||||||||
Interest income, net |
186 | 110 | 305 | 241 | ||||||||||||
Net loss |
$ | (2,909 | ) | $ | (3,955 | ) | $ | (6,775 | ) | $ | (8,673 | ) | ||||
Basic and diluted net loss per share |
$ | (0.12 | ) | $ | (2.23 | ) | $ | (0.48 | ) | $ | (4.91 | ) | ||||
Shares used to compute basic and
diluted net loss per share |
24,594 | 1,776 | 14,215 | 1,766 | ||||||||||||
Dynavax Technologies Corporation
Condensed Balance Sheet Data
(in thousands)
(unaudited)
June 30, | December 31, | |||||||
2004 |
2003 |
|||||||
Cash, cash equivalent, restricted cash and marketable securities |
$ | 74,036 | $ | 29,097 | ||||
Total assets |
$ | 81,104 | $ | 31,585 | ||||
Total stockholders equity (net capital deficiency) |
$ | 67,368 | $ | (71,932 | ) |