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In a release on October 22, the Company reported $46.4 million in cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI), collectively referred to as total cash, at September 30. This compared to $53.0 million at June 30.
"During the third quarter, we began the first of two planned Phase 3 registration trials for our lead product HEPLISAV and our goal is to complete these trials within 24 months," said Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "With our commercialization strategy focused on directly serving high-value markets in the U.S. and a partnering strategy to expand into broader market segments and internationally, HEPLISAV can become a company-building product for Dynavax."
Total revenues for the third quarter 2009 were $2.9 million, compared to $8.9 million reported for the third quarter in 2008. The decline in total revenues for the third quarter was primarily due to a decrease in collaboration revenue following the termination of the Merck & Co., Inc. collaboration for Heplisav. Total revenues were $38.1 million for the nine months ended September 30, compared to $25.1 million for the same period in 2008. The increase in revenues for the nine months ended September 30, was primarily attributable to the recognition of $28.5 million of non-cash deferred revenue that was accelerated upon the termination of the Merck collaboration.
On a pro forma basis, including collaboration funding from SDI and excluding the non-cash deferred revenue from the Merck collaboration, revenues were $3.9 million and $12.2 million, respectively, for the third quarter and nine months ended September 30, compared to $9.9 million and $27.9 million for the same period in 2008.
Total operating expenses were $13.6 million for the third quarter 2009, compared to $14.6 million for the third quarter 2008. Total operating expenses were $41.6 million for the nine months ended September 30, compared to $51.2 million for the same period in 2008. The decrease in operating expenses for 2009 was primarily due to a reduction in clinical development costs associated with HEPLISAV and the discontinuation of development for the TOLAMBA ragweed allergy program in May 2008.
On a pro forma basis, excluding the non-cash charges for stock-based compensation and amortization of intangible assets, operating expenses were $12.5 million and $38.8 million, respectively, for the third quarter and nine months ended September 30, compared to $13.3 million and $47.9 million for the same periods in 2008.
The net loss of $9.5 million, or $0.24 per share, reported for the third quarter 2009 increased from the net loss of $5.4 million, or $0.14 per share, for the same period in 2008. The increase in net loss for third quarter is due to a decrease in collaboration revenue partially offset by a decrease in total operating expenses. The net loss of $0.3 million, or $0.01 per share, reported for the nine months ended September 30, significantly improved compared to the net loss of $23.9 million, or $0.60 per share, for the same period in 2008. The improvement in net loss for the nine months ended September 30, is due to the recognition of non-cash deferred revenue and a decrease in total operating expenses.
Dynavax Technologies Corp., a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases.
((Comments on this story may be sent to health@closeupmedia.com))
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