397 0 Kommentare Dynavax Reports Fourth Quarter and Year End 2014 Financial Results

BERKELEY, CA--(Marketwired - Mar 5, 2015) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2014.

The Company had $122.7 million in cash, cash equivalents and marketable securities as of December 31, 2014. Loss from operations of $91.3 million for the year ended December 31, 2014 increased by $24.8 million compared to the year ended December 31, 2013 primarily as a result of expenses relating to conduct of clinical trials. A Phase 3 clinical trial of hepatitis B vaccine HEPLISAV-B™ (known as HBV-23) was initiated in the second quarter of 2014 and an independent Data and Safety Monitoring Board (DSMB) reviewed available data in early November 2014 and late February 2015 and recommended continuation of the trial without change. A Phase 1/2 study of SD-101 in combination with local radiation for the treatment of indolent lymphoma was initiated in the fourth quarter.

The net loss allocable to common stockholders for the twelve months ended December 31, 2014 was $90.7 million, or $3.45 per basic and diluted share. The net loss allocable to common stockholders for the twelve months ended December 31, 2013 was $75.2 million, or $3.83 per basic and diluted share, which includes a one-time non-cash deemed dividend of $8.5 million related to the beneficial conversion feature of the Series B Convertible Preferred Stock.

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. Dynavax has worldwide commercial rights to HEPLISAV-B.

About SD-101

SD-101 is a proprietary, second-generation, TLR 9 agonist CpG oligodeoxynucleotide (CPG ODN). In preclinical studies, TLR 9 agonists have shown activity as monotherapy or in combination with various interventions, including immunotherapeutic and tumor-specific antibodies. SD-101 has been evaluated in two Phase 1 studies to assess its preliminary safety and tolerability.

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.


DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)

		Three Months Ended December 31,						Years Ended December 31,
		2014			2013			2014			2013
Revenues:
	Collaboration revenue	$	1,734		$	1,580		$	7,933		$	4,929
	Grant revenue		142			1,283			2,688			5,138
	Service and license revenue		401			(16	)		411			1,184
Total revenues			2,277			2,847			11,032			11,251

Operating expenses:
	Research and development		19,638			12,131			84,580			50,870
	General and administrative		5,052			3,700			17,377			25,943
	Unoccupied facility expense		--			8			386			926
Total operating expenses			24,690			15,839			102,343			77,739

Loss from operations			(22,413	)		(12,992	)		(91,311	)		(66,488	)

Interest income			29			(47	)		191			116
Interest expense			(35	)		83			(35	)		--
Other income (expense), net			133			(100	)		433			(348	)

Net loss			(22,286	)		(13,056	)		(90,722	)		(66,720	)

Preferred stock deemed dividend			--			(8,469	)		--			(8,469	)

Net loss allocable to common stockholders		$	(22,286	)	$	(21,525	)	$	(90,722	)	$	(75,189	)

Basic and diluted net loss per share allocable to common stockholders		$	(0.85	)	$	(0.91	)	$	(3.45	)	$	(3.83	)

Shares used to compute basic and diluted net loss per share allocable to common stockholders			26,298			23,588			26,289			19,628


DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)

		December 31,		December 31,
		2014		2013
Assets
	Cash, cash equivalents and marketable securities	$	122,652	$	189,376
	Property and equipment, net		7,924		8,706
	Goodwill		2,277		2,579
	Other assets		5,437		3,961
Total assets		$	138,290	$	204,622

Liabilities and stockholders'equity
	Deferred revenues	$	12,765	$	7,298
	Other liabilities		15,484		11,030
	Long-term debt		9,559		--
	Total liabilities		37,808		18,328
	Stockholders' equity		100,482		186,294
Total liabilities and stockholders' equity		$	138,290	$	204,622