UPDATE 1-Dynavax gets going-concern warning

Tue Mar 16, 2010 9:01am EDT

* Auditors express doubts on co's financial position

* Co sees filing for Heplisav approval in Q3 2011

* Shares rise 10 pct in premarket trade

March 16 (Reuters) - Dynavax Technologies Corp (DVAX.O) said its auditors have expressed doubts on the company's ability to continue as a going concern as a result of the company's current financial position.

The company also said it expects to submit a regulatory application for the approval of its experimental hepatitis B vaccine in the third quarter of 2011.

Dynavax said it has completed enrollment for a late-stage study of the vaccine, Heplisav, and expects immunization of all 2,000 subjects with the vaccine will be completed in the "near future."

Hepatitis B is a chronic disease which can lead to cirrhosis of the liver. There is no cure for the condition.

Heplisav was placed on a clinical hold by the U.S. regulators in March 2008 due to safety concerns, but the hold was raised in September last year. [ID:nN09475398]

The company, which on Monday said it would get $4 million from Merck & Co Inc (MRK.N) to cover expenses for the wind-down period following the termination of a deal, reported $36.7 million in unrestricted cash and cash equivalents as of Dec. 31, 2009. [ID:nSGE62E0OW]

The year-end cash figure does not include the Merck payment as it was announced this week, the company said.

Shares of the company were up 10 percent to $1.75 in premarket trade. They closed at $1.59 Monday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Unnikrishnan Nair)