Dynavax Technologies Corporation (NASDAQ:DVAX) reported financial results for the first quarter endedMarch 31, 2016.
The Company had $166.8 million in cash, cash equivalents and marketable securities as of March 31, 2016, compared to $196.1 million at December 31, 2015. The net loss for the first quarter of 2016 was $27.0 million, compared to $26.2 million for the first quarter of 2015.
First Quarter Financials
Total revenues for the three months ended March 31, 2016 increased by $0.3 million, or 50%, compared to the same period in 2015.
Research and development expenses for the first quarter decreased by $2.2 million, or 10%, compared to the same period in 2015, reflecting an increase in employee headcount and activities in preparation for the anticipated commercial launch of HEPLISAV-B™ and a reduction in outside services expense due to lower activity related to HBV-23 following its completion in the fourth quarter of 2015.
General and administrative expenses for the three months ended March 31, 2016, increased by $3.3 million, or 68%, compared to the same period in 2015, as we added headcount and addressed information technology systems and other infrastructure needs in preparation for the anticipated commercial launch of HEPLISAV-B.
The net loss for the quarter ended March 31, 2016 was $27.0 million, or $0.70 per basic and diluted share compared to $26.2 million, or $0.97 per basic and diluted share for the quarter ended March 31, 2015.
At the end of the quarter, the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for HEPLISAV-B, the company’s vaccine for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established December 15th as the Prescription Drug User Fee Act (PDUFA) action date for the BLA.
“We are focused on working with the FDA to obtain approval of HEPLISAV-B before year end and on preparing for launch, including preparation for an advisory panel in case one is called, hiring of key commercial personnel, market and pricing research and manufacturing of launch inventory,” said Dynavax Chief Executive Officer, Eddie Gray.
In April, we reported additional details from the HBV-23 pivotal Phase 3 HEPLISAV-B trial at the National Foundation for Infectious Diseases’ (NFID) 19th Annual Conference on Vaccine Research (ACVR).
Also in April, we presented encouraging additional data from Part 1 of the Phase 1/2 study evaluating our lead immunotherapy product candidate, SD-101, in lymphoma patients. The clinical data, along with preclinical SD-101 data, were presented at the American Association for Cancer Research (AACR) Annual Meeting. (Original Source)
Shares of Dynavax are currently trading at $14.32, up $0.23 or 1.64%. DVAX has a 1-year high of $32.49 and a 1-year low of $13.58. The stock’s 50-day moving average is $19.46 and its 200-day moving average is $21.97.
On the ratings front, Dynavax has been the subject of a number of recent research reports. In a report issued on April 28, Cowen analyst Phil Nadeau reiterated a Buy rating on DVAX, with a price target of $60, which implies an upside of 325.8% from current levels. Separately, on April 27, J.P. Morgan’s Anupam Rama downgraded the stock to Hold and has a price target of $22.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Anupam Rama have a total average return of -2.6% and -7.0% respectively. Nadeau has a success rate of 35.7% and is ranked #3215 out of 3828 analysts, while Rama has a success rate of 18% and is ranked #3345.
Dynavax Technologies Corp. is a clinical-stage biopharmaceutical company that uses toll-like receptor TLR biology to discover and develop novel vaccines and therapeutics. The company’s development programs are organized under its three areas of focus: vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. Its lead product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. The company’s other products under pipeline are SD-101, DV1179 Autoimmune Disease and AZD1419 Asthma Therapy. Dynavax Technologies was founded by Lawrence M. Lichtenstein, Dennis A. Carson and Eyal Raz on August 29, 1996 and is headquartered in Berkeley, CA.