Knobias Clip Report (08-06-2008) DVAX
Submitted By Knobias ClipReport
DVAX: Shares Climb on Successful Phase 3 Trial and Q2 Financial Results
By Fain Hughes, fhughes@knobias.com
Shares of Dynavax Technologies Corporation (DVAX) were higher on Wednesday after the Company announced top line immunogenicity results from a Phase 3 clinical trial comparing HEPLISAV(TM), an investigational hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine, GlaxoSmith Kline’s (GSK) Engerix-B(R). The study achieved its primary endpoint. HEPLISAV is being jointly developed by Dynavax and Merck (MRK) for use in adults and in patients with end stage renal disease.
The primary endpoint was the proportion of subjects who developed protective antibodies to hepatitis B after administration. In the study, 95.1 percent of subjects who received two doses of HEPLISAV developed protective antibodies to hepatitis B when measured at 12 weeks versus 81.1 percent of subjects who received three doses of Engerix-B(R) when measured at 28 weeks.
The FDA previously placed a clinical hold on the two Investigational New Drug (IND) Applications for HEPLISAV that is still in effect. In issuing the clinical hold, the FDA requested a review of clinical and preclinical safety data for HEPLISAV. Additionally, the FDA requested all available information about a single case of Wegener’s granulomatosis reported in this Phase 3 trial.
Dino Dina, M.D., President and CEO of Dynavax, commented in a conference call, “The completion of the Phase 3 trial is an important final step in preparing a complete response to the FDA with a goal of having the clinical hold lifted.”
The Company also financial results for the second quarter ended June 30, 2008. Total revenues were $10.0 million, compared to $1.8 million reported for the second quarter in 2007. The increase in revenues for the second quarter reflects research and development funding under a collaboration with Merck & Co. Inc.for HEPLISAV(TM).
The net loss of $6.1 million, or $0.15 per share, reported for the second quarter 2008 improved from the net loss of $17.7 million, or $0.45 per share, for the same period in 2007. The consensus of analysts had been a loss of $0.19.
Dr. Dina added, “Our revenues and ability to support programs has steadily increased over the last 24 months. Partnerships with Merck, AstraZeneca, Novartis and symphony and a concerted effort to reduce our burn rate have allowed us to envision an operating plan to maintain more than two years of cash. We believe it is critical to continue to operate in a fiscally responsible manner that provides sufficient run rate for this year and next.”
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