Key Developments For Dynavax Technologies Corporation
Dynavax Technologies Corporation (DVAX.O) (Consolidated Issue listed on NASDAQ Capital Market)
Dynavax Technologies Corporation Acquire Symphony Dynamo, Inc
Dynavax Technologies Corporation announced that it has exercised its option to purchase all of the equity of Symphony Dynamo, Inc. As a result, Dynavax will acquire approximately $20 million in cash and regain all rights to its hepatitis C and cancer therapy programs. The transaction, described below, is subject to Dynavax stockholder approval, and is expected to close in the first quarter of 2010. Under this agreement, Dynavax will acquire the cash held by SDI, currently $20.446 million, and issue to Symphony 13 million shares of Dynavax Common Stock, which represents $1.57 per share. Issue five-year warrants to Symphony for two million shares of Dynavax Common Stock at an exercise price of $1.94 per share and cancel Symphony's currently outstanding warrants for two million shares. Upon closing, Symphony and its co-investors are expected to own approximately 24% of total Dynavax Common Stock outstanding. Dynavax will also expand its Board of Directors to include one Director designated by Symphony and one independent Director acceptable to both Symphony and Dynavax, as long as Symphony's ownership exceeds more than 10% of the total Dynavax Common Stock outstanding.
Dynavax Technologies Corporation's HEPLISAV Shows Increased Protection Rate For Chronic Kidney Disease Patients
Dynavax Technologies Corporation announced the first clinical data for HEPLISAVTM investigational hepatitis B vaccine in chronic kidney disease patients. Vaccinated with HEPLISAV, chronic kidney disease patients demonstrated rapid, increased protection against hepatitis B viral infection in fewer doses than patients receiving licensed vaccine. 96% of patients (n = 36) receiving 3 doses of HEPLISAV achieved seroprotection at month 7, compared to 88% of patients (n = 10) receiving 8 doses of Engerix-B. Dynavax recently began vaccinating chronic kidney disease patients with HEPLISAV in a Phase 3 registration trial. Two single-blind, randomized, multi-center studies were conducted in 87 chronic kidney disease patients. In both studies, HEPLISAV was safe and well tolerated. - In the first trial, 46 patients were randomized to receive 3 doses of HEPLISAV (HBsAg-ISS), administered at 0, 1, and 6 months, or 8 doses of Engerix-B licensed vaccine, administered at 0, 1, 2, and 6 months. - In the second trial, 41 patients were enrolled to receive 3 doses of HEPLISAV, administered at 0, 1 and 6 months. This trial was halted after patients received two doses of HEPLISAV. In the first trial, seroprotection rates were higher and achieved earlier for patients receiving HEPLISAV than for patients receiving Engerix-B. In the second trial, seroprotection rates were 10% post first immunization, 59% post second immunization, and 100% at month 6 without any additional immunizations.
Dynavax Technologies Corporation Announces Q3 2009 Financial Results
Dynavax Technologies Corporation announced that it has reported financial results for the third quarter and nine months ended September 30, 2009. 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, 2009. This compared to $53.0 million at June 30, 2009. 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, 2009, compared to $25.1 million for the same period in 2008. The increase in revenues for the nine months ended September 30, 2009 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.
Dynavax Technologies Corporation Initiates Phase 3 Registration Trial In Chronic Kidney Disease Patients For HEPLISAVTM Hepatitis B Vaccine
Dynavax Technologies Corporation announced the initiation of a Phase 3 registration trial for HEPLISAVTM hepatitis B vaccine in individuals with chronic kidney disease. A second registration trial, a Phase 3 lot-to-lot consistency trial, is expected to begin in early 2010. HEPLISAV is an investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines. Dynavax believes that these studies, taken together, could support registration filing of HEPLISAV with the Food and Drug Administration (FDA). Dynavax`s Phase 3 trial is enrolling approximately 600 patients with chronic kidney disease. After being randomized 1 to 1, patients will receive either 3 doses of HEPLISAV (at 0, 1, and 6 months) or 8 doses of the current licensed vaccine Engerix-B® (2 doses at 0, 1, 2, and 6 months). The primary endpoint is seroprotection rate at month 7.
Dynavax Technologies Corporation Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine
Dynavax Technologies Corporation announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines. As a result of the FDA`s decision, Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.
