BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced financial results for the year ended December 31, 2011 and additional corporate highlights.
As of December 31, 2011, BioSante’s cash balance was approximately $57.2 million as compared to $38.2 million at December 31, 2010. BioSante’s net loss was $51.6 million or $0.52 per share for the year ended December 31, 2011, compared to a net loss of $46.2 million or $0.70 per share for 2010. The net losses for 2011 were primarily due to expenses associated with the clinical development of LibiGel ®.
BioSante’s corporate strategy always has included product development of high value medically-needed pharmaceutical products. In light of the top-line results from the two pivotal LibiGel Phase III efficacy trials, which indicated that LibiGel did not meet its co-primary or secondary endpoints, management continues to assess LibiGel’s path forward and potential alternative strategies to utilize the continuing LibiGel Phase III cardiovascular events and breast cancer safety study. It is BioSante’s objective to meet with the U.S. Food and Drug Administration (FDA) to determine the best path forward, and to make a decision during the second quarter of 2012 whether to continue the LibiGel Phase III safety study. Management also has expanded efforts to explore new product development projects through in-licensing and mergers and acquisitions. In addition, a full review of the GVAX cancer vaccine portfolio is underway.
The current projected cash burn rate for 2012 is approximately $2.5 million per month, assuming the LibiGel safety study continues per protocol. If the safety study is halted, the monthly cash burn rate will decline to approximately $1.5 million per month, pending other product development and activities.Additional Corporate Highlights BioSante’s GVAX cancer vaccines are in 17 Phase I and Phase II cancer clinical trials, most of which are being conducted in cooperation with The Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, and are sponsored or funded by others at no cost to BioSante. During 2011, BioSante announced two licensing agreements for the cancer vaccines. In April 2011, BioSante licensed its GVAX Pancreas Cancer Vaccine and GVAX Prostate Cancer Vaccine to Aduro BioTech, a clinical-stage immunotherapy company, solely for use in combination with Aduro's proprietary vaccine platform based on Listeria monocytogenes. Additionally, in July 2011, BioSante licensed the GVAX Melanoma Vaccine to The John P. Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities, and which has committed $10.9 million to GVAX Melanoma Vaccine Phase I and Phase II studies. Last month, BioSante announced that on February 14, 2012 the FDA approved its testosterone gel for male hypogonadism, which BioSante has licensed to Teva Pharmaceuticals USA, Inc. Teva is responsible for all regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of the product.