BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced financial results for the third quarter ended September 30, 2011 and provided an update on the Company's pipeline.
As of September 30, 2011, BioSante's cash and cash equivalents were approximately $69.6 million, compared to $38.2 million at December 31, 2010. BioSante's net loss was $12.7 million or $(0.12) per share for the third quarter of 2011, compared to a net loss of $11.6 million or $(0.16) per share for the third quarter 2010. This increase in net loss was due primarily to increased LibiGel® (testosterone gel) clinical development expenses during the third quarter of 2011.
Pipeline Update
On October 4, 2011, BioSante announced the completion of its two pivotal LibiGel Phase III efficacy trials. Trial data are being collected from the 141 investigative sites in the U.S. and Canada that participated in the trials and the Company remains blinded to the results. BioSante expects to announce top-line LibiGel efficacy results from both trials in December 2011.
The LibiGel clinical development program also includes the ongoing LibiGel Phase III cardiovascular event and breast cancer safety study, which completed enrollment of 3,656 subjects in June 2011. On October 11, the Company announced that an independent Data Monitoring Committee completed its seventh unblinded safety review and recommended that the study continue as per the FDA-agreed protocol, without modifications. The primary analysis of safety data is targeted for the third quarter of 2012. The LibiGel New Drug Application (NDA) submission will include data from the two efficacy trials as well as the safety study, and is targeted for the fourth quarter of 2012.
In addition, BioSante's Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals, has been assigned a new PDUFA date of February 14, 2012. Teva is responsible for all regulatory and marketing activities for Bio-T-Gel.
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