BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced its financial results for the second quarter of 2010.
“With more than $46 million in cash, we are aggressively recruiting, screening and enrolling new subjects in all three LibiGel Phase III clinical studies”
The Company's cash and cash equivalents as of June 30, 2010 were approximately $46.4 million. BioSante incurred a net loss of approximately $10.8 million or ($0.17) per share for the quarter ended June 30, 2010, compared to a net loss of $4.6 million or ($0.17) per share for the same period in 2009. This increase in net loss was primarily a result of the expanded recruitment and conduct of the LibiGel® Phase III clinical development program. As a result of this focus on LibiGel development and the Company's planned acceleration of the LibiGel program, research and development expenses increased to $8.7 million and $18.1 million for the three and six month periods ended June 30, 2010 from $3.5 million and $6.6 million for the three and six month periods ended June 30, 2009.
"With more than $46 million in cash, we are aggressively recruiting, screening and enrolling new subjects in all three LibiGel Phase III clinical studies," stated Stephen M. Simes, president and chief executive officer of BioSante. "More than 2,000 women have been enrolled in the LibiGel cardiovascular and breast cancer safety study, and we expect to enroll our 2,500th subject early in the fourth quarter of this year. That important event will trigger the first statistical analysis by the independent DMC (data monitoring committee) to determine whether enrollment in the safety study is sufficient and complete, or if additional subjects must continue to be enrolled in order to demonstrate statistically the relative safety of LibiGel. The maximum number of subjects as per protocol is 4,000 women. We continue to target the submission of the LibiGel NDA (New Drug Application) by late 2011."