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Bionovo Announces Third Quarter 2011 Highlights and Financial Results
Date:11/10/2011

tency compared to the highest dose tested in our Phase 2 study. This level of efficacy at 4 weeks is equivalent to or superior to estrogen-based hormone therapy.
  • The Company successfully completed non-clinical toxicology studies of Menerba in two animal species.  As expected, no serious adverse events or toxicities were observed to date from these studies, at doses much higher than are being tested in the Phase 3 clinical trial. The drug was well tolerated by the animals.
  • The Company has completed the manufacture of the requisite ten batches for the Phase 3 clinical trial of Menerba, and demonstrated to the FDA excellent consistency and quality.

  • Third Quarter ResultsTotal operating expenses for the three months ending September 30, 2011 were $6.4 million compared to $4.7 million for the same period in 2010. Total operating expenses for the third quarter included manufacturing costs at the Company's cGMP manufacturing facility in Hayward, California for ten clinical batches of Menerba, clinical trial costs for the tolerability trial assessing the safety and tolerability of higher doses of Menerba and other costs in preparation for the Company's Phase 3 trial of Menerba.

    The Company reported a net loss for the three months ended September 30, 2011 of $3.9 million, or $0.07 per share, compared with a net loss of $4.6 million, or $0.21 per share, for the same period in 2010.  The difference in net loss is primarily due to the increase in operating expenses as described above offset by the change in fair value of the Company's warrant liability representing a gain of $2.3 million included in non-operating income for the three months ended September 30, 2011.

    The Company ended the quarter with $8.1 million in cash, cash equivalents and short term investments, and began the quarter with $13.0 million, a difference of $4.9 million. The cash balance at the end of the quarter reflects the proceeds of the Company'
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    SOURCE Bionovo, Inc.
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