(Source: PRNewswire-FirstCall)

EMERYVILLE, Calif., Aug. 10 /PRNewswire-FirstCall/ -- Bionovo, Inc. today announced second quarter highlights and financial results for the three months ended June 30, 2009.
Company Highlights -- Further results from the phase 1B clinical trial of Bezielle (BZL101) in 27 patients with metastatic breast cancer showed Bezielle to be safe and well-tolerated with encouraging evidence of clinical activity in a heavily pretreated patient population - most importantly including: -- 31% had stable disease for more than 90 days; -- 13% had stable disease for more than 180 days; -- three patients had objective tumor regression; -- one patient had objective tumor regression while on Bezielle therapy for 449 days and continues to be stable off of study medication for over 600 days; -- a second patient continues to be stable for 832 days and has not started any new anticancer treatment; -- a third patient was stable without any new anticancer therapy for 591 days; -- there were no deaths or serious adverse events that were attributed to Bezielle (BZL101); and -- the most common side effects associated with Bezielle (BZL101) were minor and gastrointestinal in nature. These results provide further evidence that Bezielle (BZL101) may provide an important option for women suffering from advanced breast cancer, an extremely difficult to treat subset of the breast cancer population. -- On the SERM platform, a peer-reviewed study published in the journal "Public Library of Science One" found that when comparing the gene expression induced by ERb compounds to that induced by estradiol, some differences existed in both the classes of genes regulated and the magnitude of regulation. These results demonstrate that ERb-selective agonists do not entirely mimic the actions of estradiol after binding to ERb, suggesting that the two classes of drugs will have different biological effects and different side effect profiles. Additionally, this study found that different types of ERb-selective drugs regulated different genes to varying extents and that therefore different ERb-selective drugs should exert distinct clinical effects. Of the different compounds investigated, Menerba (MF101) was one of the most ERb-selective, and patterns of gene expression were most disparate between Menerba and estradiol. Menerba also demonstrated unique cell type-specific gene regulation. -- The Company continues to work towards satisfying the FDA's requests for clarification of the manufacturing and analytical strategy to be used in ensuring the consistency of its drug products. -- The Company is aggressively pursuing a variety of funding options which include government grants, partnering, and debt and equity offerings. -- The Company has selected two more potential contract manufacturing organizations (CMO) to handle clinical, and possibly, commercial needs, and expects to qualify the primary CMO for clinical production by the end of September. Second Quarter Results
Total operating expenses for the three months ending June 30, 2009 were $4.1 million compared to $4.4 million for the same period in 2008 and $4.6 million for the first quarter of 2009. Total operating expenses for the second quarter included purchases of lab supplies and raw materials to support the manufacturing process development efforts of its lead drug candidate, Menerba. Company management expects operating expenses to decrease further in the third quarter.
The Company reported a net loss for the three months ended June 30, 2009 of $4.1 million, or $0.05 per share, compared with a net loss of $4.2 million, or $0.06 per share, for the same period in 2008.
The Company ended the quarter with $5.4 million in cash, cash equivalents and short term investments, and began the quarter with $9.1 million, a difference of $3.7 million. The cash balance at the end of the quarter reflects the expenses mentioned above. The Company received $116,000 in a government grant payment following the quarter close, and is aggressively pursuing further grants and other forms of financing.
The Company has secured additional long-term debt funding from its landlord, totaling $204,000 year-to-date, and is continuing to explore alternative financing from a variety of sources.