logo


Bionovo Announces Second Quarter 2009 Highlights and Financial Results
Monday, August 10, 2009 3:56 PM


(Source: PRNewswire-FirstCall)trackingEMERYVILLE, 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.



(0)
No Comments
Post Comment
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
   
 
 
 
 
   
 

  
Related Press Releases
Advertisement
Popular Articles
Advertisement
Partner Center
Fundamental data is provided by Zacks Investment Research, market data is provided by AlphaTrade. , and Commentary and Press Releases provided by Quotemedia