EMERYVILLE, Calif., May 11, 2010 /PRNewswire via COMTEX/ --Bionovo, Inc. (Nasdaq: BNVI) today announced first quarter highlights and financial results for the three months ended March 31, 2010.
"The first four months of 2010 were characterized by intense activity within the company, as we prepared data for the regulatory agencies. We, along with our regulatory, scientific and medical advisors, have compiled a body of information on Menerba that should help it move forward in 2010," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "The rest of 2010 is poised to be even more intense for Bionovo, as we expect to be able to initiate the next stage of clinical trials for Menerba, with positive feedback from the regulatory agencies."
"While the company has been strongly focused on progressing Menerba, we have been making good progress in the scientific and clinical community in developing our cancer program. For example, Bezielle, our promising, novel, oral drug for metastatic breast cancer, was selected as one of the 'top 100 investigational drugs' by the prestigious publication R&D Directions," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "Furthermore, the U.S. Patent and Trademark Office has now issued a key patent for Bezielle, as described in our previous press release."
Key Events To Date
--The Company announced that the US Patent and Trademark Office (USPTO) has issued a patent covering a method of using Bionovo's proprietary drug candidate Bezielle(R) (BZL101) for the treatment of metastatic breast cancer. Bionovo's US Patent covers a method of treating breast cancer using Bezielle. This patent also covers the use of Bionovo's proprietary Bezielle formulation as a monotherapy for the treatment of breast cancer. The patent is expected to provide coverage through at least November 13, 2026. "Following two positive Phase 1 trials of Bezielle, this is another critical milestone in Bionovo's efforts to develop Bezielle into a valuable treatment option for an indication that needs new, safe treatment options. Furthermore, intellectual property protection is essential for successfully partnering our drug candidates, and further assuring shareholder value creation," said Dr. Cohen. --The Company held its Annual Meeting of Stockholders on Monday, May 3, 2010. In this meeting, all nominated directors were elected and all proposals were approved by the stockholders. On behalf of the Board of Directors, Dr. Cohen continued, "We are gratified by the support offered by our stockholders in these challenging times. We are focused on creating long term shareholder value." -- The Company announced the appointment of quality control and botanical authentication expert, Paul Pui-Hay But, Ph.D., to the company's Scientific Advisory Board. Dr. But is the Chief Scientist for the Food and Drug Authentication Laboratory Ltd., Hong Kong, China, and a leading investigator and consultant on botanical authentication and Chinese medicine quality control. "We are honored to have Dr. Paul But join our Scientific Advisory Board, given his well established expertise in the field of botanical authentication and Chinese medicine quality control. This expertise has proven invaluable to the development of our manufacturing process for our botanical drug candidates," said Dr. Cohen.
First Quarter Results
Total operating expenses for the three months ending March 31, 2010 were $4.7 million compared to $4.6 million for the same period in 2009. Total operating expenses for the first quarter included the purchase of manufacturing supplies and raw materials and testing for the Menerba manufacturing process development. The Company expects operating expenses to decrease in the second quarter.
The Company reported a net loss for the three months ended March 31, 2010 of $4.7 million, or $0.04 per share, compared with a net loss of $4.7 million, or $0.06 per share, for the same period in 2009.
The Company ended the quarter with $11.8 million in cash, cash equivalents and short term investments, and began the quarter with $15.9 million, a difference of $4.1 million. The cash balance at the end of the quarter reflects the cash expenses mentioned above as well as capital expenditures to support the Menerba manufacturing process development.
The Company will conduct a conference call and webcast to review the financial results and the Company's plans for 2010 later today, Tuesday, May 11, 2010 at 5:00 p.m. (Eastern).
Interested parties can access the call by dialing (877) 317-6789 or (412) 317-6789, or can listen via a live internet webcast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via webcast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 440464, through May 14, 2010.
About Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit: http://www.bionovo.com/.
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov/. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Financial Tables on Following Pages Bionovo, Inc. (A Development Stage Company) Condensed Consolidated Statements of Operations (Unaudited, in thousands, except per share amounts) Three months ended Accumulated from February March 31, 1, --------- 2002 (Date of inception) to March 31, --------- 2010 2009 2010 ---- ---- Revenues $- $- $1,180 Operating expenses: Research and development 3,806 3,601 43,512 General and administrative 852 1,009 18,454 Merger cost - 1,964 Total operating expenses 4,658 4,610 63,930 ----- ----- ------ Loss from operations (4,658) (4,610) (62,750) Change in fair value of warrant liability - - 831 Interest income 8 54 2,082 Interest expense (14) (33) (474) Other income (expense), net 3 (79) (164) --- --- ---- Net loss $(4,661) $(4,668) $(60,475) ======= ======= ======== Basic and diluted net loss per common share $(0.04) $(0.06) $(1.23) ====== ====== ====== Shares used in computing basic and diluted net loss per share 107,541 76,363 49,163 ======= ====== ====== Bionovo, Inc. (A Development Stage Company) Consolidated Balance Sheets (in thousands, except share amounts) December March 31, 31, 2010 2009 ---- ---- (unaudited) ASSETS Current assets: Cash and cash equivalents $3,366 $2,799 Short-term investments 8,393 13,135 Receivables 114 251 Prepaid expenses 191 214 Other current assets 126 161 --- --- Total current assets 12,190 16,560 Property and equipment, net 6,599 6,197 Patent pending, net 978 822 Other assets 531 570 Total assets $20,298 $24,149 ======= ======= LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $724 $311 Accrued compensation and benefits 340 367 Current portion of lease obligations 403 476 Current portion of notes payable 60 59 Other current liabilities 1,046 823 ----- --- Total current liabilities 2,573 2,036 Non-current portion of lease obligations 15 96 Non-current portion of notes payable 106 121 Total liabilities 2,694 2,253 ----- ----- Commitments and contingencies Shareholders' equity: Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued and outstanding - - Common stock $0.0001 par value, 190,000,000 shares authorized, 107,618,690 and 107,518,690 shares outstanding at March 31, 2010 and December 31, 2009, respectively 11 11 Additional paid-in capital 78,069 77,704 Accumulated other comprehensive loss (1) (5) Accumulated deficit (60,475) (55,814) ------- ------- Total shareholders' equity 17,604 21,896 ------ ------ Total liabilities and shareholders' equity $20,298 $24,149 ======= =======
* The balance sheet at December 31, 2009 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
SOURCE Bionovo, Inc.