EMERYVILLE, Calif., Nov. 10, 2011 /PRNewswire/ -- Bionovo, Inc. (NASDAQ: BNVI) today announced third quarter highlights and financial results for the three months ended September 30, 2011.
"We initiated the first pivotal Phase 3 clinical trial and are actively recruiting patients," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We are now concentrating on the timely execution of the study and we anticipate results in approximately 18 months."
Key Events and Milestones
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's February 2011 public offering offset by clinical trial costs and operating expenses and capital expenditures to support the Menerba manufacturing facility in Hayward, California.
Conference CallBionovo will conduct a conference call and webcast to review the Company's financial results on Monday, November 14, 2011, at 1:30 PM PST, when further information on the non-clinical and clinical progress of Menerba will also be provided.
Interested parties can access the call by dialing 800-705-7067 or can listen via a live audio only webcast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available by dialing 800-633-8284 (replay code 21544924) through November 18, 2011, and archived via audio webcast at http://bionovo.com/investors/events.
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 StatementsThis 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 PagesBionovo, Inc.(A Development Stage Company)Condensed Consolidated Statements of Operations(Unaudited, in thousands, except per share amounts)Three months ended
September 30,Nine months ended
1, 2002 (Date of
2,007 Operating expenses:Research and development
5,6093,67314,99910,80769,347General and administrative
----1,964Total operating expenses
6,3784,66017,69313,43495,133Loss from operations
(6,229)(4,592)(17,479)(13,352)(93,126)Other income (expense):Change in fair value of warrant liability
(24)(9)(77)(33)(599)Other income (expense)
-(28)3(39)(202)Total other income (expense)
(4,627)$ (13,512)$ (13,408)$
(87,058)Basic and diluted net loss per common share
(6.22)Shares used in computing basic and diluted
net loss per share
54,56121,78550,93121,60714,005Bionovo, Inc.(A Development Stage Company)Consolidated Balance Sheets(in thousands, except share amounts)September 30,
2010(unaudited)ASSETSCurrent assets:Cash and cash equivalents
937973Other current assets
842396Total current assets
9,8684,056Property and equipment, net
11,7606,647Patent pending, net
2,982LIABILITIES AND SHAREHOLDERS’ EQUITYCurrent liabilities:Accounts payable
55Accrued compensation and benefits
822901Current portion of lease obligations
1,0511,055Current portion of notes payable
8,0171,843Other current liabilities
1,791970Total current liabilities
12,2565,464Non-current portion of lease obligations
121836Non-current portion of notes payable
12,4526,381Commitments and contingenciesShareholders’ equity:Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued and outstanding
--Common stock $0.0001 par value, 340,000,000 shares authorized, 54,561,312 and 24,530,112 shares outstanding at September 30, 2011 and December 31, 2010, respectively
52Additional paid-in capital
98,62280,145Accumulated other comprehensive loss
(87,058)(73,546)Total shareholders’ equity
11,5686,601Total liabilities and shareholders’ equity
2,982* The balance sheet at December 31, 2010 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.|
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