EMERYVILLE, Calif., March 30, 2012 /PRNewswire/ -- Bionovo, Inc. (OTCQB: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced financial results for the year ended December 31, 2011.
"In 2011 we initiated our Phase 3 trial for Menerba for the treatment of menopausal hot flashes and enrollment in that trial has progressed very well," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "Unfortunately, due to financial constraints, we have voluntarily suspended enrollment until we obtain additional financing. If we are able to obtain adequate financing, we plan to evaluate the results of the 280 patients who have already enrolled in the trial. We believe these results will provide additional evidence regarding the progress of Menerba towards approval for our shareholders and for potential partners."
The Company has experienced and continues to experience operating losses and negative cash flows from operations, as well as an ongoing requirement for substantial additional capital investment. Our cash balance as of March 29, 2012, was approximately $400,000. We expect that we will need to raise substantial additional capital to continue our operations beyond April 15, 2012. We are currently pursuing a variety of funding options, including equity offerings, partnering/co-investment, venture debt and commercial licensing agreements for our products. On February 8, 2012, we filed a registration statement on Form S-1 with the SEC (File No. 33-179429), as amended, to register the offering of an aggregate of up to $25 million in convertible preferred stock and warrants to purchase shares of common stock. We expect that the terms and conditions of this potential offering, if consummated, will change. There can be no assurance as to the availability or terms upon which such financing and capital might be available. If we are not successful in our efforts to raise additional funds by April 15, 2012, we may be required to further delay, reduce the scope of, or eliminate one or more of our development programs or discontinue operations altogether.
Key Events and Milestones
Full Year ResultsFor the year ended December 31, 2011 total revenues were $0.3 million compared with $0.6 million for the same period in 2010. Revenues in 2011 consisted of $0.3 million in a National Institute of Health (NIH) grant. Revenues in 2010 consisted of a Qualifying Therapeutic Discovery Project Credit of $0.5 million and $0.1 million in a National Institute of Health (NIH) grant.
For the year ended December 31, 2011 total operating expenses were $23.9 million compared with $18.2 million for the same period in 2010. The increase in 2011 operating expenses is primarily due to completion of Menerba tolerability studies, initiation of the Menerba Phase 3 clinical study and manufacturing costs at our Hayward, California manufacturing facility, partially offset by no employee or officer bonuses for 2011.
The net loss for the year ended December 31, 2011 was $13.7 million, or $0.26 per share, compared with a net loss of $17.7 million, or $0.80 per share, for the same period in 2010. The year-over-year decrease in net loss was driven primarily by change in fair value of the warrant liability offset by increased operating expenses as noted above.
As of December 31, 2011, cash, cash equivalents and short-term investments totaled approximately $3.0 million compared to $2.6 million at December 31, 2010. The decrease is due to cash used in operating activities of $17.6 million and cash used in investing activities of $8.5 million offset by the net cash provided from financing activities of $26.0 million. The net cash used in operating activities for 2011 was $17.6 million, compared with $14.2 million in 2010.
2012 GuidanceThe Company is providing the following guidance on key milestones for 2012: Note that all milestones are dependent on the Company's ability to raise additional funding.Data Safety Monitoring Board interim reviews of Menerba clinical study safety data
Multiple reviews are planned during the course of the Menerba clinical studyCompletion of recruitment for 280 patients for Menerba clinical study
Completed Q1 2012Data available from 280 patients for Menerba clinical study
Anticipated by Q3 2012AboutBionovo,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 OTCQB under the symbol, "BNVI ". For more information about Bionovo and its programs, visit: http://www.bionovo.com.
ForwardLookingStatementsThis 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)Consolidated Statements of OperationsFor the Years Ended December 31,Accumulated fromFebruary 1, 2002(Date of inception)to December 31,2011201020092011(in thousands, except per share data)Revenue
2,058Operating expenses:Research and development
20,52814,64212,49974,876General and administrative
---1,964Total operating expenses
23,89518,16816,552101,336Loss from operations
(23,630)(17,555)(16,264)(99,278)Other income (expense):Change in fair value of warrant liability
(97)(61)(95)(618)Other expense, net
(113)(39)(88)(304)Total other income (expense)
9,932(176)(99)12,048Loss before income tax
(13,698)(17,731)(16,363)(87,230)Income tax provision
(87,245)Basic and diluted net loss per common share
(5.80)Shares used in computing basic and diluted net loss per share
51,84822,29916,72515,036Bionovo, Inc.(A Development Stage Company)Consolidated Balance SheetsDecember 31,20112010(in thousands, except share amounts)ASSETSCurrent assets:Cash and cash equivalents
$ 2,549$ 2,638Short-term investments
1,180973Other current assets
507396Total current assets
4,7414,056Property and equipment, net
11,3826,647Patents pending, net
$18,458$12,982LIABILITIES AND SHAREHOLDERS’ EQUITYCurrent liabilities:Accounts payable
55Accrued clinical trial expenses
9677Accrued compensation and benefits
304901Current portion of capital lease obligations
8721,055Current portion of notes payable
2,5151,843Other current liabilities
1,131963Total current liabilities
7,3415,464Non-current portion of capital lease obligations
42836Non-current portion of notes payable
7,4556,381Commitments and contingenciesShareholders’ equity:Preferred stock, $0.0001 par value; 10,000,000 shares authorized; 10% Series A Cumulative Preferred Stock, 1000 shares authorized, none issued and outstanding
--Common stock $0.0001 par value, 340,000,000 shares authorized, 54,581,955 and 24,530,112 shares outstanding at December 31, 2011 and 2010, respectively
52Additional paid-in capital
98,24380,145Accumulated other comprehensive income (loss)
(87,245)(73,546)Total shareholders’ equity
11,0036,601Total liabilities and shareholders’ equity
$18,458$12,982* The balance sheets at December 31, 2011 and 2010 have been derived from the audited financial statements at those dates but do 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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