EMERYVILLE, Calif., March 12 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced financial results for the year ended December 31, 2008.
"Scientific development, regulatory progress and growth accurately characterize Bionovo in 2008," said Isaac Cohen, O.M.D., Bionovo's chairman and chief executive officer. "We successfully laid the scientific groundwork and regulatory filings which ultimately is essential for the successful approval and marketing of several safe and efficacious drug candidates, which address significant areas of currently unmet medical need. We look forward to 2009 as a year for clinical progress and commercial partnering. This progress is reflected by the increased interest by the scientific community and is evidenced by the number of key opinion leaders, with three National Academy of Science members, who are now actively involved with the progress and development of Bionovo's drugs."
BZL101 and other Cancer Drug Candidates
Full Year Result
For the year ended December 31, 2008 total revenues were $0.2 million compared with $0.6 million for the same period in 2007. Revenues in 2008 consisted of a National Institute of Health (NIH) grant drawdown, whereas revenues in 2007 included the recognition of licensing revenues from a licensing and technology agreement with a Taiwanese company that has been terminated.
For the year ended December 31, 2008 total operating expenses were $17.5 million compared with $14.2 million for the same period in 2007. The increase in 2008 operating expenses include the impact of research and development expenses for the development of our lead drug candidates, clinical trial expenses and a related increase in operational support.
The net loss for the year ended December 31, 2008 was $16.7 million, or $0.22 per share, compared with a net loss of $12.9 million, or $0.20 per share, for the same period in 2007. The year-over-year increase in net loss was driven primarily by the increased activity related to our clinical trials and a related increase in operational support.
As of December 31, 2008, cash, cash equivalents and short-term investments totaled approximately $13.6 million compared to $33.3 million at December 31, 2007. The decrease in cash, cash equivalents and short-term investments included $3.2 million in capital expenditures for a facility expansion which is now complete. The net cash used in operating activities for 2008 was $15.2 million, compared with $10.3 million in 2007.
2009 Expense and Cash Guidance
Revenues for 2009 will include a further drawdown on an NIH grant. The company has submitted and will submit further applications for grants throughout the year.
Operating expenses in 2009 are expected follow a run-rate slightly under $1.0 million per month - which is the current run rate -- due to decreased clinical activities in the first half of the year and operational efficiencies implemented in the first quarter of 2009. Operating expenses will increase as and when clinical trial activities increase.
The Company currently has enough funds to continue operating through 2009 into the first quarter of 2010. The Company will need to seek additional funding prior to that time, in order to continue operations and/or to increase the clinical testing program and other research.
The Company will conduct a conference call and web cast to review the financial results and the Company's plans for 2009 later today, Thursday, March 12, 2009 at 4:30 p.m. ET.
Interested parties can access the call by dialing (877) 356-5706 or (706) 643-0580, or can listen via a live Internet web cast, which can be found at http://bionovo.com/investors/events. A replay of the call is available via web cast at http://bionovo.com/investors/events for 30 days or by playback at (800) 642-1687 or (706) 645-9291, access code 88102099, through March 15, 2009.
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.
Company Contacts: Investor Contacts: Claire Fong Joe Diaz, Robert Blum Tom Chesterman Joe Dorame Tel: 510.601.2000 Lytham Partners, LLC email@example.com Tel: 602.889.9700 firstname.lastname@example.org Financial Tables on Following Pages
Bionovo, Inc. (A Development Stage Company) Consolidated Statements of Operations (Unaudited) Three months ended Twelve months ended December 31, December 31, 2008 2007 2008 2007 Revenues $232,676 $330,875 $232,676 $581,750 Operating expenses: Research and development 2,534,329 2,725,299 11,415,669 9,937,743 General and administrative 1,244,777 1,594,320 6,097,426 4,283,567 Merger cost - - - - Total operating expenses 3,779,106 4,319,619 17,513,095 14,221,310 Loss from operations (3,546,430) (3,988,744) (17,280,419) (13,639,560) Change in fair value of warrant liability - - - - Interest income 91,507 331,987 730,069 849,944 Interest expense (30,514) (17,685) (128,712) (86,582) Other expense (35) (16,158) (16,971) (21,398) Loss before income tax (3,485,472) (3,690,600) (16,696,033) (12,897,596) Income tax provision (484) (1,002) (3,740) (3,402) Net loss $(3,485,956) $(3,691,602) $(16,699,773)$(12,900,998) Basic and diluted net loss per common share $(0.05) $(0.05) $(0.22) $(0.20) Shares used in computing basic and diluted net loss per common share 76,363,101 72,867,303 76,353,428 65,762,764 Accumulated from February 1, 2002 (Date of Inception) to 2008 Revenues $892,166 Operating expenses: Research and development 27,207,874 General and administrative 13,549,193 Merger cost 1,964,065 Total operating expenses 42,721,132 Loss from operations (41,828,966) Change in fair value of warrant liability 831,288 Interest income 1,990,486 Interest expense (365,730) Other expense (64,074) Loss before income tax (39,436,996) Income tax provision (12,742) Net loss $(39,449,738) Basic and diluted net loss per common share $(0.94) Shares used in computing basic and diluted net loss per common share 42,100,877
Bionovo, Inc. (A Development Stage Company) Consolidated Balance Sheets December 31, December 31, 2008 2007 (Unaudited) (Note *) ASSETS Current assets: Cash and cash equivalents $3,270,180 $28,472,485 Short-term investments 10,292,495 4,823,938 Receivables 126,038 285,899 Prepaid expenses and other current assets 804,646 405,381 Total current assets 14,493,359 33,987,703 Property and equipment, net 6,937,610 3,900,248 Other assets and patent pending, net 1,073,478 277,220 Total assets $22,504,447 $38,165,171 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $520,560 $299,677 Accrued clinical and costs of other studies 72,882 298,559 Accrued compensation and benefits 456,214 462,485 Current portion of lease obligation 682,087 706,710 Other current liabilities 596,453 949,200 Total current liabilities 2,328,196 2,716,631 Non-current portion of lease obligation 544,603 526,346 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; 76,363,101 and 76,343,101 shares issued and outstanding as of June 30, 2008 and December 31, 2007, respectively 7,636 7,634 Additional paid-in capital 59,049,514 57,660,045 Accumulated other comprehensive income 24,236 4,480 Accumulated deficit (39,449,738) (22,749,965) Total shareholders' equity 19,631,648 34,922,194 Total liabilities and shareholders' equity $22,504,447 $38,165,171 * The balance sheet at December 31, 2007 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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