EMERYVILLE, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced results for the third quarter of 2008.
The company did not report any revenue for the three and nine months ended September 30, 2008.
Total operating expenses for the three and nine months ending September 30, 2008 were $5.2 million and $13.7 million, respectively, compared to $3.6 million and $9.9 million, respectively, for the same period in 2007. This reflects the increase in costs related to the clinical trials of our leading drug candidates.
The Company reported a net loss for the three and six months ended September 30, 2008 of $5.1 million, or $0.07 per share, and $13.2 million, or $0.17 per share, respectively, compared with a net loss of $3.2 million, or $0.05 per share, and $9.2 million, or $0.15 per share, respectively, for the same periods in 2007.
The Company ended the quarter with $17.3 million in cash, cash equivalents and short term investments, and began the quarter with $24.6 million, a difference of $7.3 million. This difference includes $3.4 million in non- recurring capital expenditures associated with tenant improvements for laboratory and production capability expansion.
The Company has continued the scientific and clinical development of its drug candidates for the treatment of advanced breast cancer, menopausal hot flashes, and menopausal vaginal atrophy. Recent advances have included:
-- The Phase 1 portion of the BZL101 Phase 1/2 clinical trial for advanced metastatic breast cancer has now been completed successfully, showing positive safety and tolerability profiles, as well as the early signs of clinical efficacy. The Phase 2 part of the trial is now open for enrollment at 17 clinical sites in the U.S., and is expected to enroll 80 patients in the trial. There are currently over 160,000 women living with metastatic breast cancer in the U.S. -- The Company presented an analysis of the metabolism of one of the active chemical ingredients of MF101, the Company's drug candidate for the treatment of menopausal hot flashes. The presentation, to the American Society for Pharmacology and Experimental Therapeutics, Drug Metabolism and Disposition, adds to the growing body of data supporting MF101's mechanism of action, safety and potential potency, as well as furthering the intellectual property protection for the Company. -- Also on MF101, the Company released data from its previous Phase 2 study that showed MF101's superior efficacy with respect to "night sweats" or "night awakenings due to hot flashes" -- a particularly debilitating form of hot flash for which many women seek medical treatment and improved quality of life. This adds to the increasing evidence of the possible efficacy of MF101 and the market opportunity awaiting MF101 if and when it is approved by the FDA and put on the market. -- The Company is currently in discussions with the FDA on the specific requirements for progression to Phase 3 pivotal trials of MF101. The Company expects to have resolution, and to be in a position to continue the clinical development and trials for MF101, by the end of the year. -- The Company presented a report to the North American Menopause Society (NAMS), showing laboratory results of superior efficacy for VG101, the Company's drug candidate for menopausal vaginal dryness, over other treatments. The Company expects to begin human clinical trials for VG101 late in 2008 or early in 2009.
"The third quarter of the year continued the positive scientific progress for Bionovo," said Dr. Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "After much preparation and discussion with the FDA and our advisors, we are now poised to begin the next phase of clinical testing for our portfolio of women's health and oncology drug candidates. We are also continuing promising discussions with potential pharmaceutical partners."
"With over seventeen million dollars in cash, cash equivalents and short- term investments, and a lower than industry clinical trial cost profile, we are poised to progress our lead drug candidates through these challenging economic times," added Tom Chesterman, Bionovo's Senior Vice President and Chief Financial Officer. "Given our current plans and expectations, this funding will be sufficient for at least the next 12 months"
A full financial report on Form 10-Q is expected to be filed by Tuesday, November 4, 2008.
Bionovo 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.
Bionovo, Inc (A Development Stage Company) Condensed Statements of Operations (Unaudited) Three months ended Nine months ended September 30, September 30, 2008 2007 2008 2007 Revenues $- $243,375 $- $250,875 Operating expenses: Research and development 3,941,303 2,444,674 8,881,340 7,212,445 General and administrative 1,222,319 1,129,402 4,852,648 2,689,246 Merger cost - - - - Total operating expenses 5,163,622 3,574,076 13,733,988 9,901,691 Loss from operations (5,163,622) (3,330,701) (13,733,988) (9,650,816) Change in fair value of warrant liability - - - - Interest income 142,815 170,272 638,562 517,958 Interest expense (36,286) (42,370) (98,198) (68,898) Other income (expense) (1,322) (5,241) (16,938) (5,241) Loss before income tax (5,058,415) (3,208,040) (13,210,562) (9,206,997) Income tax provision - - (3,256) (2,400) Net loss $(5,058,415) $(3,208,040) $(13,213,818) $(9,209,397) Basic and diluted net loss per common share $(0.07) $(0.05) (0.17) (0.15) Shares used in computing basic and diluted net loss per common share 76,363,100 65,571,108 76,350,180 63,368,561 Accumulated from February 1, 2002 (Date of Inception) to September 30, 2008 Revenues $659,490 Operating expenses: Research and development 24,673,545 General and administrative 12,304,415 Merger cost 1,964,065 Total operating expenses 38,942,025 Loss from operations (38,282,535) Change in fair value of warrant liability 831,288 Interest income 1,706,979 Interest expense (335,216) Other income (expense) 127,959 Loss before income tax (35,951,525) Income tax provision (12,258) Net loss $(35,963,783) Basic and diluted net loss per common share $(0.88) Shares used in computing basic and diluted net loss per common share 40,805,306 Bionovo, Inc (A Development Stage Company) Condensed Balance Sheets September 30, December 31, 2008 2007 (Unaudited) (Note 1) ASSETS Current assets: Cash and cash equivalents $6,664,427 $28,472,485 Short-term investments 10,645,621 4,823,938 Receivables 262,233 285,899 Prepaid expenses and other current assets 1,159,263 405,381 Total current assets 18,731,544 33,987,703 Property and equipment, net 6,777,308 3,900,248 Other assets and patent pending, net 1,027,306 277,220 Total assets $26,536,158 $38,165,171 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $881,452 $299,677 Accrued clinical and costs of other studies 102,814 298,559 Accrued compensation and benefits 870,435 462,485 Current portion of lease obligation 793,242 706,710 Other current liabilities 467,088 949,200 Total current liabilities 3,115,031 2,716,631 Non-current portion of lease obligation 693,519 526,346 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 September 30, 2008 and December 31, 2007, respectively 7,636 7,634 Additional paid-in capital 58,737,205 57,660,045 Accumulated other comprehensive income (53,450) 4,480 Accumulated deficit (35,963,783) (22,749,965) Total shareholders' equity 22,727,608 34,922,194 Total liabilities and shareholders' equity $26,536,158 $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. -0- 11/03/2008 /CONTACT: Tom Chesterman of Bionovo, Inc., +1-510-601-2000, firstname.lastname@example.org/ /Web site: http://www.bionovo.com / (BNVI) CO: Bionovo, Inc. ST: California IN: HEA MTC BIO SU: ERN SO-AM -- AQM545 -- 5635 11/03/2008 16:38 EST http://www.prnewswire.com