EMERYVILLE, Calif., May 9 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced results for the first quarter of 2008.
The company did not report any revenue for the three months ended March 31, 2008. Revenues for the three months ended March 31, 2007 were $3,750, received from our licensing and technology transfer agreement with United Biotechnology Corporation of Taiwan. In October of 2007, we terminated the agreement following notice of material breach of the Agreement by UBC and we recognized the remaining deferred revenue of $91,250 in December 2007.
Total operating expenses for the three months ending March 31, 2008 were $4.2 million compared to $3.5 million for the same period in 2007.
The company reported a net loss for the three months ended March 31, 2008 of $3.9 million, or $0.05 per share, compared with a net loss of $3.3 million, or $0.05 per share, for the same period in 2007.
The Company ended the quarter with $29.4 million in cash, cash
equivalents and short term investments, and began the quarter with $33.3
million, a difference of $3.9 million.
-- Patient enrollment and dosing continues in the Phase 1 portion of the
BZL101 Phase 1/2 clinical trial for advanced metastatic breast cancer.
Presentations, papers and scientific discussions have expounded the
mechanisms of action and described the positive progress to date.
-- Bionovo presented data on two additional preclinical anti-cancer drug
candidates -- BN107 and BN108 -- at the American Association of Cancer
Research (AACR) conference in April. BN107 induces apoptosis through
the mitochondrial pathway, and induces cell death only in estrogen
receptor negative breast cancer cells. BN108 induces cancer cell death
by rapid inactivation of both AKT and mTOR pathways in breast cancer
cells, but not in normal cells.
-- The Company commissioned and reported results from two independent
physician surveys which showed the Company's drug candidate MF101
could become first-line treatment for menopausal vasomotor symptoms
(hot flashes). In both qualitative and quantitative studies, 124 board
certified physicians in internal medicine or obstetrics and gynecology
specializing in the treatment of menopause reported that MF101, if
approved, would be their drug of choice for the treatment of hot
flashes. In addition, 92% of physicians reported they would prescribe
MF101 before prescribing an antidepressant agent for hot flashes.
-- Three additional members were appointed to the Board of Directors:
George Butler, Louis Drapeau, and John Baxter.
"The first quarter of the year was a very productive quarter for Bionovo, with tremendous scientific and operational progress," said Dr. Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We are positioned quite well for 2008, a year in which we will have additional new drug candidates in clinical trials, each addressing a significant unmet medical need with great commercial opportunity."
"We believe that our scientific and operational success is not yet reflected in our stock price," Dr. Cohen continued. "However, our value has been re-affirmed throughout the scientific community, as reflected by the industry reception of our scientific papers and quality of our new board members."
A full financial report on Form 10-Q is expected to be filed on Friday, May 9, 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.
(A Development Stage Company)
Condensed Statements of Operations
(Date of inception)
Three months to
ended March 31, March 31,
2008 2007 2008
Revenues $- $3,750 $659,490
Research and development 2,387,393 2,788,668 18,179,598
General and administrative 1,822,027 694,921 9,273,794
Merger cost - - 1,964,065
Total operating expenses 4,209,420 3,483,589 29,417,457
Loss from operations (4,209,420) (3,479,839) (28,757,967)
Change in fair value of
warrant liability - - 831,288
Interest income 306,192 149,712 1,374,609
Interest expense (26,537) (14,081) (263,554)
Other income (expense) (15,575) - 129,321
Loss before income tax (3,945,340) (3,344,208) (26,686,303)
Income tax provision (3,256) (800) (12,258)
Net loss $(3,948,596) (3,345,008) $(26,698,561)
Basic and diluted net loss per $(0.05) $(0.05) $(0.70)
Shares used in computing
basic and diluted net loss
per common share 76,343,101 61,525,518 37,914,036
(A Development Stage Company)
Condensed Balance Sheets
March 31, December 31,
(Unaudited) (Note 1)
Cash and cash equivalents $19,187,934 $ 28,472,485
Short-term investments 10,198,744 4,823,938
Receivables 19,942 285,899
Prepaid expenses and other current
assets 530,709 405,381
Total current assets 29,937,329 33,987,703
Property and equipment, net 4,040,105 3,900,248
Other assets and patent pending, net 733,445 277,220
Total assets $34,710,879 $38,165,171
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable $ 206,799 $ 299,677
Accrued clinical and costs of other
studies 152,444 298,559
Accrued compensation and benefits 553,242 462,485
Current portion of lease obligation 928,252 706,710
Deferred revenue - -
Other current liabilities 540,922 949,200
Total current liabilities 2,381,659 2,716,631
Non-current portion of lease obligation 1,018,976 526,346
Non-current portion of deferred revenue - -
Commitments and contingencies
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; 76,343,101 shares issued
and outstanding as of March 31, 2008 and
December 31, 2007, respectively 8,166 8,166
Additional paid-in capital 57,980,224 57,659,513
Accumulated other comprehensive income 20,415 4,480
Accumulated deficit (26,698,561) (22,749,965)
Total shareholders' equity 31,310,244 34,922,194
Total liabilities and shareholders' equity 34,710,879 38,165,171
(1) 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
|SOURCE Bionovo, Inc.|
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