- Company Outlines Milestones for 2008 -
EMERYVILLE, Calif., March 13 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced financial results for the fourth quarter and full year ended December 31, 2007.
Fourth Quarter Results
The company reported revenues for the three months ended December 31, 2007 of $330,875 compared to $3,750 for the same period in 2006. The increase in revenues over the comparable period in 2006, is due primarily to the recognition of $239,625 from our National Institute of Health grant drawdown earned in 2007 and the recognition of unamortized deferred revenue of $91,250 as a result of the termination of our licensing agreement with United Biotechnology Corporation ("UBC") of Taiwan on October 15, 2007.
Total operating expenses for the three months ended December 31, 2007 were $4.3 million compared to $2.0 million for the same period in 2006.
The company reported a net loss for the three months ended December 31, 2007 of $3.7 million, or $0.05 per share, compared with a net loss of $1.9 million, or $0.04 per share, for the same period in 2006.
Full Year Results
For the year ended December 31, 2007 total revenues were $581,750 compared with $15,000 for the same period in 2006. Revenues in 2007 also included a National Institute of Health (NIH) grant drawdown of $239,625 received for 2006 and the recognition of $11,250 in amortization from the proceeds of our licensing and technology transfer agreement with UBC of Taiwan
For the year ended December 31, 2007 total operating expenses were $14.2 million compared with $5.8 million for the same period in 2006. The increase in 2007 operating expenses include the impact of research and development expense 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, 2007 was $12.9 million, or $0.20 per share, compared with a net loss of $5.6 million, or $0.11 per share, for the same period in 2006. 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, 2007, cash, cash equivalents and short-term
investments totaled approximately $33.3 million compared to $3.1 million at
December 31, 2006. The increase in cash, cash equivalents and short term
investments in 2007 is due primarily to $14.5 million, net of financing
expense, raised from our Private Placement (a.k.a. "PIPE") completed in
January 2007, a public offering completed in October 2007, which raised
aggregate net cash proceeds of $24.0 million, and $4.8 million received
from the exercise of stock options and warrants, offset by net cash used in
operating activities of $10.3 million.
2007 Highlights and 2008 Plans
* Clinical Trials -- In addition to starting a pharmacokinetics trial
of its lead menopause drug candidate, MF101, early in the year,
Bionovo also announced results from the Phase 2 trial.
-- In June 2007, Bionovo reported on a trial in which 217 severe
menopausal women were treated and showed positive results with
respect to safety, tolerability and efficacy. This trial
successfully met its objectives, and will now allow the company
to move forward in developing this safe and efficacious
treatment for an indication that is poorly served by the
current pharmaceutical offerings.
-- Data from this Phase 2 trial was presented and deemed the top
scoring abstract at the North American Menopause Society's
annual meeting. The abstract, entitled, "A Novel Selective
Estrogen Receptor-Beta Agonist for the Treatment of Menopausal
Hot Flushes," was presented by the company's principal
investigator, Dr. Deborah Grady, a world leading expert on
menopause. The abstract was also published in the journal,
* Bionovo described a new class of therapeutic compounds. A paper was
published in the journal, Molecular and Cellular Endocrinology,
covering the isolation, identification and description of a chemical
compound, liquiritigenin (an active ingredient in Bionovo's drug
candidate, MF101), which represents the new class of therapeutic
compounds showing promise for the safe, effective treatment of
menopausal symptoms such as hot flashes. This is an important
milestone in the development and protection of our intellectual
* During 2008, we expect to review the Phase 2 study results and Phase
3 proposal with the FDA, and to initiate the Phase 3 study by the
end of the third quarter.
* Bionovo presented the mechanism of action data behind its
anti-cancer agent, BZL101, currently undergoing Phase 1/2 clinical
testing for late stage breast cancer, at the American Association of
Cancer Research (AACR). The presentation described how BZL101
elicits its cytotoxic activity on cancer cells while avoiding normal
* Bionovo began enrolling patients into a Phase 1/2 clinical trial of
BZL101 for the treatment of advanced breast cancer, after presenting
positive Phase 1 findings of BZL101 at the American Association of
* During 2008, we expect to continue the Phase 2 study being conducted
in centers around the U.S. We also expect to discuss the drug
candidate's mechanism of action in more detail, as well as to report
progress of the on-going trial at major scientific conferences.
* During 2008, we expect to receive an IND and commence a Phase 1/2
trial of VG101, our drug candidate for the treatment of menopausal
* During 2007, Bionovo closed a $15.7 million private placement. Later
in the year the company began trading on the NASDAQ Capital Market.
In October 2007, Bionovo completed a successful public follow-on
offering, from which net proceeds to the company were approximately
"We believe our achievements in the last year have positioned Bionovo well for an exciting and promising 2008," said Isaac Cohen, O.M.D., Bionovo's chairman and CEO. "With the proceeds of our recent public offering, we are in a strong financial position to support the ongoing product development and clinical trials for our lead product candidates for metastatic breast cancer, BZL101, and menopausal hot flashes, MF101. We are also pleased with the interest we have received from potential partners in ongoing discussions of our programs and drug candidates. With the combination of our strong financial position, our partner discussions, and the momentum in our clinical trials we believe we are on the right path to become a leader in the areas of breast cancer and women's health."
About Bionovo, Inc.
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
Three Three Twelve Twelve (Date of
months months months months inception)
ended ended ended ended To
December December December December December
31, 31, 31, 31, 31,
2007 2006 2007 2006 2007
Revenues $330,875 $3,750 $581,750 $15,000 $659,490
opment 2,725,299 1,403,550 9,937,743 4,021,149 15,792,205
rative 1,550,431 493,124 4,126,078 1,488,225 6,909,101
marketing 43,889 77,924 157,489 310,941 542,666
Merger cost - - - - 1,964,065
expenses 4,319,619 1,974,598 14,221,310 5,820,315 25,208,037
tions (3,988,744) (1,970,848) (13,639,560) (5,805,315) (24,548,547)
liability - - - - 831,288
income 139,987 71,860 657,944 261,515 1,068,416
expense (17,685) (15,928) (86,582) (47,354) (237,017)
(expense) 175,842 (23,450) 170,602 (23,446) 144,897
tax (3,690,600) (1,938,362) (12,897,596) (5,614,600) (22,740,963)
provision (1,002) (800) (3,402) (3,200) (9,002)
loss $(3,691,602) $(1,939,162) $(12,900,998) $(5,617,800) $(22,749,965)
share $(0.05) $(0.04) $(0.20) $(0.11) $(0.63)
share 72,867,303 51,276,537 65,762,764 49,923,115 36,294,284
(A Development Stage Company)
Consolidated Balance Sheet
December 31, December 31,
Cash and cash equivalents $28,472,485 $2,571,439
Short-term investments 4,823,938 484,017
Receivables from officers and employees 285,899 1,796
Prepaid expenses and other current assets 405,381 183,528
Total current assets 33,987,703 3,240,780
Property and equipment, net 3,900,248 1,672,904
Other assets and patent pending, net 277,220 58,613
Total assets $38,165,171 $4,972,297
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable $299,677 $546,909
Accrued clinical costs 298559 -
Accrued compensation and benefits 462,485 114,392
Current portion of lease obligation 706,710 292,333
Deferred revenue - 15,000
Other current liabilities 949,200 119,092
Total current liabilities 2,716,631 1,087,726
Non-current portion of lease obligation 526,346 300,741
Non-current portion of deferred revenue - 87,500
Commitments and contingencies
Common stock, $0.0001 par value, 190,000,000
shares authorized; issued and outstanding shares:
66,036,435 at December 31, 2007; 51,337,224
at December 31, 2006. 8,166 5,134
Additional paid-in capital 57,659,513 13,340,163
Accumulated other comprehensive income 4,480 -
Accumulated deficit (22,749,965) (9,848,967)
Total shareholders' equity 34,922,194 3,496,330
Total liabilities and shareholders' equity $38,165,171 $4,972,297
* The balance sheets at December 31, 2007 and 2006 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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