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 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.
(A Development Stage Company)
Condensed Statements of Operations
Three months ended Nine months ended
September 30, September 30,
2008 2007 2008 2007
Revenues $- $243,375 $- $250,875
development 3,941,303 2,444,674 8,881,340 7,212,445
administrative 1,222,319 1,129,402 4,852,648 2,689,246
Merger cost - - - -
expenses 5,163,622 3,574,076 13,733,988 9,901,691
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)
(expense) (1,322) (5,241) (16,938) (5,241)
income tax (5,058,415) (3,208,040) (13,210,562) (9,206,997)
provision - - (3,256) (2,400)
Net loss $(5,058,415) $(3,208,040) $(13,213,818) $(9,209,397)
loss per common
share $(0.07) $(0.05) (0.17) (0.15)
Shares used in
and diluted net
loss per common
share 76,363,100 65,571,108 76,350,180 63,368,561
February 1, 2002
(Date of Inception) to
September 30, 2008
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
(A Development Stage Company)
Condensed Balance Sheets
September 30, December 31,
(Unaudited) (Note 1)
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
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
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.|
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