EMERYVILLE, Calif., Aug. 5 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced results for the second quarter of 2008.
The company did not report any revenue for the three and six months ended June 30, 2008. Revenues were $3,750 and $7,500 for the three and six months ended June 30, 2007, respectively, received from a licensing and technology transfer agreement with a Taiwanese company. In October of 2007, we terminated the agreement following notice of material breach by the other party and recognized the remaining deferred revenue of $91,250 in December 2007.
Total operating expenses for the three and six months ending June 30, 2008 were $4.4 million and $8.6 million, respectively, compared to $2.8 million and $6.3 million, respectively, for the same period in 2007.
The Company reported a net loss for the three and six months ended June 30, 2008 of $4.2 million, or $0.06 per share, and $8.2 million, or $0.11 per share, respectively, compared with a net loss of $2.7 million, or $0.04 per share, and $6.0 million, or $0.09 per share, respectively, for the same periods in 2007.
The Company ended the quarter with $24.6 million in cash, cash equivalents and short term investments, and began the quarter with $29.2 million, a difference of $4.6 million.
-- The Phase 1 portion of the BZL101 Phase 1/2 clinical trial for advanced metastatic breast cancer continues successfully, demonstrating both positive safety and tolerability profiles, as well as the early signs of efficacy.
-- 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 participated in a number of studies that have further elucidated the mechanisms of the estrogen receptor beta pathway, which are the basis of the Company's MF101 and VG101 drug candidates, for menopausal hot flashes and vaginal dryness, respectively.
"The second quarter of the year was again a very productive quarter for Bionovo," said Dr. Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We have continued to advance our scientific base with several key publications of our discoveries. We have had very productive discussions with our advisors and the FDA, and we are now poised to launch clinical trials for both MF101 and VG101."
"We are very excited at the progress BZL101 is making in the clinical trials for advanced breast cancer. This drug candidate is showing excellent tolerability and safety, and the early signs of significant efficacy," stated Dr. Mary Tagliaferri, M.D., Bionovo's President and CMO.
A full financial report on Form 10-Q is expected to be filed by Tuesday, August 5, 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
Revenues $ - $ 3,750
Research and development 2,552,644 1,979,103
General and administrative 1,808,303 864,924
Merger cost - -
Total operating expenses 4,360,947 2,844,027
Loss from operations (4,360,947) (2,840,277)
Change in fair value of warrant
liability - -
Interest income 189,555 197,975
Interest expense (35,375) (12,446)
Other income (expense) (39) -
Loss before income tax (4,206,806) (2,654,748)
Income tax provision - (1,600)
Net loss $ (4,206,806) $ (2,656,348)
Basic and diluted net loss per
common share $ (0.06) $ (0.04)
Shares used in computing basic and
diluted net loss per common share 76,344,199 65,213,935
February 1, 2002
Six months ended Inception)
June 30, to
2008 2007 2008
Revenues $ - $ 7,500 $ 659,490
Research and development 4,940,036 4,767,771 20,732,241
General and administrative 3,630,330 1,559,845 11,082,097
Merger cost - - 1,964,065
Total operating expenses 8,570,366 6,327,616 33,778,403
Loss from operations (8,570,366) (6,320,116) (33,118,913)
Change in fair value of
warrant liability - - 831,288
Interest income 495,747 347,687 1,564,163
Interest expense (61,912) (26,527) (298,929)
Other income (expense) (15,616) - 129,281
(8,152,147) (5,998,956) (30,893,110)
Loss before income tax
Income tax provision (3,256) (2,400) (12,258)
$(8,155,403) $(6,001,356) $(30,905,368)
Basic and diluted net loss
per common share $ (0.11) $ (0.09) $ (0.78)
Shares used in computing
basic and diluted
net loss per common share 76,343,649 63,388,724 39,407,904
(A Development Stage Company)
Condensed Balance Sheets
June 30, December 31,
(Unaudited) (Note 1)
Cash and cash equivalents $11,918,365 $28,472,485
Short-term investments 12,698,636 4,823,938
Receivables 136,904 285,899
Prepaid expenses and other current assets 1,027,786 405,381
Total current assets 25,781,691 33,987,703
Property and equipment, net 3,966,475 3,900,248
Other assets and patent pending, net 938,257 277,220
Total assets $30,686,423 $38,165,171
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable $296,981 $299,677
Accrued clinical and costs of other studies 201,554 298,559
Accrued compensation and benefits 630,323 462,485
Current portion of lease obligation 874,851 706,710
Other current liabilities 358,970 949,200
Total current liabilities 2,362,679 2,716,631
Non-current portion of lease obligation 866,210 526,346
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 June 30, 2008 and
December 31, 2007, respectively 7,636 7,634
Additional paid-in capital 58,388,703 57,660,045
Accumulated other comprehensive income (33,437) 4,480
Accumulated deficit (30,905,368) (22,749,965)
Total shareholders' equity 27,457,534 34,922,194
Total liabilities and shareholders' equity $30,686,423 $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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