View printer-friendly versionSubsequent to the end of the quarter, in
"The third quarter was an extremely productive quarter for
Third Quarter 2009 Company Highlights
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During the third quarter of 2009,
Bionovo completed the raw material characterization, analytical method development and pilot manufacturing process development that constitutes a large part of the Chemistry, Manufacturing and Control (CMC) specifications necessary to satisfy theFDA's requests for clarification of the Company's manufacturing and analytical strategy for guaranteeing the consistency of its drug products. The Company is currently concluding work on the analytical method application and the commercial scale manufacturing batches. -
Bionovo presented the positive results of its Phase 2 clinical trial of Menerba to the international women's health community at the 8th AnnualEuropean Society for Gynecology (EGS) inRome, Italy . The overall reaction of the European scientific, clinical, and pharmaceutical community was extremely positive and demonstrated an international interest in finding a safer alternative to hormone therapy for the treatment of menopausal vasomotor symptoms. - The Company presented the results of a study on the effects of two
plant-derived, tissue-selective estrogen receptor alpha (ERa) modulators
(TSERaM) on menopausal obesity at the 20th Annual Meeting of the
North American Menopause Society . In this study, plant-derived TSERaMs, like estrogens, were shown to reduce body fat in mice, but while estrogens also caused cell proliferation in the mammary gland and uterus, the plant-derived TSERaMs did not elicit these potentially cancer-causing side effects. These results suggest that the development of botanically-derived, tissue-selective ERa modulators could result in a safer alternative for the treatment of menopausal weight gain, a condition that can lead to the development of metabolic syndrome, a combination of risk factors for cardiovascular disease and diabetes. -
Bionovo published a paper describing the molecular mechanisms underlying the selective cytotoxic activity of its preclinical drug candidate BN108 and its active compound, timosaponin AIII (TAIII), in the peer-reviewed, open-access journal,Public Library of Science One . BN108 and TAIII kill tumor cells by eliciting two responses: first, they inhibit mTORC1, an oncogenic pathway that is abnormally activated in many tumors, and second, they induce a profound stress in the endoplasmic reticulum (ER) of tumor cells. This dual effect of the drug activates cell suicide, or apoptosis, in tumor cells, but because these drugs do not inhibit mTORC1 and induce little ER stress in normal cells, normal cells are left unharmed. -
Bionovo published the results of its study on the inhibitory effect of tamoxifen on estrogen receptor beta (ERb) gene regulation in the peer-reviewed journal, Molecular and Cellular Endocrinology. The results of this study demonstrate that tamoxifen inhibits the beneficial effects of ERb in the prevention of breast cancer cell proliferation. This suggests that there is a biological rationale for the development of ERb drugs for the treatment of breast cancer. - The Company announced the addition of Dr.
Debu Tripathy , a leading researcher and clinician in the area of breast cancer, to itsMedical Advisory Board . Dr. Tripathy is a Professor of Medicine at the Keck School of Medicine at theUniversity of Southern California (USC ) and Co-Leader of the Women's Cancer Program atUSC Norris Comprehensive Cancer Center .
Third Quarter Results
Total operating expenses for the three months ended
The Company reported a net loss for the three months ended
The Company commenced the quarter with
Conference Call
The Company will conduct a conference call and webcast to review the financial results for the third quarter of fiscal year 2009 and the Company's plans for the remainder of the year at
Interested parties can access the call by dialing (800) 860-2442 or (412) 858-4600, or can listen via a live Internet webcast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via webcast at http://bionovo.com/investors/events for 30 days or by playback at (877) 344-7529 or (412) 317-0088, conference code 434779, through
About
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of
Bionovo, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited, in thousands, except per share amounts)
Accumulated
from
February 1,
2002
(Date of
inception)
Three months Nine months to
ended ended September
September 30, September 30, 30,
------------ ------------ ---------
2009 2008 2009 2008 2009
---- ---- ---- ---- ----
Revenues $155 $- $162 $- $1,054
---- -- ---- -- ------
Operating expenses:
Research and development 2,938 3,942 9,493 8,881 36,701
General and administrative 926 1,222 3,110 4,853 16,660
Merger cost - - - - 1,964
--- --- --- --- -----
Total operating expenses 3,864 5,164 12,603 13,734 55,325
----- ----- ------ ------ ------
Loss from operations (3,709) (5,164) (12,441) (13,734) (54,271)
Change in fair value of
warrant liability - - - - 831
Interest income 5 143 75 639 2,066
Interest expense (22) (36) (77) (98) (443)
Other expense - (1) (86) (21) (162)
--- -- --- --- ----
Net loss $(3,726) $(5,058) $(12,529) $(13,214) $(51,979)
======= ======= ======== ======== ========
Basic and diluted net loss
per common share $(0.05) $(0.07) $(0.16) $(0.17) $(1.14)
====== ====== ====== ====== ======
Shares used in computing
basic and diluted
net loss per share 76,436 76,363 76,388 76,350 45,444
====== ====== ====== ====== ======
Bionovo, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
(in thousands, except share amounts)
September 30, December 31,
2009 2008
---- ----
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $2,252 $3,270
Short-term investments - 10,292
Receivables 56 126
Prepaid expenses and other current assets 651 805
--- ---
Total current assets 2,959 14,493
Property and equipment, net 6,141 6,938
Other assets and patent pending, net 1,349 1,073
----- -----
Total assets $10,449 $22,504
======= =======
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $406 $521
Accrued clinical and costs of other studies 67 73
Accrued compensation and benefits 406 456
Current portion of lease obligations 544 682
Current portion of notes payable 57 -
Other current liabilities 772 595
--- ---
Total current liabilities 2,252 2,327
Non-current portion of lease obligations 180 545
Non-current portion of notes payable 136 -
--- ---
Total liabilities 2,568 2,872
----- -----
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, 76,585,550 and 76,363,101
shares outstanding at September 30, 2009 and
December 31, 2008, respectively 8 8
Additional paid-in capital 59,852 59,050
Accumulated other comprehensive gain - 24
Accumulated deficit (51,979) (39,450)
------- -------
Total shareholders' equity 7,881 19,632
----- ------
Total liabilities and shareholders' equity $10,449 $22,504
======= =======
SOURCE
Company, Tom Chesterman of Bionovo, Inc., +1-510-601-2000, investor@bionovo.com; or Investors, Joe Diaz, Robert Blum or Joe Dorame, All Of Lytham Partners, LLC, +1-602-889-9700, bnvi@lythampartners.com, For Bionovo, Inc.