View printer-friendly versionEMERYVILLE, Calif., Aug. 4 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced second quarter highlights and financial results for the three months ended June 30, 2010.
"We have now had critical discussions with both the FDA and the EMA. Both agencies have provided guidance and requirements for marketing license approval of Menerba," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We can now turn our attention to initiating pivotal clinical trials for Menerba by year end."
"Any potential treatment for such a large indication as menopausal symptom alleviation will require careful consideration and review by the regulatory agencies," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "The details of the regulatory agencies' review will be particularly useful to a prospective partner for assessing the development costs and market potential of Menerba."
Key Events To Date
The Company announced that it had received final guidance from the
European Medicines Agency (EMA) in order to advance Menerba, the
company's lead drug candidate for menopausal symptoms, to Phase 3
-- clinical trials in Europe.
"The EMA guidance is an essential step in our clinical development of
Menerba in Europe, and defines the regulatory and clinical path for
eventual approval. We are eager to start our late stage pivotal
studies for Menerba with this guidance in hand," said Dr.
Tagliaferri.
The Company has also had a meeting with the U.S. Food and Drug
Administration (FDA) on the development of Menerba in the U.S.
Earlier this month, the Company had a meeting with the FDA
regarding Menerba's Chemistry, Manufacturing and Controls (CMC)
-- package.
"As a result of the meeting with the FDA, we are confident we can now
satisfy all the details and requirements with the proposed CMC
package. Unfortunately we cannot comment further on the meeting
details until the FDA minutes are finalized", said Dr. Isaac Cohen.
"We have ongoing discussions with the FDA concerning the rest of the
clinical development of Menerba that should conclude swiftly."
The Company published a study in the Public Library of Science
(PLoS) One, describing a novel model for thermoregulatory control
with neurons that are differentiated from stem cells, and express
native estrogen receptors. The company's drug candidate, Menerba,
an estrogen receptor beta selective modulator, was shown to
regulate calcium influx, which is related to temperature
-- regulation.
"This is a novel and valuable model for investigating
thermoregulation. This study provides further explanation on how
Menerba is able to control hot flashes," said Isaac Cohen, Bionovo's
Chairman and Chief Executive Officer.
The Company announced the publication of results from a study
demonstrating the three distinct classes of genes regulated by
estrogen receptor beta (ERb). The results are published in the
Journal of Biological Chemistry. This is an important discovery for
-- future development of selective drugs regulating this pathway.
"Bionovo's mission to discover and develop unique drugs for women's
health and cancer is further enriched by the discovery of the unique
classes of genes regulated by ERb. We now know we can selectively
regulate via the ERb genes similar to estrogen as well as enhance the
activity of genes regulated independently by ERb. This opens the door
for new cancer preventive drugs and inflammatory diseases afflicting
women far more than men. It also further elucidates the potential
need for multiple compounds pharmacologically causing gene activation
of various classes of genes along a single path," said Dr. Cohen.
The Company announced that it entered into a common stock purchase
agreement with Aspire Capital Fund LLC, an Illinois limited
liability company, which provides that, subject to certain
conditions and limitations, Aspire Capital is committed to purchase
up to an aggregate of $15.0 million of Bionovo shares of common
stock over a two year term, based on prevailing market prices over
-- a period preceding each sale.
"The intent of this agreement is to continue that strategy, to provide
a flexible and fair source of committed capital, with a known cost -
at market prices -and without warrant overhang. This agreement with
Aspire meets that intent and provides the Company flexibility from a
timing perspective and favorable terms," said Tom Chesterman,
Bionovo's Senior Vice President and Chief Financial Officer.
Second Quarter Results
For the quarter ending June 30, 2010 total revenue was $14,000 compared with $7,000 for the same period in 2009. This revenue was the result of limited research services the Company performed for one customer. The Company does not expect to continue performing these services for the remainder of 2010.
Total operating expenses for the three months ending June 30, 2010 were $4.1 million compared to $4.1 million for the same period in 2009 and $4.7 million for the first quarter of 2010. Total operating expenses for the second quarter included the purchase of manufacturing supplies and raw materials and testing in support of the Menerba manufacturing process development. The Company expects operating expenses to increase in the last half of the year as clinical trials begin.
The Company reported a net loss for the three months ended June 30, 2010 of $4.1 million, or $0.04 per share, compared with a net loss of $4.1 million, or $0.05 per share, for the same period in 2009.
The Company ended the quarter with $6.9 million in cash, cash equivalents and short term investments, and began the quarter with $11.8 million. The cash balance at the end of the quarter reflects the cash expenses mentioned above combined with $1.0 million in capital equipment purchases during the year.
Conference Call
The Company will conduct a conference call and webcast to review the financial results and the Company's plans for 2010 later today, Wednesday, August 4th, at 5:00 p.m. (Eastern).
Interested parties can access the call by dialing (877) 317-6789 or (412) 317-6789, 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 or by playback at (877) 344-7529 or (412) 317-0088, conference code 442845, through August 10, 2010.
About Bionovo, Inc.
Bionovo, Inc. 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.
Financial Tables on Following Pages
Bionovo, Inc.
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except per share amounts)
Three months ended Six months ended
June 30, June 30,
-------- --------
2010 2009 2010 2009
---- ----
Revenues $14 $7 $14 $7
--- --- --- ---
Operating expenses:
Research and
development 3,328 2,954 7,135 6,555
General and
administrative 788 1,175 1,639 2,184
Merger cost - - - -
Total operating
expenses 4,116 4,129 8,774 8,739
----- ----- ----- -----
Loss from operations (4,102) (4,122) (8,760) (8,732)
Change in fair value
of warrant liability - - - -
Interest income 6 16 14 70
Interest expense (10) (22) (24) (55)
Other expense (14) (6) (11) (85)
--- --- --- ---
Net loss $(4,120) $(4,134) $(8,781) $(8,802)
======= ======= ======= =======
Basic and diluted net
loss per common
share $(0.04) $(0.05) $(0.08) $(0.12)
====== ====== ====== ======
Shares used in
computing basic and
diluted 107,619 76,363 107,580 76,363
net loss per share ======= ====== ======= ======
Accumulated
from February
1,
2002 (Date of
inception) to
June 30,
--------
2010
----
Revenues $1,194
------
Operating expenses:
Research and development 46,841
General and administrative 19,241
Merger cost 1,964
Total operating expenses 68,046
------
Loss from operations (66,852)
Change in fair value of
warrant liability 831
Interest income 2,088
Interest expense (485)
Other expense (177)
----
Net loss $(64,595)
========
Basic and diluted net loss per
common share $(1.27)
======
Shares used in computing basic
and diluted 50,895
net loss per share ======
Bionovo, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
(in thousands, except share amounts)
December
June 30, 31,
2010 2009
---- ----
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $3,981 $2,799
Short-term investments 2,951 13,135
Receivables 49 251
Prepaid expenses 456 214
Other current assets 299 161
--- ---
Total current assets 7,736 16,560
Property and equipment, net 6,445 6,197
Patent pending, net 1,085 822
Other assets 530 570
Total assets $15,796 $24,149
======= =======
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $352 $311
Accrued compensation and benefits 403 367
Current portion of lease obligations 247 476
Current portion of notes payable 62 59
Other current liabilities 968 823
--- ---
Total current liabilities 2,032 2,036
Non-current portion of lease
obligations 12 96
Non-current portion of notes payable 90 121
Total liabilities 2,134 2,253
----- -----
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,
107,618,690 and 107,518,690 shares
outstanding at June 30, 2010 and
December 31, 2009, respectively 11 11
Additional paid-in capital 78,246 77,704
Accumulated other comprehensive loss - (5)
Accumulated deficit (64,595) (55,814)
------- -------
Total shareholders' equity 13,662 21,896
------ ------
Total liabilities and shareholders'
equity $15,796 $24,149
======= =======
* The balance sheet at December 31, 2009 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.