SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
March 12,
2009
Date of
Report (Date of earliest event reported)
BIONOVO,
INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
(State or
Other Jurisdiction of Incorporation)
|
001-33498
|
|
20-5526892
|
|
(Commission
File Number)
|
|
(IRS
Employer Identification No.)
|
5858
Horton Street, Suite 375, Emeryville, CA 94608
(Address
of Principal Executive Office) (Zip Code)
(510)
601-2000
(Registrant's
Telephone Number, Including Area Code)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
|
¨
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
¨
|
Soliciting
material pursuant to Rule 14a12 under the Exchange Act (17 CFR
240.14a-12)
|
|
¨
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
¨
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
|
Item
2.02
|
Results
of Operations and Financial
Condition
|
(a) On March 12, 2009,
Bionovo, Inc. (the "Company") announced via press release the Company's
financial results for its fourth quarter and fiscal year ended December 31,
2008. A copy of the Company's press release is attached hereto as Exhibit 99.1
and is incorporated herein by reference.
The
information in the report, including Exhibit 99.1 attached hereto, shall not be
deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended, or otherwise subject to the liabilities of that Section or
Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The
information contained herein and in the accompanying exhibit shall not be
incorporated by reference into any filing with the U.S. Securities and Exchange
Commission made by the Company, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.
|
Item
9.01
|
Financial
Statements and Exhibits.
|
|
99.1
|
Press
Release, March 12, 2009, entitled “Bionovo Announces 2008 Highlights and
Year-End Financial Results”
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this Report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
|
BIONOVO,
INC
|
|
|
(Registrant)
|
| |
|
|
Date:
March 12, 2009
|
By:
|
/s/ Isaac Cohen
|
|
|
|
|
Isaac
Cohen
|
|
|
|
Chairman
and Chief Executive Officer
|
|
|
|
(Principal
Executive
Officer)
|
EXHIBIT
INDEX
|
EXHIBIT
99.1
|
Insert
earnings press release here.
|
|
|
Company
Contacts:
|
Investor
Contacts:
|
|
|
|
|
Claire
Fong
|
Joe
Diaz, Robert Blum
|
|
Tom
Chesterman
|
Joe
Dorame
|
|
Tel:
510.601.2000
|
Lytham
Partners, LLC
|
|
investor@bionovo.com
|
Tel:
602.889.9700
|
|
|
bnvi@lythampartners.com
|
Bionovo
Announces 2008 Highlights and Year-End
Financial
Results
EMERYVILLE,
Calif. — March 12, 2009 —
Bionovo, Inc. (NASDAQ: BNVI) today announced financial results for the
year ended December 31, 2008.
“Scientific
development, regulatory progress and growth accurately characterize Bionovo in
2008,” said Isaac Cohen, O.M.D., Bionovo’s chairman and chief executive officer.
“We successfully laid the scientific groundwork and regulatory filings which
ultimately is essential for the successful approval and marketing of several
safe and efficacious drug candidates, which address significant areas of
currently unmet medical need. We look forward to 2009 as a year for clinical
progress and commercial partnering. This progress is reflected by the increased
interest by the scientific community and is evidenced by the number of key
opinion leaders, with three National Academy of Science members, who are now
actively involved with the progress and development of Bionovo’s
drugs.”
Corporate
Issues
|
|
·
|
Bionovo
made several notable additions to its Board of Directors; leading
healthcare professionals with extensive experience in the development of
life science companies, including:
|
|
|
o
|
George
Butler, formerly of Astra Zeneca and
Novartis,
|
|
|
o
|
Louis
Drapeau, CEO of Insite Vision and formerly in leadership roles at Nektar
Therapeutics and BioMarin, and
|
|
|
o
|
John
D. Baxter. M.D., member of the National Academy of Sciences, and a founder
and director of Scios/Nova, Karo-Bio A.B. (Stockholm), Calhoun Vision,,
and SciClone Pharmaceuticals
(SCLN).
|
|
|
·
|
During
2008, Bionovo significantly strengthened its Scientific Advisory Board
(SAB) with the addition of several world-renowned scientists and
clinicians:
|
|
|
o
|
Ethan
Weiss, M.D., University of California at San
Francisco,
|
|
|
o
|
Willa
A Hsueh, M.D., The Methodist Hospital,
Houston,
|
|
|
o
|
Jan
Ake Gustafsson, M.D., Ph.D., member, National Academy of Sciences and
formerly of the Karolinska Institute,
and
|
|
|
o
|
Bert
W. O'Malley, M.D., Recipient of the 2008 National Medal for Science, member, the National
Academy of Sciences, and currently at
the Baylor College of Medicine.
|
MF101
|
|
·
|
An
independent physician survey shows strong evidence that, if approved,
MenerbaTM
(MF101) could become first-line treatment for menopausal symptoms. This
suggests that Menerba could take a leading position in a multi-billion
dollar market.
|
|
|
·
|
Bionovo
announced that it has developed a novel analytical 2-dimensional liquid
chromatography mass spectrometry-based (LC/LC-MS/MS) multiplexing platform
that allows for the rapid, specific, sensitive automated quantification of
the active pharmaceutical compounds of Menerba. If applied to botanical
drug product production, this technique should facilitate exquisite
batch-to-batch consistency and control of the final drug
product.
|
|
|
·
|
Multiple
papers were presented to the Endocrine Society indicating that estrogen
receptor beta may have a role in cancer prevention – suggesting that
Menerba may have an ultimate role in cancer treatment beyond its current
proposed indication for menopausal hot
flashes.
|
|
|
·
|
Also
presented at the Endocrine Society was a study describing the development
of a neural model for thermoregulation in the brain, providing more
specific scientific support for Menerba’s mechanism of action and efficacy
potential.
|
|
|
·
|
Bionovo
announced that further analysis of the data from its successfully
completed phase 2 study of Menerba showed that Menerba was able to reduce
“night awakenings” from menopausal hot flashes at a statistically
significant level. This sign of efficacy in the most debilitating aspect
of hot flashes is further evidence that Menerba may provide an unmatched
combination of safety and efficacy in comparison to other treatments being
developed or currently on the
market.
|
BZL101 and other Cancer Drug
Candidates
|
|
·
|
A
peer-reviewed study published in the journal Cancer Biology and
Treatment, described the powerful and selective mechanism of action
for BZL101 in cancer tumors.
|
|
|
·
|
Another
study was presented at American Association for Cancer Research (AACR)
that detailed the unique mechanisms of action for two other Bionovo drug
candidates for the treatment of cancer, BN107 and
BN108.
|
|
|
·
|
Results
from a second clinical study of BZL101 in advanced breast cancer was
presented at ASCO, indicating BZL101’s favorable tolerability and safety
profile, and exhibiting encouraging signs of positive
efficacy.
|
|
|
o
|
Further
results from this study were presented to the Society of Integrative
Oncology (SIO), where the abstract was the highest scoring
abstract.
|
|
|
·
|
Additional
studies of BN107 and BN108 were presented at the San Antonio Breast Cancer
Symposium, indicating promising signs of potential efficacy for both
cancer drug candidates.
|
VG101
|
|
·
|
Laboratory
studies were presented at the 7th Annual Oxford International Conference
on the Science of Botanicals & American Society of Pharmacognosy 4th
Interim Meeting, describing the structural elucidation of active estrogen
receptor beta selective compounds from VG101, Bionovo's drug candidate for
vaginal atrophy. This structural elucidation is key to the development of
the drug candidate's mechanism of action and intellectual property
protection.
|
|
|
·
|
In
vivo safety and efficacy data were presented to the Endocrine Society,
indicating VG101 may have superior clinical activity to existing drug
products for the treatment of menopausal vaginal
dryness.
|
|
|
·
|
This
data was further detailed to the North American Menopause Society (NAMS),
indicating that VG101 may well provide superior efficacy and safety versus
estrogen therapy.
|
Full Year
Results
For the
year ended December 31, 2008 total revenues were $0.2 million compared with $0.6
million for the same period in 2007. Revenues in 2008 consisted of a National
Institute of Health (NIH) grant drawdown, whereas revenues in 2007 included the
recognition of licensing revenues from a licensing and technology agreement with
a Taiwanese company that has been terminated.
For the
year ended December 31, 2008 total operating expenses were $17.5 million
compared with $14.2 million for the same period in 2007. The increase in 2008
operating expenses include the impact of research and development expenses 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, 2008 was $16.7 million, or $0.22 per share,
compared with a net loss of $12.9 million, or $0.20 per share, for the same
period in 2007. 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, 2008, cash, cash equivalents and short-term investments totaled
approximately $13.6 million compared to $33.3 million at December 31, 2007. The
decrease in cash, cash equivalents and short-term investments included $3.2
million in capital expenditures for a facility expansion which is now complete.
The net cash used in operating activities for 2008 was $15.2 million, compared
with $10.3 million in 2007.
2009
Expense and Cash Guidance
Revenues
for 2009 will include a further drawdown on an NIH grant. The company has
submitted and will submit further applications for grants throughout the
year.
Operating
expenses in 2009 are expected follow a run-rate slightly under $1.0 million per
month – which is the current run rate — due to decreased clinical activities in
the first half of the year and operational efficiencies implemented in the first
quarter of 2009. Operating expenses will increase as and when clinical trial
activities increase.
The
Company currently has enough funds to continue operating through 2009 into the
first quarter of 2010. The Company will need to seek additional funding prior to
that time, in order to continue operations and/or to increase the clinical
testing program and other research.
Conference
Call
The
Company will conduct a conference call and web cast to review the financial
results and the Company’s plans for 2009 later today, Thursday, March 12, 2009
at 4:30 p.m. ET.
Interested
parties can access the call by dialing (877) 356-5706 or (706) 643-0580, or can
listen via a live Internet web cast, which can be found at http://bionovo.com/investors/events.
A replay of the call is available via web cast at http://bionovo.com/investors/events
for 30 days or by playback at (800) 642-1687 or (706) 645-9291, access code
88102099, through March 15, 2009.
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
(A Development Stage
Company)
Consolidated
Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
Accumulated
from
|
|
|
|
|
|
|
|
|
|
|
February
1,
2002
|
|
|
|
|
Three
months ended
|
|
|
Twelve
months ended
|
|
|
(Date
of
Inception)
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
to
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
Revenues
|
|
$ |
232,676 |
|
|
$ |
330,875 |
|
|
$ |
232,676 |
|
|
$ |
581,750 |
|
|
$ |
892,166 |
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
2,534,329 |
|
|
|
2,725,299 |
|
|
|
11,415,669 |
|
|
|
9,937,743 |
|
|
|
27,207,874 |
|
|
General
and administrative
|
|
|
1,244,777 |
|
|
|
1,594,320 |
|
|
|
6,097,426 |
|
|
|
4,283,567 |
|
|
|
13,549,193 |
|
|
Merger
cost
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,964,065 |
|
|
Total
operating expenses
|
|
|
3,779,106 |
|
|
|
4,319,619 |
|
|
|
17,513,095 |
|
|
|
14,221,310 |
|
|
|
42,721,132 |
|
|
Loss
from operations
|
|
|
(3,546,430 |
) |
|
|
(3,988,744 |
) |
|
|
(17,280,419 |
) |
|
|
(13,639,560 |
) |
|
|
(41,828,966 |
) |
|
Change
in fair value of warrant liability
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
831,288 |
|
|
Interest
income
|
|
|
91,507 |
|
|
|
331,987 |
|
|
|
730,069 |
|
|
|
849,944 |
|
|
|
1,990,486 |
|
|
Interest
expense
|
|
|
(30,514 |
) |
|
|
(17,685 |
) |
|
|
(128,712 |
) |
|
|
(86,582 |
) |
|
|
(365,730 |
) |
|
Other
expense
|
|
|
(35 |
) |
|
|
(16,158 |
) |
|
|
(16,971 |
) |
|
|
(21,398 |
) |
|
|
(64,074 |
) |
|
Loss
before income tax
|
|
|
(3,485,472 |
) |
|
|
(3,690,600 |
) |
|
|
(16,696,033 |
) |
|
|
(12,897,596 |
) |
|
|
(39,436,996 |
) |
|
Income
tax provision
|
|
|
(484 |
) |
|
|
(1,002 |
) |
|
|
(3,740 |
) |
|
|
(3,402 |
) |
|
|
(12,742 |
) |
|
Net
loss
|
|
$ |
(3,485,956 |
) |
|
$ |
(3,691,602 |
) |
|
$ |
(16,699,773 |
) |
|
$ |
(12,900,998 |
) |
|
$ |
(39,449,738 |
) |
|
Basic
and diluted net loss per common share
|
|
$ |
(0.05 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.94 |
) |
|
Shares
used in computing basic and diluted net loss per common
share
|
|
|
76,363,101 |
|
|
|
72,867,303 |
|
|
|
76,353,428 |
|
|
|
65,762,764 |
|
|
|
42,100,877 |
|
(A Development Stage
Company)
Consolidated
Balance Sheets
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
(Unaudited)
|
|
|
(Note
*)
|
|
|
ASSETS
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
3,270,180
|
|
|
$
|
28,472,485
|
|
|
Short-term
investments
|
|
|
10,292,495
|
|
|
|
4,823,938
|
|
|
Receivables
|
|
|
126,038
|
|
|
|
285,899
|
|
|
Prepaid
expenses and other current assets
|
|
|
804,646
|
|
|
|
405,381
|
|
|
Total
current assets
|
|
|
14,493,359
|
|
|
|
33,987,703
|
|
|
Property
and equipment, net
|
|
|
6,937,610
|
|
|
|
3,900,248
|
|
|
Other
assets and patent pending, net
|
|
|
1,073,478
|
|
|
|
277,220
|
|
|
Total
assets
|
|
$
|
22,504,447
|
|
|
$
|
38,165,171
|
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
520,560
|
|
|
$
|
299,677
|
|
|
Accrued
clinical and costs of other studies
|
|
|
72,882
|
|
|
|
298,559
|
|
|
Accrued
compensation and benefits
|
|
|
456,214
|
|
|
|
462,485
|
|
|
Current
portion of lease obligation
|
|
|
682,087
|
|
|
|
706,710
|
|
|
Other
current liabilities
|
|
|
596,453
|
|
|
|
949,200
|
|
|
Total
current liabilities
|
|
|
2,328,196
|
|
|
|
2,716,631
|
|
|
Non-current
portion of lease obligation
|
|
|
544,603
|
|
|
|
526,346
|
|
|
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; 76,363,101 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
|
|
|
59,049,514
|
|
|
|
57,660,045
|
|
|
Accumulated
other comprehensive income
|
|
|
24,236
|
|
|
|
4,480
|
|
|
Accumulated
deficit
|
|
|
(39,449,738
|
)
|
|
|
(22,749,965
|
)
|
|
Total
shareholders’ equity
|
|
|
19,631,648
|
|
|
|
34,922,194
|
|
|
Total
liabilities and shareholders’ equity
|
|
$
|
22,504,447
|
|
|
$
|
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.
