View printer-friendly version EMERYVILLE, Calif.,
Company Highlights
-- Further results from the phase 1B clinical trial of Bezielle (BZL101)
in 27 patients with metastatic breast cancer showed Bezielle to be
safe and well-tolerated with encouraging evidence of clinical activity
in a heavily pretreated patient population - most importantly
including:
-- 31% had stable disease for more than 90 days;
-- 13% had stable disease for more than 180 days;
-- three patients had objective tumor regression;
-- one patient had objective tumor regression while on Bezielle
therapy for 449 days and continues to be stable off of study
medication for over 600 days;
-- a second patient continues to be stable for 832 days and has not
started any new anticancer treatment;
-- a third patient was stable without any new anticancer therapy for
591 days;
-- there were no deaths or serious adverse events that were attributed
to Bezielle (BZL101); and
-- the most common side effects associated with Bezielle (BZL101) were
minor and gastrointestinal in nature.
These results provide further evidence that Bezielle (BZL101) may
provide an important option for women suffering from advanced breast
cancer, an extremely difficult to treat subset of the breast cancer
population.
-- On the SERM platform, a peer-reviewed study published in the journal
"Public Library of Science One " found that when comparing the gene
expression induced by ERb compounds to that induced by estradiol, some
differences existed in both the classes of genes regulated and the
magnitude of regulation. These results demonstrate that ERb-selective
agonists do not entirely mimic the actions of estradiol after binding
to ERb, suggesting that the two classes of drugs will have different
biological effects and different side effect profiles. Additionally,
this study found that different types of ERb-selective drugs regulated
different genes to varying extents and that therefore different
ERb-selective drugs should exert distinct clinical effects. Of the
different compounds investigated, Menerba (MF101) was one of the most
ERb-selective, and patterns of gene expression were most disparate
between Menerba and estradiol. Menerba also demonstrated unique cell
type-specific gene regulation.
-- The Company continues to work towards satisfying the FDA's requests
for clarification of the manufacturing and analytical strategy to be
used in ensuring the consistency of its drug products.
-- The Company is aggressively pursuing a variety of funding options
which include government grants, partnering, and debt and equity
offerings.
-- The Company has selected two more potential contract manufacturing
organizations (CMO) to handle clinical, and possibly, commercial
needs, and expects to qualify the primary CMO for clinical production
by the end of September.
Second Quarter Results
Total operating expenses for the three months ending
The Company reported a net loss for the three months ended
The Company ended the quarter with
The Company has secured additional long-term debt funding from its
landlord, totaling
"We are encouraged by the progress we have been making over the last
quarter and are confident we can address the FDA's requests in a timely
fashion and resume clinical testing of Menerba in the near future," stated
Conference Call
The Company will conduct a conference call and webcast to review the
financial results for the second 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 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
(877) 344-7549 or (412) 317-0088, conference code 432836, through
About
Forward Looking Statements
This release contains certain forward-looking statements relating to the
business of
Financial Tables on Following Pages
Bionovo, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited, in thousands, except per share amounts)
Accumulated
from February 1,
2002 (Date of
Three months ended Six months ended inception) to
June 30, June 30, June 30,
------------------ ---------------- ------------
2009 2008 2009 2008 2009
---- ---- ---- ---- ----
Revenues $7 $- $7 $- $899
Operating expenses:
Research and
development 2,954 2,553 6,555 4,940 33,763
General and
administrative 1,175 1,808 2,184 3,630 15,733
Merger cost - - - - 1,964
--- --- --- --- -----
Total operating
expenses 4,129 4,361 8,739 8,570 51,460
----- ----- ----- ----- ------
Loss from operations (4,122) (4,361) (8,732) (8,570) (50,561)
Change in fair
value of warrant
liability - - - - 831
Interest income 16 190 70 496 2,061
Interest expense (22) (36) (55) (62) (421)
Other expense (6) - (85) (19) (162)
--- --- --- --- ----
Net loss $(4,134) $(4,207) $(8,802) $(8,155) $(48,252)
====== ===== ===== ===== =====
Basic and diluted
net loss per
common share $(0.05) $(0.06) $(0.12) $(0.11) $(1.09)
===== ===== ===== ===== =====
Shares used in
computing basic
and diluted
net loss per share 76,363 76,344 76,363 76,344 44,393
====== ====== ====== ====== ======
Bionovo, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
(in thousands, except share amounts)
June 30, December 31,
2009 2008
---- ----
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $4,397 $3,270
Short-term investments 1,006 10,292
Receivables 44 126
Prepaid expenses and other current
assets 472 805
--- ---
Total current assets 5,919 14,493
Property and equipment, net 6,601 6,938
Other assets and patent pending, net 1,334 1,073
----- -----
Total assets $13,854 $22,504
======= =======
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $408 $521
Accrued clinical and costs of other
studies 60 73
Accrued compensation and benefits 443 456
Current portion of lease obligations 638 682
Current portion of notes payable 7 -
Other current liabilities 717 595
--- ---
Total current liabilities 2,273 2,327
Non-current portion of lease obligation 260 545
Non-current portion of notes payable 92 -
--- ---
Total liabilities 2,625 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,
76,363,101 and 76,363,101 shares
outstanding at June 30, 2009 and
December 31, 2008, respectively 8 8
Additional paid-in capital 59,471 59,050
Accumulated other comprehensive gain 2 24
Accumulated deficit (48,252) (39,450)
------- -------
Total shareholders' equity 11,229 19,632
------ ------
Total liabilities and shareholders'
equity $13,854 $22,504
======= =======
* The balance sheet at December 31, 2008 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.
SOURCEBionovo, Inc. -0-08/10/2009 /CONTACT:Claire Fong orTom Chesterman , both ofBionovo, Inc. , +1-510-601-2000, investor@bionovo.com; or Investors,Joe Diaz ,Robert Blum , orJoe Dorame , all ofLytham Partners, LLC , +1-602-889-9700, bnvi@lythampartners.com, forBionovo, Inc. / /Web Site: http://www.bionovo.com / (BNVI) CO:Bionovo, Inc. ST:California IN: HEA MTC PHA IDC SU: ERN CCA TRI PR -- SF59358 -- 095808/10/2009 15:00 EDT http://www.prnewswire.com