Upcoming Milestones Include Presentation of Key Randomized Data in Phase 2
Study of ZYBRESTAT in Patients With Non-small Cell Lung Cancer
SOUTH SAN FRANCISCO, Calif., Nov. 9, 2009 (GLOBE NEWSWIRE) -- OXiGENE, Inc.
(Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage, biopharmaceutical company
developing novel therapeutics to treat cancer and eye diseases, reported
financial results for the quarter and nine months ended September 30, 2009 and
presented an update on recent clinical and corporate progress.
Financial Results
The Company reported that the consolidated net loss for the third quarter of
2009 was $6.9 million, compared with a consolidated net loss of $7.1 million
for the same period in 2008. The consolidated net loss for the quarter ended
September 30, 2009 was impacted by the inclusion of the loss attributed to the
Company's non-controlling interest in Symphony ViDA, Inc. of $0.5 million.
For the nine-month period ended September 30, 2009, the consolidated net loss
was $21.5 million, compared to a consolidated net loss of $19.6 million for the
comparable period in 2008. The consolidated net loss for the nine-month period
ended September 30, 2009 was impacted by the inclusion of the loss attributed
to the Company's non-controlling interest in Symphony ViDA, Inc. of $4.2
million.
The increase in loss for the nine-month period ended September 30, 2009 was
driven primarily by a higher level of clinical development activities,
including the continued enrollment of the FACT (fosbretabulin in anaplastic
cancer of the thyroid) pivotal registration study, the FALCON (fosbretabulin in
advanced lung oncology) study, and the initiation of the FAVOR (fosbretabulin
against vasculopathy of the retina/choroid) study, as well as the management of
other ongoing clinical trials and drug development activities. For the
three-month period ended September 30, 2009, the increase in research and
development expenses attributable to the continued clinical development
activities described above was offset by lower general and administrative
expenses, compared to those in the three-month period ended September 30, 2008.
The net loss applicable to common stock was $0.29 per share for the three-month
period ended September 30, 2009, compared to $0.25 per share for the same
three-month period of 2008. The net loss applicable to common stock was $0.55
per share for the nine-month period ended September 30, 2009, compared to $0.69
per share for the same nine-month period of 2008.
OXiGENE recorded the acquisition of the Symphony ViDA variable interest entity
as a capital transaction, and the $10.4 million excess of the fair market value
of the shares of common stock issued by OXiGENE ($15.6 million) over the
carrying value of the non-controlling interest ($5.2 million) is reflected
directly in equity as a reduction to the "Additional paid-in capital" line
item. As a result, the non-controlling interest balance was eliminated. The
reduction to Additional paid-in capital was also presented as an increase in
the loss applicable to common stock within the calculation of basic and diluted
earnings per share for both the three and nine-month periods ended September
30, 2009.
At September 30, 2009, OXiGENE had cash, cash equivalents, restricted cash and
marketable securities of approximately $22.0 million. This compared with
approximately $33.6 million at December 31, 2008, of which $14.6 million was
held by Symphony ViDA.
"The third quarter of 2009 was transformative for OXiGENE as we worked to
strengthen our balance sheet, reacquired full rights to our VDA candidates, and
entered into a definitive merger agreement with VaxGen, Inc., which we expect
to further strengthen our financial future," commented Peter Langecker, OXiGENE
Interim Chief Executive Officer. "As we approach year-end, we are
well-positioned to deliver on our many upcoming milestones. We are looking
forward to the presentation of interim data from our randomized, controlled
Phase 2 study of ZYBRESTAT in patients with non-small cell lung cancer at the
upcoming AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics meeting."
In October, OXiGENE announced plans to merge with VaxGen in a stock-for-stock
transaction. Upon closing of the transaction, which is subject to approval by
stockholders of both OXiGENE and VaxGen and is expected to occur during the
first quarter of 2010, VaxGen will become a wholly-owned subsidiary of OXiGENE,
and VaxGen stockholders will become stockholders of OXiGENE.
Upcoming Milestones
- Presentation of safety and early survival data from the
Phase 2 study of ZYBRESTAT in patients with non-small cell
lung cancer at the EORTC-AACR-NCI meeting in Boston on
November 17, 2009.
- Presentation of a poster highlighting preclinical data for
OXi4503 in acute myelogenous leukemia (AML) models at the
American Society of Hematology meeting in December 2009 in
New Orleans.
- Interim results from the FACT study of ZYBRESTAT in patients
with anaplastic thyroid cancer in the first half of 2010.
Conference Call Today
Members of OXiGENE's management team will review third quarter results via a
webcast and conference call today at 9:00 a.m. EDT (6:00 a.m. PDT). To listen
to a live or an archived version of the audio webcast, please log on to the
Company's website, www.oxigene.com. Under the "Investors" tab, select the link
to "Events and Presentations."
OXiGENE's earnings conference call can also be heard live by dialing
888-504-7949 in the United States and Canada, and 719-325-2215 for
international callers, five minutes prior to the beginning of the call. A
replay will be available starting at 12:00 p.m. EDT, (9:00 a.m. PDT) on
November 9, 2009 and ending at midnight EDT (9:00 p.m. PDT) on Monday, November
23, 2009. To access the replay, please dial (888) 203-1112 if calling from the
United States or Canada, or (719) 457-0820 from international locations. Please
refer to replay pass code 4502965.
About ZYBRESTAT (fosbretabulin)
ZYBRESTAT is currently being evaluated in a pivotal registration study in
anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement
with the U.S. Food and Drug Administration (FDA). OXiGENE believes that
ZYBRESTAT is poised to become the first therapeutic product in a novel class of
small-molecule drug candidates called vascular disrupting agents (VDAs).
Through interaction with vascular endothelial cell cytoskeletal proteins,
ZYBRESTAT selectively targets and collapses tumor vasculature, thereby
depriving the tumor of oxygen and causing death of tumor cells. In clinical
studies in solid tumors, ZYBRESTAT has demonstrated potent and selective
activity against tumor vasculature, as well as clinical activity against ATC,
ovarian cancer and various other solid tumors. In clinical studies in patients
with forms of macular degeneration, intravenously-administered ZYBRESTAT has
demonstrated activity, and the Company's objective is to develop a convenient
and patient-friendly topical formulation of ZYBRESTAT for ophthalmological
indications.
About OXi4503
OXi4503 (combretastatin A1 di-phosphate / CA1P) is a dual-mechanism vascular
disrupting agent (VDA) that is being developed in clinical studies for the
treatment of solid tumors. Like its structural analog, ZYBRESTAT(TM)
(fosbretabulin / CA4P), OXi4503 has been observed to block and destroy tumor
vasculature, resulting in extensive tumor cell death and necrosis. In addition,
preclinical data indicate that OXi4503 is metabolized by oxidative enzymes
(e.g., tyrosinase and peroxidases), which are elevated in many solid tumors and
tumor white blood cell infiltrates, to an orthoquinone chemical species that
has direct cytotoxic effects on tumor cells. Preclinical studies have shown
that OXi4503 has (i) single-agent activity against a range of xenograft tumor
models; and (ii) synergistic or additive effects when incorporated in various
combination regimens with chemotherapy, molecularly-targeted therapies
(including tumor-angiogenesis inhibitors), and radiation therapy. OXi4503 is
currently being evaluated as a monotherapy in a Phase 1 dose-escalation study
in patients with advanced solid tumors and as a monotherapy in a phase 1b/2a
dose-escalation study in patients with solid tumors with hepatic involvement.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel
therapeutics to treat cancer and eye diseases. The company's major focus is
developing vascular disrupting agents (VDAs) that selectively disrupt abnormal
blood vessels associated with solid tumor progression and visual impairment.
OXiGENE is dedicated to leveraging its intellectual property and therapeutic
development expertise to bring life-extending and life-enhancing medicines to
patients.
The OXiGENE, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4969
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Any or all of the
forward-looking statements in this press release may turn out to be wrong.
Forward-looking statements can be affected by inaccurate assumptions OXiGENE
might make or by known or unknown risks and uncertainties, including, but not
limited to, the enrollment rate for patients in the ZYBRESTAT pivotal trial for
anaplastic thyroid cancer, timing for receipt and reporting of interim data
from the randomized, controlled phase 2 trial of ZYBRESTAT in non-small cell
lung cancer; timing for receipt of interim data from the pivotal trial of
ZYBRESTAT in anaplastic thyroid cancer; timing for receipt of data from the
phase 2 trial of ZYBRESTAT in polypoidal choroidal vasculopathy; timing for
receipt of data from the trial of OXi5403 in hepatic tumors; timing for receipt
and reporting of preclinical data for OXi4503 in AML models; timing of the IND
filing and Phase 1 trial initiation for topical ZYBRESTAT; and timing, receipt
of stockholder approvals and closing of the proposed merger with VaxGen, Inc.
Additional information concerning factors that could cause actual results to
materially differ from those in the forward-looking statements is contained in
OXiGENE's reports to the Securities and Exchange Commission, including
OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no
obligation to publicly update forward-looking statements, whether because of
new information, future events or otherwise. Please refer to our Annual Report
on Form 10-K for the fiscal year ended December 31, 2008.
OXiGENE, Inc.
Condensed Consolidated Balance Sheets
(All amounts in 000's)
(Unaudited)
September 30, December 31,
2009 2008
------------- -------------
Assets
Cash, cash equivalents, restricted
cash, and marketable securities $ 22,023 $ 18,918
Marketable securities held by
Symphony ViDA, Inc. -- 14,663
License agreement 508 581
Other assets 1,736 869
------------- -------------
Total assets $ 24,267 $ 35,031
============= =============
Liabilities and stockholders' equity
Accounts payable, accrued liabilities,
and other liabilities $ 7,962 $ 5,826
Derivative liability 3,334 466
OXiGENE, Inc. stockholders' equity 12,971 19,307
Non controlling interest -- 9,432
------------- -------------
Total liabilities and stockholders'
equity $ 24,267 $ 35,031
============= =============
OXiGENE, Inc.
Condensed Consolidated Statements of Operations
(All amounts in 000's except per share amounts)
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
------------------ ------------------
2009 2008 2009 2008
-------- -------- -------- --------
License revenue $ -- $ 13 $ -- $ 13
Costs and expenses:
Research and development 5,978 5,004 16,459 13,869
General and administrative 1,762 2,234 6,089 6,304
-------- -------- -------- --------
Total costs and expenses 7,740 7,238 22,548 20,173
Operating loss (7,740) (7,225) (22,548) (20,160)
-------- -------- -------- --------
Investment and other income 797 117 1,064 559
Consolidated net loss $ (6,943) $ (7,108) $(21,484) $(19,601)
======== ======== ======== ========
Loss attributed to non
controlling interest $ (468) $ -- $ (4,186) $ --
Net loss attributed to
OXiGENE, Inc. $ (6,475) $ (7,108) $(17,298) $(19,601)
-------- -------- -------- --------
Excess purchase price over
carrying value of
noncontrolling interest in
the Symphony ViDA, Inc. $(10,383) $ -- $(10,383) $ --
-------- -------- -------- --------
Net loss applicable to common
stock $(16,858) $ (7,108) $(27,681) $(19,601)
======== ======== ======== ========
Basic and diluted net loss
per share attributed to
OXiGENE, Inc.common shares $ (0.29) $ (0.25) $ (0.55) $ (0.69)
Weighted average number of
common shares outstanding 59,096 28,816 50,503 28,374
CONTACT: OXiGENE, Inc.
Investor and Media Contact:
Michelle Edwards, Investor Relations
650-635-7006
medwards@oxigene.com
OXiGENE Reports Third Quarter 2009 Financial Results
| Source: Oxigene, Inc.