SOUTH SAN FRANCISCO, Calif., July 30, 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 ended June 30, 2009 and presented an update
on recent clinical and corporate progress.
Financial Results
The Company reported that the net loss attributable to OXiGENE for the second
quarter of 2009 was $5.3 million, or $0.11 per share, compared with a net loss
attributable to OXiGENE of $7.0 million, or $0.25 per share, for the same
period in 2008.
For the six-month period ended June 30, 2009, the net loss attributable to
OXiGENE was $10.8 million, or $0.24 per share, compared to a net loss
attributable to OXiGENE of $12.5 million, or $0.44 per share, for the
comparable period in 2008.
The consolidated net loss, which includes the costs and expenses of Symphony
ViDA, Inc. for the fiscal 2009 periods was $8.0 million for the three month
period ended June 30, 2009 compared with a net loss of $7.0 million, for the
same period in 2008 and was $14.5 million for the six month period ended June
30, 2009 compared with a net loss of $12.5 million, for the same period in
2008.
The increase in loss is 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.
At June 30, 2009, OXiGENE had cash, cash equivalents and marketable securities
of approximately $20.8 million of which $12.6 million were held by Symphony
ViDA compared with approximately $33.6 million, of which $14.6 million were
held by Symphony ViDA at December 31, 2008. In July 2009, OXiGENE completed two
transactions that positively affected the Company's cash resources. The Company
exercised its option to acquire all of the equity of Symphony ViDA, Inc. in
exchange for 10 million newly-issued shares of OXiGENE common stock. As a
result of this option exercise, the Company reacquired the rights to the
ZYBRESTAT for Ophthalmology and OXi4503 programs and the approximately $12.4
million in cash and marketable securities held by Symphony ViDA at the time of
closing the transaction. The Company also closed a registered direct offering
of 6,250,000 units of its common stock and warrants at a price of $1.60 per
unit resulting in gross proceeds of approximately $10 million. On a proforma
basis, these transactions combined result in an increase in the Company's cash,
cash equivalents and marketable securities balance to $30.0 million and an
increase in common shares outstanding to 62.5 million.
"By all measures, OXiGENE has delivered a strong and successful performance in
the quarter and year-to-date, highlights of which include positive data
presented at major oncology meetings, marked progress in all drug development
programs, enhancement of our management team, and the fortification of our
balance sheet," commented John Kollins, OXiGENE Chief Executive Officer. "We
intend to continue to build upon our leadership position in the vascular
disrupting agent field by advancing our three key drug development programs,
ZYBRESTAT for oncology, OXi4503, and ZYBRESTAT for ophthalmology, to value
inflection points in the second half of this year and the first part of 2010."
Additional Second Quarter Highlights
* In June, the Company presented positive data from an
investigator-sponsored Phase 2 study of patients with
platinum-resistant ovarian cancer at the annual meeting of the
American Society of Clinical Oncology (ASCO). Of 44 patients
enrolled in the study, 11 (25%) had confirmed partial responses as
determined by tumor imaging (RECIST) and/or ovarian cancer
biomarker (CA-125) criteria. An additional 4 patients had
unconfirmed partial responses, and stable disease responses were
reported in an additional 16 patients. The combination regimen of
ZYBRESTAT and carboplatin plus paclitaxel chemotherapy was
well-tolerated with approximately half of the patients completing
all 6 cycles of therapy.
* In April, the Company reported data at the American Association of
Cancer Research (AACR) annual meeting showing that OXi4503 has
pronounced antitumor activity when administered as a single agent
or in combination with chemotherapy in an acute myelogenous
leukemia (AML) xenograft model. Preclinical studies have shown that
OXi4503 has single-agent activity against a range of xenograft
tumor models, and 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 a Phase Ib/IIa study in
patients with hepatic tumor burden.
* In June, the Company initiated a randomized, double-masked,
placebo-controlled Phase 2 study of ZYBRESTAT for ophthalmology in
patients with polypoidal choroidal vasculopathy (PCV). PCV is a
form of choroidal neovascularization characterized by the growth of
abnormal blood vessels in the back of the eye and is similar to wet
age-related macular degeneration (AMD). Current therapies active
against wet AMD appear to have limited benefits in patients with
PCV, and OXiGENE believes the abnormal vasculature in the retina
and choroid that contributes to PCV patients' loss of vision may be
susceptible to treatment with ZYBRESTAT.
* Enrollment in the FALCON trial, a randomized, controlled study
evaluating ZYBRESTAT, bevacizumab and chemotherapy as a first-line
treatment for non-small cell lung cancer, continues to progress,
and the Company is on track to report interim data later this year,
with final data expected in 2010. The data from this study will
represent the first randomized, controlled data from a study of
ZYBRESTAT in oncology.
* The Company announced the appointment of Peter J. Langecker, MD,
PhD, as Executive Vice President and Chief Development Officer to
oversee the development of OXiGENE's drug candidates, ZYBRESTAT for
oncology, ZYBRESTAT for ophthalmology and OXi4503. Dr. Langecker
has more than 20 years of experience in successfully developing
both oncology drugs and biological products.
Conference Call Today
Members of OXiGENE's management team will review first quarter results via a
webcast and conference call today at 10:00 a.m. EDT (7:00 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
888-204-4517 in the United States and Canada, and 913-312-0714 for
international callers, five minutes prior to the beginning of the call. A
replay will be available starting at 1:00 p.m. EDT, (10:00 a.m. PDT) on July
30, 2009 and ending at midnight EDT (9:00 p.m. PDT) on Thursday, August 13,
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 6002745.
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 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 of the IND filing and Phase
1 trial initiation for topical ZYBRESTAT, timing or execution of a strategic
collaboration on any product or indication, and cash utilization rate for 2009.
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)
June 30, December 31,
2009 2008
------------ ------------
Assets
Cash, cash equivalents and marketable
securities $ 8,185 $ 18,918
Marketable securities held by Symphony
ViDA, Inc. 12,626 14,663
License agreement 532 581
Other assets 1,101 869
------------ ------------
Total assets $ 22,444 $ 35,031
============ ============
Liabilities and stockholders' equity
Accounts payable and accrued
liabilities $ 7,588 $ 5,826
Derivative liability 225 466
OXiGENE, Inc. stockholders' equity 8,916 19,307
Non controlling interest 5,715 9,432
------------ ------------
Total liabilities and stockholders'
equity $ 22,444 $ 35,031
============ ============
OXiGENE, Inc.
Condensed Consolidated Statements of Operations
(All amounts in 000's except per share amounts)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
------------------ ------------------
2009 2008 2009 2008
-------- -------- -------- --------
Costs and expenses:
Research and development $ 5,813 $ 5,176 $ 10,481 $ 8,865
General and administrative 2,362 2,023 4,327 4,070
-------- -------- -------- --------
Total costs and expenses 8,175 7,199 14,808 12,935
Operating loss (8,175) (7,199) (14,808) (12,935)
-------- -------- -------- --------
Investment income 18 158 70 445
Other expense, net 191 (7) 197 (2)
-------- -------- -------- --------
Consolidated net loss $ (7,966) $ (7,048) $(14,541) $(12,492)
======== ======== ======== ========
Loss attributed to non
controlling interest $ (2,693) $ -- $ (3,717) $ --
Net loss attributed to
OXiGENE, Inc. $ (5,273) $ (7,048) $(10,824) $(12,492)
Basic and diluted net loss per
share attributed to OXiGENE,
Inc. common shares $ (0.11) $ (0.25) $ (0.24) $ (0.44)
Weighted average number of
common shares outstanding 46,014 28,258 46,011 28,164
CONTACT: OXiGENE, Inc.
Investor and Media Contact:
Michelle Edwards, Investor Relations
650-635-7006
medwards@oxigene.com
OXiGENE Reports Second Quarter 2009 Financial Results; Company Continues to Achieve Pipeline Progress With Strengthened Cash Position
| Source: Oxigene, Inc.