OXiGENE Reports Fourth Quarter and Year-End 2007 Results
Company Provides Updates; Milestones; Financial Guidance for 2008
WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 28, 2008--Regulatory News:
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a clinical-stage,
biopharmaceutical company developing novel therapeutics to treat
cancer and eye diseases, reported financial results for the quarter
and year ending December 31, 2007; summarized recent clinical and
corporate progress; and provided financial and milestone guidance for
2008.
Financial Results
The Company reported that the net loss for the fourth quarter of
2007 was $5.8 million, or $0.21 per share, compared with a net loss of
$3.4 million, or $0.12 per share, for the same period in 2006.
For the year ending December 31, 2007, the net loss was $20.4
million, or $0.73 per share, compared with a net loss of $15.5
million, or $0.56 per share, for the comparable period in 2006.
The increase in loss is attributable to an increase in operating
expenses which was driven primarily by a higher level of clinical
development activities, including the initiation of the ZYBRESTAT(TM)
(fosbretabulin) pivotal registration trial in anaplastic thyroid
cancer (ATC) as well as the management of other ongoing clinical
trials and drug development activities.
At December 31, 2007, OXiGENE had cash, cash equivalents and
marketable securities of approximately $28.4 million compared with
approximately $45.8 million on December 31, 2006."In 2007, we advanced key drug development programs, in
particular, our pivotal Phase II/III registration study for ZYBRESTAT
in ATC and our topical ophthalmology program," commented Richard Chin,
OXiGENE President and CEO. "We remain highly confident in our vascular
disrupting agent (VDA) drug development programs, and we are committed
to translating our product candidates into innovative drug products
that deliver meaningful benefits to patients with cancer and
ophthalmological diseases. We expect that the financial resources
available to us, including cash and the recently-established committed
equity line, will allow us to continue to build value in these
programs."
Fourth Quarter 2007 Highlights
Oncology
-- Subsequent to Dr. Patricia Walicke joining the OXiGENE team in
August 2007 as Chief Medical Officer, OXiGENE accelerated
clinical site initiation and patient recruitment activities in
the ongoing Phase II/III pivotal registration study for
ZYBRESTAT in anaplastic thyroid cancer. As of year-end,
OXiGENE had initiated four sites in the U.S. and India, and
continues to initiate sites and enroll patients in 2008.
-- In December, OXiGENE announced that ZYBRESTAT achieved the
pre-specified primary efficacy endpoint for Stage 1 of an
ongoing Simon two-stage design Phase II study of ZYBRESTAT in
combination with chemotherapy in patients with
platinum-resistant ovarian cancer. Enrollment of an additional
25 patients is proceeding in the second stage of the trial.
-- In October, OXiGENE announced that the Phase Ib study of
ZYBRESTAT in combination with bevacizumab in patients with
advanced solid tumors resulted in significantly enhanced and
sustained tumor blood-flow inhibition, demonstrated early
evidence of clinical activity in the absence of concurrent
cytotoxic chemotherapy, and appeared to be well-tolerated.
-- In October, OXiGENE reported interim data from a Phase I
dose-escalation study of OXi4503, its second-generation,
dual-mechanism VDA product candidate. The study showed, among
other things, that OXi4503 appeared to be well-tolerated, had
no dose-limiting toxicity, achieved tumor blood flow shutdown
and metabolic inactivation, and demonstrated early signs of
clinical activity. The Company also announced publication of
an article describing the mechanism-of-action by which OXi4503
may exert direct cytotoxic effects on tumor cells--in addition
to its demonstrated vascular-disrupting activity.
-- In November, OXiGENE announced publication of preclinical
study results online and ahead of print in the journal Blood
by Dr. Shahin Rafii, Howard Hughes Investigator at Cornell
University, indicating that ZYBRESTAT has anti-leukemic
effects and prolonged survival in an animal model of acute
leukemia.
Ophthalmology
-- In December, OXiGENE reported positive preclinical ocular
penetration data with a topical formulation of ZYBRESTAT for
ophthalmology. These studies, performed in industry-standard
rabbit models, indicate that two formulations of ZYBRESTAT,
when applied topically to the surface of the eye, are absorbed
and result in concentrations of drug in target tissues in the
back of the eye (i.e., the retina and choroid) that the
Company believes will be sufficient for therapeutic activity
in eye diseases in which abnormal neovascularization plays a
role, such as age-related macular degeneration, diabetic
retinopathy, and neovascular glaucoma. The Company reported in
May 2007 positive results from a Phase II study of
intravenously-administered ZYBRESTAT in patients with myopic
macular degeneration.
Financial Guidance for 2008
OXiGENE expects cash utilization from operations for fiscal 2008
to range from $22 million to $28 million, which reflects an increase
in activity in all programs. OXiGENE estimates that it has
approximately one year of operating cash and marketable securities on
hand as of December 31, 2007. Also, as previously announced, OXiGENE
entered into a Committed Equity Financing Facility with Kingsbridge
Capital in February 2008. This facility allows Kingsbridge to
purchase, at OXiGENE's discretion, up to $40 million in OXiGENE common
stock for a period of up to three years.
Company Milestones for 2008
Oncology
-- In the first quarter of 2008, the Company expects to initiate
a randomized, controlled, double-blind Phase II study that
will evaluate the combination of ZYBRESTAT, bevacizumab and
chemotherapy versus bevacizumab and chemotherapy as a
potential first-line therapy in patients with Stage IIIb/IV
non-small cell lung cancer (NSCLC).
-- In the first half of 2008, the Company anticipates initiating
most of the clinical sites for the ongoing 180-patient,
pivotal registration study of ZYBRESTAT in ATC. Consistent
with the Company's objective of reaching the study's planned
interim analysis by mid-2009, the Company plans to have
enrolled approximately half of the patients in the study by
year-end 2008.
-- In the first half of 2008, the Company expects to report
results from the Phase Ib combination study of ZYBRESTAT and
bevacizumab in patients with advanced solid tumors.
-- In the first half of 2008, the Company expects to report
results from the Phase I dose-escalation study of OXi4503 and
announce preclinical study data that will inform clinical
development of the product candidate.
-- In the second half of 2008, the Company expects to report
results from an ongoing Phase Ib study evaluating the
combination of ZYBRESTAT, cetuximab and radiation therapy as a
treatment for patients with head-and-neck cancer.
-- In 2008, the Company expects to complete enrollment in the
ongoing Phase 2 study of ZYBRESTAT in platinum-resistant
ovarian cancer.
Ophthalmology (ZYBRESTAT Topical)
-- In the first quarter of 2008, the Company expects to report
results from ongoing primate tolerance and topical penetration
studies that, if positive, will provide key support for
further investment in the program and a subsequent IND filing.
The Company anticipates presenting preclinical ocular
penetration and tolerance data at an appropriate scientific
meeting later in 2008.
-- By mid-year, the Company expects to file an IND for a topical
formulation of ZYBRESTAT and proceed into clinical evaluation
of the product candidate in patients with age-related macular
degeneration and/or another ophthalmological condition
characterized by abnormal ocular neovascularization.
Members of OXiGENE's management team will review fourth quarter
results via a webcast and conference call today at 10:00 a.m. ET (7:00
a.m. PST). 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 "Investor Center" tab, select the link to "Presentations &
Conference Calls."
OXiGENE's earnings conference call can also be heard live by
dialing (800) 909-7113 in the United States and Canada, and (785)
830-1914 for international callers, five minutes prior to the
beginning of the call. A replay will be available starting at 1:00
p.m. ET, (10:00 a.m. PST) on February 28, 2008 and ending at 1:00 p.m.
ET (10:00 a.m. PST) on Thursday, March 6, 2008. 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 9542510.
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 clinical
activity, and the Company is working 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
indicates 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 I
dose-escalation study in patients with advanced solid tumors.
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 -enhancing medicines to patients.
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, enrollment rate for
patients in the ZYBRESTAT pivotal trial for anaplastic thyroid cancer,
interim analysis of the same, timing of the IND filing and Phase I
trial initiation for topical ZYBRESTAT, timing of a phase II study of
ZYBRESTAT and Avastin in NSCLC, timing or execution of a strategic
collaboration on any product or indication, and cash utilization rate
for 2008. 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, 2006.
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in 000's)
(Unaudited)
December December
31, 31,
2007 2006 --------- ---------
Assets
Cash, cash equivalents and marketable
securities $28,438 $45,839
License agreement 679 777
Other assets 947 1,026
--------- ---------
Total assets $30,064 $47,642
========= =========
Liabilities and stockholders' equity
Accounts payable and accrued liabilities $ 5,207 $ 4,222
Total stockholders' equity 24,857 43,420
--------- ---------
Total liabilities and stockholders' equity $30,064 $47,642
========= =========
OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in 000's except per share amounts)
(Unaudited)
Three months endedTwelve months ended
December 31, December 31,
----------------- -------------------
2007 2006 2007 2006
-------- -------- --------- ---------
License revenue $ 5 $ - $ 12 $ -
Costs and expenses:
Research and development 4,494 2,482 14,130 10,816
General and administrative 1,667 1,515 8,155 7,100
-------- -------- --------- ---------
Total costs and expenses 6,161 3,997 22,285 17,916
Operating loss (6,156) (3,997) (22,273) (17,916)
-------- -------- --------- ---------
Investment income 394 609 1,955 2,502
Other expense, net (35) (7) (71) (43)
-------- -------- --------- ---------
Net loss $(5,797) $(3,395) $(20,389) $(15,457)
======== ======== ========= =========
Basic and diluted net loss per
common share $ (0.21) $ (0.12) $ (0.73) $ (0.56)
Weighted average number of
common shares outstanding 28,035 27,846 27,931 27,626
CONTACT: OXiGENE, Inc.
Michelle Edwards, 415-315-9413
Investor Relations
medwards@oxigene.com
OXiGENE Reports Fourth Quarter and Year-End 2007 Results
| Source: Oxigene, Inc.
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