OXiGENE Reports Fourth Quarter and Fiscal Year 2006 Results and Sets Fiscal 2007 Priorities
WALTHAM, Mass.--(BUSINESS WIRE)--March 6, 2007--Regulatory News:
-- Company Achieves Regulatory and Clinical Milestones, Focuses
on Targeted Strategic Plan and Execution in 2007
-- OXiGENE prepares to initiate registrational study of CA4P for
anaplastic thyroid cancer
-- OXiGENE commits to build strong collaborations with the
addition of a Chief Business Officer
OXiGENE, Inc. (NASDAQ:OXGN) (STO:OXGN), a clinical-stage
biotechnology company developing novel therapeutics to treat cancer
and eye diseases, today reported operational and financial results for
its fourth quarter and Fiscal Year 2006.
Dr. Richard Chin, President and Chief Executive Officer of
OXiGENE, commented that, "OXiGENE has developed a clear and focused
strategy, demonstrated sound execution on key scientific and
development projects and committed to establishing strong partnerships
with the addition of a Chief Business Officer." Dr. Chin continued,"We are pursuing anaplastic thyroid cancer as our lead targeted
indication, and we believe we have a development strategy that will
make CA4P the first vascular disrupting agent on the market."
Priorities for 2007
The Company indicated that its operational priorities for its
fiscal 2007 will be the following:
-- Continue to build on its successful pre-IND meetings with the
FDA for both its oncology program in anaplastic thyroid cancer
and its ophthalmology program;
-- Develop non-invasive administration formulations for the
ophthalmologic therapeutic area for CA4P;
-- Complete studies to determine the most science-driven and
comprehensive set of biomarkers of treatment response for its
lead compounds; and
-- Aggressively pursue strategically driven collaboration and
partnership initiatives.
Commenting on the year ahead, Dr. Peter Harris, Chief Medical
Officer stated, "For our oncology program, our focus will be to enroll
our first patient in the advanced thyroid cancer Phase III trial by
the end of the first half of 2007. With regards to our ophthalmology
program, barring no unforeseen circumstances with our formulation
development, we hope to be in the clinic for age-related macular
degeneration with a non-invasive formulation by late 2007 or early
2008," Dr. Harris continued, "One of our goals in 2007 is to further
elucidate the therapeutic potential of OXi4503 and help identify the
appropriate Phase II program for this drug."
Financial Results and 2007 Guidance
In the fourth quarter of 2006, OXiGENE's net loss was
approximately $3.4 million, or $0.12 per share, compared to a net loss
of approximately $3.4 million, or $0.16 per share, in the fourth
quarter of 2005. For the twelve-month period ended December 31, 2006,
the Company reported a net loss of approximately $15.5 million, or
$0.56 per share compared to a net loss of approximately $11.9 million,
or $0.61 per share in 2005.
At December 31, 2006, OXiGENE had cash, cash equivalents and
marketable securities of approximately $45.8 million compared with
approximately $58.9 million at December 31, 2005.
Cash utilization for 2007 is anticipated to be between
approximately $16 and $22 million in support of the Company's ongoing
research and development efforts.
2006: The Year in Review
Clinical Update: Oncology
In March 2006, OXiGENE announced the completion of patient
enrollment in a Phase II clinical trial evaluating CA4P with
chemotherapy in imageable solid tumors. Dr. Wallace Akerley of the
Huntsman Cancer Center in Salt Lake City, Utah was the lead
investigator on this study and will be presenting the study findings
at an upcoming scientific meeting this year.
In May 2006, OXiGENE announced the US FDA granted orphan drug
designation to CA4P for the treatment of ovarian cancer, which marked
the second indication for which CA4P has received orphan drug status,
the first being anaplastic thyroid cancer.
In June 2006, OXiGENE announced the release of positive data from
two Phase II clinical trials involving patients with anaplastic
thyroid cancer. This was the basis for the Company's decision to have
this as a lead indication in its oncology strategy.
In November 2006 the Company announced the enrollment of the first
patient in its study of CA4P in combination with Avastin for the
treatment of advanced cancers.
Clinical Update: Ophthalmology
In September 2006, OXiGENE announced that it would be closing
enrollment of the Phase II CA4P clinical trial in myopic macular
degeneration (MMD). All patients in the study met the primary endpoint
of maintenance of vision, and the full results from the MMD clinical
trial will be presented at the Annual Meeting of the Association for
Research in Vision and Ophthalmology in Fort Lauderdale, FL in May
2007 by David M. Brown MD FACS and Tien P. Wong MD of The Methodist
Hospital, Houston, TX. After carefully reviewing the results of the
MMD study, consulting with experts in the field of ophthalmology and
meeting with the FDA, the Company has decided to pursue the
development of CA4P for the treatment of age-related macular
degeneration. The primary goal will be to develop an eye drop
formulation or other non-invasive administration approaches.
Preclinical Update
In September 2006, OXiGENE announced the publication in the
journal Science of the results of a preclinical study that
demonstrated the ability of OXiGENE's vascular disrupting agents to
enhance the suppression of tumor growth when used in combination with
an antiangiogenic drug.
About OXiGENE, Inc.
OXiGENE is a clinical-stage biotechnology company developing novel
small-molecule therapeutics to treat cancer and eye diseases. The
Company's major focus is the clinical advancement of drug candidates
that selectively disrupt abnormal blood vessels associated with solid
tumor progression and visual impairment. OXiGENE is dedicated to
leveraging its intellectual property position and therapeutic
development expertise to bring life saving 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
including the initiation of a Phase III study in anaplastic thyroid
cancer, CA4P becoming the first vascular disrupting agent on the
market, development of a non-invasive form of administration of CA4P,
establishing collaborations and partnerships, the initiation of a
study of age-related macular degeneration, and the utilization of cash
in 2007, 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. 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
Form 10-Q, 8-K and 10-K reports. 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, 2005 for a description of these risks.
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OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in 000's)
Unaudited
December December
Assets 31, 31,
2005 2006
--------- ---------
Cash, cash equivalents and marketable
securities $58,855 $45,839
Licensing agreement 873 777
Other assets 540 1,026
--------- ---------
Total assets $60,268 $47,642
========= =========
Liabilities and stockholders' equity
Accounts payable and accrued liabilities $3,734 $4,222
Total stockholders' equity 56,534 43,420
--------- ---------
Total liabilities and stockholders' equity $60,268 $47,642
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OXiGENE, Inc
Statements of Operations
(All amounts in 000's except per share
amounts)
Unaudited
Three months Twelve months
ended ended
----------------- -------------------
December 31, December 31,
----------------- -------------------
2005 2006 2005 2006
-------- -------- --------- ---------
License revenue $1 $- $1 $-
Costs and expenses:
Research and development 2,039 2,482 7,098 10,816
General and administrative 1,665 1,515 5,951 7,100 -------- -------- --------- ---------
Total costs and expenses: 3,704 3,997 13,049 17,916
Operating loss (3,703) (3,997) (13,048) (17,916)
Investment income 324 609 1,135 2,502
Other (expense) income, net - (7) 4 (43)
Net loss $(3,379) $(3,395) $(11,909) $(15,457)
======== ======== ========= =========
Basic and diluted net loss per
common share $(0.16) $(0.12) $(0.61) $(0.56)
Weighted average number of
common shares outstanding 20,956 27,846 19,664 27,626
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CONTACT: OXiGENE, Inc.
Investor Relations
781-547-5900
OXiGENE Reports Fourth Quarter and Fiscal Year 2006 Results and Sets Fiscal 2007 Priorities
| Source: Oxigene, Inc.
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