Exhibit 99.1
OXiGENE Reports Fourth-Quarter and Year-End 2003 Financial Results;
Sets 2004 Milestones
WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 12, 2004--OXiGENE, Inc.
(NASDAQ: OXGN) (XSSE: OXGN):
Accomplishments in 2003:
-- Lead Compound Enters Four New Cancer Trials
-- CA4P Becomes First Vascular Targeting Agent Tested in
Ophthalmology
-- Company Plans for Major Expansion of Ophthalmology Program
-- CA4P Granted Fast Track and Orphan Drug Designation in Certain
Thyroid Cancers
-- Company Strengthens Balance Sheet
OXiGENE, Inc. (NASDAQ: OXGN) (XSSE: OXGN), a leading developer of
biopharmaceutical compounds designed to target aberrant blood vessels
within solid tumor cancers and ocular neovascular diseases, today
reported financial results for the fourth quarter and year ended
December 31, 2003.
"By any measure, 2003 was the most successful year in OXiGENE's
history," said President and Chief Executive Officer Fred Driscoll.
"We advanced Combretastatin A4 Prodrug (CA4P) into a total of five new
human clinical trials in the United States and Europe, and broadened
its therapeutic use into two very large disease areas with unmet
medical needs - cancer and ophthalmology. The year also was
highlighted by key regulatory milestones as CA4P secured the U.S.
FDA's fast track designation and orphan drug status in certain thyroid
cancers. Including the $24.2 million stock offering that closed in
January 2004, the Company has significantly strengthened its balance
sheet by generating gross proceeds over the past eight months of more
than $39 million."
Financial Results
In the fourth quarter of 2003, OXiGENE narrowed its net loss to
$1.7 million, or $0.12 per share, from a net loss of $2.4 million, or
$0.19 per share, in the comparable period one year earlier. Included
in the financial results for the fourth quarter of 2003 is a one-time
$635,000 gain related to the liquidation of OXiGENE AB, the Company's
Sweden-based subsidiary, and stock-based compensation expense of
$95,000. Included in the financial results for the fourth quarter of
2002 is stock-based compensation expense of $523,000.
For the 12-month period ended December 31, 2003, the Company
reported a net loss of $8.4 million, or $0.63 per share. This compares
with a net loss of $11.0 million, or $0.88 per share, in the 12-month
period ended December 31, 2002. Included in the net loss for full-year
2003 are $620,000 in stock-based compensation expense, $945,000 in
one-time charges related to the relocation of the Company's former
office in Watertown, Massachusetts, and a $635,000 gain related to the
liquidation of the Company's Sweden-based subsidiary. Included in the
net loss for the same period in 2002 is $2,940,000 in stock-based
compensation expense and a gain of $1,325,000 related to the sale of
the Company's joint venture with ARCUS Therapeutics.
-- OXiGENE ended the fourth quarter of 2003 with approximately
$18.9 million in cash and marketable securities and restricted
cash. In addition, the Company raised gross proceeds of $24.2
million in a Common Stock offering completed in January 2004.
The Company currently has in excess of $40 million of cash,
marketable securities and restricted cash.
Significant Accomplishments in 2003
-- New Cancer Trials. During the year, CA4P entered four Phase
I/II human cancer trials in combination with a number of
established treatment regimens. In Europe, the compound moved
into the following studies: a clinical trial in combination
with radiotherapy in patients with advanced carcinoma of the
lung, head & neck and prostate; a clinical trial in
combination with the chemotherapy drugs carboplatin and
paclitaxel in advanced ovarian cancer; and a clinical trial in
combination with a monoclonal antibody in advanced colorectal
cancer. In the United States, the Ireland Cancer Center at
University Hospitals of Cleveland (Ohio) began evaluating CA4P
in combination with the chemotherapy drugs
doxorubicin/cisplatin and radiation for the treatment of
patients with newly diagnosed anaplastic thyroid cancer.
-- First VTA Tested in Ophthalmology. The Johns Hopkins
University School of Medicine began a Phase I/II study of CA4P
in patients with wet age-related macular degeneration (AMD),
the cause of severe vision loss in between two million and
three million Americans. This marks the first time a vascular
targeting agent has ever been evaluated in a
non-life-threatening disease where current treatments are
inadequate.
-- Expansion of Ophthalmology Program. In December 2003, OXiGENE
announced that the vision of a patient with a subfoveal
neovascular disease known as myopic macular degeneration
improved significantly after treatment with CA4P. Based on
pre-clinical data of CA4P in ophthalmology, the Phase I/II
trial in wet AMD and the response of this patient, the Company
announced plans to broaden its research and development
initiatives in ophthalmology. As part of that effort, in 2004
the Company expects to launch a clinical study in myopic
macular degeneration.
-- Fast Track Status. The U.S. Food and Drug Administration (FDA)
granted fast-track status to CA4P for the treatment of
advanced anaplastic thyroid cancer, the rarest and deadliest
form of the disease. The FDA's fast track program is designed
to facilitate the development and expedite the review of new
drugs intended to treat life-threatening conditions for which
there is no approved therapy.
-- Orphan Drug Designation. The FDA awarded the orphan drug
designation to CA4P for the treatment of anaplastic,
medullary, Stage IV papillary and Stage IV follicular thyroid
cancers. Orphan drug designations are granted to provide
economic incentives to stimulate the research, development and
approval of promising products that treat rare diseases. The
Orphan Drug Act guarantees seven years of market exclusivity
in the United States to the first sponsor that obtains market
approval for an orphan drug-designated product.
-- Strengthened Balance Sheet. OXiGENE substantially improved its
cash position in 2003 with a private placement of Common Stock
that generated $15 million of gross proceeds to the Company.
Last month, OXiGENE raised an additional $24.2 million in
gross proceeds from the sale of approximately 2.8 million
shares of Common Stock. With this recent infusion of cash, the
Company currently has in excess of $40 million of cash,
marketable securities and restricted cash.
"From virtually every perspective, we are a vastly stronger
company than we were one year ago," Driscoll said. "During the year,
we took significant steps to advance our pre-clinical and clinical
development. This progress validated our expectations for the
technology and, in turn, allowed us to raise the necessary financial
resources to execute our strategy. We are now in a position of
strength as we continue to advance our clinical pipeline, with the
flexibility to be both opportunistic and measured in exploring
strategic alliances that can further enhance value for our
shareholders."
Goals for 2004
"During the past year, we have made outstanding progress in
expanding the clinical opportunities for our lead vascular targeting
compound in cancer and ophthalmology, and our goal is to sustain that
momentum in 2004," Driscoll said. OXiGENE's goals for the year
include:
-- Accelerating enrollment in current trials by opening
additional research sites
-- Expanding certain existing trial protocols to include
randomized, dual-arm studies
-- Filing Investigational New Drug Applications (INDs) to begin
CA4P clinical trials in new cancer indications
-- Completing pre-clinical toxicology testing of Oxi4503 by
Cancer Research UK and the initiation of a clinical study in
the second half of 2004
-- Filing an IND to initiate a clinical study in a disease
involving subfoveal neovascularization
-- Adding key personnel to accommodate the Company's aggressive
clinical program
-- Continuing partnership discussions
Fourth-quarter Conference Call Information
In conjunction with its fourth-quarter financial results, OXiGENE
will conduct a conference call at 10:00 a.m. ET today. Mr. Driscoll
and Chief Scientific Officer David Chaplin, Ph.D. will moderate the
call.
Time: 10:00 a.m. ET
Date: Thursday, February 12, 2004
Dial-in numbers 800-289-0508 (U.S.)
913-981-5550 (international)
Webcast: www.oxigene.com
A telephone replay of the conference call will be available for
one week and can be accessed by dialing 888-203-1112 (U.S.) or
719-457-0820 (international). Please refer to reservation number
733731.
About OXiGENE
OXiGENE is the world leader in the development of vascular
targeting agents (VTAs), novel biopharmaceutical compounds designed to
selectively target and destroy new blood vessels. The Company's lead
compound, Combretastatin A4 Prodrug (CA4P), is in clinical development
in patients with solid tumor cancers and wet age-related macular
degeneration. Three other OXiGENE VTAs, OXi4503, OXi6197 and OXi8007,
are in pre-clinical development. For more information about OXiGENE,
visit www.oxigene.com.
Safe Harbor Statement
Statements in this news release concerning OXiGENE's business
outlook are considered "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. These
statements include, but are not limited to: the negotiation of a
potential agreement with a pharmaceutical partner; the acceleration of
enrollment in OXiGENE's current clinical trials and the opening of
additional trial research sites; the expansion of certain existing
trial protocols to include randomized, dual-arm studies; the filing of
Investigational New Drug Applications to begin clinical trials of CA4P
new cancer indications; the completion of pre-clinical toxicology
testing of Oxi4503 by Cancer Research UK; the initiation of a clinical
study of Oxi4503 in the second half of 2004; the filing of an IND in a
disease involving subfoveal neovascularization; the addition of key
personnel to accommodate the Company's aggressive clinical program;
and continuation of discussions with potential licensing partners. Any
or all of the forward-looking statements in this press release may
turn out to be wrong. They can be affected by inaccurate assumptions
OXiGENE might make or by known or unknown risks and uncertainties,
including, but not limited to: the early stage of product development;
the ability to secure necessary patents; uncertainties as to the
future success of ongoing and planned clinical trials; and the
unproven safety and efficacy of products under development.
Consequently, no forward-looking statement can be guaranteed, and
actual results may vary materially. Additional information concerning
factors that could cause actual results to materially differ from
those in the forward-looking statements are contained in OXiGENE's
reports to the Securities and Exchange Commission, including OXiGENE's
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.
Financial tables follow...
OXiGENE, Inc.
Condensed Consolidated Balance Sheets
(All amounts in 000's)
Assets December 31, December 31,
2003 2002
--------------- --------------
Cash, marketable securities and
restricted cash $18,936 $11,831
Licensing agreement 1,069 1,166
Furniture, fixtures and
equipment, net 44 487
Other assets 156 114
--------------- --------------
Total assets $20,205 $13,598
=============== ==============
Liabilities and stockholders' equity
Accounts payable $1,448 $1,861
Accrued expenses 2,287 1,717
Total stockholders' equity 16,470 10,020
--------------- --------------
Total liabilities and
stockholders' equity $20,205 $13,598
=============== ==============
OXiGENE, Inc.
Consolidated Statements of Operations
(All amounts in 000's except per share amounts)
Three months ended Year ended
--------------------- --------------------
December 31, December 31,
--------------------- --------------------
2003 2002 2003 2002
------------ -------- ---------- ---------
(Unaudited) (Audited)
--------------------- --------------------
Revenues:
Licensing revenue $9 $- $30 $-
------------ -------- ---------- ---------
9 - 30 -
Operating expenses:
Amortization of license
agreement 27 31 98 98
Research and development 1,430 1,002 3,938 5,103
General and administrative 1,021 1,498 5,282 7,438
------------ -------- ---------- ---------
Total Operating expenses: 2,478 2,531 9,318 12,639
Interest income 149 111 321 335
Interest expense (4) (24) (36) (53)
Other income (expense),
net 636 7 635 1,344
------------ -------- ---------- ---------
Net loss $(1,688) $(2,437) $(8,368) $(11,013)
============ ======== ========== =========
Net loss per common share $(0.12) $(0.19) $(0.63) $(0.88)
Weighted average number
of common shares
outstanding 13,906 12,546 13,184 12,514
CONTACT: Sharon Merrill Associates, Inc.
Investors:
David Calusdian, 617-542-5300
dcalusdian@investorrelations.com
or
Media:
Scott Solomon, 617-542-5300
ssolomon@investorrelations.com