Exhibit 99.1
OXiGENE Reports Second Quarter 2004 Financial Results
WALTHAM, Mass.--(BUSINESS WIRE)--July 28, 2004--OXiGENE, Inc.
(NASDAQ: OXGN) (XSSE: OXGN):
Recent Highlights
-- CA4P Demonstrates Anti-Tumor Responses in Ovarian Cancer
-- Clinical Investigators Report No Dose-limiting Toxicities or
Drug-related Serious Adverse Events
-- OXi4503 Induces Vascular Shutdown in Pre-clinical Studies
-- Early Success in Ophthalmology Puts CA4P on Path Toward New
Clinical Trial in Myopic Macular Degeneration
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 second quarter ended June 30, 2004.
The net loss for the three months ended June 30, 2004 was $2.8
million, or $0.17 per share, compared with a net loss of $1.8 million,
or $0.15 per share, in the second quarter of 2003. Total operating
expenses increased approximately 57 percent in the second quarter of
2004 to $2.9 million from $1.9 million in the second quarter of 2003.
For the six-month period ended June 30, 2004, the net loss was
$4.9 million, or $0.30 per share, compared with a net loss of $3.3
million, or $0.26 per share, for the comparable period in 2003. Total
operating expenses for the first six months of 2004 increased
approximately 51 percent to $5.1 million from $3.4 million for the
first half of 2003.
The year-over-year increase in total operating expenses for the
three- and six-month periods of 2004 primarily reflects the Company's
continued expansion of its Combretastatin A4 Prodrug (CA4P) clinical
development program and the preclinical development of OXi4503. Since
the end of the second quarter of 2003, CA4P has advanced into clinical
trials in patients with colorectal cancer, newly diagnosed anaplastic
thyroid cancer and wet age-related macular degeneration. The Company
also has initiated several pre-clinical studies involving OXi4503.
At June 30, 2004, OXiGENE had cash, marketable securities and
restricted cash of $35.5 million, compared with $18.9 million at
December 31, 2003.
"Early results from two current clinical studies of CA4P have
reinforced the compound's position as a first-in-class vascular
targeting agent," said OXiGENE President and Chief Executive Officer
Fred Driscoll. "These results, presented by the principal
investigators at the 2nd International Conference on Vascular
Targeting in May, demonstrated CA4P's ability to induce blood flow
shutdown in tumors and to reduce foveal thickness associated with
retinal degenerative disease. Cancer and ophthalmology are the target
markets for CA4P, and our strategy is to expand the breadth of our
clinical programs to move as quickly as possible toward market
registration."
Preliminary data from a dose-escalation combination trial of CA4P
and carboplatin and paclitaxel chemotherapy in advanced ovarian cancer
were presented at the 2nd International Conference on Vascular
Targeting. A total of 12 evaluable patients had been entered into the
trial at the time of the presentation. Partial tumor response was
observed in five patients, while an equal number experienced a period
in which their disease was stable. The spectrum and severity of
symptoms noted were consistent with the administration of carboplatin
and paclitaxel alone. In studies to date, CA4P has been shown to be
safe and well tolerated, without drug-related serious adverse events
or dose-limiting toxicities.
Interim data also were presented from the Johns Hopkins University
School of Medicine study of CA4P in patients with wet age-related
macular degeneration (wet AMD). The compound was well tolerated in
that study. The side effects observed were below clinical
significance, and there were no serious adverse events or dose-
limiting toxicities reported. Evidence of CA4P's biological activity
was observed in one patient who experienced a significant reduction in
foveal thickness, a condition associated with wet AMD.
During the vascular targeting conference, one of the trial's
clinical investigators also discussed the case of a 35-year-old myopic
macular degeneration patient treated with CA4P under a special
exemption. Vision in the patient's study eye improved from 20/50 to
20/20 following therapy with CA4P.
"We are very encouraged by the progress of CA4P, and by the safety
profile the compound has exhibited in our current trials," Driscoll
said. "We have opened additional centers in our anaplastic thyroid
cancer studies, and plan to open another center in the current ovarian
cancer study, which is ongoing at Mount Vernon Hospital in the U.K."
Other recent accomplishments include:
-- The appointment of Adrian L. Harris, M.D. to the Company's
Scientific Advisory Board. Dr. Harris is Cancer Research UK
Professor of Clinical Oncology at the University of Oxford,
and Director of the Cancer Research UK Molecular Oncology
Laboratories at the University's Weatherall Institute of
Molecular Medicine. He is involved in clinical trials of
anti-angiogenesis therapy, signal blockade inhibitors and
immunotherapy. His clinical research interests include breast
cancer, melanoma and renal cancer.
-- The publication of peer-reviewed research demonstrating the
anti-tumor effects of OXiGENE's lead pre-clinical compound,
OXi4503. Published in the International Journal of Cancer, the
paper said OXi4503 properties warrant study of the compound as
a single-agent cancer therapy and as a complement to other
treatments.
Business Strategy and Milestones
Outlining OXiGENE's development strategy, Driscoll said, "Our
oncology clinical program is focused on making CA4P the first vascular
targeting agent to reach the market, and we have devised a four-point
plan to maximize our opportunity for success. The key elements of this
strategy are: Create as many potential opportunities for CA4P as
possible by testing the compound in a broad range of indications.
Conduct large-scale, multi-center trials evaluating the compound in
multiple treatment modalities. Open new combination trials to test
CA4P with conventional cancer therapies. And, seek the U.S. Food and
Drug Administration's (FDA) Fast Track and Orphan Drug designations
where possible to provide for rapid FDA response and market
exclusivity.
"In 2004, we plan to initiate a new combination clinical trial
with CA4P and chemotherapy in an indication as yet untested with the
compound. In our pre-clinical pipeline, Cancer Research U.K. is
continuing its development of our next-generation vascular targeting
agent, OXi4503, and the compound is on track to enter a clinical trial
at the end of 2004," Driscoll said.
"In ophthalmology, over the past several quarters we've made great
progress toward completing the steps necessary to file an
Investigational New Drug (IND) application to initiate a clinical
trial in myopic macular degeneration," he continued. "We are on
schedule to file our IND by the end of this year."
Second-quarter Conference Call Information
In conjunction with its second-quarter financial results,
OXiGENE's senior management will conduct a conference call at 10:00
a.m. ET today. Please note new dial-in numbers.
Time: 10:00 a.m. ET
Date: Wednesday, July 28, 2004
Dial-in numbers 800-662-5508 (U.S.)
913-981-5568 (international)
Confirmation Code: 233665
Webcast: www.oxigene.com
A replay of the call will be available beginning approximately two
hours after the call and ending at midnight ET Tuesday, August 3. To
access the replay, dial 888-203-1112 (domestic) or 719-457-0820
(international) and refer to reservation number 233665.
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: OXiGENE's plan to initiate
a new combination clinical study of CA4P with chemotherapy; initiation
of a clinical study of OXi4503 by the end of 2004; and submission of
an IND by the end of 2004 to initiate a clinical trial in myopic
macular degeneration. 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
Consolidated Statements of Operations
(All amounts in 000's except per share amounts)
Three months ended Six months ended
June 30, June 30,
2004 2003 2004 2003
(Unaudited) (Unaudited)
-------------------- ---------------------
Revenues:
License revenue $- $- $7 $20
----------- -------- ------------ --------
- - 7 20
Costs and expenses:
Research and development 1,846 397 2,774 1,123
General and administrative 1,072 1,454 2,332 2,242
Amortization of license
agreement 24 25 48 45
----------- -------- ------------ --------
Total costs and expenses: 2,942 1,876 5,154 3,410
Operating loss (2,942) (1,876) (5,147) (3,390)
Investment income 138 45 281 94
Interest expense - (18) - (25)
Other expense, net 1 - 1 (1)
Net loss $(2,803) $(1,849) $(4,865) $(3,322)
=========== ======== ============ ========
Basic and diluted net loss
per common share $(0.17) $(0.15) $(0.30) $(0.26)
Weighted average number
of common shares
outstanding 16,669 12,758 16,452 12,603
OXiGENE, Inc.
Condensed Consolidated Balance Sheets
(All amounts in 000's)
Assets June 30, December 31,
2004 2003
------------- -------------
Cash, marketable securities and
restricted cash $35,525 $18,936
Licensing agreement 1,020 1,069
Furniture, fixtures and equipment,
net 48 44
Other assets 504 156
------------- -------------
Total assets $37,097 $20,205
============= =============
Liabilities and stockholders' equity
Accounts payable $1,045 $1,701
Accrued expenses 2,094 2,034
Total stockholders' equity 33,958 16,470
------------- -------------
Total liabilities and stockholders'
equity $37,097 $20,205
============= =============
CONTACT: OXiGENE, Inc.
James B. Murphy, 781-547-5900
jmurphy@oxigene.com