Exhibit 99.1
OXiGENE Reports Second-Quarter 2003 Financial Results and Operational
Goals for Remainder of Year
WATERTOWN, Mass.--(BUSINESS WIRE)--Aug. 8, 2003--OXiGENE, Inc.
(NASDAQ: OXGN, XSSE: OXGN), a leader in the development of
biopharmaceutical compounds designed to target aberrant blood vessels
in solid tumors and ocular neovascular diseases, today reported
financial results for the second quarter and six months ended June 30,
2003.
"In recent months we have announced numerous financial and
operational accomplishments," said OXiGENE President and Chief
Executive Officer Fred Driscoll. "Notable among these achievements,
CA4P has entered new human clinical trials in cancer and
ophthalmology, creating potential new opportunities for our vascular
targeting technology in large and growing markets. In addition, CA4P
received the U.S. Food and Drug Administration's orphan drug and fast
track designations, which we view as important milestones as we
advance our lead compound forward.
"These events provided the impetus that enabled us to close in
June on a $15 million private placement of common stock that
strengthens our balance sheet and enhances our overall financial
position," Driscoll said. "We are now poised to advance our lead
compound aggressively toward commercialization and to continue the
development of our exciting pre-clinical pipeline."
Financial Discussion
Net loss for the second quarter of 2003 was $1.8 million, or $0.14
per share, compared with a net loss of $2.7 million, or $0.23 per
share, in the second quarter of 2002. For the first six months of
2003, the net loss was $3.3 million, or $0.26 per share, compared with
a net loss of $6.9 million, or $0.58 per share, for the first six
months of 2002. Based on its current expense run-rate, OXiGENE expects
its full-year 2003 net loss to be approximately $7 million. The
Company reported a net loss of $11 million for full-year 2002.
As of June 30, 2003, OXiGENE had $22.9 million in cash and
marketable securities, compared with $11.8 million as of December 31,
2002.
"The continued improvement in our bottom line is a direct result
of the focused drug-development strategy we initiated in late 2001,"
Driscoll said. "Concentrating on vascular targeting, which we believe
will offer the greatest potential return for our shareholders, has
allowed us to reduce total expenses in 2003 by approximately 60
percent year-to-date compared with the same period in 2002. We
continue to be selective about how and where we allocate our clinical
and pre-clinical resources. As evidenced by our relationships with
such pre-eminent organizations as The Foundation Fighting Blindness,
the National Cancer Institute and Cancer Research UK, we are taking
advantage of opportunities to secure alliances that will help to fund
our programs and build our pipeline of compounds."
Recent highlights:
-- Private placement: Three large institutional investors
purchased 1,500,000 shares of the Company's Common Stock at
$10 per share. OXiGENE received approximately $14 million from
the sale after the deduction of commissions and expenses. The
three institutional investors also received warrants for a
term of two years to purchase an aggregate of 375,000 shares
of OXiGENE Common Stock, which will be exercisable at a price
of $15 per share in cash.
-- Fast-track designation: The U.S. Food and Drug Administration
granted the fast-track designation to OXiGENE's lead compound,
Combretastatin A4 Prodrug, for the treatment of anaplastic
thyroid cancer. CA4P is currently in Phase II human trials in
this indication. The fast-track program is intended to foster
the development of new drugs designed to treat
life-threatening conditions for which there is no approved
therapy. This designation creates opportunities for OXiGENE to
meet with and receive input from the agency in the design of
clinical efficacy studies needed to support market approval.
-- Orphan-drug status: The FDA approved OXiGENE's application to
classify CA4P as an "orphan drug" for the treatment of
anaplastic thyroid cancer. In addition, the agency broadened
the orphan drug designation for CA4P to include the treatment
of medullary, Stage IV papillary and Stage IV follicular
thyroid cancers. OXiGENE estimates a prevalence of
approximately 58,000 people in the United States with one of
these four stages or sub-types of cancer.
-- New clinical trials: CA4P moved into new clinical trials in
cancer and ophthalmology. In the United Kingdom, the
investigational compound is being studied in a Phase I/II
combination with a standard-of-care chemotherapeutic regimen
(carboplatin and paclitaxel) in women with advanced ovarian
cancer. CA4P also is being evaluated in a Phase I/II study in
patients with wet age-related macular degeneration, the cause
of significant vision loss in between 2 million and 3 million
Americans. This trial is being conducted at The Johns Hopkins
University School of Medicine's Wilmer Eye Institute in
Baltimore. CA4P is now in a total of five human clinical
studies.
-- Peer-reviewed pre-clinical research: Investigators writing in
the August 2003 issue of the journal Investigative
Ophthalmology and Visual Science reported the results of
independent animal studies into the potential role of CA4P in
preventing and treating certain retinal degenerative diseases.
The pre-clinical studies showed that CA4P suppresses
development and induces regression of choroidal
neovascularization, a condition that leads to severe vision
loss.
-- Cancer Research UK Alliance: Cancer Research UK (CRUK) is
collaborating with OXiGENE on the final pre-clinical
development of OXi4503, one of the Company's three
second-generation vascular targeting agents. CRUK, one of the
world's largest cancer research organizations, plans to move
the compound into Phase I clinical trials next year.
Business Outlook
Commenting on the Company's clinical development outlook for the
remainder of 2003, Driscoll said, "Seven months into 2003, I am proud
of the fact that we already have accomplished many of the clinical and
pre-clinical objectives we announced in tandem with our fourth-quarter
results in February. Patient accrual is on schedule in the Phase II
and Phase I/II oncology studies of CA4P, and we expect to initiate a
fifth cancer trial before the end of the year. Recruitment also has
begun in the wet AMD trial at Johns Hopkins, the first study of a
vascular targeting agent in a non-life-threatening indication. In
addition, Cancer Research UK is moving ahead with final pre-clinical
testing of our lead second-generation drug candidate, OXi4503, which
is on pace to enter the clinic in 2004. Development also continues on
our other pre-clinical compounds, OXi6197 and OXi8007, giving us a
strong pipeline of Vascular Targeting Agents to complement CA4P.
"On the business side, we remain focused on identifying potential
licensing opportunities for CA4P," Driscoll continued. "The clinical
development progress we have made during the past 12 months has
demonstrated the potential breadth of our vascular targeting platform.
We continue to engage in positive discussions with prospective
licensing partners in both oncology and ophthalmology."
Company to Host Conference Call
OXiGENE will host a conference call with investors at 10:00 a.m.
ET today, Friday, August 8, to review its second-quarter 2003
financial results and provide a business update. Callers in the U.S.
can participate by dialing (888) 214-7596, while international callers
should dial (415) 537-1841. For a live and archived audio Webcast of
the call, go to www.oxigene.com/investor/confcalls.asp.
A telephone rebroadcast will be available two hours after the call
until noon ET August 10, 2003. To hear this replay, dial (800)
633-8284 (U.S.) or (402) 977-9140 (international) and use passcode
21155054.
About OXiGENE
OXiGENE is the world leader in the development of novel
biopharmaceutical compounds called vascular targeting agents (VTAs),
which are designed to block the flow of blood that supplies solid
cancer tumors and other abnormal vasculature, while leaving healthy
cells intact. OXiGENE's lead VTA, Combretastatin A4 Prodrug, has
advanced into Phase II and combination clinical trials in cancer
patients in the United States and Europe. The investigational compound
also is being evaluated in an ophthalmic study in patients with 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
This news release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements include but are not limited to: the Company's ability to
substantially advance its lead compound toward commercialization; the
continuation of the development of the Company's pre-clinical
pipeline; the expectation that the Company's full-year 2003 net loss
will be approximately $7 million; the future exercise of warrants for
OXiGENE Common Stock; CRUK's plans to move OXi4503 into Phase I
clinical trials next year; the initiation of a fifth cancer trial of
CA4P in 2003; the planned initiation of a clinical study of OXi4503 in
2004; OXiGENE's expectation of continued progress in the development
of its pre-clinical drug candidates; and future partnership and/or
licensing agreements. 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 Balance Sheet
(All amounts in thousands US Dollars)
June 30 December 31,
Assets 2003 2002
--------------------------
Current Assets: (Unaudited) (Audited)
--------------------------
Cash $ 11,643 $ 3,752
Available-for-sale marketable
securities 11,219 $ 8,078
Other current assets 176 40
--------------------------
Total current assets 23,038 11,870
Net property and equipment 219 487
Other assets 1,193 1,241
--------------------------
Total assets $ 24,450 $ 13,598
==========================
Liabilities and stockholders' equity
Current Liabilities:
Amount payable for license agreement -
current $ 296 $ 290
Accrued expenses 1,716 1,717
Accounts payable 994 1,417
--------------------------
Total current liabilities 3,006 3,424
Amount payable under license agreement -
non-current - 154
Stockholders' equity
Common stock 142 127
Additional paid-in capital 97,603 83,465
Accumulated deficit (74,980) (71,654)
Notes receivable (1,590) (2,187)
Other 269 269
--------------------------
Total stockholders' equity 21,444 10,020
--------------------------
Total liabilities and stockholders' equity $ 24,450 $ 13,598
==========================
OXiGENE, Inc.
GAAP Consolidated Statement
of Operations
(All amounts in thousands US 3 months 3 months 6 months 6 months
Dollars, except per share ended ended ended ended
amounts) June 30, June 30, June 30, June 30,
2003 2002 2003 2002
----------------------------------------
(unaudited) (unaudited)
----------------------------------------
Revenues:
Licensing revenue $ - $ - $ 20 $ -
----------------------------------------
Total revenues - - 20 -
Expenses:
Costs relating to licensing
revenue - - - -
Amortization of license
agreement 25 22 45 42
Operating expenses 1,851 2,781 3,365 8,321
----------------------------------------
Total expenses 1,876 2,803 3,410 8,363
----------------------------------------
Operating loss (1,876) (2,803) (3,390) (8,363)
----------------------------------------
Gain on sale of Joint
Venture - - - 1,325
Other income, net 27 63 68 127
----------------------------------------
Net loss $ (1,849) $ (2,740) $ (3,322) $ (6,911)
========================================
Net loss per common share:
Basic $ (0.14) $ (0.23) $ (0.26) $ (0.58)
========================================
Diluted $ (0.14) $ (0.23) $ (0.26) $ (0.58)
========================================
Shares used to compute net
loss per share:
Basic 12,758 11,819 12,603 11,844
========================================
Diluted 12,758 11,819 12,603 11,844
========================================
CONTACT: Sharon Merrill Associates, Inc.
617-542-5300
David Calusdian (Investors)
dcalusdian@investorrelations.com
Scott Solomon (Media)
ssolomon@investorrelations.com