OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical
company developing novel therapeutics to treat cancer and eye
diseases, reported financial results for the quarter ending June
30, 2011 and provided an update on recent clinical and corporate
progress.
Financial Results
The Company reported a net loss for the three-month period ended
June 30, 2011 of $2.9 million compared with net income of $2.5
million for the same three-month period of 2010. The difference in
results for the comparable three-month periods was due to a
non-recurring non-cash gain resulting from the change in fair value
of warrants and other financial instruments in the 2010 three month
period of $7.5 million, partially offset by a $2.1 million
reduction in total costs and expenses from $5.0 million in the 2010
period to $2.9 million in the 2011 period.
The Company reported a net loss for the six-month period ended
June 30, 2011 of $3.8 million compared with a net loss of $8.5
million for the same six-month period of 2010. The difference
in results for the comparable six-month periods was due primarily
to a reduction in total costs and expenses of $5.4 million from
$11.4 million in the 2010 period to $6.0 million in the 2011
period, offset by the non-cash change in fair value of warrants and
other financial instruments from a $2.9 million gain in the 2010
six month period to a $2.2 million gain in the 2011 six month
period.
The reduction in operating costs and expenses for both the three
and six month comparable periods is primarily attributable to
reductions in spending in a number of clinical program and support
costs in connection with the restructuring plan implemented in the
first quarter of 2010. Operating expenses for the six months
of 2010 were also impacted by a $0.5 million one-time restructuring
charge.
During the six months ended June 30, 2011, the Company sold
approximately 4.6 million shares of common stock pursuant to an "at
the market" (ATM) sales agreement executed in July 2010, resulting
in net proceeds to the Company of approximately $10.4
million. In addition, during its third quarter, the Company
has sold approximately 2.7 million shares of common stock pursuant
to the ATM, resulting in net proceeds to the Company of
approximately $6.0 million. This additional capital is
allowing the Company to continue to pursue its future product
development options. Based on the current clinical projects
that the Company has committed to, the Company believes that its
cash resources, including amounts raised during the third quarter,
are sufficient to fund operations through 2012.
At June 30, 2011, OXiGENE had cash, cash equivalents and
restricted cash of approximately $8.5 million compared with
approximately $4.7 million at December 31, 2010.
"The presentation of data at ASCO in June was a significant
milestone for OXiGENE," said Peter J. Langecker, M.D., Ph.D.,
OXiGENE's Chief Executive Officer. "The FACT data on overall
survival in patients with anaplastic thyroid cancer strongly
suggests that ZYBRESTAT⢠may be effective in battling one of the
most lethal cancers, and has generated enthusiasm from the oncology
community and the key opinion leaders in this field. Our immediate
focus now is to obtain sufficient financing to conduct the FACT2
Phase 3 registration trial in ATC, and we are actively pursuing
this goal."
Continued Langecker, "While financing FACT2 is a near-term
challenge, OXiGENE currently has sufficient capital to continue
development of our other clinical programs, including the FALCON
study in non-small cell lung cancer, which has been fully enrolled
for over a year and for which we expect to present overall survival
data by the end of 2011. The Phase 2 study of ZYBRESTAT and
bevacizumab in patients with ovarian cancer continues to advance
under the auspices of the Gynecologic Oncology Group (GOG), as does
the Phase 1 study of OXi4503 in patients with acute myelogenous
leukemia (AML) being conducted at the University of Florida, for
which we expect to present data in 2012."
Corporate Highlights
- In June, the Company presented data from two clinical studies
at the annual ASCO meeting in Chicago.
- Data from the FACT study of ZYBRESTAT plus chemotherapy in
patients with anaplastic thyroid cancer showed that the median
overall survival (OS) time was 5.2 months for patients who received
ZYBRESTAT and chemotherapy, compared with 4.0 months for patients
receiving chemotherapy alone (Hazard Ratio (95% CI) of 0.72 (0.43,
1.20)), representing a 28% reduction in the risk of death for
patients receiving ZYBRESTAT and chemotherapy. At one year,
the likelihood of being alive was 26% for patients treated with
ZYBRESTAT and chemotherapy compared with 9% for patients treated
with chemotherapy alone. As in other studies of ZYBRESTAT, the most
clinically relevant side effects reported in the study were
neutropenia, transient hypertension, clinically asymptomatic QTc
prolongation and tumor pain.
- An updated analysis of data from the FALCON study of ZYBRESTAT
plus bevacizumab and chemotherapy in patients with non-small cell
lung cancer (NSCLC) conducted approximately 11 months after the
enrollment of the last patient in June 2010 showed that the
combination regimen of ZYBRESTAT plus bevacizumab and chemotherapy
was observed to be well-tolerated with no significant cumulative
toxicities when compared with the control arm of the study. In
addition, a pre-specified subgroup analysis showed meaningful
improvements in median time to progression for patients with poor
performance status (ECOG Performance Status 1).
- In June, the Company announced that it had regained compliance
with certain NASDAQ listing requirements under review by the NASDAQ
Hearing Panel.
- In April, the Company announced initiation of an
investigator-sponsored Phase 1 trial of OXi4503 in patients with
AML or myelodysplastic syndrome (MDS), being conducted at the
University of Florida and with support by The Leukemia &
Lymphoma Society's Therapy Acceleration Program.
- As of July, the Company raised additional capital to allow it
to pursue its future product development options.
- Upcoming highlights in the third quarter include the
presentation of overall survival data from the FALCON study at a
medical conference, and data from the Phase 1 study of OXi4503 in
AML patients in the first half of 2012.
Conference Call Today
Members of OXiGENE's management team will review second quarter
2011 results via a webcast and conference call today, August 10,
2011, at 4:30 p.m. EDT (1:30 p.m. PDT). 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 "Investors" tab,
select the link to "Events and Presentations."
OXiGENE's earnings conference call can also be heard live by
dialing (888) 841-3431 in the United States and Canada, and +1
(678) 809-1060 for international callers, five minutes prior to the
beginning of the call. A replay will be available starting at 7:30
p.m. EDT, (4:30 p.m. PDT) on August 10, 2011 and ending at midnight
EDT (9:00 p.m. PDT) on Tuesday, August 16, 2011. To access the
replay, please dial (855) 859-2056 if calling from the United
States or Canada, or +1 (404) 537-3406 from international
locations. Please refer to replay pass code 88795709.
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.
The OXiGENE, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4969
About ZYBRESTAT (fosbretabulin tromethamine / CA4P)
ZYBRESTAT is being evaluated in studies of patients with
anaplastic thyroid cancer, non-squamous non-small cell lung cancer,
platinum-sensitive ovarian cancer and other clinical trials.
OXiGENE believes that ZYBRESTAT is poised to become an important
therapeutic option in a novel class of small-molecule drug
candidates called vascular disrupting agents. 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 trials in solid tumors, ZYBRESTAT has suggested potent and
selective activity against tumor vasculature, as well as possible
clinical activity against anaplastic thyroid cancer, ovarian cancer
and various other solid tumors.
About OXi4503
OXi4503 (combretastatin A1 di-phosphate / CA1P) is a
dual-mechanism vascular disrupting agent (VDA) that is being
developed in clinical trials for the treatment of leukemias and
solid tumors. Like its structural analog ZYBRESTAT, OXi4503 has
been observed to block and destroy tumor vasculature, resulting in
extensive tumor cell death and necrosis. In addition, preclinical
data indicate 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
single-agent activity against a range of xenograft tumor models;
and synergistic or additive effects when incorporated in various
combination regimens with chemotherapy, molecularly-targeted
therapies (including tumor-angiogenesis inhibitors), and radiation
therapy. OXi4503 has been evaluated as a monotherapy in a Phase 1
dose-escalation trial in patients with advanced solid tumors and in
patients with cancers involving the liver.
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, which include the timing of advancement or outcomes of our
clinical programs and achievement of our business and financing
objectives 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, the inherent risks of drug development and
regulatory review, and the availability of additional financing to
continue development of our programs.
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,
2010.
OXiGENE,
Inc. |
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Condensed Balance
Sheets |
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(Unaudited) |
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|
June 30, 2011 |
December 31,
2010 |
|
(Amounts in
000's) |
Assets |
|
|
|
|
|
Cash, cash equivalents and
restricted cash |
$ 8,500 |
$ 4,677 |
Prepaid expenses |
396 |
256 |
License agreement |
337 |
386 |
Other assets |
227 |
248 |
|
|
|
Total assets |
$ 9,460 |
$ 5,567 |
|
|
|
Liabilities and stockholders'
equity (deficit) |
|
|
|
|
|
Accounts payable and accrued
liabilities |
$ 2,190 |
$ 3,211 |
Derivative liabilities |
48 |
7,611 |
Total stockholders' equity
(deficit) |
7,222 |
(5,255) |
|
|
|
Total liabilities and
stockholders' equity (deficit) |
$ 9,460 |
$ 5,567 |
|
|
|
|
|
OXiGENE, Inc. |
|
|
|
|
Condensed Statements of
Operations |
|
|
|
(Unaudited) |
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Three months ended
June 30, |
Six months ended
June 30, |
|
|
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|
2011 |
2010 |
2011 |
2010 |
|
(All amounts in
000's except per share amounts) |
Costs and expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
$ 1,499 |
$ 3,348 |
$ 3,182 |
$ 7,533 |
General and
administrative |
1,401 |
1,678 |
2,786 |
3,381 |
Restructuring |
-- |
-- |
-- |
510 |
|
|
|
|
|
Total costs and expenses |
2,900 |
5,026 |
5,968 |
11,424 |
|
|
|
|
|
Operating loss |
(2,900) |
(5,026) |
(5,968) |
(11,424) |
|
|
|
|
|
Change in fair value of
warrants and other financial instruments |
(31) |
7,539 |
2,179 |
2,906 |
Investment income |
1 |
4 |
2 |
11 |
Other (expense) income,
net |
(2) |
20 |
(8) |
16 |
|
|
|
|
|
Net (loss) income |
$ (2,932) |
$ 2,537 |
$ (3,795) |
$ (8,491) |
|
|
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Basic and diluted net (loss) income per
common share |
$ (0.32) |
$ 0.73 |
$ (0.49) |
$ (2.54) |
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|
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Weighted average number of common shares
outstanding - basic and diluted |
9,110 |
3,477 |
7,820 |
3,348 |
CONTACT: Investor and Media Contact:
Michelle Edwards, Investor Relations
medwards@oxigene.com
650-635-7006