OXiGENE, Inc. (Nasdaq:OXGND), a clinical-stage, biopharmaceutical
company developing novel therapeutics to treat cancer and eye
diseases, reported financial results for the year ending December
31, 2010. The Company also provided an update on recent clinical
and corporate progress and outlook for 2011.
Financial Results
For the year ended December 31, 2010, the consolidated net loss
was $23.8 million, compared with a consolidated net loss of $28.9
million for 2009. The consolidated net loss for the year ended
December 31, 2010 was impacted primarily by a reduction in
operating expenses of approximately $12.7 million, offset by an
$8.2 million fluctuation in the gain (loss) from the change in fair
value of warrants and other financial instruments – from a non-cash
gain of approximately $2.2 million in the 2009 fiscal period to a
noncash loss of approximately $6.0 million in the 2010 fiscal
period.
The decrease in operating expenses for the twelve-month period
ended December 31, 2010 over the same period in 2009 is primarily
the result of OXiGENE's decision in February 2010 to implement a
restructuring plan in order to focus the Company's resources on its
highest-value clinical assets and reduce its cash utilization. This
restructuring resulted in the discontinuation of enrollment in some
of the Company's clinical programs and the reduction of its work
force by approximately 49%. By this action, OXiGENE was able
to reduce its average quarterly cash utilization by approximately
48 % over the course of 2010.
The net loss applicable to common stock was $5.96 per share for
the year ended December 31, 2010, compared with a net loss
applicable to common stock of $13.15 per share for fiscal
2009. These per share results reflect the effect of the 1:20
reverse stock split that became effective on February 22, 2011.
In fiscal 2009, OXiGENE recorded the acquisition of the Symphony
ViDA variable interest entity as a capital transaction, and the
$10.4 million excess of the fair market value of the shares of
common stock issued to Symphony by OXiGENE ($15.6 million) over the
carrying value of the non-controlling interest at the time of the
acquisition ($5.2 million) is reflected as an increase in the loss
applicable to common stock within the calculation of basic and
diluted earnings per share for the year ended December 31,
2009.
At December 31, 2010, OXiGENE had cash, cash equivalents and
restricted cash of approximately $4.7 million, compared with
approximately $14.1 million at December 31, 2009.
"OXiGENE has made significant progress in advancing our clinical
programs toward tangible milestones, such as the presentation of
the ATC clinical data at scientific meetings in Paris and Milan and
the upcoming meeting with the FDA. Furthermore, a key
priority for 2010 was to simplify our balance sheet and focus on
managing the company in a fiscally responsible manner," said Peter
Langecker, M.D., Ph.D., OXiGENE's Chief Executive Officer. "Over
the past several months we have undertaken practical, meaningful
measures to strengthen our financial standing, including the
reverse stock split which is now effective and which brings us
towards compliance with NASDAQ listing requirements. We remain
focused on maximizing the value of our ZYBRESTAT™ oncology programs
through clinical progress and partnering efforts. We are looking
forward to our upcoming meeting with the FDA on March 16th which
should, in due course, provide us with insight into the next
appropriate regulatory steps to pursue in anaplastic thyroid
cancer, which is a rare but aggressive and devastating disease for
which no effective therapy is available. We believe that 2011 will
be a pivotal year for OXiGENE as our programs gain additional
visibility within the oncology community and among potential
pharmaceutical partners."
Fourth Quarter 2010 and Recent Clinical
Highlights
-- In October, OXiGENE presented initial results from the
FACT study, a randomized, controlled, Phase 2/3 study of ZYBRESTAT
(fosbretabulin, CA4P) in patients with anaplastic thyroid cancer at
the European Society for Medical Oncology (ESMO) meeting in Milan,
Italy, showing an increased overall survival (OS) in patients
receiving ZYBRESTAT in addition to standard chemotherapy. The
data also suggested a survival benefit in multiple subgroups of
patients, including patients who had more advanced Stage IVC
disease, patients who were heavily pretreated with surgery,
radiation or chemotherapy, and patients less than 60 years of age,
who tend to have a more aggressive course of
disease. Importantly, the data also showed that 23% of
patients who received ZYBRESTAT and chemotherapy were alive at one
year, compared with 9% of patients who received chemotherapy
alone.
-- In November, OXiGENE announced positive interim data
from the FALCON trial, a randomized, controlled Phase 2 study of
ZYBRESTAT in patients with non-small cell lung cancer (NSCLC) at
the AACR/EORTC/NCI meeting in Berlin, Germany. The combination
regimen including ZYBRESTAT was observed to be well-tolerated, with
no significant cumulative toxicities when compared with the control
arm. The updated analysis showed that the median time to
progression for patients receiving ZYBRESTAT plus bevacizumab and
chemotherapy remained stable (as compared to the data presented at
ASCO 2010) at 9.5 months, compared with a median time to
progression of 8.8 months for patients receiving bevacizumab and
chemotherapy alone. Of the patients in the study arm, 50% achieved
a partial response, compared with 38% in the control arm.
Business Highlights
-- In November, OXiGENE announced that the Company was
awarded $733,000 in tax credit grants by the U.S. Internal Revenue
Service under a new program created as part of the Patient
Protection and Affordable Care Act of 2010, called the Qualifying
Therapeutic Discovery Project. The credit is a tax benefit awarded
to therapeutic discovery projects that show a reasonable potential
to result in new therapies that treat areas of unmet medical need
or prevent, detect or treat chronic or acute diseases and
conditions. OXiGENE intends to use the proceeds of the grant funds
to continue its trials of ZYBRESTAT and OXi4503.
-- In January 2011, OXiGENE entered into separate Warrant
Exchange Agreements with each of the holders of outstanding
warrants originally issued in March 2010 to eliminate all of such
warrants having "ratchet" price-based anti-dilution protection
features in exchange for shares of Company common stock and a lower
number of warrants having no price based anti-dilution
protections.
-- The board of directors voted unanimously to implement a 1:20
reverse stock split of the Company's common stock, following
authorization of the reverse split by a shareholder vote on
December 21, 2010. The reverse split became effective on
February 22, 2011. OXiGENE is also pursuing measures to regain
compliance with NASDAQ's listing standards and is transferring the
Company's listing from The NASDAQ Global Market to The NASDAQ
Capital Market upon the open of NASDAQ trading on March 3,
2011.
Outlook for 2011
Acquiring additional capital to continue the development of our
valued assets remains a high priority for the Company. The
Company believes that the outcome of its scheduled meeting with the
FDA on March 16, 2011 will be a significant factor in its ability
to obtain additional financial resources, and in the amount and
nature of those additional financial resources. OXiGENE will
announce the outcome of that meeting as soon as practicable after
receiving final minutes of the meeting from the FDA, which may not
be for several weeks following the date of the
meeting. Meanwhile, the Company continues to maintain a
disciplined financial strategy with its remaining capital
resources.
Anticipated Milestones for 2011
-- The company expects the University of Florida to
initiate a Phase 1 study of OXi4503 in patients with acute
myelogenous leukemia (AML) in Q1 2011, pursuant to an investigator
sponsored clinical trial agreement previously entered into with
OXiGENE.
-- The company expects to meet with the FDA on March 16th to
discuss the results of the FACT study and to receive guidance on an
appropriate regulatory path. The company plans to announce the
outcome of the meeting when it receives the meeting minutes from
the agency, anticipated in mid-April.
-- The company expects the Gynecologic Oncology Group (GOG)
to initiate a National Cancer Institute / Cancer Therapy Evaluation
Program (NCI/CTEP)-sponsored Phase 2 study of ZYBRESTAT used in
conjunction with bevacizumab in patients with relapsed ovarian
cancer in Q1 2011. The company announced on February 14th,
2011, that it has entered into a Cooperative Research and
Development Agreement (CRADA) with NCI/CTEP to collaborate on this
study. Under the terms of the agreement, OXiGENE will provide
ZYBRESTAT to NCI/CTEP for an NCI/CTEP-sponsored study to be
conducted by the Gynecologic Oncology Group (GOG), an organization
dedicated to clinical research in the field of gynecologic
cancer.
-- The company has submitted an abstract and expects to
present the final data from the FACT study at ASCO in June
2011.
-- The company has submitted an abstract and expects to
present additional data from the FALCON study at ASCO in June
2011.
Conference Call Today
Members of OXiGENE's management team will review fourth quarter
and full-year 2010 results via a webcast and conference call today,
March 3, 2011, at 4:30 p.m. ET (1:30 p.m. PST). 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. EST, (4:30 p.m. PST) on March 3, 2011 and ending at midnight
EST (9:00 p.m. PST) on Wednesday, March 9, 2011. To access the
replay, please dial (800) 642-1687 if calling from the United
States or Canada, or +1 (706) 645-9291 from international
locations. Please refer to replay pass code 44782248.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing
novel therapeutics to treat cancer and eye diseases. The Company's
major focus is developing vascular disrupting agents that
selectively disrupt abnormal blood vessels associated with solid
tumor progression and visual impairment. OXiGENE is dedicated to
leveraging its intellectual property and therapeutic development
expertise to bring life-extending and life-enhancing medicines to
patients.
The OXiGENE, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4969
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, outcomes, and
regulatory guidance relative to our clinical programs, achievement
of our business and financing objectives and ability to regain
compliance with Nasdaq listing standards 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,
2009.
OXiGENE,
Inc. |
Condensed Consolidated
Balance Sheets Data |
|
|
|
|
December 31,
2010 |
December 31,
2009 |
|
(Amounts in
000's) |
|
(Unaudited) |
Assets |
|
|
|
|
|
Cash, cash equivalents and
restricted cash |
$ 4,677 |
$ 14,072 |
Prepaid expenses |
256 |
644 |
License agreement |
386 |
484 |
Other assets |
248 |
417 |
|
|
|
Total assets |
$ 5,567 |
$ 15,617 |
|
|
|
Liabilities and stockholders'
(deficit) equity |
|
|
|
|
|
Accounts payable and accrued
liabilities |
$ 3,211 |
$ 7,618 |
Derivative liabilities |
7,611 |
2,200 |
Total stockholders' (deficit)
equity |
(5,255) |
5,799 |
|
|
|
Total liabilities and
stockholders' (deficit) equity |
$ 5,567 |
$ 15,617 |
|
OXiGENE, Inc. |
Condensed Consolidated Statements
of Operations |
|
|
|
|
Years ended
December 31, |
|
(Amounts in 000's except
per share amounts) |
|
(Unaudited) |
|
2010 |
2009 |
|
|
|
Costs and expenses: |
|
|
|
|
|
Research and
development |
$ 12,114 |
$ 22,256 |
General and
administrative |
5,885 |
8,900 |
Restructuring |
510 |
-- |
|
|
|
Total costs and expenses |
18,509 |
31,156 |
|
|
|
Operating loss |
(18,509) |
(31,156) |
|
|
|
Change in fair value of
warrants and other financial instruments |
(6,018) |
2,166 |
Investment income |
17 |
110 |
Other (expense) income,
net |
740 |
(63) |
|
|
|
Consolidated net loss |
$ (23,770) |
$ (28,943) |
Loss attributed to non controlling
interest |
-- |
(4,215) |
|
|
|
Net loss attributed to OXiGENE
Inc. |
$ (23,770) |
$ (24,728) |
|
|
|
Excess purchase price over carrying value of
noncontrolling interest acquired in Symphony ViDA, Inc. |
-- |
(10,383) |
|
|
|
Net loss applicable to common stock |
$ (23,770) |
$ (35,111) |
|
|
|
Basic and diluted net loss per common
share |
$ (5.96) |
$ (13.15) |
|
|
|
Weighted average number of common shares
outstanding |
3,988 |
2,671 |
CONTACT: Investor and Media Contact:
Michelle Edwards, Investor Relations
medwards@oxigene.com
650-635-7006
Oxigene, Inc. (MM) (NASDAQ:OXGND)
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