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8-K - 8-K - Oncotelic Therapeutics, Inc. | b79808e8vk.htm |
Exhibit
99.1
Investor and Media Contact:
Michelle Edwards, Investor Relations
medwards@oxigene.com
650-635-7006
Michelle Edwards, Investor Relations
medwards@oxigene.com
650-635-7006
OXiGENE Reports Fourth Quarter and Year-End 2009 Results
SOUTH SAN FRANCISCO, CA February 25, 2010 OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a
clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye
diseases, reported financial results for the quarter and year ending December 31, 2009. The Company
also provided an update on recent clinical and corporate progress and outlook for 2010.
Financial Results
The Company reported a consolidated net loss for the fourth quarter of 2009 of $7.5 million,
compared with a consolidated net loss of $2.3 million for the same period in 2008. The
consolidated net loss for the quarter ended December 31, 2009 was impacted primarily by an increase
in operating expenses of approximately $2.8 million and a reduction in the non-cash gain
attributable to changes in the fair value of warrants and other financial instruments of
approximately $2.2 million.
For year ended December 31, 2009, the consolidated net loss was $28.9 million, compared to a
consolidated net loss of $21.9 million for 2008. The consolidated net loss for the year ended
December 31, 2009 was impacted primarily by an increase in operating expenses of approximately $5.2
million, a reduction in the non-cash gain attributable to changes in the fair value of warrants and
other financial instruments of approximately $1.2 million and a decrease in investment income of
approximately $0.5 million.
The increases in operating expenses for the three- and twelve-month periods ended December 31, 2009
over the same periods in 2008 were significantly impacted by an increase in the average headcount
of our research and development group to enable the management of several international clinical
studies, costs associated with the attempted merger with VaxGen, Inc. in the fourth quarter of 2009
and expenses associated with the departure of senior executives in the 2009 periods.
The net loss applicable to common stock was $0.12 per share for the three-month period ended
December 31, 2009, compared to a net loss of $0.05 per share for the same three-month period of
2008. The net loss applicable to common stock was $0.66 per share for the year ended December 31,
2009, compared to a net loss of $0.70 per share for 2008.
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 by OXiGENE ($15.6 million) over the carrying value of the non-controlling interest at
the time of the acquisition ($5.2 million)
4Q, YE 2009 OXGN Results
February 25, 2010
Page 2 of 7
February 25, 2010
Page 2 of 7
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, 2009, OXiGENE had cash, cash equivalents, restricted cash and marketable securities
of approximately $14.1 million. This compared with approximately $33.6 million at December 31,
2008, of which $14.7 million was held by Symphony ViDA.
OXiGENE today is focused on maximizing the potential of our highest priority clinical programs,
streamlining our operations and operating efficiently and cost-effectively, said Peter Langecker,
M.D., Ph.D., OXiGENEs Chief Executive Officer. We believe that our ZYBRESTAT clinical program in
non-small cell lung cancer is our most valuable near-term product opportunity, and we are looking
forward to presenting updated safety and efficacy data from this trial at the American Society for
Clinical Oncology meeting in early June. Even though we have curtailed enrollment in the FACT
trial, our ZYBRESTAT clinical program in anaplastic thyroid cancer is expected to yield important
data later this year or because the data analysis is event driven early in 2011. The program
remains a valuable asset not as a registration study under a special protocol assessment, but
rather as a potential proof-of-concept study for the antitumor activity of ZYBRESTAT. Similarly, we
see significant future value and opportunity in our second-generation vascular disrupting agent
OXi4503, which is showing promise in acute myelogenous leukemia models and in solid tumors. We
believe that our ophthalmology program is a monetizeable asset for which we intend to find an
outlicensing partner. In the near term, we anticipate implementing a plan that is designed to
position OXiGENE to realize its goals for 2010 and advance key programs toward important inflection
and decision points this year.
Fourth Quarter 2009 and Recent Highlights
Oncology
| In November, OXiGENE announced interim safety data from the FALCON trial, a Phase 2 study of ZYBRESTAT plus bevacizumab and chemotherapy in patients with non-small cell lung cancer (NSCLC). The data presented showed that the combination appeared to be well-tolerated, with no overlapping toxicities, and that of the 6 patients to date that have died, 5 were on the control arm of the study while only one was on the treatment (ZYBRESTAT) arm. |
| In December, OXiGENE announced that studies conducted in mouse xenograft and orthotopic models of acute myelogenous leukemia (AML) showed that OXi4503, a second-generation, dual-action vascular disrupting agent (VDA), demonstrated a higher level of anti-leukemic activity when administered as a single agent or in combination with bevacizumab, an anti-VEGF antibody, than when bevacizumab was used alone. The data were presented at the 2009 ASH [SPELL OUT] meeting and results showed that OXi4503 alone and in combination with bevacizumab showed more effectiveness in inducing regression of leukemic cells in bone marrow than bevacizumab alone or placebo. |
4Q, YE 2009 OXGN Results
February 25, 2010
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February 25, 2010
Page 3 of 7
Business Highlights
| In October, Peter Langecker, M.D., Ph. D., was appointed interim Chief Executive Officer. The OXiGENE Board of Directors has since appointed Dr. Langecker as Chief Executive Officer. |
Financial Outlook for 2010
Statements concerning OXiGENEs financial outlook for 2010 are forward-looking and are based on
current expectations. These statements do not include the potential impact of new business
collaborations, equity offerings or other transactions that may be closed or entered into after
February 25, 2010.
Cash utilized for operations in fiscal 2009 was approximately $28.7 million. Due to a recently
implemented restructuring, OXiGENE expects a reduction in cash utilized for operations in fiscal
2010 from a quarterly average in the first two quarters of the year of approximately $7.5 million
to a quarterly average of approximately $4.5 million in the last two quarters of the year.
Anticipated Milestones for 2010
Oncology
| The company expects to present efficacy and safety data from the FALCON study of ZYBRESTAT in patients with NSCLC at the American Society of Clinical Oncology (ASCO) meeting in June. |
| The company expects to present the final data from the Phase 1 study of OXi4503 in patients with advanced solid tumors at the ASCO meeting in June. |
| The company anticipates completion of enrollment in the ongoing study of OXi4503 in patients with hepatic tumor burden, with final data from this study to be reported by the end of the year. |
| The company anticipates the initiation of a Phase 1 study of OXi4503 in patients with AML. This investigator-sponsored study will be conducted in the United States, and we expect it to build upon the exciting preclinical data presented at 2009 ASH meeting. |
Ophthalmology
| The company anticipates the completion of enrollment in the FAVOR study, a Phase 2 proof-of-mechanism study of ZYBRESTAT, administered intravenously, in patients with polypoidal choroidal vasculopathy (PCV). Data from this study, combined with the preclinical work done to date, will be used to further partnering discussions. |
4Q, YE 2009 OXGN Results
February 25, 2010
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February 25, 2010
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Conference Call Today
Members of OXiGENEs management team will review fourth quarter and full-year 2009 results via a
webcast and conference call today 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 Companys website, www.oxigene.com.
Under the Investors tab, select the link to Events and Presentations.
OXiGENEs 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. ET, (4:30 p.m. PST)
on February 25, 2010 and ending at 7:30 p.m. ET (4:30 p.m. PST) on Wednesday, March 9, 2010. 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 58560383.
About ZYBRESTAT (fosbretabulin)
ZYBRESTAT is being evaluated in a Phase 2 study of patients with non-small cell lung cancer and
other clinical trials. OXiGENE believes that ZYBRESTAT is poised to become an important product in
a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). 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 demonstrated potent and selective
activity against tumor vasculature, as well as clinical activity against ATC, 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 solid tumors. Like its structural
analog, ZYBRESTAT (fosbretabulin / CA4P), 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 (i) single-agent activity against a range of xenograft tumor models; and (ii)
synergistic or additive effects when incorporated in various combination regimens with
chemotherapy, molecularly-targeted therapies (including tumor-angiogenesis inhibitors), and
radiation therapy. OXi4503 is currently being evaluated as a monotherapy in a Phase 1
dose-escalation trial in patients with advanced solid tumors and in patients with hepatic tumor
burden.
4Q, YE 2009 OXGN Results
February 25, 2010
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February 25, 2010
Page 5 of 7
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer
and eye diseases. The Companys major focus is developing vascular
disrupting agents (VDAs) 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.
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 OXiGENEs anticipated cash utilization, expected initiation, progress,
conclusion and reporting on clinical studies and availability of potential strategic collaborations
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,
timing of reporting interim and final data from the Phase 2 clinical trial of ZYBRESTAT in NSCLC,
timing of reporting data from the Phase 2/3 clinical trial of ZYBRESTAT in anaplastic thyroid
cancer, the enrollment rate and reporting of final results of a Phase 1b clinical trial of OXi4503
in patients with hepatic tumors, initiation of a Phase 1 clinical trial of OXi4503 in acute myeloid
leukemia, timing of reporting final results from the ongoing Cancer Research United Kingdom
sponsored Phase 1 clinical trial of OXi4503 in patients with advanced solid tumors, enrollment rate
and timing of reporting final results from a Phase 2 clinical trial of ZYBRESTAT for ophthalmology
in polypoidal choroidal vasculopathy, and timing or execution of a potential strategic
collaboration on any product or indication or any other strategic or financing transaction.
Additional information concerning factors that could cause actual results to materially differ from
those in the forward-looking statements is contained in OXiGENEs reports to the Securities and
Exchange Commission, including OXiGENEs 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, 2008.
# # #
4Q, YE 2009 OXGN Results
February 25, 2010
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February 25, 2010
Page 6 of 7
December 31, | December 31, | |||||||
2009 | 2008 | |||||||
Assets |
||||||||
Cash, cash equivalents and marketable securities |
$ | 14,072 | $ | 18,918 | ||||
Investments held by Symphony ViDA, Inc. |
| 14,663 | ||||||
License agreement |
484 | 581 | ||||||
Other assets |
1,061 | 869 | ||||||
Total assets |
$ | 15,617 | $ | 35,031 | ||||
Liabilities and stockholders equity |
||||||||
Accounts payable, accrued liabilities and other
liabilities |
$ | 7,618 | $ | 5,826 | ||||
Derivative liabilty |
2,200 | 466 | ||||||
OXiGENE Inc. stockholders equity |
5,799 | 19,307 | ||||||
Noncontrolling interest |
| 9,432 | ||||||
Total liabilities and stockholders equity |
$ | 15,617 | $ | 35,031 | ||||
4Q, YE 2009 OXGN Results
February 25, 2010
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February 25, 2010
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Three months ended | Twelve months ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
License revenue |
$ | | $ | | $ | | $ | 12 | ||||||||
Operating costs and expenses: |
||||||||||||||||
Research and development |
5,252 | 4,706 | 22,256 | 18,995 | ||||||||||||
General and administrative |
3,356 | 1,074 | 8,900 | 6,957 | ||||||||||||
Total operating costs and expenses |
8,608 | 5,780 | 31,156 | 25,952 | ||||||||||||
Loss from operations |
(8,608 | ) | (5,780 | ) | (31,156 | ) | (25,940 | ) | ||||||||
Gain from change in fair value of warrants and |
1,134 | 3,335 | 2,166 | 3,335 | ||||||||||||
other financial instruments |
||||||||||||||||
Investment income |
16 | 72 | 110 | 618 | ||||||||||||
Other income (expense), net |
(1 | ) | 53 | (63 | ) | 66 | ||||||||||
Consolidated net loss |
$ | (7,459 | ) | $ | (2,320 | ) | $ | (28,943 | ) | $ | (21,921 | ) | ||||
Net loss attributed to noncontrolling interest |
(31 | ) | (520 | ) | (4,215 | ) | (520 | ) | ||||||||
Net loss attributed to OXiGENE Inc. |
$ | (7,428 | ) | $ | (1,800 | ) | $ | (24,728 | ) | $ | (21,401 | ) | ||||
Excess purchase price over carrying value of |
| | (10,383 | ) | | |||||||||||
noncontrolling interest acquired in Symphony ViDA,
Inc. |
||||||||||||||||
Net loss applicable to common stock |
$ | (7,428 | ) | $ | (1,800 | ) | $ | (35,111 | ) | $ | (21,401 | ) | ||||
Basic and diluted net loss per common share, |
$ | (0.12 | ) | $ | (0.05 | ) | $ | (0.66 | ) | $ | (0.70 | ) | ||||
attributed to OXiGENE, Inc. common shares |
||||||||||||||||
Weighted average number of common shares outstanding |
62,492 | 37,482 | 53,414 | 30,653 |