Attached files
| file | filename |
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| 8-K - FORM 8-K - Oncotelic Therapeutics, Inc. | b87622e8vk.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 Second Quarter 2011 Financial Results
SOUTH SAN FRANCISCO, Calif., August 10, 2011 (GLOBE NEWSWIRE) — 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.
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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). |
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| • | 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 EST (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.
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
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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.
###
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OXiGENE, Inc.
Condensed Balance Sheets
(Unaudited)
Condensed Balance Sheets
(Unaudited)
| 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 | ||||
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OXiGENE, Inc.
Condensed Statements of Operations
(Unaudited)
Condensed Statements of Operations
(Unaudited)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 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 | ) | |||||
Basic and diluted net (loss)
income per common share |
$ | (0.32 | ) | $ | 0.73 | $ | (0.49 | ) | $ | (2.54 | ) | |||||
Weighted average number of
common shares outstanding -
basic and diluted |
9,110 | 3,477 | 7,820 | 3,348 | ||||||||||||