-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Gus4PnxTxOsbdD2cby0ZiVlzej7rmECzB5L4OUDpkTJmeZXdbXjAnq61cEQgGsPj ml5mRenxpwDOX5CDQmLVEw== 0000950135-08-001286.txt : 20080228 0000950135-08-001286.hdr.sgml : 20080228 20080228094937 ACCESSION NUMBER: 0000950135-08-001286 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080228 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080228 DATE AS OF CHANGE: 20080228 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OXIGENE INC CENTRAL INDEX KEY: 0000908259 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133679168 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21990 FILM NUMBER: 08648637 BUSINESS ADDRESS: STREET 1: 321 ARSENAL STREET CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 6176737800 8-K 1 b68928oxe8vk.htm OXIGENE, INC. FORM 8-K e8vk
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United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): February 28, 2008
OXiGENE, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other
jurisdiction of
incorporation)
  0-21990
(Commission File
Number)
  13-3679168
(I.R.S. Employer
Identification No.)
230 Third Ave, Waltham, MA 02451
(Address of principal executive offices)
Registrant’s telephone number, including area code: (781) 547-5900
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the obligation of the registrant under any of the following provisions:
o   Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 2.02 Results of Operations and Financial Condition.
Item 9.01 Financial Statements and Exhibits.
SIGNATURE
EXHIBITS
Ex-99.1 Press Release dated February 28, 2008


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Item 2.02 Results of Operations and Financial Condition.
On February 28, 2008 OXiGENE, Inc. issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2007. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. This information shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) The following exhibits are furnished with this report:
     
Exhibit Number   Description
 
   
99.1
  Press Release dated February 28, 2008 reporting OXiGENE’s financial results for the fourth quarter and fiscal year ended December 31, 2007.

 


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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
     
Date: February 28, 2008  /s/ James B. Murphy    
  James B. Murphy, Vice President and Chief Financial Officer   
     

 


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EXHIBITS
     
Exhibit Number   Description
 
   
99.1
  Press Release dated February 28, 2008 reporting OXiGENE’s financial results for the fourth quarter and fiscal year ended December 31, 2007.

 

EX-99.1 2 b68928oxexv99w1.htm EX-99.1 PRESS RELEASE DATED FEBRUARY 28, 2008 exv99w1
 

Exhibit 99.1
(OXIGINE LOGO)
Investor and Media Contact:
Michelle Edwards, Investor Relations
medwards@oxigene.com
415-315-9413
OXiGENE Reports Fourth Quarter and Year-End 2007 Results
Company Provides Updates; Milestones; Financial Guidance for 2008
WALTHAM, MA — February 28, 2008 — 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, 2007; summarized recent clinical and corporate progress; and provided financial and milestone guidance for 2008.
Financial Results
The Company reported that the net loss for the fourth quarter of 2007 was $5.8 million, or $0.21 per share, compared with a net loss of $3.4 million, or $0.12 per share, for the same period in 2006.
For the year ending December 31, 2007, the net loss was $20.4 million, or $0.73 per share, compared with a net loss of $15.5 million, or $0.56 per share, for the comparable period in 2006.
The increase in loss is attributable to an increase in operating expenses which was driven primarily by a higher level of clinical development activities, including the initiation of the ZYBRESTAT™ (fosbretabulin) pivotal registration trial in anaplastic thyroid cancer (ATC) as well as the management of other ongoing clinical trials and drug development activities.
At December 31, 2007, OXiGENE had cash, cash equivalents and marketable securities of approximately $28.4 million compared with approximately $45.8 million on December 31, 2006.
“In 2007, we advanced key drug development programs, in particular, our pivotal Phase II/III registration study for ZYBRESTAT in ATC and our topical ophthalmology program,” commented Richard Chin, OXiGENE President and CEO. “We remain highly confident in our vascular disrupting agent (VDA) drug development programs, and we are committed to translating our product candidates into innovative drug products that deliver meaningful benefits to patients with cancer and ophthalmological diseases. We expect that the financial resources available to us, including cash and the recently-established committed equity line, will allow us to continue to build value in these programs.”
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4Q, YE 2007 OXGN Results
February 28, 2008
Page 2 of 8
Fourth Quarter 2007 Highlights
Oncology
    Subsequent to Dr. Patricia Walicke joining the OXiGENE team in August 2007 as Chief Medical Officer, OXiGENE accelerated clinical site initiation and patient recruitment activities in the ongoing Phase II/III pivotal registration study for ZYBRESTAT in anaplastic thyroid cancer. As of year-end, OXiGENE had initiated four sites in the U.S. and India, and continues to initiate sites and enroll patients in 2008.
 
    In December, OXiGENE announced that ZYBRESTAT achieved the pre-specified primary efficacy endpoint for Stage 1 of an ongoing Simon two-stage design Phase II study of ZYBRESTAT in combination with chemotherapy in patients with platinum-resistant ovarian cancer. Enrollment of an additional 25 patients is proceeding in the second stage of the trial.
 
    In October, OXiGENE announced that the Phase Ib study of ZYBRESTAT in combination with bevacizumab in patients with advanced solid tumors resulted in significantly enhanced and sustained tumor blood-flow inhibition, demonstrated early evidence of clinical activity in the absence of concurrent cytotoxic chemotherapy, and appeared to be well-tolerated.
 
    In October, OXiGENE reported interim data from a Phase I dose-escalation study of OXi4503, its second-generation, dual-mechanism VDA product candidate. The study showed, among other things, that OXi4503 appeared to be well-tolerated, had no dose-limiting toxicity, achieved tumor blood flow shutdown and metabolic inactivation, and demonstrated early signs of clinical activity. The Company also announced publication of an article describing the mechanism-of-action by which OXi4503 may exert direct cytotoxic effects on tumor cells—in addition to its demonstrated vascular-disrupting activity.
 
    In November, OXiGENE announced publication of preclinical study results online and ahead of print in the journal Blood by Dr. Shahin Rafii, Howard Hughes Investigator at Cornell University, indicating that ZYBRESTAT has anti-leukemic effects and prolongs survival in an animal model of acute leukemia.
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4Q, YE 2007 OXGN Results
February 28, 2008
Page 3 of 8
Ophthalmology
    In December, OXiGENE reported positive preclinical ocular penetration data with a topical formulation of ZYBRESTAT for ophthalmology. These studies, performed in industry-standard rabbit models, indicate that two formulations of ZYBRESTAT, when applied topically to the surface of the eye, are absorbed and result in concentrations of drug in target tissues in the back of the eye (i.e., the retina and choroid) that the Company believes will be sufficient for therapeutic activity in eye diseases in which abnormal neovascularization plays a role, such as age-related macular degeneration, diabetic retinopathy, and neovascular glaucoma. The Company reported in May 2007 positive results from a Phase II study of intravenously-administered ZYBRESTAT in patients with myopic macular degeneration.
Financial Guidance for 2008
OXiGENE expects cash utilization from operations for fiscal 2008 to range from $22 million to $28 million, which reflects an increase in activity in all programs. OXiGENE estimates that it has approximately one year of operating cash and marketable securities on hand as of December 31, 2007. Also, as previously announced, OXiGENE entered into a Committed Equity Financing Facility with Kingsbridge Capital in February 2008. This facility allows Kingsbridge to purchase, at OXiGENE’s discretion, up to $40 million in OXiGENE common stock for a period of up to three years.
Company Milestones for 2008
Oncology
    In the first quarter of 2008, the Company expects to initiate a randomized, controlled, double-blind Phase II study that will evaluate the combination of ZYBRESTAT, bevacizumab and chemotherapy versus bevacizumab and chemotherapy as a potential first-line therapy in patients with Stage IIIb/IV non-small cell lung cancer (NSCLC).
 
    In the first half of 2008, the Company anticipates initiating most of the clinical sites for the ongoing 180-patient, pivotal registration study of ZYBRESTAT in ATC. Consistent with the Company’s objective of reaching the study’s planned interim analysis by mid-2009, the Company plans to have enrolled approximately half of the patients in the study by year-end 2008.
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4Q, YE 2007 OXGN Results
February 28, 2008
Page 4 of 8
Oncology (cont.)
    In the first half of 2008, the Company expects to report results from the Phase Ib combination study of ZYBRESTAT and bevacizumab in patients with advanced solid tumors.
 
    In the first half of 2008, the Company expects to report results from the Phase I dose-escalation study of OXi4503 and announce preclinical study data that will inform clinical development of the product candidate.
 
    In the second half of 2008, the Company expects to report results from an ongoing Phase Ib study evaluating the combination of ZYBRESTAT, cetuximab and radiation therapy as a treatment for patients with head-and-neck cancer.
 
    In 2008, the Company expects to complete enrollment in the ongoing Phase 2 study of ZYBRESTAT in platinum-resistant ovarian cancer.
Ophthalmology (ZYBRESTAT Topical)
    In the first quarter of 2008, the Company expects to report results from ongoing primate tolerance and topical penetration studies that, if positive, will provide key support for further investment in the program and a subsequent IND filing. The Company anticipates presenting preclinical ocular penetration and tolerance data at an appropriate scientific meeting later in 2008.
 
    By mid-year, the Company expects to file an IND for a topical formulation of ZYBRESTAT and proceed into clinical evaluation of the product candidate in patients with age-related macular degeneration and/or another ophthalmological condition characterized by abnormal ocular neovascularization.
Members of OXiGENE’s management team will review fourth quarter results via a webcast and conference call today at 10:00 a.m. ET (7:00 a.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 “Investor Center” tab, select the link to “Presentations & Conference Calls.”
OXiGENE’s earnings conference call can also be heard live by dialing (800) 909-7113 in the United States and Canada, and (785) 830-1914 for international callers, five minutes prior to the beginning of the call. A replay will be available starting at 1:00 p.m. ET, (10:00 a.m. PST) on February 28, 2008 and ending at 1:00 p.m. ET (10:00 a.m. PST) on Thursday, March 6, 2008. To access the replay, please dial (888) 203-1112 if calling from the United States or Canada, or (719) 457-0820 from international locations. Please refer to replay pass code 9542510.
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4Q, YE 2007 OXGN Results
February 28, 2008
Page 5 of 8
About ZYBRESTAT (fosbretabulin)
ZYBRESTAT is currently being evaluated in a pivotal registration study in anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). OXiGENE believes that ZYBRESTAT is poised to become the first therapeutic 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 studies 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. In clinical studies in patients with forms of macular degeneration, intravenously-administered ZYBRESTAT has demonstrated clinical activity, and the Company is working to develop a convenient and patient-friendly topical formulation of ZYBRESTAT for ophthalmological indications.
About OXi4503
OXi4503 (combretastatin A1 di-phosphate / CA1P) is a dual-mechanism vascular disrupting agent (VDA) that is being developed in clinical studies 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 indicates 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 I dose-escalation study in patients with advanced solid tumors.
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 (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 -enhancing medicines to patients.
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4Q, YE 2007 OXGN Results
February 28, 2008
Page 6 of 8
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 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, enrollment rate for patients in the ZYBRESTAT pivotal trial for anaplastic thyroid cancer, interim analysis of the same, timing of the IND filing and Phase I trial initiation for topical ZYBRESTAT, timing of a phase II study of ZYBRESTAT and Avastin in NSCLC, timing or execution of a strategic collaboration on any product or indication, and cash utilization rate for 2008. 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, 2006.
# # #

 


 

4Q, YE 2007 OXGN Results
February 28, 2008
Page 7 of 8
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in 000’s)
(Unaudited)
                 
    December 31,     December 31,  
    2007     2006  
Assets
               
 
               
Cash, cash equivalents and marketable securities
  $ 28,438     $ 45,839  
License agreement
    679       777  
Other assets
    947       1,026  
 
           
 
               
Total assets
  $ 30,064     $ 47,642  
 
           
 
               
Liabilities and stockholders’ equity
               
 
               
Accounts payable and accrued liabilities
  $ 5,207     $ 4,222  
Total stockholders’ equity
    24,857       43,420  
 
           
 
               
Total liabilities and stockholders’ equity
  $ 30,064     $ 47,642  
 
           

 


 

4Q, YE 2007 OXGN Results
February 28, 2008
Page 8 of 8
OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in 000’s except per share amounts)
(Unaudited)
                                 
    Three months ended     Twelve months ended  
    December 31,     December 31,  
    2007     2006     2007     2006  
 
                               
License revenue
  $ 5     $     $ 12     $  
 
                               
Costs and expenses:
                               
 
                               
Research and development
    4,494       2,482       14,130       10,816  
General and administrative
    1,667       1,515       8,155       7,100  
 
                       
 
                               
Total costs and expenses
    6,161       3,997       22,285       17,916  
 
                               
Operating loss
    (6,156 )     (3,997 )     (22,273 )     (17,916 )
 
                       
 
                               
Investment income
    394       609       1,955       2,502  
Other expense, net
    (35 )     (7 )     (71 )     (43 )
 
                       
 
                               
Net loss
  $ (5,797 )   $ (3,395 )   $ (20,389 )   $ (15,457 )
 
                       
 
                               
Basic and diluted net loss per common share
  $ (0.21 )   $ (0.12 )   $ (0.73 )   $ (0.56 )
 
                               
Weighted average number of common shares outstanding
    28,035       27,846       27,931       27,626  

 

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