-----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, NXZ1opnOZEorBTLVkv7z0B1Ndf3G04SWprAwsxdxLwKUtac9vQmGKfoVmKU+fGAZ yh76/62lBhEC1j5qjkZ9qw== 0000950135-05-005978.txt : 20051026 0000950135-05-005978.hdr.sgml : 20051026 20051026143030 ACCESSION NUMBER: 0000950135-05-005978 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051026 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051026 DATE AS OF CHANGE: 20051026 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: 051156696 BUSINESS ADDRESS: STREET 1: 321 ARSENAL STREET CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 6176737800 8-K 1 b57488oie8vk.htm OXIGENE, INC. e8vk
 

 
 
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): October 26, 2005
OXiGENE, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   0-21990   13-3679168
(State or other
jurisdiction of
incorporation)
  (Commission File
Number)
  (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))
 
 

 


 

Item 2.02 Results of Operations and Financial Condition.
    On October 26, 2005, OXiGENE, Inc. issued a press release announcing its financial results for the second quarter ended September 30, 2005. 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. In addition, on a conference call following the press release the company reaffirmed its guidance that cash utilization for 2005 would be somewhere between $11 and $13 million.
Item 9.01 Financial Statements and Exhibits.
(c) The following exhibits are furnished with this report:
     
Exhibit Number   Description
99.1
  Press Release dated October 26, 2005, reporting OXiGENE’s financial results for the third quarter ended September 30, 2005.

 


 

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: October 26, 2005  /s/ James B. Murphy    
  James B. Murphy, Vice President and Chief Financial Officer   
     
 

 


 

EXHIBITS
     
Exhibit Number   Description
99.1
  Press Release dated October 26, 2005, reporting OXiGENE’s financial results for the third quarter ended September 30, 2005.

 

EX-99.1 2 b57488oiexv99w1.htm EX-99.1 PRESS RELEASE DATED OCTOBER 26, 2005 exv99w1
 

Exhibit 99.1
FOR IMMEDIATE RELEASE
OXiGENE REPORTS THIRD-QUARTER 2005 OPERATIONAL AND
FINANCIAL RESULTS
Company Reports Significant Achievements for the Quarter including:
    Initiation of a Phase II Clinical Trial in Platinum-Resistant Ovarian Cancer
 
    Observation of an Early Indication of Survival Benefit in Non Small Cell Lung Cancer Patients in a Phase Ib Clinical Trial Evaluating CA4P in Combination with Radiotherapy
 
    Addition of Pharmaceutical Executive, Richard Chin, M.D., to OXiGENE’s Board of Directors
Waltham, MA, — October 26, 2005 — OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases, today reported operational and financial results for the third quarter ended September 30, 2005.
“The third quarter was a robust and productive period for OXiGENE, as the Company progressed both clinically and operationally,” stated Frederick Driscoll, President and CEO of OXiGENE. “We believe the Company is well poised for continued growth and evolution as we advance our lead vascular disrupting agent, CA4P, in a number of clinical trials, including combination trials with chemotherapy for the treatment of platinum-resistant ovarian cancer, with radiotherapy for the treatment of non small cell lung cancer, and as a single agent therapeutic for myopic macular degeneration.”
Financial Results
The net loss for the three months ended September 30, 2005 was $3.4 million, or $0.17 per share, compared with a net loss of $2.9 million, or $0.17 per share, in the third quarter of 2004.
For the nine-month period ended September 30, 2005, the net loss was $8.5 million, or $0.44 per share, compared with a net loss of $7.8 million, or $0.47 per share, for the comparable period in 2004.
At September 30, 2005, OXiGENE had cash, cash equivalents and marketable securities of approximately $36.8 million compared with approximately $30.5 million at December 31, 2004.
Clinical Update
OXiGENE announced several significant clinical updates for its lead vascular disrupting agent, Combretastatin A4P. Most notably, and on the heels of positive clinical trial data from an ongoing Phase Ib/II trial evaluating CA4P in combination with chemotherapy (data announced at the 9th International Workshop of the Tumor Microenvironment

 


 

OXiGENE Reports Third Quarter 2005 Operational and Financial Results / 2
Meeting), the Company announced the initiation of an international, open-label Phase II clinical trial evaluating the safety of CA4P in triple combination with carboplatin and paclitaxel in patients with platinum-resistant ovarian cancer.
Further, OXiGENE announced an update on the second Phase Ib trial evaluating CA4P in combination with radiotherapy. At the National Cancer Research Institute Cancer Conference, Quan Ng, M.D., of the Mount Vernon Cancer Centre in the United Kingdom, reported an early indication of survival benefit in patients with Stage IIIB/IV inoperable, non small cell lung cancer when CA4P is administered in combination with radiotherapy. Dr. Ng presented data that showed that patients who received weekly radiotherapy in combination with CA4P for three weeks demonstrated a statistically significant—and sustained—forty percent reduction in tumor blood volume at the completion of the three-week treatment period.
“We are extremely pleased with the clinical progress made with CA4P in the third quarter,” Mr. Driscoll stated. “OXiGENE now has a defined clinical pathway in platinum-resistant ovarian cancer; and, we are optimistic about initiating a later-stage clinical trial in 2005 in a second key indication, advanced, inoperable, non small cell lung cancer. Further, we remain encouraged not only by the anti-tumor effects demonstrated by CA4P to date, but also by the positive safety profile reported by investigators. Collectively, the investigators are reporting that CA4P is well tolerated by patients and that the side effects of CA4P appear to be minimal and self-limiting, with no unexpected toxicities or significant adverse events reported to-date in these trials.”
OXiGENE’s ophthalmology program also continues forward progress, and the Company reports that enrollment is accelerating for its Phase II clinical trial evaluating CA4P in patients with Myopic Macular Degeneration (MMD). Mr. Driscoll stated, “We are on schedule with our local formulation program in ophthalmology, and we expect to complete the ongoing experiments evaluating periorbital injection and novel eye drops by the end of the year.”
Preclinical Update
OXiGENE provided an update on preclinical studies evaluating the therapeutic potential of its second candidate, OXi4503. Investigators at the 9th International Workshop of the Tumor Microenvironment Meeting presented evidence for an additional and novel mechanism of action for OXi4503, which leads to the formation of a highly reactive ortho-quinone. This mechanism could lead to direct killing of tumor cells and would be augmented by the previously observed vascular disrupting activity of OXi4503, making the compound a promising potential candidate for advanced cancers.
Investigational Update
OXiGENE, in October 2005, announced new research that elucidates another molecular pathway through which CA4P appears able to selectively regress the abnormal new vasculature associated with disease pathologies, such as cancer and macular degeneration. This research, presented in a paper entitled “Combretastatin A4 phosphate induces rapid regression of tumor neovessels and growth through interference with

 


 

OXiGENE Reports Third Quarter 2005 Operational and Financial Results / 3
vascular endothelial-cadherin signaling,” will be published in the peer-reviewed journal, The Journal of Clinical Investigation, Vol. 115, Number 11, November 2005.
In the study, researchers observed that CA4P induces destabilization of VE-cadherin and that the associated inhibition of the VE—cadherin/b-catenin/Akt pathway profoundly influences many aspects of endothelial cell function, including inhibition of endothelial cell migration, proliferation and capillary tube formation pathways critical in angiogenesis.
Operational Update
“OXiGENE made significant strides this quarter in preparation for our continued growth,” stated Driscoll. “The addition of new office space in Oxford, United Kingdom, and the ability to raise capital pursuant to our newly filed shelf registration statement, provide us with the infrastructure necessary to aggressively advance the Company’s ongoing preclinical research and clinical trials. Further, OXiGENE announced the addition of Dr. Richard Chin to our Board of Directors. Dr. Chin, who currently serves as Senior Vice President and Head of Global Development for Elan Corporation, plc, brings tremendous pharmaceutical and drug commercialization expertise to OXiGENE. His experience will be invaluable as OXiGENE continues its progress towards commercial availability of CA4P.”
About OXiGENE, Inc.
OXiGENE is an emerging pharmaceutical 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.
Safe Harbor Statement
Certain statements in this news release concerning OXiGENE’s business are considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the timing and success of a Phase II trial of CA4P in triple combination therapy for platinum-resistant ovarian cancer; the timing and success of a later stage trial of CA4P in combination with radiotherapy for non small cell lung cancer; OXiGENE’s ability to enroll patients in a Phase II clinical trial for myopic macular degeneration; the potential tumor killing effect of OXi4503 and its promise as a candidate for advanced cancers; and, the timing, success or advancement of OXiGENE’s ongoing preclinical research and clinical trials. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; the ability to secure necessary patents; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. 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-Q, 8-K and 10-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.

 


 

OXiGENE Reports Third Quarter 2005 Operational and Financial Results / 4
Contact:
         
 
  OXiGENE Inc.    
 
       
 
  Susan Hager    
 
  Director of Communications    
 
  (781) 547-5900    
 
  shager@oxigene.com    
 
       
 
  OR    
 
       
 
  MacDougall BioCommunications    
 
  Chris Erdman    
 
  Vice President    
 
  (508) 647-0209    
 
  chris@macbiocom.com    

 


 

OXiGENE Reports Third Quarter 2005 Operational and Financial Results / 5
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in 000’s)
(Unaudited)
                 
    September 30,     December 31,  
    2005     2004  
Assets
               
 
               
Cash, cash equivalents and marketable securities
  $ 36,839     $ 30,502  
Licensing agreement
    898       971  
Furniture, fixtures and equipment, net
    104       67  
Other assets
    498       217  
 
           
Total assets
  $ 38,339     $ 31,757  
 
           
 
               
Liabilities and stockholders’ equity
               
 
               
Accounts payable and accrued expenses
  $ 3,833     $ 2,622  
Total stockholders’ equity
    34,506       29,135  
 
           
Total liabilities and stockholders’ equity
  $ 38,339     $ 31,757  
 
           

 


 

OXiGENE, Inc
Statements of Operations
(All amounts in 000’s except per share amounts)
                                 
    Three months ended     Nine months ended  
    September 30,     September 30,  
    2005     2004     2005     2004  
    (Unaudited)     (Unaudited)  
License revenue
  $     $     $     $ 7  
 
                               
Costs and expenses:
                               
 
                               
Research and development
    2,273       1,837       5,060       4,660  
General and administrative
    1,492       1,209       4,285       3,541  
 
                       
 
                               
Total costs and expenses:
    3,765       3,046       9,345       8,201  
 
                               
Operating loss
    (3,765 )     (3,046 )     (9,345 )     (8,194 )
 
                               
Investment income
    321       140       810       421  
Other income (expense), net
    (1 )     (4 )     5       (2 )
 
                               
Net loss
  $ (3,445 )   $ (2,910 )   $ (8,530 )   $ (7,775 )
 
                       
 
                               
Basic and diluted net loss per common share
  $ (0.17 )   $ (0.17 )   $ (0.44 )   $ (0.47 )
 
                               
Weighted average number of common shares outstanding
    20,042       16,668       19,233       16,524  

 

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