OXiGENE Reports Third Quarter 2004 Financial Results.WALTHAM, Mass. -- OXiGENE, Inc.:
Recent Accomplishments
-- Announced positive pre-clinical data on OXi4503 at EORTC
-- Initiated additional Phase I clinical trial with CA4P in
advanced cervical cancer patients
-- Positive clinical and pre-clinical data on CA4P in combination
with radiotherapy presented at ESTRO
OXiGENE, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : OXGN, XSSE: OXGN), an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases, today reported financial results for the third quarter ended September 30, 2004. Results The net loss for the three months ended September 30, 2004 was $2,910,000 or $0.17 per share, compared with a net loss of $3,354,000 or $0.24 per share, in the third quarter of 2003. For the nine-month period ended September 30, 2004, the net loss was $7,775,000 or $0.47 per share, compared with a net loss of $6,676,000 or $0.53 per share, for the comparable period in 2003. At September 30, 2004, OXiGENE had cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has of $33,238,000 compared with $18,936,000 (including restricted cash) at December 31, 2003. Third Quarter Events "I'm pleased with the continued progress we have made by initiating a new cancer trial with CA4P as well as the announcements of positive pre-clinical data on OXi4503 and positive clinical results with CA4P in combination with radiotherapy radiotherapy /ra·dio·ther·a·py/ (-ther´ah-pe) treatment of disease by means of ionizing radiation; tissue may be exposed to a beam of radiation, or a radioactive element may be contained in devices (e.g. ," said Fred Driscoll, President and Chief Executive Officer of OXiGENE. "We expect to accomplish our remaining 2004 milestones which are to file with the applicable regulatory bodies to move CA4P into myopic my·o·pi·a n. 1. A visual defect in which distant objects appear blurred because their images are focused in front of the retina rather than on it; nearsightedness. Also called short sight. 2. macular degeneration macular degeneration, eye disorder causing loss of central vision. The affected area, the macula, lies at the back of the retina and is the part that produces the sharpest vision. and to receive clearance to enter into a Phase I trial with OXi4503 in oncology." As announced on September 14, 2004, OXiGENE has initiated a sixth clinical trial with CA4P in oncology. This Phase I trial will study CA4P in combination with cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. in advanced cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. patients. Dr. Jacob Lindegaard from the Arhus University Hospital in Denmark will head up this study in conjunction with Nordic Society of Gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. Oncology (NSGO NSGO National Sea Grant Office ). The Denmark site has received the necessary approvals to begin its study and the two additional sites in Norway and the United Kingdom are in the process of obtaining their approvals. Among the trial's objectives are safety, preliminary evidence of efficacy, and a determination of the recommended Phase II dose. Data on OXiGENE's lead pre-clinical compound, OXi4503, was presented at the European Organization for the Research and Treatment of Cancer (EORTC EORTC European Organization for Research and Treatment of Cancer ) Symposium on Molecular Targets and Cancer Therapeutics which took place in Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland in late September. The findings from these studies are consistent with previously seen data indicating that OXi4503 has an additional and distinct mechanism of action compared to the Company's lead vascular targeting agent, CA4P. This additional mechanism may enable destruction of the outside rim of cells residing next to and feeding off of the blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. in the surrounding normal tissue in addition to its ability to attack the central regions of the tumor tumor: see neoplasm. . Most recently, the Company announced that new data on the combination of CA4P and radiation was presented at the European Society for Therapeutic Radiology radiology, branch of medicine specializing in the use of X rays, gamma rays, radioactive isotopes, and other forms of radiation in the diagnosis and treatment of disease. and Oncology (ESTRO ESTRO European Society for Therapeutic Radiology and Oncology ) meeting in Amsterdam that began this week. Michael Horsman of the Arhus University Hospital in Denmark presented pre-clinical data on CA4P in combination with radiotherapy. The results show that CA4P significantly enhances the anti-tumor effects of radiation without enhancing normal tissue damage due to treatment. Professor Peter Hoskin presented data from the ongoing Phase Ib trial at Mount Vernon hospital Mount Vernon Hospital is one of two hospitals run by The Hillingdon Hospital Trust. Together with West Hertfordshire Hospital Trust and East and North Hertfordshire Trust it provides specialist non-surgical cancer services and a burns unit. in the UK. In this study, where CA4P is used in conjunction with external beam radiotherapy External beam radiotherapy otherwise known as teletherapy, is the most frequently used form of radiotherapy. The patient sits or lies on a couch and an external source of radiation is pointed at a particular part of the body. , prolonged reductions in tumor blood flow were seen following CA4P treatment. This finding is particularly encouraging since in pre-clinical models such blood flow reductions induced by CA4P post radiotherapy have been associated with enhanced treatment response. Third Quarter Conference Call Information In conjunction with its third quarter financial results, OXiGENE's senior management will conduct a conference call at 10:00 a.m. ET today.
Time: 10:00 a.m. ET
Date: Thursday, October 28, 2004
Dial-in numbers: 800-822-4794 (U.S.)
913-981-4912 (international)
Webcast: www.oxigene.com
A replay will be available starting at 2:00 p.m. ET (1:00 p.m. CT, 12:00 noon MT & 11:00 a.m. PT) and ending at midnight ET, November 3rd. To access the replay, dial 888-203-1112 (domestic) or 719-457-0820 (international) and refer to reservation number 837263. About OXiGENE 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 Visual Impairment Definition Total blindness is the inability to tell light from dark, or the total inability to see. Visual impairment or low vision is a severe reduction in vision that cannot be corrected with standard glasses or contact lenses and . OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Statements in this news release concerning OXiGENE's business outlook are considered "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements include, but are not limited to: the accomplishment of the additional 2004 milestones, the completion of necessary study-site approvals associated with the cervical cancer trial using CA4P in combination with cisplatin, the efficacy of OXi4503 and its ability to attack cells at the tumor's periphery periphery /pe·riph·ery/ (pe-rif´er-e) an outward surface or structure; the portion of a system outside the central region.periph´eral pe·riph·er·y n. 1. through a secondary mechanism of action, and the efficacy of CA4P in combination with radiotherapy. 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 unproven Dubious, nonscientific, not proven, quack, questionable, unscientific adjective Relating to that which has not been validated by reproducible experiments or other scientific methods for determining effect or efficacy 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 are contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's 10-Q, 8-K and 10-K reports. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
OXiGENE, Inc.
Condensed Consolidated Balance Sheets
(All amounts in 000's)
Assets September 30, December 31,
2004 2003
----------- ------------
Cash, marketable securities and
restricted cash $ 33,238 $ 18,936
Licensing agreement 996 1,069
Other assets 323 200
----------- ------------
Total assets $ 34,557 $ 20,205
=========== ============
Liabilities and stockholders' equity
Accounts payable $ 1,306 $ 1,701
Accrued expenses 1,964 2,034
Total stockholders' equity 31,287 16,470
----------- ------------
Total liabilities and stockholders'
equity $ 34,557 $ 20,205
=========== ============
OXiGENE, Inc
Consolidated Statements of Operations
(All amounts in 000's except per share amounts)
(Unaudited)
Three months Nine months
ended ended
September 30, September 30,
------------------ ---------------
2004 2003 2004 2003
------- ------- ------- -------
License revenue $ - $ - $ 7 $ 20
Costs and expenses:
Research and development 1,813 1,385 4,587 2,508
General and administrative 1,209 2,017 3,541 4,259
Amortization of license agreement 24 24 73 69
------- ------- ------- -------
Total costs and expenses: 3,046 3,426 8,201 6,836
Operating loss (3,046) (3,426) (8,194) (6,816)
Investment income 140 78 421 172
Interest expense - (6) - (31)
Other expense, net (4) - (2) (1)
Net loss $(2,910) $(3,354) $(7,775)$(6,676)
======= ======= ======= =======
Basic and diluted net loss per
common share $ (0.17) $ (0.24) $ (0.47)$ (0.53)
Weighted average number
of common shares outstanding 16,668 14,007 16,524 12,611
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