OXiGENE Reports Third-Quarter 2005 Operational and Financial Results.WALTHAM, Mass. -- Company Reports Significant Achievements for the Quarter including: --Initiation of a Phase II Clinical Trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in Platinum-Resistant Ovarian Cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast --Observation of an Early Indication of Survival Benefit in Non Small Cell Lung Cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. 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 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 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 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. ." 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 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 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 microenvironment /mi·cro·en·vi·ron·ment/ (-en-vi´ron-ment) the environment at the microscopic or cellular level. 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 paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); 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 inoperable /in·op·er·a·ble/ (in-op´er-ah-b'l) not susceptible to treatment by surgery. in·op·er·a·ble adj. Unsuitable for a surgical procedure. , 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 clinical pathway Critical pathway, treatment pathway Clinical medicine A standardized algorithm of a consensus of the best way to manage a particular condition Modalities used Teletherapy, brachytherapy, hyperthermia and stereotactic radiation. 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 Side effects Effects of a proposed project on other parts of the firm. 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 MMD Movement for Multiparty Democracy (Zambia) MMD Make My Day MMD Merchant Mariner Document MMD Myotonic Muscular Dystrophy MMD Myotonic Dystrophy MMD Mass Median Diameter MMD Metal Matrix Diaphragm ). 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 preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. 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 REGRESS. Returning; going back opposed to ingress. (q.v.) the abnormal new vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur) 1. circulatory system. 2. any part of the circulatory system. vas·cu·la·ture n. 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 vascular endothelial-cadherin signaling," will be published in the peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. , The Journal of Clinical Investigation The Journal of Clinical Investigation (JCI or J Clin Invest) is a leading biomedical journal, which is radically different from many of its peers in having a high impact factor (in 2006, 15.754) and offering all its contents entirely free. , 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/(beta)-catenin/Akt pathway profoundly influences many aspects of endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium. Endothelial A layer of cells that lines the inside of certain body cavities, for example, blood vessels. cell function, including inhibition of endothelial cell migration, proliferation and capillary tube formation pathways critical in angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. . 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 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. 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 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 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 timing and success of a Phase II trial of CA4P in triple combination therapy triple combination therapy AIDS See HAART. 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 Form 10-Q See 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, Inc.
Condensed Balance Sheets
(All amounts in 000's)
(Unaudited)
Assets September 30, December 31,
2005 2004
-------------- -------------
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 Nine months
ended 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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