OXiGENE Reports First-Quarter 2006 Operational and Financial Results.WALTHAM, Mass. -- OXiGENE Secures Regulatory Clearance in Russia for its Ongoing 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. (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 ) 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 ; Patient Screening To Begin Shortly Company Highlights First Quarter Accomplishments, Including: --Initiation of a Phase II Clinical Trial in the United States in Stage IIIa/IIIb 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. (NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there ) --Completion of Patient Enrollment in a Phase II Clinical Trial in Solid Tumors --A Newly Granted Patent for Combretastatin A4P (CA4P) 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 first quarter ended March 31, 2006. "Following what we believe was a very strong conclusion to fiscal year-end Fiscal Year-End The completion of a one-year, or 12-month, accounting period. Notes: The reason that a company's fiscal year often differs from the calendar year and does not close on Dec 31, is due to the nature of company's needs. 2005, the first quarter of 2006 was marked with clinical progress and operational successes," stated Frederick Driscoll, President and Chief Executive Officer of OXiGENE. "We remain steadfast in our commitment to achieving the requisite steps necessary to begin patient enrollment later this year in our U.S. and European clinical trials in NSCLC, and we continue to concentrate our efforts on driving patient enrollment in OXiGENE's core clinical programs in oncology and ophthalmology indications." Financial Results The Company's net loss for the three months ended March 31, 2006 was $3.3 million or $0.12 per share, compared with a net loss of $2.0 million, or $0.12 per share, in the first quarter of 2005. On January 1, 2006, OXiGENE adopted SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System 123R, "Share-Based Payment," requiring the expense recognition of the estimated fair value of all share-based payments issued to employees. Prior to this, the estimated fair value associated with such awards was not recorded as an expense, but rather was disclosed in a footnote to the Company's financial statements. For the three months ended March 31, 2006, OXiGENE recorded approximately $315,000 of expense associated with share-based payments as a result of SFAS 123R. In addition, the Company recorded an expense of $160,000 for restricted stock awards for the three months ended March 31, 2006, compared to $0 for the three months ended March 31, 2005. At March 31, 2006, 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 $55.4 million, compared with approximately $58.9 million at December 31, 2005. Clinical Progress: Ophthalmology OXiGENE announced today that it has received clearance from regulatory authorities in Russia to initiate its ongoing Phase II clinical trial with CA4P for the treatment of Myopic Macular Degeneration. Russia's top five ophthalmology clinics have elected to participate in the trial. Regional oversight boards have granted the required ethics approvals and patient screening is expected to begin shortly. "With our sights squarely focused on the on-time completion of patient enrollment in this indication, we have elected to initiate this trial in an area of the world where the current, approved treatment for MMD is cost prohibitive, making it inaccessible for most individuals afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, ," stated Mr. Driscoll. "With these sites ready to commence patient screening, and in combination with the ongoing activity in centers in the US, Canada and Taiwan, we remain confident that we will achieve our target of completing patient enrollment in the first half of this year." Mr. Driscoll added, "We believe that clearance to commence this trial in Russia is an important and strategically significant regulatory achievement for OXiGENE as we contemplate the potential next steps in this indication. This clearance may create regulatory and potential registrational opportunities for CA4P in Russia, as well as other geographic areas in eastern Europe, not only in this indication, but also for other indications, such as oncology." Clinical Progress: Oncology OXiGENE advanced its lead therapeutic candidate, CA4P, into a Phase II clinical trial in the United States for the treatment of patients with Stage IIIa/IIIb NSCLC. The trial, which was cleared to proceed by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in February 2006, is currently recruiting participation from clinical trial sites. OXiGENE expects patient enrollment to begin on schedule, in the third quarter of 2006. OXiGENE also announced this quarter that patient enrollment is now complete in a Phase II clinical trial of CA4P in imageable, solid tumors. The trial, which is being conducted in the United States under OXiGENE's Investigational New Drug (IND) application on file with the FDA, is designed to evaluate the safety and anti-cancer activity of the triple combination of CA4P with the widely-used chemotherapy agents, 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); . The objectives of this trial are to assess the safety of several dose levels of CA4P in combination with the two chemotherapeutic agents, gather data on anti-tumor activity and establish a recommended Phase II/III dose. Additionally, the study is designed to assess, by Magnetic Resonance Imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ), changes in tumor blood flow, which may provide additional insight into the biological activity of CA4P. With several patients enrolled in this trial continuing to receive prolonged therapy, OXiGENE anticipates that top-line data from this trial will be available later in 2006. OXiGENE's second clinical candidate, OXi4503, continues to be evaluated in a Phase I dose-escalating safety trial in solid tumors. Since the initiation of this clinical trial, clinical investigators have increased the dose of OXi4503 to several times the compound's initial dosing level, and have yet to achieve the maximum tolerated dose in humans. Depending on when maximum tolerated dose is reached, OXiGENE anticipates that this trial will be concluded by year's end. Presentation of Data OXiGENE anticipates that clinical investigators will present data at scientific conferences later this year. More specifically, the Company expects interim clinical trial data to be presented in June 2006 at the American Society for Clinical Oncology (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) conference from an ongoing Phase II clinical trial evaluating CA4P as a monotherapy for treatment of advanced Anaplastic an·a·plas·tic adj. 1. Relating to the surgical restoration of a lost or absent part. 2. Of, relating to, or characterized by cells that have become less differentiated. anaplastic 1. Thyroid Cancer Thyroid Cancer Definition Thyroid cancer is a disease in which the cells of the thyroid gland become abnormal, grow uncontrollably, and form a mass of cells called a tumor. . The Company also believes that data will be presented from the recently completed Phase II clinical trial combining CA4P with carboplatin and paclitaxel in imageable, solid tumors at the Conference of the Tumor Microenvironment microenvironment /mi·cro·en·vi·ron·ment/ (-en-vi´ron-ment) the environment at the microscopic or cellular level. (TME See Tivoli Systems Management Software. ) in September. Operational Update In the first quarter, OXiGENE announced the issuance of U.S. Patent No. 7,018,987 for novel methods of synthesizing its lead therapeutic candidate, CA4P. This award provides patent coverage for at least 13 years, through 2019. The patent award also provides broad-based patent protection for additional salt-form compositions of CA4P. The patent was granted to Arizona State University Arizona State University, at Tempe; coeducational; opened 1886 as a normal school, became 1925 Tempe State Teachers College, renamed 1945 Arizona State College at Tempe. Its present name was adopted in 1958. , where researchers discovered and isolated CA4P and other Combretastatin compounds. OXiGENE has exclusive, worldwide rights to the manufacturing and commercialization of products based on select Combretastatins. 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 Phase II and Phase III clinical trials of CA4P for NSCLC and a Phase II clinical trial of CA4P for imageable, solid tumors; OXiGENE's ability to enroll patients in a Phase II clinical trial for myopic macular degeneration in a timely manner; 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 March 31, December 31,
2006 2005
----------- -----------
Cash, cash equivalents and
marketable securities $ 55,391 $ 58,855
Licensing agreement 849 873
Other assets 771 540
----------- -----------
Total assets $ 57,011 $ 60,268
=========== ===========
Liabilities and stockholders' equity
Accounts payable $ 392 $ 693
Accrued expenses 2,954 3,041
Total stockholders' equity 53,665 56,534
----------- -----------
Total liabilities and
stockholders' equity $ 57,011 $ 60,268
=========== ===========
OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in 000's except per share amounts)
(Unaudited)
Three months ended
------------------
March 31,
--------
2006 2005
---- ----
License revenue $ - $ -
Costs and expenses:
Research and development 2,321 1,217
General and administrative 1,621 997
-------------- --------------
Total costs and expenses: 3,942 2,214
Operating loss (3,942) (2,214)
Investment income 612 181
Other (expense) income, net (6) 5
Net loss $ (3,336) $ (2,028)
============== ==============
Basic and diluted net loss per common
share $ (0.12) $ (0.12)
Weighted average number of common
shares outstanding 27,517 17,604
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