OXiGENE Reports Second Quarter 2004 Financial Results.WALTHAM, Mass. -- 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):
Recent Highlights
-- CA4P Demonstrates Anti-Tumor Responses in Ovarian Cancer
-- Clinical Investigators Report No Dose-limiting Toxicities or
Drug-related Serious Adverse Events
-- OXi4503 Induces Vascular Shutdown in Pre-clinical Studies
-- Early Success in Ophthalmology Puts CA4P on Path Toward New
Clinical Trial in Myopic Macular Degeneration
OXiGENE, Inc. (NASDAQ: OXGN) (XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to target aberrant aberrant /ab·er·rant/ (ah-ber´ant) (ab´ur-ant) wandering or deviating from the usual or normal course. ab·er·rant adj. 1. 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. within solid tumor cancers and ocular ocular /oc·u·lar/ (ok´u-lar) 1. of, pertaining to, or affecting the eye. 2. eyepiece. oc·u·lar adj. 1. Of or relating to the eye or the sense of sight. neovascular diseases, today reported financial results for the second quarter ended June 30, 2004. The net loss for the three months ended June 30, 2004 was $2.8 million, or $0.17 per share, compared with a net loss of $1.8 million, or $0.15 per share, in the second quarter of 2003. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. increased approximately 57 percent in the second quarter of 2004 to $2.9 million from $1.9 million in the second quarter of 2003. For the six-month period ended June 30, 2004, the net loss was $4.9 million, or $0.30 per share, compared with a net loss of $3.3 million, or $0.26 per share, for the comparable period in 2003. Total operating expenses for the first six months of 2004 increased approximately 51 percent to $5.1 million from $3.4 million for the first half of 2003. The year-over-year increase in total operating expenses for the three- and six-month periods of 2004 primarily reflects the Company's continued expansion of its Combretastatin A4 Prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. (CA4P) clinical development program and the preclinical development of OXi4503. Since the end of the second quarter of 2003, CA4P has advanced into clinical trials in patients with colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. , newly diagnosed 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. and wet age-related macular degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. . The Company also has initiated several pre-clinical studies involving OXi4503. At June 30, 2004, OXiGENE had cash, 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 and restricted cash of $35.5 million, compared with $18.9 million at December 31, 2003. "Early results from two current clinical studies of CA4P have reinforced the compound's position as a first-in-class vascular targeting agent," said OXiGENE President and Chief Executive Officer Fred Driscoll. "These results, presented by the principal investigators at the 2nd International Conference on Vascular Targeting in May, demonstrated CA4P's ability to induce blood flow shutdown in tumors and to reduce foveal thickness associated with retinal retinal /ret·i·nal/ (ret´i-n'l) 1. pertaining to the retina. 2. the aldehyde of retinol, derived from absorbed dietary carotenoids or esters of retinol and having vitamin A activity. degenerative disease A degenerative disease is a disease in which the function or structure of the affected tissues or organs will progressively deteriorate over time, whether due to normal bodily wear or lifestyle choices such as exercise or eating habits. . Cancer and ophthalmology ophthalmology (ŏf'thălmŏl`əjē), branch of medicine specializing in the anatomy, function and diseases of the eye. Ophthalmologists specialize in the medical and surgical treatment of eye disorders, vision measurements for are the target markets for CA4P, and our strategy is to expand the breadth of our clinical programs to move as quickly as possible toward market registration." Preliminary data from a dose-escalation combination trial of CA4P and 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); chemotherapy in advanced 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 were presented at the 2nd International Conference on Vascular Targeting. A total of 12 evaluable patients had been entered into the trial at the time of the presentation. Partial tumor response was observed in five patients, while an equal number experienced a period in which their disease was stable. The spectrum and severity of symptoms noted were consistent with the administration of carboplatin and paclitaxel alone. In studies to date, CA4P has been shown to be safe and well tolerated, without drug-related serious adverse events or dose-limiting toxicities. Interim data also were presented from the Johns Hopkins University School of Medicine The Johns Hopkins University School of Medicine, located in Baltimore, Maryland, USA, is a highly regarded medical school and biomedical research institute in the United States. study of CA4P in patients with wet age-related macular degeneration (wet AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ). The compound was well tolerated in that study. The side effects Side effects Effects of a proposed project on other parts of the firm. observed were below clinical significance, and there were no serious adverse events or dose- limiting toxicities reported. Evidence of CA4P's biological activity was observed in one patient who experienced a significant reduction in foveal thickness, a condition associated with wet AMD. During the vascular targeting conference, one of the trial's clinical investigators also discussed the case of a 35-year-old 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. patient treated with CA4P under a special exemption. Vision in the patient's study eye improved from 20/50 to 20/20 following therapy with CA4P. "We are very encouraged by the progress of CA4P, and by the safety profile the compound has exhibited in our current trials," Driscoll said. "We have opened additional centers in our anaplastic thyroid cancer studies, and plan to open another center in the current ovarian cancer study, which is ongoing 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 U.K." Other recent accomplishments include: --The appointment of Adrian L. Harris, M.D. to the Company's Scientific Advisory Board. Dr. Harris is Cancer Research UK Professor of Clinical Oncology at the University of Oxford, and Director of the Cancer Research UK Molecular Oncology Laboratories at the University's Weatherall Institute of Molecular Medicine An Institute of Molecular Medicine, or IMM for short, may refer to a scientific research institution in molecular medicine. Several IMMs exist around the world: Portugal --The publication of peer-reviewed research demonstrating the anti-tumor effects of OXiGENE's lead pre-clinical compound, OXi4503. Published in the International Journal of Cancer, the paper said OXi4503 properties warrant study of the compound as a single-agent cancer therapy and as a complement to other treatments. Business Strategy and Milestones Outlining OXiGENE's development strategy, Driscoll said, "Our oncology clinical program is focused on making CA4P the first vascular targeting agent to reach the market, and we have devised a four-point plan to maximize our opportunity for success. The key elements of this strategy are: Create as many potential opportunities for CA4P as possible by testing the compound in a broad range of indications. Conduct large-scale, multi-center trials evaluating the compound in multiple treatment modalities treatment modality Medtalk The method used to treat a Pt for a particular condition . Open new combination trials to test CA4P with conventional cancer therapies. And, seek the U.S. Food and Drug Administration's (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. ) Fast Track and Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designations where possible to provide for rapid FDA response and market exclusivity. "In 2004, we plan to initiate a new combination clinical trial with CA4P and chemotherapy in an indication as yet untested with the compound. In our pre-clinical pipeline, Cancer Research U.K. is continuing its development of our next-generation vascular targeting agent, OXi4503, and the compound is on track to enter a clinical trial at the end of 2004," Driscoll said. "In ophthalmology, over the past several quarters we've made great progress toward completing the steps necessary to file an Investigational New Drug (IND) application to initiate a clinical trial in myopic macular degeneration," he continued. "We are on schedule to file our IND by the end of this year." Second-quarter Conference Call Information In conjunction with its second-quarter financial results, OXiGENE's senior management will conduct a conference call at 10:00 a.m. ET today. Please note new dial-in numbers.
Time: 10:00 a.m. ET
Date: Wednesday, July 28, 2004
Dial-in numbers 800-662-5508 (U.S.)
913-981-5568 (international)
Confirmation Code: 233665
Webcast: www.oxigene.com
A replay of the call will be available beginning approximately two
hours after the call and ending at midnight ET Tuesday, August 3. To
access the replay, dial 888-203-1112 (domestic) or 719-457-0820
(international) and refer to reservation number 233665.
About OXiGENE OXiGENE is the world leader in the development of vascular targeting agents (VTAs), novel biopharmaceutical compounds designed to selectively target and destroy new blood vessels. The Company's lead compound, Combretastatin A4 Prodrug (CA4P), is in clinical development in patients with solid tumor cancers and wet age-related macular degeneration. Three other OXiGENE VTAs, OXi4503, OXi6197 and OXi8007, are in pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. . For more information about OXiGENE, visit www.oxigene.com. 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" 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: OXiGENE's plan to initiate a new combination clinical study of CA4P with chemotherapy; initiation of a clinical study of OXi4503 by the end of 2004; and submission of an IND by the end of 2004 to initiate a clinical trial in myopic macular degeneration. 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 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. Financial tables follow...
OXiGENE, Inc
Consolidated Statements of Operations
(All amounts in 000's except per share amounts)
Three months ended Six months ended
June 30, June 30,
2004 2003 2004 2003
(Unaudited) (Unaudited)
-------------------- ---------------------
Revenues:
License revenue $- $- $7 $20
----------- -------- ------------ --------
- - 7 20
Costs and expenses:
Research and development 1,846 397 2,774 1,123
General and administrative 1,072 1,454 2,332 2,242
Amortization of license
agreement 24 25 48 45
----------- -------- ------------ --------
Total costs and expenses: 2,942 1,876 5,154 3,410
Operating loss (2,942) (1,876) (5,147) (3,390)
Investment income 138 45 281 94
Interest expense - (18) - (25)
Other expense, net 1 - 1 (1)
Net loss $(2,803) $(1,849) $(4,865) $(3,322)
=========== ======== ============ ========
Basic and diluted net loss
per common share $(0.17) $(0.15) $(0.30) $(0.26)
Weighted average number
of common shares
outstanding 16,669 12,758 16,452 12,603
OXiGENE, Inc.
Condensed Consolidated Balance Sheets
(All amounts in 000's)
Assets June 30, December 31,
2004 2003
------------- -------------
Cash, marketable securities and
restricted cash $35,525 $18,936
Licensing agreement 1,020 1,069
Furniture, fixtures and equipment,
net 48 44
Other assets 504 156
------------- -------------
Total assets $37,097 $20,205
============= =============
Liabilities and stockholders' equity
Accounts payable $1,045 $1,701
Accrued expenses 2,094 2,034
Total stockholders' equity 33,958 16,470
------------- -------------
Total liabilities and stockholders'
equity $37,097 $20,205
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