OXiGENE Reports First Quarter 2004 Financial Results.Business Editors/Health/Medical Writers WALTHAM, Mass.--(BUSINESS WIRE)--April 28, 2004 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 Accomplishments
-- Announced positive pre-clinical data on OXi4503 at AACR
-- Raised net proceeds of $22.3 million
-- Strengthened management team
-- Received European Union Orphan Drug Designation for CA4P
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 first quarter ended March 31, 2004. Licensing revenue for the first quarter of 2004 was $7,000 compared with $20,000 in the same period of 2003. The net loss for the three months ended March 31, 2004 was $2.1 million, or $0.13 per share, compared with a net loss of $1.5 million, or $0.12 per share, in the first 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 44 percent in the first quarter of 2004 to $2.2 million from $1.5 million in the first quarter of 2003. This increase reflects higher research and development expenses and general and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. . The R&D expenses are related to the ongoing clinical trials of the Company's lead compound, 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), and to the advancement of OXi4503 into numerous pre-clinical tests. Since the end of the first quarter of 2003, CA4P has advanced into three human clinical trials in cancer and one in 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 . The G&A costs are associated with the strengthening and retention of Company management and increased professional service fees in connection with being a public company. At March 31, 2004, OXiGENE had cash and available-for-sale securities of $39.0 million, up from $18.9 million at December 31, 2003. Patient enrollment is well underway in the six post-Phase I human studies of CA4P. These studies -- five in cancer and one in ophthalmology -- will enroll a total of approximately 200 patients in addition to the 100 patients treated in the Company's initial Phase I studies. At next month's 2nd International Vascular Targeting Conference in Florida, clinical investigators involved in several of the current clinical trials of CA4P are scheduled to present in the conference's Clinical Developments section. These investigators are involved in: 1) the Phase I/II study of CA4P in combination with the chemotherapy drugs Carboplatin/Paclitaxel in patients with advanced cancer and advanced ovarian carcinoma; 2) the Phase I/II combination trial of CA4P and radiotherapy in patients with advanced cancer of the lung, head & neck and prostate; and 3) the Phase I/II ophthalmology study of CA4P in patients with 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. . During the first quarter of 2004, pre-clinical data on OXiGENE's lead pre-clinical compound, OXi4503, was presented at the American Association American Association refers to one of the following professional baseball leagues:
n.pr See therapy, Koryo hand. and human KSY sarcoma sarcoma (särkō`mə), highly malignant tumor arising in connective- and muscle-cell tissue. It is the result of oncogenes (the cancer causing genes of some viruses) and proto-oncogenes (cancer causing genes in human cells). models and in a Caki-1 model of human renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. . Cancer Research UK, the world's largest volunteer-sponsored cancer research organization, is conducting pre-clinical toxicology testing on OXi4503. "Cancer Research UK is making steady progress in readying OXi4503 for study in humans," said Fred Driscoll, OXiGENE's president and chief executive officer. "Dose-escalating toxicology studies of the compound are being conducted in animals, and the data collected from these studies will be used to design the protocol for our initial study of the compound in humans. Pre-clinical testing continues on schedule, and we expect that OXi4503 will enter the clinic by the end of this year." Other recent highlights include: -- OXiGENE generated net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of $22.3 million through a sale of 2,755,695 shares of Common Stock to certain institutional investors at $8.78 per share. -- James B. Murphy was hired as OXiGENE's chief financial officer and Scott L. Young, previously the Company's vice president of clinical and regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: created post of chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. . -- Retinal surgeon Eugene de Juan, Jr., M.D. was named to the Company's Clinical Trial Advisory Board. A professor of ophthalmology at the University of Southern California's Keck School of Medicine, de Juan will advise OXiGENE on the design of future ophthalmology trials and clinical study site selection. -- The 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 Medicinal Product medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. Designation was awarded to CA4P as a treatment for 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 designation would provide OXiGENE with market exclusivity in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community for 10 years following CA4P's market authorization. First-quarter Conference Call Information In conjunction with its first-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: Wednesday, April 28, 2004
Dial-in numbers: 888-208-1814 (U.S.)
719-457-2655 (international)
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, May 4. To access the replay, dial 888-203-1112 (domestic) or 719-457-0820 (international) and refer to reservation number 640356. 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: the expectation that clinical investigators involved in three current trials of CA4P will present during the Clinical Developments section of the 2nd International Vascular Targeting Conference; the role of Eugene de Juan, Jr., M.D. on the Company's Clinical Trial Advisory Board; the expected progress of pre-clinical trials of OXi4503; and the expectation that OXi4503 will enter clinical trials in 2004. 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.
OXiGENE, Inc.
Condensed Consolidated Balance Sheets
(All amounts in 000's)
March 31, December 31,
2004 2003
--------------------------
(Unaudited)
Assets
Cash, available-for-sale securities and
restricted cash $ 39,025 $ 18,936
Licensing agreement 1,044 1,069
Furniture, fixtures and equipment, net 52 44
Other assets 759 156
--------------------------
Total assets $ 40,880 $ 20,205
=========== ===========
Liabilities and stockholders' equity
Accounts payable $ 1,593 $ 1,701
Accrued expenses 2,148 2,034
Total stockholders' equity 37,139 16,470
--------------------------
Total liabilities and stockholders'
equity $ 40,880 $ 20,205
=========== ===========
OXiGENE, Inc.
Consolidated Statements of Operations
(All amounts in 000's except per share amounts)
Three months ended
--------------------------
March 31,
--------------------------
2004 2003
--------------------------
(Unaudited)
--------------------------
License revenue $ 7 $ 20
Costs and expenses:
Research and development 929 726
General and administrative 1,259 791
Amortization of license agreement 24 20
----------- -----------
Total costs and expenses: 2,212 1,537
Operating loss (2,205) (1,517)
Investment income 143 49
Interest expense - (7)
Other expense, net - (1)
Net loss $ (2,062) $ (1,476)
=========== ===========
Basic and diluted net loss per common share $ (0.13) $ (0.12)
Weighted average number of common shares
outstanding 16,236 12,637
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