-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, N/7X8U3O4EHGnO8zhSZzwIdhFCPJjJOdYIMWm6jMcUcvR8ap+GMfXplBo9c3IC2q ZGePk0VqSo1zw6uFdsH+wA== 0001157523-04-003921.txt : 20040428 0001157523-04-003921.hdr.sgml : 20040428 20040428082722 ACCESSION NUMBER: 0001157523-04-003921 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040428 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040428 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OXIGENE INC CENTRAL INDEX KEY: 0000908259 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133679168 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21990 FILM NUMBER: 04758571 BUSINESS ADDRESS: STREET 1: 321 ARSENAL STREET CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 6176737800 8-K 1 a4627225.txt OXIGENE 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 -------------- FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 -------------- Date of Report (Date of earliest event reported): April 28, 2004 -------------- OXiGENE, INC. ------------- (Exact name of registrant as specified in its charter) Delaware 0-21990 13-3679168 - ------------------------- ----------------------- ------------------- (State or other (Commission (IRS Employer jurisdiction of File Number) Identification No.) incorporation) 230 Third Avenue, Waltham, MA 02451 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (781) 547-5900 -------------- Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. (a) Financial statements of businesses acquired. Not applicable. (b) Pro forma financial information. Not applicable. (c) The following exhibits are furnished with this report: Exhibit Number Description ------ ----------- 99.1 Press Release of OXiGENE, Inc. dated April 28, 2004. Item 12. Disclosure of Results of Operations and Financial Condition. OXiGENE issued a news release on April 28, 2004, a copy of which is attached as Exhibit 99.1 to this report and incorporated herein by this reference, in which it announced financial results for the first quarter ended March 31, 2004. This information shall not be deemed to be "filed" for the purposes of Section 18 of the Securities and Exchange Act of 1934 and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. OXiGENE, INC. (Registrant) Date: April 28, 2004 /s/ Frederick W. Driscoll Frederick W. Driscoll EXHIBIT INDEX Exhibit No. Description -------------------------------- 99.1 Press Release of OXiGENE, Inc. dated April 28, 2004. EX-99.1 2 a4627225ex99.txt EXHIBIT 99.1 PRESS RELEASE Exhibit 99.1 OXiGENE Reports First Quarter 2004 Financial Results WALTHAM, Mass.--(BUSINESS WIRE)--April 28, 2004--OXiGENE, Inc. (NASDAQ: 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 blood vessels within solid tumor cancers and ocular 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 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. The R&D expenses are related to the ongoing clinical trials of the Company's lead compound, Combretastatin A4 Prodrug (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. 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. During the first quarter of 2004, pre-clinical data on OXiGENE's lead pre-clinical compound, OXi4503, was presented at the American Association for Cancer Research's 95th Annual Meeting. One study assessed the synergistic effects of OXi4503 with standard-of-care chemotherapy drugs Carboplatin and Paclitaxel in human breast and ovarian carcinoma models grown in mice. Another study measured OXi4503's pre-clinical efficacy and histopathologic effects in rodent KHT and human KSY sarcoma models and in a Caki-1 model of human renal cell carcinoma. 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 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, was promoted to the newly created post of chief operating officer. -- 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 Medicinal Product Designation was awarded to CA4P as a treatment for anaplastic thyroid cancer. The designation would provide OXiGENE with market exclusivity in the European Union 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. For more information about OXiGENE, visit www.oxigene.com. Safe Harbor 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 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 CONTACT: Sharon Merrill Associates, Inc. David Calusdian (Investors), 617-542-5300 dcalusdian@investorrelations.com or Scott Solomon (Media), 617-542-5300 ssolomon@investorrelations.com -----END PRIVACY-ENHANCED MESSAGE-----