CancerVax Corporation Reports First Quarter 2004 Financial Results.Business Editors CARLSBAD, Calif.--(BUSINESS WIRE)--May 13, 2004 CancerVax Corporation (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 : CNVX), a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer, announced today financial results for the first quarter of 2004. For the three months ended March 31, 2004, the Company reported a net loss of $12.8 million, as compared to a net loss of $7.8 million for the same period in 2003. As of March 31, 2004, the Company had cash, cash equivalents and securities-available-for-sale of $92.4 million. "In the first few months of 2004, CancerVax has focused on increasing enrollment in the Company's Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. of Canvaxin(TM) for the treatment of patients with advanced-stage melanoma, and on continuing to build our manufacturing and quality systems infrastructures. We are currently on track to complete enrollment in our Phase 3 clinical trial for patients with Stage III melanoma this year," said David F. Hale, 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 CancerVax. "In addition, we have continued to advance our pipeline of key biologics for the treatment of cancer. At the American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational annual meeting in March of this year, we announced positive results of preclinical testing of two of our humanized monoclonal antibodies in the suppression of 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. and inhibition of tumor growth in animal models of melanoma and breast cancer. We also enhanced our technology portfolio by licensing novel technology using telomere telomere /telo·mere/ (tel´o-mer) an extremity of a chromosome, which has specific properties, one of which is a polarity that prevents reunion with any fragment after a chromosome has been broken. homolog hom·o·log n. Variant of homologue. oligonucleotides, or T-oligonucleotides, for the potential treatment or prevention of cancer." Financial Review 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. were $12.9 million for the first quarter of 2004, as compared to $7.7 million for the first quarter of 2003. The increase in expenses primarily reflects additional investment in personnel in the manufacturing, clinical affairs, research and development and marketing and business development departments, increased clinical trial expenses associated with the resumption of patient enrollment in the Phase 3 clinical trials of CancerVax's lead product candidate, Canvaxin(TM), in April 2003, including costs associated with the production of Canvaxin(TM) for use in these clinical trials, increased insurance premiums and other expenses associated with CancerVax becoming a publicly-traded company, increased legal fees related to business development activities and payments made under the sublicense agreement with SemaCo, Inc., which were recognized as research and development expenses. Net loss applicable to common stockholders for the three months ended March 31, 2004, was $12.8 million, or $0.48 per share, on a basic and diluted basis, versus $10.0 million, or $27.72 per share, on a basic and diluted basis, for the same period in 2003. Included in the net loss applicable to common stockholders for the three months ended March 31, 2003 was $2.2 million of accretion to the redemption value of the Company's redeemable convertible preferred stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". . Upon the completion of CancerVax's initial public offering (IPO (Initial Public Offering) The first time a company offers shares of stock to the public. While not a computer term per se, many founders, employees and insiders of computer companies have found this acronym more exciting than any tech term they ever heard. ) on November 4, 2003, all shares of redeemable convertible preferred stock were converted into common stock. The net loss per share amounts for the three months ended March 31, 2004 and 2003 were computed based on the shares of common stock outstanding during the periods. Net loss per share for the three months ended March 31, 2004 includes the full effect of the 6.0 million shares of the common stock issued in CancerVax's IPO on November 4, 2003 and the 20.1 million shares of common stock issued upon conversion of the preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. in conjunction with the IPO. On a pro forma As a matter of form or for the sake of form. Used to describe accounting, financial, and other statements or conclusions based upon assumed or anticipated facts. The phrase pro forma basis, assuming the conversion of all the preferred stock from the original dates of issuance, net loss would have been $0.48 per share and $0.49 per share for the three months ended March 31, 2004 and 2003, respectively. Corporate Highlights -- As of the end of April 2004, 947 patients out of a planned 1,118 were enrolled in CancerVax's Phase 3 clinical trial of Canvaxin(TM) for patients with Stage III melanoma, and 369 patients out of a planned 670 were enrolled in the Phase 3 clinical trial of Canvaxin(TM) for patients with Stage IV melanoma, at 80 sites around the world. -- After completing the second of three planned interim analyses, an independent Data and Safety Monitoring Board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ) recommended the continuation of CancerVax's Phase 3 clinical trial of Canvaxin(TM) for patients with Stage III melanoma. The DSMB also recommended the continuation of the Company's Phase 3 clinical trial of Canvaxin(TM) for patients with Stage IV melanoma. -- CancerVax obtained an exclusive, worldwide sublicense to develop novel telomere homolog oligonucleotide, or T-oligonucleotide, technologies from SemaCo., Inc. Preclinical studies in murine murine /mu·rine/ (mur´en) pertaining to, derived from, or characteristic of mice or rats. mu·rine adj. models suggest that T-oligonucleotides may activate defense mechanisms used by healthy cells to prevent malignant transformation malignant transformation Oncology The constellation of changes in the growth properties of cells in culture evoked by various agents–eg, radiation, toxins, and viruses that result in development of tumors . Other preclinical data have shown that T-oligonucleotides may cause apoptosis, or programmed cell death, of cultured human melanoma and lymphoma cells. -- CancerVax announced positive preclinical data relating to its anti-angiogenesis program during the 95th Annual Meeting of the American Association for Cancer Research (AACR AACR American Association for Cancer Research AACR Anglo-American Cataloging Rules AACR Australasian Association of Cancer Registries AACR African Armed Conflicts Resolved ). Preclinical findings suggest that two humanized monoclonal antibodies licensed to the Company's wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , Cell-Matrix, Inc., suppress blood vessel blood vessel n. An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates. blood vessel(s), n the network of muscular tubes that carry blood. formation (angiogenesis) and inhibit tumor growth in animal models of melanoma and breast cancer, and that a synthetic peptide licensed to Cell-Matrix inhibited angiogenesis and melanoma metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to in a chick embryo model. -- During the AACR meeting, CancerVax also announced favorable Phase 2 results from a retrospective, matched pair analysis which compared patients with Stage II melanoma who were treated with Canvaxin(TM) in Phase 2 clinical trials phase 2 clinical trial Phase 2 study. See Phase study. with a group of historical control patients with Stage II melanoma who did not receive Canvaxin(TM). Outlook for 2004 -- CancerVax anticipates that, by the end of 2004, it will complete enrollment in its Phase 3 clinical trial in patients with Stage III melanoma, and that the DSMB will complete its review of the second interim analysis of data from its Phase 3 clinical trial in patients with Stage IV melanoma. -- At the upcoming 2004 Annual Meeting of the American Society of 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 ) in New Orleans, Louisiana from June 5th to 8th, data will be presented from an additional retrospective analysis comparing the median overall survival of patients with Stage IV melanoma who received Canvaxin(TM) in Phase 2 clinical trials with the median overall survival of patients with Stage IV melanoma who did not receive Canvaxin(TM). -- Data from Phase 2 clinical trials for the treatment of patients with non-small-cell lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. with an EGF EGF abbr. epidermal growth factor specific active immunotherapeutic that the Company plans to in-license will also be presented at the June 2004 ASCO meeting. In late 2003, the Company signed non-binding letters of intent relating to the license of three specific active immunotherapeutic agents that target epidermal growth factor Epidermal growth factor or EGF is a growth factor that plays an important role in the regulation of cell growth, proliferation and differentiation. Human EGF is a 6045 Da protein with 53 amino acid residues and three intramolecular disulfide bonds. , or EGF, signal transduction pathways. The specific targets for these agents are EGF, TGF-a and the extracellular domain of HER-1. CancerVax has submitted a license application to the United States Department of Treasury's Office of Foreign Assets Control (OFAC OFAC Office of Foreign Assets Control (US Treasury) OFAC Ontario Farm Animal Council (Canada) OFAC Olmsted Falls Airport Committee OFAC Organic Fertilizer Association of California ) seeking approval to enter into definitive license agreements for this technology, and plans to execute the license agreements for this technology as soon as such approval is received. While the Company's license application is currently being reviewed, there can be no assurance that such a license will be granted. Conference Call and Webcast Today at 4:30 p.m. Eastern Time CancerVax management will host a conference call today to discuss the first quarter financial results and its business overview at 4:30 p.m. Eastern Time. A live audio webcast of management's presentation will be available at http://ir.cancervax.com. Alternatively, callers may participate in the conference call by dialing 800-599-9795 (domestic) or 617-786-2905 (international) and requesting the CancerVax Corporation call hosted by David F. Hale, President and CEO. Following the call, the webcast will be archived on the investor relations Investor relations The process by which the corporation communicates with its investors. section of the CancerVax website. About CancerVax Corporation (www.cancervax.com) CancerVax Corporation is a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer. The Company's lead product candidate, Canvaxin(TM), is one of a new class of products being developed in the area of specific active immunotherapy active immunotherapy The administration of substances to evoke a protective immune response in the form of specific antibodies. Cf Passive immunotherapy, Vaccine. , also known as therapeutic cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine . Canvaxin(TM) is currently being studied in two international Phase 3 clinical trials for the treatment of patients with Stage III or Stage IV, or advanced-stage, melanoma. The Company is also finalizing the design of exploratory Phase 2 clinical trials for patients with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. and, potentially, other advanced-stage solid tumors. CancerVax also plans to identify and develop new product candidates based on its proprietary specific active immunotherapy, anti-angiogenesis and T-oligonucleotide, or telomere homolog oligonucleotide, technology platforms, as well as on its human monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing technology. CancerVax's corporate headquarters and research and development facility is located in Carlsbad, Calif., and its biologics manufacturing facility is located in the Los Angeles area. CancerVax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by CancerVax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in CancerVax's business including, without limitation, statements about: the potential for its product candidates to result in marketable products; difficulties or delays in research, development, testing, obtaining regulatory approval, producing and marketing its technologies and product candidates; unexpected adverse side effects Side effects Effects of a proposed project on other parts of the firm. or inadequate therapeutic efficacy of its product candidates that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its product candidates; its ability to meet product candidate development objectives; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to attract and retain experienced scientists and management; its ability to obtain the U.S. government approvals necessary to license, test and commercialize three specific active immunotherapeutic agents that target the epidermal growth factor, or EGF, signal transduction pathways; and other risks detailed in CancerVax's Securities and Exchange Commission filings, including CancerVax's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended December 31, 2003. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and CancerVax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. CancerVax(R) is a registered trademark of CancerVax Corporation. Canvaxin(TM) is a trademark of CancerVax Corporation.
CancerVax Corporation
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
March 31, Dec. 31,
2004 2003
Assets
Cash, cash equivalents and securities
available-for-sale $92,448 $107,092
Property and equipment, net 10,476 10,529
Goodwill and intangibles, net 5,876 5,900
Other assets 2,359 3,486
Total assets $111,159 $127,007
Liabilities and stockholders' equity
Current liabilities $8,858 $11,741
Long-term debt, net of current portion 1,008 1,811
Other liabilities 740 682
Total stockholders' equity 100,553 112,773
Total liabilities and stockholders' equity $111,159 $127,007
CancerVax Corporation
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31,
2004 2003
Operating expenses:
Research and development $9,572 $6,211
General and administrative 2,720 1,332
Amortization of employee stock-based
compensation 598 155
Total operating expenses 12,890 7,698
Interest income (expense), net 59 (118)
Net loss (12,831) (7,816)
Accretion to redemption value of redeemable
convertible preferred stock -- (2,150)
Net loss applicable to common stockholders $(12,831) $(9,966)
Basic and diluted net loss per share $(0.48) $(27.72)
Weighted average shares used to compute basic
and diluted net loss per share 26,660 360
Pro forma basic and diluted net loss per
share(1) $(0.48) $(0.49)
Weighted average shares used to compute pro
forma basic and diluted net loss per share(1) 26,660 15,791
(1) Pro forma basic and diluted net loss per share is calculated by
dividing net loss by the weighted average common shares
outstanding during the period assuming the conversion of the
preferred stock from the later of the original date of issuance or
the beginning of the period.
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