Calypte Announces First Quarter Financial Results ALAMEDA, Calif., May 13 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (BULLETIN BOARD: CYPT) , a developer, manufacturer and marketer of HIV diagnostic tests, today announced financial results for the first quarter ended March 31, 2004. Revenues for the quarter totaled $971,000 compared with $784,000 for the comparable period in 2003, an increase of 24% from the same quarter a year ago. The net loss attributable to common stockholders for the quarter was $4.04 million or $0.03 per common share, compared with a net loss attributable to common stockholders of $6.37 million or $1.11 per common share, for the three months ended March 31, 2003. The net loss for the first quarter of 2004 included $701,000 in non-cash charges that were related to the grants of common stock and options and warrants as compensation for services and non-cash interest expense related primarily to the accounting for Calypte's convertible debt financing instruments. During the quarter ended March 31, 2003, non-cash charges totaled $3,587,000 related to the same types of expenses. "Calypte is becoming a more efficient and streamlined company," stated Tony Cataldo, Calypte's executive chairman. "As the international demand for alternative testing grows, as well as the need to constantly evaluate the success of HIV intervention programs using novel approaches such as the HIV incidence tests that we are working on with the CDC (Centers for Disease Control and Prevention), we believe that the company is positioned properly to take a lead in the field of diagnostic testing." Recent Highlights: Following are Calypte's most significant milestones since the last quarterly release: * The Marr Group through its subsidiaries continues to work with the Company to expand the business in China. In this regard, based on a memorandum of understanding with Beijing Tiantan Biological Products Co., Inc. ("BTBP"), construction is underway on a Chinese manufacturing facility. BTBP is a biotech company listed on the Shanghai Stock Exchange (601161.SS). BTBP is the Special Vehicle Company approved for listing on the Shanghai Stock Exchange; the parent company is National Vaccine & Serum Institute who currently owns over 66 % after two private placements of the BTBP's shares, including 25 million public shares issued in 2003. BTBP manufactures multiple vaccines for both viral and bacterial infections. BTBP has experience in operating life science quality manufacturing facilities and obtaining regulatory approvals for its products. * Calypte is committed to and focused on the introduction of one or more rapid HIV-1 and HIV-2 diagnostic tests in markets including Africa, Asia, and Russia. The Company signed a manufacturing agreement with Pacific Biotech Co. Ltd. in Thailand and will transfer the first of its products, a rapid HIV-1 / 2 antibody test for blood, serum, and plasma to this facility in the upcoming weeks. Product is expected to be available for sale in the second half of this year. * Calypte continues international field trials of its developmental stage urine and blood rapid tests in Thailand, and is adding a trial site in China shortly. The Company will have three active trial sites that will enable it to accelerate the testing process. Given the similarities in manufacturing techniques, the Company expects to achieve a quick transfer of its urine product(s) into production once it is satisfied with the results coming from these field trials. * The Company initiated a CRADA (Cooperative Research and Development Agreement) with the CDC that calls for the development of a rapid blood-based HIV antibody product in conjunction with the CDC. The proposed product will not only be diagnostic but will also provide a reaction line to measure incidence, which is a measure of whether an HIV infection occurred in the recent or remote past. Research and development is under way. In addition, the manufacturing of a laboratory-based ELISA incidence test that has been undertaken in the past by the CDC is being transferred from the CDC to Calypte's Rockville, Maryland facility, thereby increasing the utilization and efficiency of Calypte's operation there. Further, because this incidence test is not for diagnostic purposes, it is expected to have a short regulatory process and quick time to market in the second half of 2004. The Company is already receiving inquiries regarding the availability of our product for sale. * The consolidation of Calypte's domestic manufacturing operations in Rockville is progressing according to schedule and, when completed, is expected to eliminate approximately $1 million of annual expense, including approximately $500,000 in annual occupancy costs, and create a more efficient and cost effective manufacturing structure. The Company expects to exit its Alameda manufacturing facility at the end of June, and has largely completed the inventory build-up necessary for the transition. Calypte will hold a conference call Thursday, May 13 at 5:00 p.m. (EDT), 2:00 p.m. (PDT). Investors can access the call from the investor section of the Calypte web site, at http://www.calypte.com/. Investors in the U.S. and Canada interested in participating in the conference call may dial 800-599-9795 and reference the Calypte Biomedical call. International investors may dial 617-786-2905. Calypte recommends dialing into the call approximately 10 minutes prior to the scheduled start time. The webcast will be available until June 12, 2004. A telephone replay will be available through June 12, 2004 by calling 888-286-8010. International callers should dial 617-801-6888 for the replay. The replay confirmation code is 42377175. About Calypte Biomedical: Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of in vitro diagnostic tests, primarily for the detection of antibodies to Human Immunodeficiency Virus (HIV), and other sexually transmitted and infectious diseases. Calypte's currently marketed laboratory-based tests include an enzyme immunoassay (EIA) HIV-1 antibody screening test and an HIV-1 antibody western blot supplemental test, the only two FDA-approved HIV-1 antibody tests for use on urine samples, as well as an FDA-approved serum HIV- 1 antibody western blot supplemental test. Calypte is actively engaged in developing new test products for the rapid detection of HIV and other infectious diseases. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other infectious diseases may make important contributions to public health. Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will continue to expand. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB for the year ended December 31, 2003 and its subsequent filings with the SEC. Investor Relations Contact: Tim Clemensen 212-843-9337 email: CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) Unaudited Three Months Ended March 31, 2004 2003 Revenues: Product sales $971 $784 Cost of product sales 1,980 1,415 Gross Margin (Loss) on product sales (1,009) (631) Other operating expenses: Research and development costs 541 314 Selling, general and administrative costs 2,196 4,009 Total other operating expenses 2,737 4,323 Loss from operations (3,746) (4,954) Interest income (expense) (primarily non-cash for both periods) (297) (1,516) Other income (expense) 5 128 Loss before income taxes (4,038) (6,342) Income taxes (2) (2) Net loss (4,040) (6,344) Less dividends on mandatorily redeemable Series A preferred stock -- (30) Net loss attributable to common stockholders $(4,040) $(6,374) Net loss per share attributable to common stockholders (basic and diluted) $(0.03) $(1.11) Weighted average shares used to compute net loss per share attributable to common stockholders (basic and diluted) 136,679 5,755 CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY CONSOLIDATED BALANCE SHEET DATA (in thousands) Unaudited March 31, December 31, 2004 2003 Cash and cash equivalents $1,656 $5,084 Working capital (414) 2,865 Total Assets 6,341 9,517 Convertible notes and debentures, net of discount 913 868 Other long term liabilities 140 157 Mandatorily redeemable Series A preferred stock 2,726 2,696 Total stockholders' equity (deficit) (2,181) 917 DATASOURCE: Calypte Biomedical Corporation CONTACT: Tim Clemensen, +1-212-843-9337, , for Calypte Biomedical Corporation Web site: http://www.calypte.com/

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