Calypte Biomedical Corporation Announces Third Quarter And Nine-Month Financial Results

LAKE OSWEGO, Ore., Nov. 15 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation today announced financial results for the third quarter and nine months ended September 30, 2005. Revenue for the quarter was $648,000 versus revenue of $361,000 for the comparable period in 2004. The net loss for the quarter decreased 22% to $2,976,000, or $.02 per common share, compared to a net loss of $3,802,000 or $.02 per common share for the quarter ended September 30, 2004. The net loss for the third quarter of 2005 included net non-cash charges of approximately $1.2 million that were primarily related to the grants of common stock and options as compensation for services and non-cash interest expense related primarily to the accounting for Calypte’s convertible debt financing instruments. Net non-cash charges in the third quarter of 2004 were insignificant.

For the nine months ended September 30, 2005, revenues were $2,107,000, versus $2,242,000 for the same period last year. The net loss for the nine months ended September 30, 2005 decreased 28% to $8,009,000, or $.05 per common share, compared with a net loss of $11,087,000 or $.07 per common share for the nine months ended September 30, 2004. The net loss for the nine months ended September 30, 2005 included approximately $0.4 million in net non-cash income, primarily related to non-cash interest income attributable to the accounting for Calypte’s convertible debt instruments, net of grants of common stock and options and warrants as compensation for services. The net loss for the nine months ended September 30, 2004 included approximately $0.9 million in net non-cash expense related primarily to grants of common stock, options and warrants as compensation for services and the accounting for Calypte’s financing instruments.

Mr. Roger Gale, Calypte’s Chairman and CEO said, “I am pleased with the progress that we have made this quarter and believe that achievements made during this period should have a positive impact on our future. Following approval of our rapid tests in Zimbabwe and Malaysia and execution of distribution agreements covering a number of African countries, we began making limited international shipments of our rapid HIV-1/2 tests and generated a small amount of revenue from those sales during the third quarter. This marks an important milestone and we hope to be able to follow through with additional country approvals and international shipments. Sales of our BED Incidence test, which began in the fourth quarter of 2004, also continue to expand, increasing by 86% over the level reported for the second quarter of 2005 to reach $165,000, representing approximately 25% of our third quarter revenues.”

Mr. Gale added, “We are also gratified with the results released in the final clinical trial report issued by The Chinese Centers for Disease Control. This report confirmed the performance of Calypte’s rapid test platform, Aware HIV-1/2 BSP, Aware HIV-1/2 OMT, and Aware HIV-1/2 U rapid tests in addition to its HIV-1 Serum Western blot and HIV-1 Urine Western blot tests. The clinical trial was completed earlier this year and the results will serve as the basis for the regulatory filings that the Company intends to submit to the Chinese SFDA before the end of the year.”

The Company plans to host an investor update conference call later this month. The date and time of that call will be announced in a subsequent press release.

About Calypte Biomedical:

Calypte Biomedical Corporation is a US-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. 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 sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.

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, if and as needed, 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 generate sufficient revenues to achieve positive cash flow and profitability. 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/A (No. 2) for the year ended December 31, 2004 and its subsequent filings with the SEC.

CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) Unaudited Quarter Ended Nine Months Ended September 30, September 30, 2005 2004 2005 2004 Revenues: Product sales $648 $361 $2,107 $2,242 Cost of product sales 940 2,095 4,226 5,088 Gross Margin (Loss) (292) (1,734) (2,119) (2,846) Other operating expenses: Research and development costs 405 509 1,877 1,623 Selling, general and administrative costs 1,095 1,487 4,555 5,834 Total other operating expenses 1,500 1,996 6,432 7,457 Loss from operations (1,792) (3,730) (8,551) (10,303) Interest and other income (expense), net (primarily non-cash for all periods) (1,184) (72) 544 (782) - - - - Loss before income taxes (2,976) (3,802) (8,007) (11,085) Income taxes - - (2) (2) Net loss $(2,976) $(3,802) $(8,009) $(11,087) Net loss per share (basic and diluted) $(0.02) $(0.02) $(0.05) $(0.07) Weighted average shares used to compute net loss per share (basic and diluted) 179,557 167,703 174,101 150,950 CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY CONSOLIDATED BALANCE SHEET DATA (in thousands) Unaudited September 30, December 31, 2005 2004 Cash and cash equivalents $658 $1,075 Working capital (3,614) (4,772) Total Assets 6,988 7,930 Convertible notes and debentures, net of discount - current portion - 37 Convertible notes and debentures, net of discount - non-current portion 1,470 - Note derivative liability 3,572 - Other long-term liabilities 187 357 Mandatorily redeemable Series A preferred stock 2,906 2,816 Total stockholders’ deficit (6,525) (3,293) Investor Relations Contact: Tim Clemensen -- 212-843-9337 tclemensen@rubensteinir.comhttp://www.calypte.com

Calypte Biomedical Corporation

CONTACT: Investors: Tim Clemensen, +1-212-843-9337, ortclemensen@rubensteinir.com, for Calypte Biomedical Corporation

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