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Calypte-Biomedical
WKN 909402
Kurs aktuell 0,16?
gruß Grenke
28.08.2002 - Calypte mit neuem HIV Urintest
Calypte Biomedical, dass als einziges Unternehmen zwei durch die US-Gesundheitsbehörde FDA zugelassene HIV- Antikörpertests besitzt, die anstelle von Blut Urin zum Nachweis benutzen, hat heute bekannt gegeben, dass erste Ergebnisse mit einem neuen schnelleren Testverfahren eine beschleunigte Entwicklung rechtfertigen. In einer kleineren Studiengruppe konnte das neue Testverfahren eine 100 prozentige Sensitivität sowie eine 100 prozentige Spezifität zeigen. Aus diesen Gründen will Calypte nun Anfang Oktober mit der US-Gesundheitsbehörde FDA über die beschleunigte Entwicklung des neuen Testverfahrens diskutieren. Die ermutigenden ersten Daten mit dem sehr schnelleren Testverfahren zum Nachweis von HIV-1 Viren im Urin sollen nun dazu beitragen, weitere Studien möglichst effizient zu gestalten und den gesamten Prüfungs- und Zulassungsprozess durch die FDA so weit wie möglich zu beschleunigen. Calyptes Direktor für Zulassungsangelegenheiten Don Kafader meinte in einem abschließenden Statement, wir hoffen mit der FDA einig zu werden, denn vorrangiges Ziel von Calypte ist es, das zukunftsträchtige neue Testverfahren, dass die weitere Ausbreitung von AIDS verhindern soll, so bald als möglich auf den Markt zu bringen.
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Den Analysten von "Der Aktionär-online" zufolge ist die Aktie von Calypte Biomed ein interessantes Investment.
Das Unternehmen verfüge über den einzigen FDA genehmigten Test zum Nachweis von HIV im Urin und habe im April wegen Mangel an finanziellen Mitteln schon einmal kurz vor der Insolvenz gestanden. Damals sei der Aktienkurs von Calypte auf etwa 0,03 US-Dollar gefallen, doch ein neues Management, neues Kapital und schließlich die weltweiten Exklusivrechte an einem weiteren interessanten Schnelltestverfahren hätten Calypte wieder auf die richtige Bahn gebracht. Seither kenne das Papier nur noch eine Richtung und zwar die nach oben.
Mit einem aktuellen Aktienkurs von 0,36 US-Dollar habe sich der Titel schon mehr als verzehnfachen können. Ein gutes Geschäft für diejenigen, die dem Rat der Analysten gefolgt seien und bei Calypte eingestiegen seien. Doch auch jetzt sei es noch nicht zu spät, um bei Calypte noch ein Investment zu wagen.
Die Produktion des HIV Schnelltests sei bereits angelaufen und für das Testverfahren zum Nachweis von Leberfunktionsstörungen besitze Calypte in den USA das alleinige Recht zur Vermarktung an sämtliche Versicherungsunternehmen, welche den Schnelltest zur Risikoabschätzung beim Abschluss von Lebensversicherungen und Invaliditätspolicen nutzen würden. Bei jährlich 6 bis 8 Millionen neuen Versicherungsnehmern in den USA dürfte Calypte also schon bald ein Multi-Millionendollar-Markt ins Haus stehen.
Beim aktuellen Aktienkurs verfüge die Gesellschaft über eine Marktkapitalisierung von nur 18 Mio. US-Dollar, die Aktie sollte also noch reichlich Spielraum nach oben haben. Kurzfristig könnte es nach dieser Rallye zwar auch wieder einen kleinen Pullback oder zumindest eine Seitwärtsbewegung geben, doch angesichts der aktuellen Fakten, sollte der Titel langfristig in Richtung Norden laufen.
Anleger, die nach diesen Ausführungen nun auch mit einem Engagement in Calypte liebäugeln würden, sollten eines bedenken, trotz aller Prognosen könne bei Calypte, das ja über keinerlei Reserven verfüge, noch einiges schief gehen. Man sollte daher seinen Einsatz eher als Spielgeld sehen, entweder man verliere alles oder vervielfache seinen Einsatz. Und bei einem Kurs von 0,38 US-Dollar könne man, ohne ein Vermögen zu verlieren, schon einmal richtig in die Vollen greifen.
Nach Ansicht der Analysten von "Der Aktionär-online" ist die Calypte Biomed-Aktie ein interessantes Investment.
gruß Grenke
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"We believe the Rapid HIV Urine Test is an important product not only for Calypte," stated Calypte President, Nancy Katz, "but for those developing countries throughout the world where there is a need for rapid results and a reluctance on the part of the local population to have blood drawn. It will provide a rapid testing alternative to other tests currently under development by several companies that utilize blood specimens. The advantages of urine specimens have been well established with our existing FDA-approved products. Urine offers painless, non-invasive sample collection making HIV testing available to individuals who prefer not to have a blood sample taken."
According to Don Kafader, Calypte''s Director of Regulatory Affairs, "This meeting with the FDA is an important step in bringing the Rapid HIV Urine Test to market. We hope to be able to come to an agreement with the FDA concerning the nature and scope of the clinical investigations and other studies necessary, so that the review and approval process can be shortened. Our goal is to bring this powerful new product to market as quickly as possible."
About Calypte Biomedical:
Calypte Biomedical Corporation headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte''s tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. When compared with existing blood-based tests, our testing algorithms are non-invasive, easier to use, less expensive and have significantly less risk than blood-based testing, and they have 99.7% sensitivity in subjects previously identified as HIV-1 infected and 100% specificity in subjects at low risk when combined with the urine-based Western Blot supplemental test. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners.
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, our ability to obtain additional financing and access funds from our existing financing arrangements that will allow us to continue our current and future operations and whether demand for our product and testing service 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-K for the year ended December 31, 2001 and its subsequent filings with the SEC.
For further information, please contact Joe Bunning of Sitrick and Company, +1-310-788-2850, for Calypte Biomedical Corporation.
© PR Newswire
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"Although the Company does not fall within the range of companies identified by the SEC, whose top officials are required to file sworn statements attesting to the accuracy of the company''s most recent financial statements, we felt it important to assure the public and investors that we are confident in the accuracy of our accounting and financial procedures," said Nancy Katz.
Congress passed the Sarbanes-Oxley Act on Thursday, July 25, 2002. The stated purpose of the Act is to increase the reliability and accuracy of corporate reporting and accounting and audit practices and to ensure the independence of securities analyst advice and recommendations.
In conjunction with the certification, the Company filed its 10-Q for the period ending June 30, 2002 with the SEC today.
About Calypte Biomedical:
Calypte Biomedical Corporation headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte''s tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners.
© PR Newswire
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The order calls for delivery of the company''s Urine HIV-1 Screening and Supplemental Tests for use in Burkina Faso. Burkina Faso, located in West Africa has a population of approximately 12 million, and according to the 2002 UNAIDS/WHO update, an adult HIV rate of 6.5%. The 380,000 adults living with HIV/AIDS in Burkina Faso are evenly divided between men and women, and there are also 61,000 children living with HIV/AIDS. In 2001, Burkina had 44,000 deaths attributable to AIDS, and a total of 270,000 children who have been orphaned by AIDS.
"Our first order is significant because it represents our entry into a region of the world where the threat of HIV/AIDS is extremely high," said Tony Cataldo, Chairman of Calypte. "We would expect that as word of favorable experience with Calypte''s urine HIV tests spreads, this initial order should drive future sales, not only in Burkina, but elsewhere in the region."
"West Africa, as a whole, has been hard hit by the HIV epidemic. We are working with a Burkinabe distributor, and anticipate that over the course of the next year we will expand our activities into other countries in the region, such as Benin, Togo, Ivory Coast, Mali, and Niger. Our test has been successfully used in several African countries already, and we have every reason to believe that Burkina Faso will derive the same benefits from the urine HIV tests as others have," said Nancy Katz, President and CEO of Calypte. "Previously published reports regarding the use of the urine HIV tests in African settings have demonstrated both the accuracy of the tests, as well as a greater willingness of people to be voluntarily tested for HIV exposure with urine than with blood."
Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte''s tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners. Current product labeling including specific product performance claims can be found on our website at http://www.calypte.com/ .
Statements in this press release that are not historical facts are forward-looking statements, including statements regarding future revenues and sales projections, plans for future financing, the ability to meet operational milestones, marketing arrangements and plans, and shipments to and regulatory approvals in international markets. 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, our ability to obtain additional financing that will allow us to continue our current and future operations and whether demand for our product and testing service 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-K for the year ended December 31, 2000 and its subsequent filings with the SEC.
Calypte Biomedical Corporation
© PR Newswire
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positiv zu bewerten ist, dass der net loss reduziert werden konnte. aber gleich zeitig die ausgaben für forschung und entwicklung um 50% runtergefahren wurden. ssind die produkte ausgereift oder ist diese entwicklung aus der not geboren, weil kein cash mehr zur verfügung stand?
fazit: interessanter zockerwert, über den ich gerne mehr erfahren würde!
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2002 2001 2002 2001
Revenues:
Product sales $ 1,209 $ 1,612 $ 2,368 $ 3,014
Operating expenses:
Product costs 1,397 1,743 3,027 3,732
Research + development costs 180 354 421 851
Selling, general and administrative costs, including $393 and $438
of non-cash expense related to warrant, stock option and stock
bonus grants for the three and six months of 2002, respectively 2,087 2,138 3,302 4,094
Total expenses 3,664 4,235 6,750 8,677
Loss from operations (2,455 ) (2,623 ) (4,382 ) (5,663 )
Interest income 1 1 2 7
Interest expense (46 ) (8 ) (67 ) (33 )
Non-cash interest expense (2,446 ) (830 ) (2,472 ) (1,318 )
Other income, net 14 501 22 524
Loss before income taxes and extraordinary items (4,932 ) (2,959 ) (6,897 ) (6,483 )
Income taxes - - (2 ) (2 )
Net loss before extraordinary items 4,932 ) (2,959 ) 6,899 ) (6,485 )
Extraordinary gain:
On extinguishment of debt, net of income taxes - - 1,319 -
On repurchase of beneficial conversion feature, net of
income taxes - 145 - 145
Net loss (4,932 ) (2,814 ) (5,580 ) (6,340 )
Less dividends on mandatorily redeemable Series A preferred stock (30 ) (30 ) (60 ) (60 )
Net loss per share attributable to common stockholders (basic and diluted) $ (0.08 ) $ (0.10 ) $ (0.11 ) $ (0.23 )
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Weighted average shares used to compute net loss per share attributable
to common stockholders (basic and diluted) 58,434 29,070 49,564 27,451
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Calypte Biomedical Corp. (ticker: CALY, exchange: NASDAQ) News Release - 3-Sep-2002
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HIV Pioneer Encourages Chinese Health Authorities to Take 'Full Advantage' Of Calypte's HIV-1 Urine Screening Test
ALAMEDA, Calif., Sep 3, 2002 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CALY), the developer and marketer of the only two FDA-approved HIV-1 antibody tests that can be used on urine samples, announced today that HIV pioneer Professor Luc Montagnier, co-discoverer of HIV-1 and discoverer of HIV-2, has suggested that Chinese health authorities take full advantage of Calypte's FDA-approved urine screening test for HIV-1 antibodies. He made these recommendations during a Calypte-sponsored, four-day speaking tour of People's Republic of China in which he spoke with a number of government agencies, including the Chinese Center for Disease Control, the National Center for AIDS Prevention and Research, and the State Drug Administration. He was also an invited plenary speaker at the first national meeting of the Chinese Association of Preventive Medicine held in JiNan, and gave a second talk at the Association's Epidemiology Section.
At each stop along the way Professor Montagnier discussed a range of HIV-related topics, but focused primarily on advances in diagnostics, therapy, and the vaccines. At each venue, Dr. Montagnier spoke at some length about the importance of testing and counseling in general, as well as the specific advantages of Calypte's novel urine-based tests for exposure to HIV-1.
"Clearly, testing and counseling form the first steps of the HIV control process. I believe that the advantages of urine testing with respect to safety, logistics, and patient appeal can be of great benefit in many settings in China, and I have encouraged the Chinese authorities to take full advantage of Calypte's novel technology. I have also indicated that my personal experience with the urine test demonstrated equivalent results to serum testing," Dr. Montagnier stated.
"At this point in time, we do not know enough about the nature of the Chinese HIV/AIDS problem, and if the spread of the disease will follow the 'northern model' seen in North America and Western Europe, or the more troubling 'southern model' we see in Africa and Southern Asia for example. As such it would be prudent for the Chinese authorities to plan for the worst and hope for the best. I urge the authorities at the highest levels to declare HIV/AIDS management a national priority, and to apply the resources necessary to tangibly impact the problem," said Dr. Montagnier.
Dr. Montagnier further stated, "Education, testing and counseling, coupled with contemporary anti-retroviral HAART, (Highly Active Anti-Retroviral Therapy) therapy are critical components of HIV control. Although the cost of HIV therapy has historically been high, I believe that between the reduced drug prices offered by pharmaceutical companies, and the future possibility of significantly shortened courses of HAART, it is appropriate to make these therapies available immediately. The availability of therapies not only reduces the spread of the disease, but also encourages more people to be tested."
Professor Montagnier's speaking tour was widely covered by the Chinese national and regional press. He discussed his views on the HIV/AIDS problem and the use of the urine tests in at least six television and newspaper interviews. Many newspaper articles covering Dr. Montagnier's visit have already been printed at this time, and additional coverage in local and regional papers is anticipated. Included in future publications will be an interview with Professor Montagnier conducted by the official newspaper of the Chinese Ministry of Health, with a circulation of 300,000.
"We are fortunate to have Dr. Montagnier as a member of our Scientific Advisory Board and, since June of this year, as a consultant to the company," stated Anthony Cataldo, Calypte's Chairman. "To have the personal support of such an eminent leader in the HIV field, and to be able to sponsor trips such as this one, not only help us to publicize the unique advantages of urine testing, but also, to provide a rare and valuable service to HIV professionals around the world," Mr. Cataldo added.
Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners. Current product labeling including specific product performance claims can be found on our website at www.calypte.com .
Statements in this press release that are not historical facts are forward-looking statements, including statements regarding future revenues and sales projections, plans for future financing, the ability to meet operational milestones, marketing arrangements and plans, and shipments to and regulatory approvals in international markets. 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, our ability to obtain additional financing that will allow us to continue our current and future operations and whether demand for our product and testing service 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-K for the year ended December 31, 2001 and its subsequent filings with the SEC.
For further information, please contact Joe Bunning of Sitrick and Company, +1-310-788-2850, for Calypte Biomedical Corporation.
SOURCE Calypte Biomedical Corporation
CONTACT: Joe Bunning of Sitrick and Company, +1-310-788-2850, for Calypte Biomedical Corporation
