Calypte Only Company with Full Menu of Tests.

dringend benötigten Bekanntheitsgrad verhelfen. Die HIV-Tests des
Unternehmens sind Studien zufolge anderen, bereits vermarkteten, Tests
zwar überlegen, doch an der Nachfrage scheiterte bisher der Erfolg des
kleinen Unternehmens. Weshalb dies Calypte bisher nicht gelang lässt sich
nicht erklären, vielleicht aber ist es ja der schlechte Ruf des ehemaligen
CEOs, der Calypte einfach nicht auf die Beine kommen lässt.
Ein Studienprogramm, dass die von Calypte zum
Schnellnachweis von HIV-1/2 entwickelte Plattform Aware™
evaluieren soll, wird nun schon demnächst in Afrika starten. Die ersten
Versuche werden gemäß der Meldung im HIV-Referenzlabor des Virus
Research Institutes in Entebbe in der Republik Uganda beginnen. Die
Studie soll die Sensitivität, also die Empfindlichkeit, wie auch die
Genauigkeit, die als Spezifität bezeichnet wird, ermitteln. Als Testmaterial
werden Blut, Urin und Speichelproben von mit HIV-1 und HIV-2 infizierten
Patienten zum Einsatz kommen. Uganda zählt zu den Ländern Afrikas, die
am schlimmsten vom HI-Virus getroffen wurden. Gemäß der UNAIDS
waren 2003 rund 530.000 Menschen mit dem Virus infiziert. Im Jahr 2004
wurden etwa 100 Millionen Dollar für AIDS-Test und die Therapie von
AIDS von ausländischen Hilfsorganisationen nach Uganda transferiert.
Calypte will nun sein Testverfahren als Standardverfahren etablieren, was
mit dem erfolgreichen Verlauf der Studien sogar Realität werden könnte.
Die Studien, die unter Leitung des Direktors des Uganda Virus Research
Institutes, Dr. Benon Biryahwaho, durchgeführt werden, sollen rund 350
Infizierte einschließen. Das Studienprogramm repräsentiert das erste
staatlich überwachte Programm für das neue Schnelltestverfahren
Aware™ in Uganda. Bereits im zweiten Quartal dieses Jahres erwartet
Calypte die Ergebnisse der Studie, sollten diese den Wünschen
entsprechend ausfallen, dann will Calypte noch im ersten Halbjahr 2005
einen Zulassungsantrag für Aware™ in Uganda einreichen. Ein positiver
Entscheid würde Calypte die Marktführerschaft zumindest in Uganda
sichern. Für Calypte ist die Chance auf eine baldige Zulassung seines
Tests in Uganda ein wichtiger Meilenstein.
Wenn es nach Dr. Benon Biryahwaho geht, dann wird Aware™ auf alle
Fälle zum Standardtest für den Nachweis des AIDS-Erregers,
vorausgesetzt die Regierung Ugandas erteilt ihr okay. Der Mediziner
arbeitet schon seit längerem mit Calypte zusammen und ist begeistert
vom einfachen Handling der AIDS-Tests, die zudem einen schnellen
Nachweis des Erregers ermöglichen. Doch Uganda soll, wenn es nach
Calypte geht, erst der Anfang sein. 2005 sind weitere Studien mit
Aware™ in anderen afrikanischen Ländern, wie auch im Fernen
Osten, geplant. Auch die erste kommerzielle Applikation der
Technologie, die Calypte im Oktober 2004 von Ani Biotech erworben hat,
soll demnächst in klinischen Studien getestet werden. Den Anfang wird
ebenfalls der Mediziner aus Uganda machen, weitere Schlüsselmärkte
sollen noch in diesem Jahr folgen. Der Transfer der Ani Biotech
Technologie Plattform auf Calyptes HIV-Tests gelang schneller als
gedacht, so der neue Calypte-Boss Dr. George. Die Ani Technologie
erlaubt nicht nur die Herstellung von HIV-Tests für medizinisches
Personal, sondern ermöglicht auch die Herstellung von Tests, die sich für
den Hausgebrauch eignen. Die Letzteren sollen rezeptfrei erhältlich und
von Jedermann leicht zu handhaben sein.
Exakt hier schlummert ein nicht unerhebliches Potenzial, denn ein
rezeptfrei erhältlicher Test würde mit Sicherheit weit mehr Menschen zur
Testung animieren, als bisher. Oftmals ist es nämlich die Scheu vor einem
Arztbesuch, die Menschen von einem HIV-Test Abstand nehmen lässt. Die
Möglichkeit, Schnelltests für alle nur erdenklichen Virusinfektionen für den
Hausgebrauch zu entwickeln, sollte Investoren aufhorchen lassen. Wenn
Calypte dies gelingt, was mit der Ani Biotech Technologie möglich ist,
dann könnten die Penny Stock Zeiten für Calypte schon früher als gedacht
ein Ende haben. Noch etwas Geduld müssen die gebeutelten Anleger aber
haben, denn die Feuertaufe für den ersten HIV-Schnelltest steht noch
bevor.

www.BioTech-Experte.de


Die letzten Informationen zeigen uns das Sie kurz vor dem Ausbruch stehen..

Bitte ernsthafte überlegungen machen...

Gruß

C.O

In past calls I have updated you on progress in the ramp-up in sales of the BED Incidence assay. For new listeners, the BED Incidence assay is a new technology that Calypte licensed from the Center for Disease Control and Prevention in the spring of 2004. This assay was developed by the CDC for use in targeting appropriate populations for HIV prevention efforts. The assay does this by identifying the number of HIV positive people in a specific population where infections occur within the past six months. These populations where new infections are appearing with the highest frequency are those populations in the greatest need for intervention programs. The BED assay is then used to re-test these populations in a year or more to quantify how affective the intervention program has been. A reduction in the number of new infections is evidence of an affective prevention program. Such metrics are indispensable to insure that the prevention dollars are well spent. Since the introduction of the BED Incidence assay many groups feel that the test has great application for clinical use as well as its well proven use in surveillance. Calypte has been contacted by several groups urging us to seek regulatory approval to use this assay for clinical purposes. Calypte has had conversations with both the CDC and the FDA and we have been encouraged to make this regulatory filing. We plan to meet soon with the FDA and with the CDC to discuss filing an IDE, an Investigational Drug Exemption application. Since acquiring a license for this test in 2004, Calypte made the first test available for sale in October 2004. In that same month the CDC announced they would support the use of the BED assay in their surveillance effort world wide. To date three workshops have been held to teach scientists from many countries to use this new technology. These workshops were held in the US and two in Africa. Additional workshops are scheduled throughout 2005. Following each workshop we experience many calls asking for information on the test and ordering instructions. To date we have shipped kits to South Africa, Ethiopia, Kenya, Zimbabwe, China, Uganda, Brazil, Taiwan and to the CDC Contract Laboratory in the United States. Some countries have ordered more than once. We expect this increase in sales to continue throughout 2005 and into 2006. We believe that we will see a marked up-tick in sales for this innovative test in the coming year.

as well as for the commercialization of our rapid tests for HIV-1/2 diagnosis.


     Under the terms of the purchase agreements with the investors (the
"Purchase Agreement"), we issued to accredited investors $8.0 million of Secured
8% Senior Convertible Notes having a term of two years and convertible into
approximately 26.7 million shares of Common Stock at $0.30 per share, five (5)
year Series A warrants to purchase approximately 26.7 million Warrant Shares,
with each Series A warrant exercisable after a period of six months and having
an exercise price of $0.325 and five (5) year Series B warrants to purchase
approximately 12.0 million Warrant Shares, with each Series B warrant
exercisable after a period of six months and having an exercise price of $0.325.
After a period of 18 months and if the daily volume weighted average price of
the Common Stock is greater than $0.60 per share for 20 consecutive trading
days, and subject to certain trading volume restrictions, we have the right to
force the conversion of any unconverted Notes into shares of Common Stock. In
the event of a change of control while the Notes are outstanding, the investors
have the right to put the Notes back to us at 115% of the face amount of the
Notes, plus accrued interest. We also entered into a Security Agreement granting
to the investors a security interest in and lien on all of our assets, subject
to a security interest of up to $1.0 million that was previously granted under
the terms of an equipment financing arrangement. After a period of six months
and if the daily volume weighted average price of the Common Stock is greater
than approximately $0.542 per share for 20 consecutive trading days, and subject
to certain trading volume restrictions, we have the right to force the exercise
of the Series B Warrants.


     We entered into registration rights agreements with investors requiring us
to file a registration statement for the re-sale of the Common Stock underlying
the Notes and Warrant Shares within 45 days of closing and to achieve
effectiveness of the registration statement within 120 days of closing. In the
event we fail to register the Common Stock within the prescribed time, we will
be obligated to pay the investors 1% of the aggregate face amount of the Notes
as partial liquidated damages. We will be required to pay 2% of the aggregate
face amount of the Notes as additional partial liquidated damages on each
monthly anniversary (or pro-rata amount thereof) of the date we were required to
have the shares of Common Stock registered. Under certain circumstances prior to
the effectiveness of the registration statement, both the Series A and Series B
Warrants have a cashless exercise feature.


     Under certain circumstances and subject to approval by our stockholders,
the Purchase Agreement provides for adjustments in the conversion price of the
Notes and the exercise price of the Series A Warrant in the event we issue
shares of Common Stock or common stock equivalents, as defined in the Purchase
Agreement, within one year of the first anniversary of the closing date at a
price less than $0.30 per share with respect to the Notes and at a price less
than $0.325 per share with respect to the Series A Warrants. This provision
terminates upon the earlier of one year or upon conversion of an investor's Note
or exercise of its Series A Warrant.


     We also granted the investors a right of participation in any future
offerings we undertake within one (1) year of the closing date.




     Marr, our largest stockholder, participated in the placement by purchasing
units which consisted of a $2.8 million Note, a Series A Warrant to purchase
approximately 9.3 million Warrant Shares and a Series B Warrant to purchase
approximately 4.2 million Warrant Shares.


     In connection with the placement, there are finders fees and/or placement
agent fees of up to 7% of the related investment amount in cash or Notes, and
warrants to purchase Common Stock in amounts of up to 7% of the related Common
Stock issued.


     On April 4, 2005, we and the investors which are parties to securities
purchase agreements and warrants dated as of May 28, 2004 or July 9, 2004 (the
"2004 PIPEs") agreed to amend those agreements with respect to anti-dilution
rights granted in the purchase agreement and warrants. The securities purchase
agreements and warrants for the 2004 PIPEs contain anti-dilution provisions that
require us to issue additional shares of common stock, reprice the existing
warrants and issue additional warrants to the investors if it raises additional
equity financing at a price below $0.40 per share in the year following the
closing of the repective transactions (the "Anti-Dilution Entitlements"). The
issuance of the Notes and Warrants described above triggers the Anti-Dilution
Entitlements.


     We and the investors in the 2004 PIPEs have agreed to amend the provisions
of the respective purchase agreements and warrants so that the Anti-Dilution
Entitlements do not arise unless and until they are approved by our stockholders
at the next annual meeting of stockholders, which we expect to hold in June
2005. In consideration of the amendment, and subject to stockholder approval, we
have agreed to issue to each investor in the 2004 PIPEs additional shares of
Common Stock and a warrant to purchase additional shares of Common Stock (the
"Additional Shares") for no additional consideration from the investors.
Additionally, we have agreed to reduce the exercise price of all the warrants
issued in the 2004 PIPE's. Assuming our stockholders approve the Anti-Dilution
Entitlements, we expect to (a) issue approximately 7.1 million additional shares
of Common Stock for no additional consideration from the investors, (b) reduce
the exercise price of the investors' existing warrants from $0.50 per share to
$0.45 per share; and (c) issue warrants to purchase approximately 1.3 million
additional shares of our Common Stock at an exercise price of $0.325 per share.
Certain of the investors in the 2004 PIPEs who held shares prior to their
investment in those transactions and who also continue to be our stockholders
have entered into a voting agreement to vote their eligible shares in favor of
approving the Anti-Dilution Entitlements at the annual meeting of stockholders.


     Additionally, on April 4, 2005 we entered into an agreement with Marr
under which Marr agreed to purchase up to $5,500,000 of 9% Promissory Notes that
we may issue between April 5, 2005 and December 31, 2005 (the "Credit
Facility"). Any notes issued under the Credit Facility will be due twelve months
after issuance, but in no event later than May 31, 2006 and will require the
unanimous approval of our Board of Directors, which includes two members
originally nominated by Marr pursuant to a previous investment agreement.. The
$5.5 million commitment amount will be reduced dollar for dollar by the amount
of any subsequent equity financing, including any proceeds from the forced
exercise of the Series B Warrants, we raise after April 4, 2005. Proceeds from
the issuance of notes under the Credit Facility, if any, may be used for general
corporate purposes.


     In consideration of the Credit Facility, we granted Marr a five-year
warrant, exercisable after a period of six months, to purchase 500,000 shares of
our Common Stock at an exercise price of $0.40 per share with piggyback
registration rights for the underlying shares of common stock. We intend to
register for re-sale the shares of Common Stock underlying this warrant with the
shares to be registered in conjunction with the shares underlying the Notes and
Series A Warrants and Series B Warrants described above.



                THIS INVESTMENT INVOLVES A HIGH DEGREE OF RISK.

                    SEE "RISK FACTORS" BEGINNING ON PAGE 5.
                                                             
     We may amend or supplement this Prospectus from time to time by filing
amendments or supplements as required. You should read the entire Prospectus and
any amendments or supplements carefully before you make your investment
decision.

     This Prospectus Supplement is incorporated by reference into the
Prospectus, and all terms used herein shall have the meaning assigned to them in
the Prospectus. See "Risk Factors" beginning on page 5 of the accompanying
prospectus and on page 55 of our annual report on Form 10-KSB for the year ended




December 31, 2003, which is being delivered to you with the accompanying
prospectus, for a description of certain factors that should be considered by
prospective Investors.

     These securities have not been approved or disapproved by the Securities
and Exchange Commission or any state securities commission nor has the
Securities and Exchange Commission or any state securities commission passed
upon the accuracy or adequacy of this prospectus. Any representation to the
contrary is a criminal offense.

           The date of this Prospectus Supplement is April 15, 2005.




Gruß


C.O

Alle warten auf Ergebnisse aus Afrika und China.
Als erstes dürfte es mit Afrika losgehen und ende diesen Monat mit China weiter nach oben bewegen..

Ich gebe zu es hat verdammt lange gedauert aber wir müssen zugeben es hat sich gelohnt..

Das Team (Die Führung von Calypte) hat hervorragende Arbeit geleistet ; )

April 4, 2005
China update:
Dr. George
"Now I’d like to review operations - the question on everyone’s mind is “what’s happening in China?” I was in China about three weeks ago and met with the contractor conducting clinical trials; I am pleased to confirm that we are near completion. The testing of the HIV positive and negative subjects has been completed. Remaining are approximately 100 subjects with other viral infections, such as Hepatitis C. The Chinese government is interested in seeing the cross reactivity in patients with HCV. China faces a large HCV problem and despite our own findings that show no cross reactivity, we respect their desire to pursue this data on a small sample size. Finding these people however has been an arduous process but we seem to be nearing the completion. We therefore believe that the study will be completed this month, at which time we will immediately file the necessary data and applications to the SFDA for review and approval. We will also announce the results of the trial once the final report has been submitted to us by the agency that is conducting the trial."

Africa:
Dick Van Maanen
You may recall that we set Africa and Asia as our initial targets for Aware® for a number of reasons including HIV prevalence, the magnitude of foreign aid as well as an IP perspective. So let’s start the discussion with Africa. Regulatory testing has been completed in Uganda and a recommendation has been made. So we’re currently awaiting a decision on final approval from the National Drug Authority of Uganda. We believe that our first approval in Africa will come from Uganda imminently



Gruß

C.O

Also noch mal  für all die , die neu hier sind ...

Unser Joelü hat vor ungefähr 4 Jahren 5000 DM mit dem Unternehmen verbrannt, Seitdem ist er so negativ gegenüber Calypte ...

Was er nicht unterscheiden kann, ist ,man sollte wissen wann man Rein und wann man Raus muß..

Er hat erst dann gehandelt, als es schon zu spät war.

Also kann nicht mit gesundem Menschenverstand , Beurteilen was richtig und was falsch ist...

Man kann meinen das er erblendet ist vor dem was auf uns zukommt..

Er ist immer noch da wo er aufgehört hat nämlich vor 4 Jahren immer auf der selben Stelle...


; )) muhahahaha


Gruß

C.O