Calypte Only Company with Full Menu of Tests.

In China, we have completed the clinical trials on our HIV rapid tests that were
conducted by the  National  Center for AIDS/STD  Control and  Prevention  of the
Chinese CDC. The trials  involved  approximately  1,500  subjects.  Based on the
results of the  trials,  we believe  that the  performance  of each of our three
rapid tests was sufficient to make them approvable;  however, the performance of
the urine test was not as robust as that of the blood or oral fluid tests. Since
our oral fluid test has  consistently  performed well in clinical trials and the
Chinese SFDA has expressed an interest in  alternative  fluid  testing,  we have
decided to  initially  submit  only our oral fluid HIV test for  approval by the
Chinese SFDA. We believe that submitting an application for only one alternative
fluid test will expedite the  development of a revenue stream in China.  We plan
to submit the oral fluid  application  by the end of the third quarter and would
expect  to  receive  approval  for the sale of the test from the SFDA by late in
this calendar year.  Beijing  Calypte,  our joint venture with Marr, will manage
the Chinese oral fluid test product  launch.  There are several large markets in
China,  including a recently  announced  commitment by the Chinese government to
offer voluntary HIV testing to its entire 1.36 billion population.  With trained
non-professionals  and a safe,  non-invasive  oral fluid test,  we expect strong
demand for our initial test.

We have not abandoned our plans to seek and obtain  approval for the urine rapid
HIV test in China.  We believe  that urine is a  valuable  alternative  to blood
testing  and has a definite  place in HIV  testing.  Further,  we have  received
verbal  guidance  from the SFDA  that the  urine  rapid  test is  desirable  and
approvable. We plan to submit an application for marketing approval of our urine
rapid  test  once we have  strategically  determined  the  appropriate  path for
getting it on the Chinese market
 

In conjunction with our efforts to secure Chinese  manufacturing  facilities and
capacity for our rapid tests,  we learned  that a small  biological  diagnostics
manufacturing  company,  possessing  full GMP  certification,  was for sale.  By
acquiring rights to this facility,  Beijing  Calypte,  our Chinese joint venture
with Marr,  would also acquire rights to the approvals and  certifications  that
this company  already  possesses,  significantly  reducing our projected time to
market.  To this end, the Chinese  company has entered into a lease  arrangement
with  Beijing  Calypte  that allows  Beijing  Calypte to occupy its facility and
begin preparation for manufacturing  before the acquisition  documents have been
finalized and signed.  The Chinese  company has ceased its operations and turned
the facility over to Beijing  Calypte,  whose  manufacturing  equipment has been
delivered to the factory. We expect that we will be ready to begin manufacturing
as soon as we have received SFDA approval. Furthermore, this Chinese company has
a blood rapid HIV-1/2 test that is already fully  approved by the SFDA and being
sold in China.  Accordingly,  we are  evaluating  alternatives  with  respect to
introducing  our HIV rapid  blood test in China and have  elected not to proceed
with a submission based on the results of our clinical trial at this time.
 

We have  successfully  completed the regulatory  approval process for our blood,
oral fluid and urine rapid tests in Uganda. We have completed clinical trials of
our rapid blood test in South Africa and anticipate  commencing  clinical trials
of our oral fluid and urine  rapid  tests by year end.  We are in the process of
finalizing  registration  requirements for all three of our rapid tests in India
and plan to commence product  evaluation  shortly  thereafter.  We have begun to
develop  distribution  channels and plan to conduct additional trials in several
African  countries  later this year. We are targeting  countries which have been
selected for funding by PEPFAR, the $15 billion  President's  Emergency Plan for
AIDS Relief,  and currently have  representation  in seven of the twelve African
countries  and in Vietnam,  the only Asian  country,  on the PEPFAR list.  While
there are different  regulations and customs in each foreign country, we believe
that the regulatory process can generally be completed within in a few months.
 

In  furtherance  of  the  Plan,  effective  May  1,  2005,  we  entered  into  a
manufacturing services and management agreement (the "Agreement"),  as discussed
in Note 1 of the unaudited  financial  statements,  with Maxim Biomedical,  Inc.
("Maxim")  pursuant to which Maxim will  manufacture,  ship and perform  quality
control  procedures  for us in connection  with the Legacy  Business.  Maxim has
hired some of our ex-employees and we transferred our Legacy Business  inventory
to Maxim for its use in performing its  obligations  at our Rockville,  Maryland
facility.  We are  obligated to maintain  and continue to pay our real  property
lease,  equipment lease and intellectual property license obligations.  Revenues
received  from  sales of the  Legacy  Business  products  during the term of the
Agreement  will be  deposited  in a bank account  maintained  by Maxim.  We will
receive  disbursements  from  these  revenues,  on a monthly  basis,  to pay our
monthly operating expenses associated with the Legacy Business, such as the real
property  and  equipment  rental  amounts and license fees to operate the Legacy
Business.  If there are insufficient revenues to cover these expenses during any
given month, we will be reimbursed for such deficiency from future revenues. The
revenues remaining in the account at the end of each month will be paid to Maxim
as a fee for  performing  its  obligations  under the  Agreement.  While we will
remain liable for our real property and equipment  lease  obligations  under the
terms of the Agreement,  we expect to reduce our operating expenses through this
arrangement. During the second quarter of 2005, we recognized approximately $1.2
million of expense related to the transfer of Legacy Business inventory to Maxim
under the terms of the Agreement.

Pursuant  to the  terms  of the  Agreement,  Maxim  has the  right,  but not the
obligation,  to  purchase  the  assets  of the  Legacy  Business  on terms to be
negotiated between the parties.  Maxim has advised us that it intends to acquire
the Legacy Business assets and negotiations are in process to reach a definitive
agreement for the sale of the Legacy  Business.  Such a sale is conditioned upon
our receipt from the FDA of its approval of our  application to manufacture  the
HIV-1  urine EIA  screening  test in  Rockville  following  the  transfer of its
manufacture from our previous location in Alameda, California. We expect the FDA
to  complete  its  review  of that  application  during  the  third  quarter  of
2005.pursuant  to its rights.  Completion of the sale and transfer of the Legacy
Business  will  require the consent of the FDA, the 2005  Investors  and certain
real property and equipment lessors and intellectual  property  licensors of the
Company.
 

Timeframe mindestens bis Ende 2006 !  

According to CC AMEX approved proposal and granted through 2006 to regain compliance. Very good news.  

In accordance with the Plan, in early August 2005, we also closed our Pleasanton
office and relocated the administrative functions to a new headquarters facility
we have leased in Lake  Oswego,  Oregon,  a suburb of  Portland,  near where our
research and  development  staff is presently  based.  In the second  quarter of
2005, we accrued approximately $348,000 of transition-related  severance expense
for certain  Pleasanton-based  administrative  personnel  not  transitioning  to
Oregon and  approximately  $188,000 in lease obligation costs for the California
offices through July 2007 in the event we are unable to sublease that facility.
 

 

 

 

They don't need to build a factory anymore. They are buying and already occupy a fully accredited GMP certified factory.  

 

There have been a problem with the urine rapid test (3 disputed samples out of 275 where the result is not clear). That is the reason for the delay in China.

They try to clarify this with the Chinese authorities but thy won't submit urine rapid now.

Oral fluid rapid will be submitted in the upcoming weeks without blood and urine rapid

 

Monate haben.
 

 

in China *g*  

übrigen liegen Preise für Test's in China zwischen 1- 1,50$  

by: bruzzones2000 (49/F/California)  08/15/05 05:51 pm
Msg: 6171 of 6171

He stated this would be the first oral test to be approved in China...with an incredible demand for HIV testing which is simplistic and not costly.

He also advised they were acquiring an existing plant and the products of that plant, which includes an existing HIV blood test that has been certified, which will reduce the time to get the new products on line.

He advised our China partner, Beijing Calypte, was bearing a disproportionate share of the cost of that acquisition--thank the Lord for that angel, Marr.......

And, BED sales are ramping more than nicely....they are escalating quickly.

Oh, and did I hear him say there is financing to the end of the year and the burn rate is reducing?

Finally, the expressed concern about HIV costs of tests versus the sales price, he stated he was confident the company could do very well on a low product margin, selling quantity within a market with incredible demand.

Very, very, good news!!!!

And an excellent job by the Calypte team. It was more than I had dreamed of, at this point.


 

 
       

Calypte Biomedical Listing Plan Accepted by American Stock Exchange
LAKE OSWEGO, Ore., Aug. 16 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that on August 12, 2005, the American Stock Exchange ("Amex" or the "Exchange") notified the Company that it accepted the Company's plan of compliance and granted the Company an extension of time to regain compliance with the continued listing standards. On June 22, 2005 Calypte received notice from the staff of the Amex indicating that it is not in compliance with certain of the Amex's continued listing standards set forth in the Amex Company Guide. Specifically, the AMEX noted that the Company is not in compliance with Section 1003(a)(i) with shareholders' equity of less than $2,000,000 and losses from continuing operations and/or net losses in two out of its three most recent fiscal years; Section 1003(a)(ii) with shareholders' equity of less than $4,000,000 and losses from continuing operations and/or net losses in three out of its four most recent fiscal years; and Section 1003(a)(iii) with shareholders' equity of less than $6,000,000 and losses from continuing operations and/or net losses in its five most recent fiscal years.

The Company was afforded the opportunity to submit a plan of compliance to the Exchange and on July 21, 2005 presented its plan to the Exchange. During the 18 month extension period granted to the Company in which to regain compliance with Amex standards, the Company will be subject to periodic review by Exchange staff. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the extension period could result in the Company being delisted from the American Stock Exchange.

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.

    Company Contact:                    Investor Relations Contact:
    Richard Brounstein, EVP & CFO       Tim Clemensen,
    (971) 204-0282                      Rubenstein Investor Relations
    Email: rbrounstein@calypte.com      Phone: (212) 843-9337
                                        Email: tclemensen@rubensteinir.com

SOURCE  Calypte Biomedical Corporation
   -0-                             08/16/2005
   /CONTACT:  Richard Brounstein, EVP & CFO of Calypte Biomedical,
+1-971-204-0282, rbrounstein@calypte.com; or Investor Relations, Tim Clemensen
of Rubenstein Investor Relations, +1-212-843-9337,
tclemensen@rubensteinir.com/
   /Web site:  http://www.calypte.com /
   (HIV)

CO:  Calypte Biomedical Corporation
ST:  Oregon
IN:  BIO HEA MTC FIN
SU:

MK
-- NYTU015 --
2637 08/16/2005 08:30 EDT http://www.prnewswire.com


Gruß

C.O
 

ver an, als noch vor dem CC. Bin jetzt doch etwas besserer Hoffnung, dass der Kurs kurzfristig in den Bereich 0,20 US$ anziehen kann. Schauen wir mal, was da heute geht. Grüße, ZN  

Gruß

C.O  

wobei sich die Amex ja vorbehält, auch vor Ablauf der 18 Monaten die Firma auszuschließen, wenn sich etwas negativer entwickelt als im vorgelegten Plan.
Inwieweit das nur ne Floskel ist, weiß ich nicht.

Reichlich undurchschaubar finde ich die Leasinggeschäfte und daraus resultierende Kosten.
Neues Gebäude geleast, altes muss weiter bezahlt werden usw. .

Aber kurzfristig sollte es etwas Luft geben.


Never argue with an idiot -- they drag you down to their level, then beat you with experience.  

und nur das mir im Moment wichtig! Grüße, ZN  

Amex Listing war eines der Positiven Ereignisse..

First Oral in China , Top Preis & Leistung ....

Sehr große Nachfrage nach den Produkten (alle 3 Produkte) , fehlt nur noch Zulassung die aber in einigen Wochen kommen wird laut Dr. George...

Siehe weitere Berichte oben in den Posting’s von Gestern ....



Gruß

C.O