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Biotech / Medical : Ciphergen Biosystems(CIPH):

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To: tuck who wrote (507)11/12/2007 5:33:51 PM
From: tuck   of 510
 
>>Vermillion Reports Third Quarter 2007 Financial Results and Business Progress

Monday November 12, 4:05 pm ET
-Vermillion To Host Conference Call Today at 4:30 p.m. Eastern Time-

FREMONT, Calif., Nov. 12 /PRNewswire-FirstCall/ -- Vermillion, Inc. (Nasdaq: VRML - News) today announced financial results for its third quarter ended September 30, 2007 and an update on business progress.

"During the third quarter of 2007, we accomplished several important milestones including completion of enrollment of our ovarian cancer diagnostic clinical trial and securing $20.6 million from a private placement. In addition, we changed the Company's name to Vermillion, Inc. to reflect our focus on specialty clinical diagnostic tests," said Gail S. Page, President and Chief Executive Officer of Vermillion. "We are making excellent progress in each of our diagnostic programs. Our ovarian tumor triage test clinical trial was a major undertaking involving 27 clinical sites. Analysis of the blood samples from 550 patients is currently underway and we expect to report top-line data results in December, and plan a submission to the FDA shortly thereafter. Our peripheral arterial disease (PAD) diagnostic test is undergoing comprehensive validation studies with Quest Diagnostics with the expectation that it will be offered as a laboratory developed test in early 2008. As we announced last week, The Ohio State University Research Foundation will launch our test for thrombotic thrombocytopenic purpura (TTP) shortly."

Third Quarter 2007 Financial Results

As a result of the November 13, 2006 sale of its former instrument business to Bio-Rad Laboratories, the Company does not anticipate having revenue until its diagnostic tests are commercialized. Accordingly, the Company had no revenue in the third quarter of 2007 compared to $4.7 million in the third quarter of 2006.

Total operating expenses for the third quarter of 2007 were $4.8 million compared to $8.7 million in the same period last year. The reduction in operating expenses was due primarily to the elimination of selling and marketing expenses associated with the Company's former instrument business as well as reductions in research and development and general and administrative expenses.

The net loss for the third quarter of 2007 was $5.1 million compared to $7.0 million for the same period in 2006. Basic and diluted net loss per share for the third quarter of 2007 was $0.11 per share based on 48.1 million shares outstanding compared to a basic and diluted net loss per share of $0.19 per share for the same period in 2006 based on 36.1 million shares outstanding.

At September 30, 2007, the Company's cash, cash equivalents and short-term investments were $23.5 million, compared to $9.6 million at June 30, 2007 and $17.7 million at December 31, 2006. Net cash used in operating activities in the third quarter of 2007 was $5.1 million and $16 million for the first nine months of 2007. During the third quarter of 2007, Vermillion raised $20.6 million in gross proceeds in a private placement.

Recent Highlights and Accomplishments

Ovarian Cancer Diagnostic Program:

-- Completed enrollment of 550 patients at 27 medical centers in a
clinical trial to evaluate Vermillion's ovarian tumor triage test to
differentiate women with ovarian cancer from women with benign pelvic
masses.

-- Presented multiple studies at the European Society for Gynecologic
Oncology meeting. These presentations described progress in
Vermillion's ovarian cancer diagnostic program including work
validating its test that aids in discriminating between benign and
malignant ovarian tumors, as well as data demonstrating that several of
Vermillion's ovarian cancer protein biomarkers could be used to detect
early-stage ovarian cancer and to predict survival.

Peripheral Arterial Disease Program:

-- Published research in Circulation that details how Vermillion
researchers and collaborators showed that elevated levels of a protein
biomarker known as beta-2 microglobulin are correlated to the presence
and severity of peripheral arterial disease (PAD).

-- With Quest Diagnostics Incorporated, we have continued to validate a
blood-based assay for the detection of PAD. There are currently 12
million Americans diagnosed with PAD and there are over 30 million
Americans at risk for the disease who would benefit from early
diagnosis.

Corporate Development:

-- Received a certificate of reissuance from the United States Patent and
Trademark Office for Patent No. 6,734,022, which is directed to a
fundamental process of SELDI mass spectrometry. With the reissuance,
Vermillion expects to receive $2.0 million from Bio-Rad Laboratories,
Inc. pursuant to the terms of the Asset Purchase Agreement entered into
in connection with the sale of Vermillion's instrument business to
Bio-Rad.

-- Announced a license agreement with The Ohio State University Research
Foundation and The Ohio State University (OSU), to permit OSU to
provide a proteomics-based diagnostic test to detect TTP, a hematologic
disease that causes abnormal clotting and carries the risk of
neurologic, renal, and cardiac dysfunction and even death. This test
is aimed at helping physicians make the correct diagnosis, initiate
timely treatment, evaluate response to therapy, and predict the risk of
recurrence in patients with TTP.

Conference Call Details for November 12, 2007

Vermillion management will host a conference call today, November 12 at 4:30 p.m. Eastern Time to discuss these results and provide an update on business developments. To access the live conference call via phone, dial (877) 325-7371 from the United States and Canada or (+1 706) 634-0768 internationally. The conference ID is 21354673. Please dial-in approximately ten minutes prior to the start of the call. Additionally, you may access the live and subsequently archived webcast of the conference call from the Investor Relations section of the Company's website at vermillion.com. Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary.

A telephone replay will be available beginning approximately two hours after the call through November 26, 2007 and may be accessed by dialing (800) 633-8284 from the United States and Canada or (+1 402) 977-9140 internationally. The replay passcode is 21354673. An archived replay of the webcast will be available until the next quarterly call.<<

snip

It's now pretty clear that Quest will wait until the ovarian test results come in, and are successful, and form the basis of filing with a chance, and getting it FDA approved before launching the test. Apparently the PAD test will come out first, which I would not have guessed. Why that test can go the quick route and the OC test can't, I'm not clear on. Partly because I haven't been paying much attention of late. Anyhow, that would mean about 2009 for ovarian test launch now.

I have no idea if they can limp along with the PAD test revenues until then. Maybe, but the stock is not far from all time lows, so definitely a seeing is believing approach from the Street. Holding still, and hoping.

Cheers, Tuck
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