Aspira Women's Health Inc (AWH) 2007 Q1 法說會逐字稿

Welcome to the Ciphergen first-quarter financial results conference call. (Operator Instructions). As a reminder, this conference is being recorded today, May 16, 2007.

I would now like to turn the conference over to Sue Carruthers. Please go ahead, ma'am.

Welcome to Ciphergen Biosystems conference call. Today, we issued a financial press release for the first quarter of 2007, which is also on our website. And we encourage you to refer to it for more details.

Today's comments contain forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2006 and in our periodic reports on Form 10-Q and Form 8-K. Ciphergen is providing this information as of the date of this webcast and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events, or otherwise.

Examples of such forward-looking statements include statements regarding Ciphergen's expectations, the timing of completion of its ovarian tumor triage test clinical trial and the related submission to the US Food and Drug Administration and its TTP and PAD program plans as well as any statements regarding future operations. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the risks that Ciphergen is unable to successfully utilize resources and execute plans for its molecular diagnostics business. Investors should consult our Form 10-K for the year ended December 31, 2006 as amended and our periodic reports on Form 10-Q and Form 8-K.

At the request of the Company, this call is being recorded. The entire contents of the call including the presentation and the question-and-answer session that will follow are the copyrighted property of Ciphergen Biosystems Inc. with all rights reserved. Any redistribution, retransmission or rebroadcast of this call in any form without the expressed written consent of Ciphergen Biosystems Incorporated is strictly prohibited.

Now, I would like to introduce Ms. Gail Page, President and CEO of Ciphergen.

With me today are Ms. Debra Young, our CFO, and Dr. Eric Fung, our Chief Scientific Officer. We enter 2007 with good momentum toward achieving our mission to harness the power of proteomics to commercialize molecular diagnostics that improve the treatment of human diseases. Accuracy, reliability, and clinical relevance of molecular diagnostics are critical and will improve allocation of healthcare resources.

We currently have three high-value diagnostic products in late-stage development, outstanding strategic alliances with Quest Diagnostics and Bio-Rad Laboratories, (technical difficulty) management team, a restructured balance sheet, and major academic collaborations fueling an expanding portfolio of potential novel diagnostic products. As a result, we are expecting to commercialize our first products in the coming year, while continuing to build our specialty diagnostics business for long-term growth and sustain shareholder value.

Our ovarian cancer program is moving forward, and our clinical trial remains on track for submission by the end of 2007 to the FDA for clearance. Development and validation of our tests for thrombotic thrombocytopenic purpura and our tests to detect peripheral arterial disease are progressing extremely well.

Turning first to our ovarian diagnostic program, based on our analysis of over 2500 clinical samples, our ovarian cancer triage test utilizes a panel of novel biomarkers to help identify women with cancer so they can be referred directly to a gynecologic oncologist, rather than a non-specialist for their initial surgery.

Ovarian masses are quite common. About 10% of women develop ovarian tumors each year. The vast majority of these tumors are benign, but the malignant tumors need to be removed as completely and early as possible. Surgeons trained as gynecologic oncologists perform a specific surgery that removes as much cancer as possible and fully evaluates the extent of the disease.

Studies show ovarian cancer patients, who are operated on by a gynecologic oncologist, survive longer and have a better chance of being cured. While women with cancer, who are initially operated on by a non-specialist, need a second surgery up to 80% of the time to fully evaluate the extent of the cancer and remove additional cancer.

Results from a prospective clinical trial were presented at the Society of Gynecologic Oncologists Annual Meeting in March. We and our collaborators, the Oncologic Clinic Rigshospitalet, the University of Copenhagen, The Danish Cancer Society and The Johns Hopkins Medical Institutions analyzed pre-operative serum samples from 525 consecutive patients. This prospective clinical trial validated that these markers improved both sensitivity and specificity with our ovarian triage test correctly identifying 84% of the ovarian cancer cases, compared to only 33% identified using standard diagnostic methods without the test.

Previous studies have demonstrated that early referrals to gynecologic oncologists for diagnosis and appropriate surgical staging of cancer patients improve survival. In this study, given the historical referral rate to gynecologic oncologists of 33% of pelvic masses, this test could have more than doubled the ovarian cancer cases referred to the gynecologic oncologists.

As I mentioned, early in the quarter, we began a prospective trial for our ovarian cancer triage tests. This trial seeks to demonstrate that the positive predictive value of our tests is better than the current standard of care, which is physiological and radiological exams for distinguishing benign from malignant ovarian tumors. Depending on the prevalence of cancer within the study population, we plan to enroll 700 to 1000 patients and we have successfully set up approximately 25 clinical trial sites. I'm pleased to report they are fully trained and recruiting subjects at this time.

PrecisionMed, a contract research organization with expertise in the collection and management of human biological samples, is supporting our efforts with this trial. We're pursuing a multi-tiered approach to commercialization for our ovarian cancer triage tests. In 2007, we plan to submit the multi-center prospective clinical trial to the US Food and Drug Administration for clearance as an in-vitro diagnostic test. At the same time, we plan to commercialize this test outside the US and have initiated steps to gain regulatory clearance in various European countries.

Our ovarian cancer development pipeline also includes a test to predict ovarian cancer recurrence, tools to help physicians identify and monitor women at high risk for the disease and markers that could be used in conjunction with medical imaging to improve diagnosis. We presented data at the AACR on the discovery of several protein biomarkers that may be potential diagnostic markers in detection of early-stage ovarian cancer. These findings support our diagnostic program with high-risk, early-stage disease.

We and our collaborators discovered four proteins in urine that separate women with early cancer from healthy individuals. These results suggest the possibility that these proteins in combination with other biomarkers could aid in the diagnosis of early-stage ovarian cancer. These promising results provide the foundation for additional studies across a larger population of women. By demonstrating that these findings are reproducible, we hope to advance these markers beyond the clinical validation process and into clinical trials.

Turning now to our pipeline of other potential diagnostics, I want to touch on two tests that we have moved into clinical development over the last quarter -- peripheral arterial disease, commonly referred to as PAD, and thrombotic thrombocytopenic purpura, or TTP. We are developing our PAD test in collaboration with Stanford University to eight physicians in the diagnosis of PAD, which is a disorder affecting approximately 12 million Americans. And that is underdiagnosed and undertreated.

With the rising incidence of diabetes, the incidence of PAD is expected to increase as well. The absence of a blood test contributes to the underdiagnosis of PAD. We're very pleased that Quest Diagnostics accepted this potential test as the second diagnostic under our existing strategic alliance agreement.

In addition to the current ovarian tumor triage test, Quest will assist us in the development of this blood-based assay for the detection of PAD. We're working with Quest to expedite release of the PAD assay. To achieve this, we have established a strong working relationship with our colleagues and the marketing and science groups at Quest. We continue to work very closely and effectively with their organization. Our goal for 2007 is to further validate this test and prepare for market launch.

The third area for which we are developing a diagnostic is TTP, a disorder of the blood coagulation system that in most cases arises from the deficiency or inhibition of a specific enzyme, ADAMTS13. TTP can cause neurologic, renal and cardiac failure and death if it is not treated effectively.

We are collaborating with the Ohio State University to commercialize a SELDI-based assay for TTP. We believe that our test has improved reproducibility and sensitivity over the conventional Western Blot. We are currently optimizing the assay for commercialization and seek to help physicians make the correct diagnosis, initiate timely treatment, evaluate response to therapy, and predict the risk of recurrence in patients with TTP.

In conclusion, in 2007, we anticipate accomplishing the following milestones. First, we intend to complete the prospective clinical trial of our ovarian tumor triage test and submit the results to the FDA for clearance. Second, we will seek registration of our products in the European Union. Third, we will continue to move our programs in TTP and PAD forward through clinical validation studies and prepare for market launch.

Finally, we will continue to bolster our management team, specifically in the areas of marketing and commercialization. To that end, yesterday, we announced the appointment of Mr. Steve Lundy as Senior Vice President of Sales and Marketing. Steve's experience building sales teams; developing innovative marketing plans; and bringing groundbreaking, high-value molecular diagnostics to market will serve Ciphergen well as we launch our products.

To mark the passion and commitment with which we undertake our mission, our Board of Directors recently voted to change the name of the Company to Vermillion. This change requires stockholder approval, which we hope to receive at our annual meeting on June 29, 2007. We believe that this new name depicts the substantial transformation that has occurred over the last 18 months and provides a new underpinning from which to build a significant diagnostics company.

Operator, we are now ready for questions.

(Operator Instructions). Stephen Handley.

A couple of things. Are there any more specific clinical timetables you could offer related to PAD and TTP? I know you expect to make significant progress this year.

Steve, we would be happy to take you through that, probably something we might want to take off-line because we do have a developed scan chart and timeline. So, I think if you would like to follow up with us, that is something that Dr. Fung will be happy to take you through. But certainly, those activities are geared toward product launches in the very near-term.

We'll just defer that one. Could you remind me of your earlier financial guidance that you gave? I wondered whether the loss in the quarter basically with your operating expenses for the quarter were maybe somewhat higher than you would expect on average for the year or not. But rather than pose the question that way, maybe just if you could repeat what your earlier guidance was and do you feel that you're on track?

I do feel like we are on track. We had projected that we thought that we would try to manage our cash around a burn of around 5 million and we reported 5.6. There were some activities that occurred in the first quarter that were associated with the transactions of the fourth quarter. So we feel like we are in line and we will continue to be consistent.

You obviously will be in need of additional capital. And it would seem that you have -- could have a variety of possibilities for that. It could be additional investments it would seem from existing partners, either one of the two or a new partner, or there could be a private placement with non-corporate investors. Could you comment about the most logical or preferred route that you would have to obtain additional monies?

I think, as with any good CEO would tell (technical difficulty) that you're right. We have a lot of opportunities. We are extremely well-positioned after this past year and we can potentially out-license. We could have additional relationships with laboratories. We could do funding.

I think it's our job to continually look at these and opportunistically fund our operations going forward. And whatever makes the most sense and is the best deal for the Company, then that's what we will pursue in light of the shareholders.

(Operator Instructions). Ms. Page, there are no further questions at this time. I will now turn the call back to you. Please continue with your presentation or closing remarks.

I just want to thank everybody for joining us today. We're very excited to move forward, and we feel like we've achieved our goals of last year of becoming a leading specialized diagnostics company. Thank you.

Ladies and gentlemen, that does conclude the conference call for today. We thank you for your participation and ask that you please disconnect your line.