FREMONT, Calif., Aug. 14 Vermillion, Inc.(Nasdaq: VRML), a molecular diagnostics company, today announced financialresults for the second quarter ended June 30, 2008, and provided an update onrecent corporate and clinical developments.
Vermillion continues to demonstrate significant clinical andcommercialization progress in each of its diagnostic programs and, with therecent retention of ThinkPanmure, an Investment Bank, the Company is workingto maximize its strategic options to bring its proteomic tests to the market.
In June 2008, the Company filed a 510(K) Application for the OVA1(TM) Testfor ovarian tumor triage with the U.S. Food and Drug Administration (FDA).Additionally, Vermillion is working on clinical studies and building marketawareness of its PAD risk assessment blood test, now named VASCLIR(TM) the PADtest. Throughout the remainder of 2008, the Company will focus oncommercializing these tests.
Second Quarter 2008 Financial Results
Total operating expenses decreased in the second quarter of 2008 to$3.4 million, from $5.9 million in the same period last year. The decrease wasdue primarily to restructuring of the company and reduced general andadministrative expenses.
The Company's net loss for the second quarter of 2008 was $4.5 million,compared to $6.8 million for the same period in 2007. Basic and diluted netloss for the second quarter of 2008 was $0.70 per share based on 6.38 milliontotal shares outstanding, compared to a basic and diluted net loss of $1.74per share based on 3.93 million total shares outstanding for the same periodin 2007. Earnings per share calculations are on a post reverse stock splitbasis.
At June 30, 2008, the Company's cash, short- and long-term investmentstotaled $9.9 million, compared to $20.4 million at December 31, 2007. Net cashused in operating activities in the second quarter of 2008 was $4.2 million.Vermillion continues to conscientiously manage expenses and cash utilization.
Recent Highlights and Accomplishments
During the first half of 2008, Vermillion achieved the followingmilestones in its diagnostic programs and continued to progress in itscorporate development efforts.
-- Ovarian Cancer Diagnostic Program:
-- Submitted data to the FDA from its OVA1 prospective clinical trial.The trial met its primary endpoint of improved sensitivity for malignantovarian tumors.
-- Hosted a roundtable teleconference focusing on Vermillion's ovariancancer diagnostic program and the need for tools that can better triage womenwith ovarian tumors. The teleconference featured keynote speaker Fred Ueland,M.D., Associate Professor of Gynecologic Oncology at the University ofKentucky, who is the Principal Investigator in Vermillion's OVA1 clinicaltrial.
-- Presented data at the annual meeting of the American Society ofClinical Oncology (ASCO) demonstrating that Vermillion's markers, inconjunction with CA125, improved detection of early stage ovarian cancer.
-- PAD Diagnostic Program:
-- Established a clinical steering committee to provide advice onstudies to support registration of VASCLIR with the FDA and to furtherpotential market adoption.
-- Engaged the Colorado Prevention Center as its academic researchorganization for assistance in designing its prospective clinical trial tosupport clearance of its VASCLIR test.
-- Presented data from a study providing further confirmation that theCompany's test may aid in the diagnosis of PAD. The research, which waspresented at the annual meeting of the Society of Vascular Medicine andBiology (SVMB), suggests that such a test may be useful in helping determine apatient's risk for developing PAD.
-- Hosted a roundtable teleconference focusing on Vermillion's PADdiagnostic program and the need for improved detection of this life- and limb-threatening