Previstage(TM) GCC test recently launched and now available
QUEBEC CITY, Sept. 8 /PRNewswire-FirstCall/ - DiagnoCure Inc. , a life sciences company commercializing high-value cancer diagnostic tests and delivering lab services, today reported financial and operating results for the third quarter ended July 31, 2008. The Company announced a net loss of $4,207,974 or $0.10 per share for the third quarter ending July 31, 2008. These results are substantially in line with Management expectations and reflect the pre-marketing and final development activities that led to the launch of the Previstage(TM) GCC test in late August. At the end of the quarter, cash, short-term and long-term investments stood at $23,384,513.
“Our sales team is now actively promoting the Previstage(TM) GCC test to clinicians across the United States”, stated John Schafer, President and CEO of DiagnoCure. “We are also very pleased by the European sales performance of PCA3. Gen-Probe, our partner in the development and commercialization of this test, recently announced that their European sales of PCA3 are now exceeding the sales in the United States. This clearly shows that Gen-Probe has implemented strong marketing efforts in Europe, where PCA3 has received full regulatory approval that allows Gen-Probe to actively promote the test in that part of the world. Altogether, this is a great time for DiagnoCure”.
Highlights of the Quarter
Previstage(TM) GCC test
In May, at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, attended by 30,000 health practitioners concerned with cancer, DiagnoCure introduced Previstage(TM) GCC, a molecular diagnostic solution for the need to more accurate staging of colorectal cancer. This major milestone allowed the Company to educate the oncology community about the potential of Previstage(TM) GCC. ASCO also featured a number of important studies about colorectal cancer, including one from Dr. Scott Waldman, from the Thomas Jefferson University, who conducted a prospective, 5-year NIH-sponsored study on GCC; Dr. Waldman presented his discovery and clinical implications of the GCC marker. Key opinion leaders from the colorectal cancer treatment community expressed interest in the Company’s Previstage(TM) GCC test and Dr. Waldman’s presentation.
In June, DiagnoCure gave presentations at important meetings in the United States on its GCC testing research and on the beneficial role of GCC in the staging of colorectal cancer to the medical community.
On August 4, DiagnoCure announced that four prominent colorectal cancer key opinion leaders had agreed to serve on the Strategic Advisory Board of its wholly-owned subsidiary, DiagnoCure Oncology Laboratories. The mandate of these renowned specialists consists of advising the Company on issues related to the Previstage(TM) GCC test and the Company’s commercialization efforts.
During the quarter, DiagnoCure Oncology Laboratories completed the development and validation of Previstage(TM) GCC. On August 26, the Company announced that it had received approval from the U.S. regulatory authorities with the specific CLIA certification required to launch Previstage(TM) GCC. The test is now offered and promoted directly to clinicians across the United States. Previstage(TM) GCC provides clinicians significantly more accurate information for staging a patient with colorectal cancer that increases their confidence in making critical treatment decisions.
PCA3 testing
In May, the PCA3 test was a subject of several key presentations and three exhibits at the meeting of the American Urological Association (AUA) in Orlando, Florida, attended by urologists from around the world. Gen-Probe featured the test in its exhibition booth, and Dianon (LabCorp) and AmeriPath (Quest) had their versions of the PCA3 test, using Gen-Probe’s analyte specific reagents, prominently featured as well. Dr. Yves Fradet, Founder and Chief Medical Officer of DiagnoCure, presented the latest clinical information on PCA3 to an audience of an estimated 10,000 attendees.
The value and performance of the PCA3 test were once again featured in one important article published in May in the Journal of Urology. This article concluded that PCA3 scores correlate with both tumor volumes and prostatectomy Gleason scores, both of which are measures of prostate cancer aggressiveness. As a result, researchers suggested that PCA3 may have clinical applicability in identifying men who have low-volume or low-grade prostate cancer and who could be followed with active surveillance instead of requiring immediate treatment. This article received significant high visibility press coverage in the United States and in Europe, and the study may further increase the market potential of PCA3.
In its June edition, the European Urology Journal published an article on the clinical utility of the PCA3 urine test in repeated biopsy cases. This European study in men with one or two previous negative biopsies indicated that the PCA3 assay may aid in deciding which patients need a repeat biopsy. An increasing PCA3 score corresponds with an increasing probability of a positive repeat biopsy. Additionally, the PCA3 score had greater diagnostic accuracy than PSA for predicting repeat prostate biopsy outcome, even at a sensitivity of 80-90 %. The utility of the PCA3 score was independent of the number of previous biopsies, prostate volume, and total PSA. The PCA3 score may also be indicative of the aggressiveness of prostate cancer.
In their second quarter conference call on July 31, Gen-Probe, to which DiagnoCure licensed its PCA3 marker in 2003, announced that the PCA3 test sales in Europe are now exceeding sales in the U.S. This reflects Gen-Probe’s ability to actively promote PCA3 in Europe where they have obtained in 2006 the necessary regulatory approval for commercialization. Such approval has yet to be obtained in the U.S.
ImmunoCyt(TM)/uCyt+(TM) test
As DiagnoCure looked to maximize the value of its portfolio and focus on high-value molecular diagnostics, the Company actively sought out a partner that would efficiently commercialize ImmunoCyt(TM)/uCyt+(TM), its bladder cancer test. In July, DiagnoCure entered into a product divestment agreement for ImmunoCyt(TM)/uCyt+(TM) with U.S.-based Scimedx Corporation. Terms of the agreement were not disclosed.
Results for the third quarter ended July 31, 2008
Total revenues for the third quarter of 2008 were $486,074 compared with $562,445 for the third quarter of 2007. This decrease of $76,371 is mostly attributable to the decrease in the interest revenue for the quarter. Royalty revenues from Gen-Probe increase in the third quarter of 2008 to $64,239, compared to $39,106 for the third quarter of 2007. Sales of DiagnoCure’s non-invasive bladder cancer test, ImmunoCyt(TM) / uCyt+(TM), were $111,754 for the third quarter of 2008 versus $63,161 for the same period a year ago. Income from research and development contracts, predominantly with Gen-Probe, has decreased in 2008 by $23,099 as specific PCA3-related contracted R&D projects are completed. Also in this quarter, DiagnoCure sold clinical samples to Gen-Probe, in support of their prostate cancer testing R&D, for an amount of $39,179 compared with $3,430 in the third quarter of 2007.
Interest income decreased by $162,747, to $270,902 for the third quarter of 2008 compared with $433,649 for the third quarter of 2007. The decrease is attributable to the use of fund to finance the operating activities and the reduction of interest levels in DiagnoCure’s investments.
Cost of sales increased by $35,067, from $52,474 for the third quarter of 2007 to $87,541 for the third quarter of 2008. This increase is related to higher samples and ImmunoCyt(TM) / uCyt+(TM) sales. Research and development expenses, net of investment tax credits, increased by $1,261,853, from $716,478 for the third quarter of 2007 to $1,978,331 for the same quarter in 2008. The increase in research and development expenses is attributable to the development and transfer, to our U.S. laboratory, of the GCC colorectal cancer staging test.
Based on the above, for the third quarter of 2008, DiagnoCure recorded a net loss of $4,207,974 or $0.10 per share, compared with $2,188,454, or $0.05 per share, for the third quarter of 2007. These results are substantially in line with Management expectations and reflect the pre-marketing and final development activities that led to the launch of the Previstage(TM) GCC test in late August 2008.
About DiagnoCure
DiagnoCure is a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services that increase clinician and patient confidence in making critical treatment decisions. DiagnoCure Oncology Laboratories, a subsidiary of DiagnoCure Inc., recently launched the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. The Company also has a strategic alliance with Gen-Probe for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure’s proprietary molecular marker. This test is also available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the CE-marked PROGENSA(TM) PCA3 in vitro assay, and in Canada. In addition to its own research, the Company intends to acquire or in-license additional promising cancer biomarkers from both academic and commercial institutions. For more information, visit www.diagnocure.com.
Forward-looking statements
This release contains forward-looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward-looking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure’s control. As a result, investors are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure’s most recent Annual Information Form under the heading “Risk Factors”. DiagnoCure undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
CONTACT: Investors: J.F. Bureau, CFA, Sr. Vice President and CFO,
DiagnoCure Inc., (418) 527-6100, communications@diagnocure.com; Media:
Jean-Pierre Trudel, Jean-Pierre Trudel & Associates, (514) 347-6111,
jp.trudel@videotron.ca
