Sep 17 2009
DiagnoCure Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced revenue of $396,468 and a net loss of $4,034,364 or $0.09 per share for the third quarter ending July 31, 2009. The net loss in this quarter reflects in part activities initiated to promote the Previstage(TM) GCC Colorectal Cancer Staging Test, but also a foreign exchange loss of $479,588 related to conversion in C$ of the short-term investments the Company held in US$ at the end of the quarter, and non-recurrent expenses of $309,184 related to the prospectus filed in June 2009. At the end of the quarter, cash, short-term investments and long-term investments stood at $17,249,422, an increase of $3,165,593 over the second quarter of 2009.
Highlights of the Quarter
The third quarter started with an investment of US$5 million in DiagnoCure by Gen-Probe, the Company's partner for the development and commercialization of the PCA3 test. In return, Gen-Probe received 4.9 million DiagnoCure's convertible preferred shares and, if the shares were converted, would own over 10% of the Company. This investment was part of a new amendment to the companies' six-year old collaboration agreement, which called for new milestones with regard to a regulatory submission of the PCA3 prostate cancer test to the U.S. Food and Drug Administration (FDA).
Pursuing this commitment to advance the commercial development of the PCA3 test, Gen-Probe announced on August 27 that they had begun a U.S. clinical trial of the PROGENSA(R) PCA3 assay with the intent of securing U.S. regulatory approval of the test. Their stated goal is to complete the study in less than one year and thereafter submit a Premarket Approval Application (PMA) to the FDA for the full marketing and commercialization of the PCA3 prostate cancer test in the United States. The study will enroll from 10 or more clinical trial sites about 500 patients who have had a negative prostate biopsy.
The Previstage(TM) GCC Colorectal Cancer Test continued to make commercial progress in the third quarter, with over 50 billable sales and 25 physicians ordering the test this year. Moreover, in order to foster the integration of the test into physicians' standard practice, the Company launched the PIONEER GCC Registry, which aims to enroll 500 patients with a billable test order over the next year in an observational study that will link their GCC test results with the treatment decision and the clinical outcome.
With $17.2 million in cash, DiagnoCure should have the liquidities necessary to carry out its activities for almost two years at the current rate of spending. Management will continue to consider appropriate financing opportunities, including potential partnerships, to support the development of its projects and leverage the value of its pipeline, and will continue to rigorously control its expenses to assure financial stability while remaining committed to its short- and long-term milestones and to its stated vision and business plan.