DiagnoCure Announces Third Quarter 2013 Results

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Strong Royalty Revenues Increase of 39 % from Hologic Gen-Probe partnership

QUEBEC CITY, Sept. 4, 2013 /PRNewswire/ - DiagnoCure Inc. (TSX: CUR) (OTCQX: DGCRF) (the “Corporation”) today reported financial and operational results for the third quarter ended July 31, 2013. The Corporation announced royalty revenues from Hologic Gen-Probe increased 39% in the third quarter, compared to the same period of 2012. This increase is attributable to an increase of 82% in the U.S. market amidst challenges in the reimbursement environment for molecular diagnostic. For this quarter, the Corporation announced a net loss of $595,262 or $0.01 per share. At the end of the quarter, cash and short-term investments stood at $4,592,221.

Third Quarter Highlights

On June 3, 2013, DiagnoCure reported positive results of a new study for its PrevistageTM GCC Colorectal Cancer Staging Testduring the 2013 ASCO Annual Meeting held in Chicago, Illinois. On a validation set, including 463 untreated stage II (T3N0) colon cancer patients from North American and European sites, the study showed that molecular staging based on GCC LNR status was able to predict higher recurrence risk for 195 patients (42%) treated by surgery alone. None of the patients in the study had been treated with adjuvant chemotherapy because their lymph nodes appeared cancerfree by examination under the microscope, yet 10% of them had a disease recurrence or died from cancer afterwards. These findings complement those obtained during the first phase of the prospectively specified multicenter VITAR study performed on 241 stage II CC patients which were published in 2011 (Sargent, Annals Surg Onc 2011).

Effective September 1, 2013 DiagnoCure appointed Mr. Richard Bordeleau as Senior Advisor to the Company. Mr. Bordeleau acts as an executive in residence and reports directly to DiagnoCure’s board of directors. In collaboration with Company management, Mr. Bordeleau’s initial mandate is to identify and implement short-term actions aimed at increasing shareholder value, and to evaluate mid- to long-term scenarios optimizing corporate value.

Results of the Third Quarter 2013

Total revenues for the third quarter 2013 were $189,585 compared with $709,754 for the same period of 2012. This decrease of $520,169 is attributable to the termination, on January 11, 2013 of the development and license agreements signed in June 2011 with Signal Genetics. That development agreement provided $567,652 of revenues in the third quarter 2012. In the third quarter 2013, royalty revenues from Hologic Gen-Probe increased by $52,742, or 39%, to $189,585, from $136,843 for the same period of 2012. This increase is attributable to an increase of 82% in the U.S. market amidst challenges in the reimbursement environment for molecular diagnostic tests offset by a decrease of 25% in the European market.

Operating expenses decreased by $530,956, to $784,847 for the third quarter of 2013 from $1,315,803 for the same period of 2012. This decrease is mainly attributable to the termination of the development agreement performed in Q3 2012 in support to the PrevistageTM GCC Colorectal Cancer Staging Test.

Financial Data

For the three months periods ended
July 31
2013 2012
$ $
Research collaboration revenues 567,652
License and royalty revenues 189,585 142,102
Total revenues 189,585 709,754
Operating expenses (before stock-based compensation, depreciation and amortization) 541,338 1,029,933
Net loss (before stock-based compensation, depreciation and amortization) (351,753) (320,179)
Stock-based compensation 26,929 43,356
Depreciation of property, plant and equipment 16,806 30,661
Amortization of intangible asset 199,774 211,853
Net loss and comprehensive loss (595,262) (606,049)
Basic and diluted net loss per share (0.01) (0.01)
Weighted average number of common shares outstanding 43,040,471 43,033,471

Consolidated Balance Sheets

July 31, 2013 October 31, 2012
Cash, cash equivalents, temporary and long-term investments 4,592,221 5,824,771
Total assets 8,967,451 11,256,369
Shareholders’ equity 8,302,949 10,448,087
Number of shares outstanding 43,040,471 43,040,471

Conference call

DiagnoCure’s management will host a conference call at 4:30 p.m. (EDT) on September 4, 2013. Interested participants may listen to the call by dialing 1-888-390-0546 or 514-225-6995 and referencing code 78274536 approximately 15 minutes prior to the call. The Corporation will also provide a live webcast of the call. Interested participants may access the webcast on DiagnoCure’s website at www.diagnocure.com, through a link on the Investors page - Presentations. A replay of the webcast will be available on DiagnoCure’s website for those unable to participate in the live webcast.

About DiagnoCure

DiagnoCure (TSX: CUR; OTCQX: DGCRF) is a life sciences corporation that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Corporation launched a colorectal cancer staging test through its U.S. CLIA laboratory. PrevistageTM GCC is currently available for licensing. The Corporation has granted a worldwide exclusive license on PCA3 to Gen-Probe, now a wholly-owned subsidiary of Hologic Inc. operating as Hologic Gen-Probe, for the development and commercialization of a prostate cancer test, DiagnoCure’s proprietary molecular biomarker. Hologic Gen-Probe’s PROGENSA® PCA3 test is commercialized in Europe under CE mark and is approved for commercialization in Canada and the United States. For more information, please visit www.diagnocure.com.

Forwardlooking statements

This release may contain forwardlooking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. Forward-looking statements can be identified by the use of the conditional or forward-looking terminology such as “anticipates”, “assumes”, “believes”, “estimates”, “expects”, “intend”, “may”, “plans”, “projects”, “should”, “will”, or the negative thereof or other variations thereon. Forward-looking statements also include any other statements that do not refer to historical facts. All such forward-looking statements are made pursuant to the “safe-harbour” provisions of applicable Canadian securities laws. By their very nature, forwardlooking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure’s control. Forward-looking statements are presented for the purpose of assisting investors and others in understanding certain key elements of the Corporation’s current objectives, strategic priorities, expectations and plans, and in obtaining a better understanding of the Corporation’s business and anticipated operating environment. Readers are cautioned that such information may not be appropriate for other purposes and that they should not place undue reliance on these forwardlooking statements. For instance, any forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues, including those related to PROGENSA® PCA3, are based on management expectations and such outcome may vary materially depending on global political and economic conditions, dependence on collaboration partners, uncertainty of healthcare reimbursement, and marketing and distribution challenges. 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 forwardlooking statements contained herein unless required by the applicable securities laws and regulations.

SOURCE DiagnoCure inc.

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