DiagnoCure announces results for third quarter of 2014

QUEBEC CITY, Sept. 11, 2014 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR) (OTCQX: DGCRF) (the "Corporation") today reported financial and operational results for the third quarter 2014 ended July 31, 2014. The Corporation announced a net loss of $504,105 or $0.01 per share for this quarter compared with a loss of $595,262 or $0.01 per share for the same period last year. During the third quarter ended July 31, 2014, total revenues decreased by 19% compared with the same quarter of 2013, due to a decrease in PCA3 royalties paid to DiagnoCure. Operating expenses decreased by $127,318 or 16%, to $657,529 for the third quarter of 2014 from $784,847 for the same period of 2013. At the end of the quarter, cash and short-term investments stood at $2,541,852.

Based in part upon recent recommendations by the American Society for Clinical Pathology and the College of American Pathologists, the United States Centers for Medicare and Medicaid Services is expected to make a decision before the end of 2014 about the amount of reimbursement for PCA3 for calendar year 2015. "This important milestone about reimbursement, the PCA3 test inclusion in American and European guidelines, and several business-related actions taken in the last months lead us to believe that shareholders should expect a positive impact on PCA3 future sales and royalties," said Dr. Yves Fradet, President and Chief Medical Officer of the Corporation.

The results of the VITAR II retrospective clinical study of the Previstage™ GCC test were published in the August 15, 2014 issue of the Clinical Cancer Research journal. This multicenter study led by Dr. Dan Sargent of the Mayo Clinic confirmed that the GCC status in lymph nodes of 366 stage II colon cancer patients can classify up to 60% of them as having a very low (8%) risk of recurrence at five years suggesting, that these patients may gain little benefit from toxic adjuvant chemotherapy. The Previstage™ GCC colorectal cancer staging test is now offered in Canada by DiagnoCure's licensed medical biology laboratory.

The Corporation also has completed the enrollment of more than 500 patients in the clinical study of its new multi-marker prostate cancer test that does not include PCA3. Collection of final clinical data is underway and completion of data analysis is expected before year's end.

Results of the Third Quarter 2014

Total revenues for the third quarter of 2014 were $153,424 compared with $189,585 for the same period of 2013. This decrease of $36,161 or 19% is mostly attributable to PCA3 royalties, reflecting a decrease in U.S. royalty revenues.

Operating expenses decreased by $127,318, to $657,529 for the third quarter of 2014 from $784,847 for the same period of 2013. This decrease is mainly attributable to reduction in professional fees and amortization of the intangible asset. Total operating expenses decreased primarily as a result of the following:

• Research and development expenses, net of investment tax credits, decreased by $55,243, to $307,294 for the third quarter of 2014 from $362,537 for the same period of 2013. This decrease in research and development expenses is attributable to the amortization charge of the GCC intangible asset following the review of its useful life and to the amortization of the Shc intangible asset, since the Corporation recognized a full impairment charge in the last quarter of fiscal year 2013. Without the amortization charges of intangible assets, the research and development expenses increased by $74,874 to $237,637 for the third quarter of 2014 compared to $162,763 for the same period of 2013. This increase is mainly attributable to the new multi-marker prostate cancer test.
• General and administrative expenses decreased by $69,678, to $305,660 for the third quarter of 2014 from $375,338 for the same period of 2013. This decrease is attributable to reduction in professional fees.

Financial Data

Consolidated Balance Sheets

About DiagnoCure

DiagnoCure (TSX: CUR; OTCQX: DGCRF) is a life science corporation that develops and provides molecular and genomic tests to support effective clinical decisions enabling personalized medicine in oncology. In 2008, the Corporation launched a colorectal cancer staging test through its U.S. CLIA laboratory. Previstage^TM GCC is currently available for licensing. The Corporation has granted a worldwide exclusive license on the diagnostic applications of its proprietary molecular biomarker PCA3 to Gen-Probe, now a wholly-owned subsidiary of Hologic Inc. Hologic Gen-Probe's PROGENSA® PCA3 prostate cancer 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.

Forward‐looking statements

This release may contain forward‐looking 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, 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. 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 forward‐looking 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 forward‐looking statements contained herein unless required by the applicable securities laws and regulations.

SOURCE DiagnoCure inc.