QUEBEC CITY, June 4, 2014 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR) (OTCQX: DGCRF) (the "Corporation") today reported financial and operational results for the second quarter 2014 ended April 30, 2014. The Corporation announced a net loss of $536,597 or $0.01 per share for this quarter compared with a loss of $849,344 or $0.02 per share for the same period last year. During the second quarter ended April 30, 2014, total revenues decreased by 21% compared with the same quarter of 2013, due to a decrease in PCA3 royalties paid to DiagnoCure. Operating expenses decreased by $346,516 or 34%, to $667,090 for the second quarter of 2014 from $1,013,606 for the same period of 2013. At the end of the quarter, cash, cash equivalents and short-term investments stood at $2,950,360.
"Our management team has continued to maintain careful control over expenses while pursuing new opportunities", said Dr. Vincent Zurawski, DiagnoCure's Lead Director. "We are continuing to monitor the PCA3 situation closely, bearing in mind the best interest of DiagnoCure" added Dr. Yves Fradet, President and CMO of the Corporation.
While the commercial advancement of the PCA3 test remains a concern for DiagnoCure, the clinical community continues to advocate the use of the test in the management and diagnosis of prostate cancer. For example, the U.S. National Comprehensive Cancer Network (NCCN) recognized its utility and specificity in predicting biopsy outcomes, recommending the test in its recently updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer Early Detection.
PCA3's attributes were also featured during a panel discussing tests that distinguish aggressive from non-aggressive prostate cancer before biopsy during the annual meeting of the American Urological Association (AUA) held from May 16-21 in Orlando. Dr. Yves Fradet, as one of the panelists, discussed the value of PCA3 in selecting men for biopsy, and Dr. John T. Wei, Professor of Urology at the University of Michigan, discussed the advantages of integrating PCA3 and other biomarkers into clinical practice. Dr. Martin G. Sanda provided insights about an ongoing study of the National Cancer Institute (NCI) Early Detection Research Network Group (EDRN) aimed at evaluating the economic advantages of introducing PCA3 and TMPRSS2-ERG tests into clinical practice before a prostate biopsy.
Furthermore, the Corporation can announce that the clinical study of its new multi-marker prostate cancer test is progressing on schedule and is expected to be completed by the end of September 2014.
Additionally, as part of its business development efforts, DiagnoCure is pleased to report that the Corporation has granted an exclusive license to Shuwen Biotech Co., Ltd. for commercialization of the Previstage™ GCC colorectal cancer staging test in the Greater China Region (China, Hong Kong, and Taiwan). This agreement includes a clear commercial development plan in which both corporations are committed to close collaboration that is expected to lead to the expansion of the clinical use of the test. Because similar discussions are underway with third parties, details of the financial terms of this agreement are not being disclosed.
"Shuwen Biotech is a leading molecular diagnostic company in China led by its Chairman and CEO Jay Z. Zhang, a diagnostic industry veteran, formerly Senior Vice President at Myriad Genetics. Collaborating with Jay and his team will undoubtedly create value for both corporations and most importantly help colon cancer patients receive the most appropriate treatment" said Dr. Fradet.
"The ability to collaborate with DiagnoCure and to market GCC in the Greater China Region provides Shuwen with an exciting opportunity, because we strongly believe in the benefits of Previstage™ GCC to help in staging and better control of colorectal cancer, a condition afflicting unfortunately a growing number of patients in China" said Jay Z. Zhang, Chairman and CEO of Shuwen Biotech Co. Ltd.
Results of the Second Quarter 2014
Total revenues for the second quarter of 2014 were $130,493 compared with $164,262 for the same period of 2013. This decrease of $33,769 or 21% is attributable to PCA3 royalties, reflecting a reduction of 32% in U.S. royalty revenues and an increase of 1% in European royalty revenues as compared to the same period in 2013.
Operating expenses decreased by $346,516 or 34%, to $667,090 for the second quarter of 2014 from $1,013,606 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 $159,957, to $260,917 for the second quarter of 2014 from $420,874 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.
- General and administrative expenses decreased by $206,280, to $350,146 for the second quarter of 2014 from $556,426 for the same period of 2013. This decrease is attributable to reduction in professional fees.
For the three months periods ended
|License and royalty revenues||130,493||164,262|
|Operating expenses (before stock-based compensation, depreciation and amortization)||562,199||774,042|
|Net loss (before stock-based compensation, depreciation and amortization)||(431,706)||(609,780)|
|Depreciation of property, plant and equipment||14,620||17,865|
|Amortization of intangible asset||69,744||199,605|
|Net loss and comprehensive loss||(536,597)||(849,344)|
|Basic and diluted net loss per share||(0.01)||(0.02)|
|Weighted average number of common shares outstanding||43,040,471||43,040,471|
|Consolidated Balance Sheets|
|April 30, 2014||October 31, 2013|
|Cash, cash equivalents and short term investments||2,950,360||4,190,296|
|Number of commons shares outstanding||43,040,471||43,040,471|
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 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.
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.