QUEBEC CITY, March 14, 2014 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR) (OTCQX: DGCRF) (the "Corporation") today reported financial and operational results for the first quarter 2014 ended January 31, 2014. The Corporation announced a net loss of $529,739 or $0.01 per share for this quarter. At the end of the quarter, cash, cash equivalents and short-term investments stood at $3,543,029.
During the first quarter ended January 31, 2014, PCA3 royalties paid to DiagnoCure by Hologic decreased by 12% compared with the same quarter in 2013. Quarterly worldwide sales of less than $US2.0 million are not meeting the Corporation's expectations for a test whose value is supported by an ever-increasing number of clinical studies and publications. In 2013 alone, 54 new papers were published on PCA3. Nearly 250 papers reporting the clinical utility of PCA3 have now been published. Consequently, the underperformance of PCA3 sales cannot be explained by a declining interest from the medical community. DiagnoCure believes that: (1) more resources need to be committed to the PCA3 marketing and sales effort and (2) the product needs to be made available on an instrument platform more suitable to the prostate cancer diagnostic and screening market. For these reasons, DiagnoCure has continued to pursue active discussions to purchase Hologic's entire prostate-oncology business unit. The intent of the Corporation in regaining all rights to PCA3 is to capitalize on its internal expertise to develop and manufacture an in-house Polymerase Chain Reaction (PCR) version of the PCA3 test. Data already generated by DiagnoCure indicates that performance of the PCR-based PCA3 test is similar to that of the currently marketed PROGENSA® PCA3 assay.
"DiagnoCure's board of directors is pressing to resolve the current situation with Hologic to ensure that PCA3 gets the attention we believe it deserves. Meanwhile the study on our new multi-marker prostate cancer test is proceeding on schedule and discussions regarding commercialization of Previstage™ GCC are progressing," stated Dr. Yves Fradet, Chairman of the Board.
Results of the First Quarter 2014
Total revenues for the first quarter of 2014 were $146,969 compared with $167,916 for the same period of 2013. This decrease of $20,947 or 12% is attributable to Hologic Gen-Probe PCA3 royalties. In the first quarter of 2014, royalty revenues from Hologic Gen-Probe were $146,969, compared to $167,916 for the same period of 2013. This decrease is attributable to a decrease of 28% in U.S. royalty revenues and 4% in European royalty revenues as compared to the same period in 2013.
Operating expenses decreased by $279,445, to $676,708 for the first three months of 2014 from $956,153 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 $165,056, to $239,803 for the first three-month of 2014 from $404,859 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 2013.
- General and administrative expenses decreased by $106,322, to $403,001 for the first three-month period of 2014 from $509,323 for the same period of 2013. This decrease is attributable to reduction in professional fees and stock-based compensation expenses.
For the three months periods ended
|License and royalty revenues||146,969||167,916|
|Operating expenses (before stock-based compensation, depreciation and amortization)||574,242||698,116|
|Net loss (before stock-based compensation, depreciation and amortization)||(427,273)||(530,200)|
|Depreciation of property, plant and equipment||14,931||19,834|
|Amortization of intangible asset||69,922||199,521|
|Net loss and comprehensive loss||(529,739)||(788,237)|
|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|
|January 31, 2014||October 31, 2013|
|Cash, cash equivalents and short term investments||3,543,029||4,190,296|
|Number of commons shares outstanding||43,040,471||43,040,471|
Annual and Special Meeting of Shareholders
DiagnoCure confirms that the Annual and Special Meeting of its shareholders will be held as follows:
|TIME:||Thursday, April 17, 2014||LOCATION:||McCarthy Tétrault's offices|
|3:00 p.m. (EDT)||1000 de la Gauchetière Street West|
|Montréal (Québec) H3B 0A2|
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.