FDA Approval of The First Molecular Prostate Cancer Test and Decreased Net Loss
QUEBEC CITY, March 30, 2012 /PRNewswire/ - DiagnoCure Inc. (TSX: CUR), a Quebec life sciences company that develops and commercializes high-value cancer diagnostic tests, today reported financial and operation results for the first quarter 2012 ended January 31, 2012. The Company announced a net loss from continuing operations of $816,164 or $0.02 per share for the first quarter ending January 31, 2012, compared to a net loss of $998,439 or 0.02$ per share for the same quarter of 2011. At the end of the quarter, cash, short-term investments and long-term investments stood at $7,832,547. The cash position was impacted by the timing of payments.
First Quarter 2012 Highlights
- On February 15, the US Food and Drug Administration (FDA) approved Gen-Probe's PROGENSA® PCA3 assay (Prostate Cancer Antigen 3), the first molecular test for prostate cancer to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. "This FDA approval marks a significant milestone achievement for the company and will generate significant long-term royalty revenues for our Company", states Dr. Fradet, President and Chief Medical Officer of DiagnoCure.
- On January 2012, a new study for the PrevistageTM GCC Colorectal Cancer Staging Test was presented at the 2012 American Society of Clinical Oncology Gastrointestinal Cancer Symposium held in San Francisco, CA. The poster entitled "Guanylyl Cyclase C (GCC) Lymph Nodes (LN) Classification as a Prognostic Marker in Patients with Stage II Colon Cancer: A Pooled Analysis" confirmed prognostic capabilities of the Previstage GCC test in patients with colon cancer.
- We are pleased to announce that two new research analysts have initiated coverage of our Company in March of 2012. Zacks Investment Research and LifeSci Advisors LLC have both released comprehensive initiation research reports including information about DiagnoCure's business model, anticipated roll out and potential markets. The complete reports can be accessed from DiagnoCure's website at www.diagnocure.com, through the hyperlink under the "Analysts" page of the "Investors" tab.
First Quarter 2012 Results
The Company' financial statements for the period ended January 31, 2012 have been prepared for the first time in accordance with IAS 34, Interim Financial Reporting, International Financial Reporting Standards (IFRS). Comparative unaudited consolidated condensed financial statements for 2011 have been adjusted to reflect the Company's adoption of IFRS on a retrospective basis, effective November 1, 2010.
Total revenues for the first quarter of 2012 were $556,158 compared with $292,878 for the same period of 2011. In the first quarter of 2012, royalty revenues amounted to $163,791 compared with $161,790 for the corresponding period of 2011. Royalty revenues from Gen-Probe decreased by $16,067 to $145,012 for the first quarter of 2012, from $161,079 for the same period of 2011. Royalty revenues from Scimedx, related to ImmunoCytTM / uCyt+TM, increased by $7,906 to $8,617 for the first quarter of 2012, from $711 for the same period of 2011. Following the agreement signed with Signal Genetics, DiagnoCure recorded Previstage GCC royalties of $10,162 in the first quarter of 2012. Also, in the first quarter of 2012, DiagnoCure provided Signal Genetics R&D services in support to the Previstage GCC Colorectal Cancer Staging Test for an amount of $268,567. Pursuant to the amendment agreement signed with Gen-Probe on April 29, 2009, DiagnoCure recorded a portion of the annual payment, that is, $123,800 for the first quarter of 2012, compared with $131,088 for the same period of 2011.
Operating expenses before stock based compensation and amortization increased by $220,506, to $1,081,923 for the first quarter of 2012 from $861,417 for the first quarter of 2011. This increase is mainly attributable to the R&D services performed in support to the Previstage GCC Colorectal Cancer Staging Test for which revenues of $268,567 were booked as stated above. Total operating expenses increased primarily as a result of the following:
- Research and development expenses, net of investment tax credits, increased by $158,517, to $802,228 for the first three-month of 2012 from $643,711 for the same period of 2011. This increase in research and development expenses is attributable to the R&D services performed in support to the Previstage GCC Colorectal Cancer Staging Test.
- General and administrative expenses decreased by $104,264, to $542,118 for the first three-month period of 2012 from $646,382 for the same period of 2011. This decrease is attributable to reduction in professional fees, stock-based compensation expenses allowance and to a cost reduction on the rent.
- Selling and business development expenses increased by $7,673, to $57,357 for the first three-month period of 2012 from $49,684 for the same period of 2011. This increase is attributable to professional fees.
Based on the above, for the first quarter of 2012, DiagnoCure recorded a net loss from continuing operation of $816,164 or $0.02 per share, compared with $998,439 or $0.02 per share, for the same period of 2011.
|For the First Quarter Ended January 31|
| Operating expenses (before stock-based compensation
| Net loss from continuing operations (before stock-based compensation
|Net loss before income taxes from continuing operations||(822,704)||(1,026,323)|
|Future income taxes||6,540||27,884|
|Net loss from continuing operations||(816,164)||(998,439)|
|Net loss from discontinued operations||—||(377,340)|
|Basic and diluted loss per share:|
|From continuing operations||(0.02)||(0.02)|
|From discontinued operations||—||(0.01)|
|Basic and diluted loss per share||(0.02)||(0.03)|
|Weighted average number of common shares outstanding||43,013,471||42,980,632|
|Consolidated Statements of Financial Position|
|As of January 31|
|Cash, cash equivalents, temporary and long-term investments||7,832,547||6,291,784|
Conference call with investors
Investors and financial analysts wishing to participate in the "DiagnoCure Q1 2012 Earnings Announcement" conference call to be hold today, March 30, 2012 at 11:30 a.m. (EST) shall dial the toll-free number 1-888-231-8191, and provide the conference ID number: 61577555.
The event will also be webcasted live on DiagnoCure's website at www.diagnocure.com, through the hyperlink under the "Presentations" page of the "Investors" tab. A replay of the audio conference will be available on April 4, 2012.
Members of the media are also invited to listen in.
Annual Meeting of Shareholders
DiagnoCure' Annual Meeting of Shareholders will be held this afternoon, March 30, 2012 at 2:00 pm at the Auberge Saint-Antoine in Quebec City.
DiagnoCure (TSX: CUR) is a life sciences company that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Company launched the Previstage GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory, and granted the worldwide exclusive rights to this test to Signal Genetics in June 2011. The Company also has a strategic alliance with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure's proprietary molecular biomarker. The PROGENSA PCA3 test is commercialized in Europe under CE mark and is now approved for commercialization in Canada and the United States. For more information, visit www.diagnocure.com.
This release contains forward‐looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. 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. As a result, investors are cautioned not to place undue reliance on these forward‐looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. 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.