FDA Approval of the First Molecular Prostate Cancer Test
QUEBEC CITY, June 6, 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 second quarter 2012 ended April 30, 2012. The
Company announced a net loss from continuing operations of $270,147 or
$0.01 per share for the second quarter ending April 30, 2012, compared
to a net loss of $1,072,224 or 0.02$ per share for the same quarter of
2011. At the end of the quarter, cash, short-term investments and
long-term investments stood at $7,407,058.
Second 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 should generate significant long-term royalty
revenues for our Company", states Dr. Fradet, President and Chief
Medical Officer of DiagnoCure.
On February 29, DiagnoCure reported that the PROGENSA® PCA3 prostate
cancer diagnostic test had been featured in seven (7) presentations by
leading professors and researchers at the 27th annual European Association of Urology (EAU) in Paris and on May 25, in
at least 14 presentations during the 107th American Urological Association (AUA) meeting held in Atlanta, Georgia.
Notably, during this last meeting, the value of PCA3 testing was
highlighted during a debate on the new USPSFT recommendation on
prostate cancer screening.
Second Quarter 2012 Results
The Company' financial statements for the period ended April 30, 2012
have been prepared 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 second quarter of 2012 were $1,063,131 compared
with $310,907 for the same period of 2011. In the second quarter of
2012, royalty revenues amounted to $173,264 compared with $187,106 for
the corresponding period of 2011. Royalty revenues from Gen-Probe
increased by $4,823 to $168,663 for the second quarter of 2012, from
$163,840 for the same period of 2011. Royalty revenues from Scimedx,
related to ImmunoCytTM / uCyt+TM, decreased by $18,665 to $4,601 for the second quarter of 2012, from
$23,266 for the same period of 2011. In the second quarter of 2012,
DiagnoCure provided R&D services to Signal Genetics related to the
PrevistageTM GCC Colorectal Cancer Staging Test for an amount of $387,267. Pursuant
to the amendment signed with Gen-Probe on April 29, 2009, and the FDA
approval of the PROGENSA® PCA3 test, DiagnoCure recorded the annual
payment, that is, $502,600 in the second quarter of 2012, compared with
$123,801 for the same period of 2011 that was representing only a
portion of the annual payment. The 2009 amended agreement with
Gen-Probe contains an FDA submission milestone to be paid on January 31st of each year until the said milestone is reached. As Gen-Probe received
the FDA approval for the PROGENSA® PCA3 test on February 15, 2012,
DiagnoCure recorded the full payment in revenues in the second quarter
of 2012 given that all the conditions in the amendment were met.
Operating expenses decreased by $75,668, to $1,335,347 for the second
quarter of 2012 from $1,411,015 for the same period of 2011. This
decrease is mainly attributable to amortization of intangible assets.
Total operating expenses decreased primarily as a result of the
Research and development expenses, net of investment tax credits,
decreased by $26,400, to $694,950 for the second quarter of 2012 from
$721,350 for the same period of 2011. This decrease in research and
development expenses is attributable to the decrease in intangible
amortization. Without the intangible amortization expenses, the
research and development expenses, net of investment tax credits
increased by $64,898 mainly attributable to the R&D services performed
in support to the PrevistageTM GCC Colorectal Cancer Staging Test.
General and administrative expenses decreased by $58,363, to $562,700
for the second quarter of 2012 from $621,063 for the same period of
2011. This decrease is attributable to reduction in professional fees
and stock-based compensation expenses allowance.
Selling and business development expenses increased by $38,056, to
$91,867 for the second quarter of 2012 from $53,811 for the same period
of 2011. This increase is attributable to professional fees.
Based on the above, for the second quarter of 2012, DiagnoCure recorded
a net loss from continuing operation of $270,147 or $0.01 per share,
compared with $1,072,224 or $0.02 per share, for the same period of
||For the Second Quarter |
Ended April 30
Operating expenses (before stock-based compensation and|
Net profit (loss) from continuing operations (before stock-based|
compensation and amortization)
Net loss before income taxes from continuing operations
Future income taxes
Net loss from continuing operations
Basic and diluted loss per share:
Weighted average number of common shares outstanding
Consolidated Statements of Financial Position
As of April 30
Cash, cash equivalents, temporary and long-term investments
Conference call with investors
Investors and financial analysts wishing to participate to the
"DiagnoCure Q2 2012 Earnings Announcement" conference call to be held
today, June 6, 2012 at 4:30 p.m. (EST) shall dial the toll-free number
1-888-231-8191, and provide the conference ID number: 85202071.
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 June 11, 2012.
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 PrevistageTM 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 has also granted a worldwide exclusive
license agreement to Gen-Probe (NASDAQ: GPRO) for the development and
commercialization of a second-generation prostate cancer test using
PCA3, DiagnoCure's proprietary molecular biomarker. Gen-Probe's
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 forwardlooking 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,
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. As a result, investors are cautioned
not to place undue reliance on these forwardlooking 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
forwardlooking statements contained herein unless required by the
applicable securities laws and regulations.
SOURCE DIAGNOCURE INC.