DiagnoCure announces second quarter financial results



    Ticker Symbol: CUR

    Gen-Probe to initiate FDA pivotal clinical study for the PCA3 prostate
    cancer test

    QUEBEC CITY, June 8 /CNW Telbec/ - DiagnoCure Inc. (TSX: CUR), a life
sciences company commercializing high-value cancer diagnostic tests and
delivering laboratory services, announced a net loss of $2,622,237 or $0.06
per share for the second quarter ending April 30, 2009. This net loss reflects
in part the budgeted sales and marketing initiatives to promote the
Previstage(TM) GCC Colorectal Cancer Staging Test, partly offset by the
increasing PCA3 royalties. At the end of the quarter, cash, short-term
investments and long-term investments stood at $14,083,829.

    Highlights of the Quarter

    The second quarter of 2009 marked a turning point for DiagnoCure's two
commercialized tests, PCA3 for prostate cancer and Previstage(TM) GCC for
colorectal cancer. Important studies were published and major initiatives were
undertaken that should significantly impact the market penetration and future
sales of both tests.

    PCA3 testing for prostate cancer

    DiagnoCure and Gen-Probe, the Company's partner for the PCA3 test, are
still fully committed to make the PCA3 test a worldwide success. In April,
they announced that they had signed an amendment to their collaboration and
license agreement. Pursuant to this amendment, Gen-Probe purchased 4.9 million
of DiagnoCure's preferred shares for a total investment of US$5million. In
addition, Gen-Probe will make annual payments of US$500,000 to DiagnoCure
until specific milestones are met.
    Along with this agreement, Gen-Probe announced that they were initiating
a 500-man multicenter clinical study designed to obtain a regulatory approval
by the Food and Drug Administration (FDA), allowing Gen-Probe to fully promote
and sell the PCA3 test in the United States. Gen-Probe stated that it will
seek an initial indication from the FDA to use PCA3 as an aid in the diagnosis
of prostate cancer in men with an elevated PSA level and a negative prostate
biopsy. The annual worldwide market potential for this initial indication is
estimated at US$180 million. But given the other potential clinical uses of
PCA3, the annual worldwide market could be much larger. The experience in
Europe is showing that PCA3 sales grow significantly and steadily when
promoted aggressively with the right strategy. In their Q1 webcast, Gen-Probe
disclosed that the global sales of PCA3, that is in both Europe and the United
States, increased 100% over the same quarter the prior year, reaching US$1.5
million.
    Several factors make Gen-Probe "highly motivated to begin their U.S.
clinical trial." They include promising clinical data, early feedback from the
FDA and opinion leaders, and the fact that they will now devote more resource
to PCA3 and the clinical trial. Furthermore, in addition to the 17
peer-reviewed articles already published to date, an impressive 13 new studies
supporting the clinical potential of PCA3 for prostate cancer management were
presented at the annual meetings of the European Association of Urology and
the American Urology Association.
    At the same time, in May, a U.S. National Cancer Institute (NCI) study
was published in the New England Journal of Medicine (2009; 360:1310-9), which
concluded that PSA did not reduce the number of prostate cancer deaths. Based
on these results, the NCI stated that a better method was needed to reduce
unnecessary biopsies and better assess the aggressiveness of the cancer to
guide treatment decisions. An article published this year in the British
Journal of Urology International (2009; 103:441-445) provided a review of many
PCA3 studies and suggested that the PCA3 test had the potential to answer
these key clinical questions.

    Previstage(TM) GCC for colorectal cancer

    In February, the peer-reviewed Journal of the American Medical
Association published the results of a major, NIH-sponsored, prospective
five-year study conducted by Dr. Scott Waldman of Thomas Jefferson University
on the GCC (or GUCY2C) marker. The results demonstrated that GCC is the
strongest independent predictor of the risk of recurrence among colorectal
cancer patients considered low risk by current assessment methods. Dr.
Waldman's study is a key validation of the clinical potential of the GCC
marker, to which DiagnoCure owns the worldwide exclusive diagnostic rights.
DiagnoCure's Previstage(TM) GCC test was developed to detect the GCC marker in
the lymph nodes removed during colorectal cancer surgery to better determine
the stage of the cancer. Moreover, it uses the latest advances in molecular
technologies and methodologies that have emerged in the past few years.

    Nomination

    In March, the Board of Directors nominated Neil J. Campbell as a
non-voting delegated director. Mr. Campbell is Chairman & CEO for Mosaigen(R),
Inc., a global healthcare and ICT technology development corporation,
headquartered in Germantown, Maryland, USA, and he serves as a General Partner
for Endeavour Capital Ltd., an Asia/Pacific private equity fund in the life
sciences, cleanTech and information technologies. He brings over 20 years of
experience as an executive of publicly traded companies, and in raising
capital from both the private and public markets. In particular, Mr. Campbell
was President & COO/CEO for EntreMed Pharmaceuticals, and Senior Director of
Commercial Development for Celera Genomics (NASDAQ). He also held General &
Executive Manager positions at Life Technologies, Inc. (acquired by
Invitrogen), at IGEN, Inc. (acquired by Roche) and and at Abbott Laboratories.

    Results for the second quarter ended April 30, 2009

    Total revenues for the second quarter of 2009 were $467,152 compared with
$516,109 for the second quarter of 2008. Royalty revenues from Gen-Probe
tripled from $46,591 to $145,107 for the second quarter of 2009. This increase
is mostly attributable to the sales of PROGENSA(TM) PCA3 in Europe by
Gen-Probe. As part of the amended agreement signed with Gen-Probe on April 29,
2009, DiagnoCure recorded a portion of the annual payment, that is, $148,400
for the second quarter of 2009.
    Interest income decreased by $211,065 to $123,903 for the second quarter
of 2009 compared with $334,968 for the second quarter of 2008. The decrease is
attributable to the use of funds to finance the Company's operations and to
the lower interest rates on its investments.
    Cost of sales decreased by $70,328, from $86,750 for the second quarter
of 2008 to $16,422 for 2009. This decrease is related to the end of direct
ImmunoCyt(TM) / uCyt+(TM) sales by DiagnoCure and to lower sample sales to
Gen-Probe relative to their prostate cancer research program.
    Operating expenses before stock-based compensation decreased by $540,944,
from $3,482,329 for the second quarter of 2008 to $2,941,385 for the same
period of 2009. This decrease reflects the impact of the layoff of nine people
in November 2008 and reduction in R&D expenses, which were mostly related to
the completion of the Previstage(TM) GCC Colorectal Cancer Staging Test.
    Based on the above, for the second quarter of 2009, DiagnoCure recorded a
net loss of $2,622,237 or $0.06 per share, compared with $3,372,374 or $0.08
per share for the same period of 2008. These results are substantially in line
with Management expectations and reflect the increasing PCA3 royalties and the
sales and marketing initiatives undertaken to promote the Previstage(TM) GCC
Colorectal Cancer Staging Test.

    
    Financial Data

    -------------------------------------------------------------------------
                                                     For the second quarters
                                                            ended April 30
                                                    -------------------------
                                                           2009         2008
    -------------------------------------------------------------------------
    Sales                                                30,564      134,550
    -------------------------------------------------------------------------
    Revenue under research and license agreement        312,685       46,591
    -------------------------------------------------------------------------
    Interest                                            123,903      334,968
    -------------------------------------------------------------------------
    Total revenues                                      467,152      516,109
    -------------------------------------------------------------------------
    Cost of sales                                        16,422       86,750
    -------------------------------------------------------------------------
    Gross margin                                        450,730      429,359
    -------------------------------------------------------------------------
    Operating expenses (before stock-based
     compensation)                                    2,941,385    3,482,329
    -------------------------------------------------------------------------
    Net loss before stock-based compensation         (2,490,655)  (3,052,970)
    -------------------------------------------------------------------------
    Stock-based compensation                            160,091      319,404
    -------------------------------------------------------------------------
    Net loss before income taxes                     (2,650,746)  (3,372,374)
    -------------------------------------------------------------------------
    Future income taxes                                  28,509            -
    -------------------------------------------------------------------------
    Net loss                                         (2,622,237)  (3,372,374)
    -------------------------------------------------------------------------
    Basic and diluted net loss per share                  (0.06)       (0.08)
    -------------------------------------------------------------------------
    Weighted average number of common shares
     outstanding                                     42,799,475   41,771,308
    -------------------------------------------------------------------------


    Consolidated Balance Sheets

    -------------------------------------------------------------------------
                                                          As at April 30
                                                    -------------------------
                                                           2009         2008
    -------------------------------------------------------------------------
    Cash, cash equivalents, temporary and long-term
     investments                                     14,083,829   26,691,514
    -------------------------------------------------------------------------
    Total assets                                     27,781,898   40,255,392
    -------------------------------------------------------------------------
    Shareholders' equity                             23,930,789   34,897,252
    -------------------------------------------------------------------------
    

    About DiagnoCure

    DiagnoCure (TSX: CUR) is a life sciences company commercializing
high-value cancer diagnostic tests and delivering laboratory services that
increase clinician and patient confidence in making critical treatment
decisions. DiagnoCure Oncology Laboratories, a subsidiary of DiagnoCure Inc.,
launched in 2008 the Previstage(TM) GCC Colorectal Cancer Staging Test, the
first GCC-based molecular test for the management of colorectal cancer. A
major study published in the February 18, 2009, edition of the Journal of the
American Medical Association demonstrated that GCC, to which DiagnoCure owns
exclusive worldwide diagnostic rights, is the strongest independent predictor
of colorectal cancer recurrence. 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 marker. This test is also available through laboratories in the U.S.
using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the
CE-marked PROGENSA(TM) PCA3 in vitro assay, and in Canada. In addition to its
own research, the Company intends to acquire or in-license additional
promising cancer biomarkers from both academic and commercial institutions.
For more information, visit www.diagnocure.com.

    Forward-looking statements

    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.
    %SEDAR: 00003671EF




For further information:

For further information: Investors: J. F. Bureau, CFA, Sr. Vice
President and CFO, DiagnoCure Inc., (418) 527-6100,
communications@diagnocure.com; Media: Paule De Blois, Vice President,
Corporate Affairs, DiagnoCure Inc., (418) 527-6100, p.deblois@diagnocure.com

Organization Profile

DiagnoCure Inc.

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890