Welcome!

News Feed Item

DiagnoCure announces fourth quarter 2013 and year-end results

Providing Corporate Update on Key Projects

QUEBEC CITY, Jan. 16, 2014 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR) (OTCQX: DGCRF) (the "Corporation") today reported financial and operational results for the fourth quarter 2013 and fiscal year ended October 31, 2013. The Corporation announced a net loss of $1,334,099 or $0.03 per share for the fourth quarter ended October 31, 2013, compared to $1,978,355 or $0.05 per share for the same period in 2012 and a net loss of $3,566,942 or $0.08 per share for fiscal year 2013 compared to $3,679,324 or $0.09 per share for the same period in 2012. At the end of the quarter, cash, short-term investments and long-term investments stood at $4,190,296 compared to $5,824,771 at the end of fiscal year 2012.

During fiscal year 2013, PCA3 royalties paid to DiagnoCure by Hologic in 2013 increased by 14% compared with 2012, representing worldwide sales of less than $US8.5 million. DiagnoCure believes that this modest increase in sales is not representative of the true commercial potential of this product, considering the consensus clinical utility that has emerged from several published studies (see "Update on PCA3" below).

Consequently, in 2013, DiagnoCure maintained diligent communications with Hologic in an effort to increase sales of PCA3. Under the leadership of Richard Bordeleau, Senior Advisor to the Board, and as part of its effort to transform the Corporation and ensure the commercial development of PCA3, in the last months of 2013, DiagnoCure approached Hologic with the intent to purchase its entire prostate oncology business, allowing the Corporation to regain the rights granted to Hologic on PCA3 and to expand its portfolio with T2:ERG, a promising biomarker identified by Dr. Arul Chinnaiyan from the University of Michigan who is currently offering the combination of PCA3 and T2:ERG in his CLIA-certified laboratory.

In 2013, DiagnoCure also obtained a grant from the National Research Council of Canada supporting research developing a new multi-marker prostate cancer test with an objective of broadening the Corporation's portfolio in this market segment. New patent applications were also filed, further strengthening DiagnoCure's intellectual property portfolio in this field. The first application is due to be published before the end of this month.

Regarding the PrevistageTM GCC colon cancer test, in the last quarter of 2013, DiagnoCure intensified discussions aimed at obtaining multiple partners to market GCC in both North America and Europe. DiagnoCure believes that the test will be made more widely available with a combination of public, academic and private partners.

Additionally, during fiscal year 2013, DiagnoCure continued to strengthen its overall intellectual property portfolio. Six more patents were obtained supporting the PCA3 biomarker. The Corporation was also granted a patent from the European Patent Office (EPO), providing exclusive rights through February 2030 regarding use of the GCC marker to gain prognostic information based on the tumor burden measured at the molecular level in lymph nodes.

Dr. Yves Fradet, Chairman of the Board, stated, "DiagnoCure's board of directors is satisfied with the thorough analysis of all opportunities and the actions undertaken in the recent months. We strongly believe in the potential of PCA3 and have applied all required resources to provoke significant change."

"During the last quarter, DiagnoCure has evaluated several scenarios aimed at increasing shareholder value, including transformational acquisitions. The Corporation also has and will continue to pursue all opportunities relating to enhancing PCA3 market penetration. Shareholders can be assured that every effort is being made to preserve cash while maintaining the Corporation's ability to seize and implement opportunities with our qualified team." added Dr. Vincent Zurawski, Lead Director of the Corporation.

Results for the Fiscal Year Ended October 31, 2013

Total revenues for fiscal year 2013 were $671,228 compared with $2,472,038 for 2012. This decrease of $1,800,810 is attributable to the termination, on January 11, 2013 of the development and license agreements signed in June 2011 with Signal Genetics. That development agreement provided $1,223,485 of revenues in fiscal year 2012. The remaining decrease is attributable to the payment of $626,401 made by Gen-Probe in relation to the FDA milestone reached for PROGENSA® PCA3 in fiscal year 2012. In 2013, royalty revenues from Hologic Gen-Probe increased by $83,613, or 14%, to $671,228, from $587,615 for 2012. This increase is attributable to an increase in sales of 45% in the U.S. market amid challenges in the reimbursement environment for molecular diagnostic tests, offset by a decrease of 30% in the European market.

Operating expenses decreased by $1,913,192, to $4,238,170 for fiscal year 2013 from $6,151,362 for fiscal year 2012. This decrease is mainly attributable to the development agreement performed in fiscal year 2012 in support to the PrevistageTM GCC Colorectal Cancer Staging Test and to an allowance for doubtful accounts of $507,092 related to the Signal Genetics development agreement. Based on the above, for fiscal year 2013, DiagnoCure recorded a net loss of $3,566,942 or $0.08 per share, compared with $3,679,324 or $0.09 per share for fiscal year 2012.

Results of the Fourth Quarter 2013

Total revenues for the fourth quarter of 2013 were $149,465 compared to $142,995 for the same period of 2012. This increase of $6,470 is attributable to royalty revenues from Hologic Gen-Probe. In the fourth quarter of 2013, royalty revenues from Hologic Gen-Probe increased by $6,470 attributable to an increase of 12% in the U.S. market amidst challenges in the reimbursement environment for molecular diagnostic tests, offset by a decrease of 9% in the European market.

Operating expenses decreased by $637,786, to $1,483,564 for the fourth quarter of 2013, from $2,121,350 for the same quarter of 2012. This decrease is attributable to the termination of the R&D services performed in support to the PrevistageTM GCC Colorectal Cancer Staging Test and to an impairment charge of $440,693 for the fourth quarter of 2013 compared to $650,000 in the fourth quarter of 2012 attributable to a re-evaluation of the Shc intangible asset. Based on the above, for the fourth quarter of 2013, DiagnoCure recorded a net loss of $1,334,099 or $0.03 per share, compared with $1,978,355 or $0.05 per share, for the same period of 2012.

Financial Data

For the periods of Three months ended
October 31
Years ended
October 31
2013 2012 2013 2012
  $ $ $ $
Revenue under research agreement 1,223,485
Revenue under license and royalty agreement 149,465 142,995 671,228 1,248,553
Total revenues 149,465 142,995 671,228 2,472,038
Operating expenses (before stock-based compensation, depreciation, amortization and impairment) 787,036 1,191,988 2,800,532 4,356,094
Net loss (before stock-based compensation, depreciation, amortization and impairment) (637,571) (1,048,993) (2,129,304) (1,884,056)
Stock-based compensation 40,411 43,356 128,116 179,713
Depreciation of property, plant and equipment 15,403 24,019 69,908 118,578
Amortization of intangible asset 200,021 211,987 798,921 846,977
Impairment of intangible asset 440,693 650,000 440,693 650,000
Net loss (1,334,099) (1,978,355) (3,566,942) (3,679,324)
Basic and diluted net loss per share (0.03) (0.05) (0.08) (0.09)
Weighted average number of common shares outstanding 43,040,471 43,029,037 43,040,471 43,029,037


Consolidated Balance Sheets

  As of October 31
  2013 2012
Cash, temporary and long-term investments 4,190,296 5,824,771
Total assets 7,849,267 11,256,369
Shareholders' equity 7,009,261 10,448,087
Number of common Shares outstanding 43,040,471 43,040,471


Conference call

DiagnoCure's management will host a conference call at 4:30 p.m. (ET) on January 16, 2014. Interested participants may listen to the call by dialing 1-888-390-0546 or 514-225-6995 and referencing code 50137031 approximately 15 minutes prior to the call. The Corporation will also provide a live webcast of the call. Interested participants may access the webcast on DiagnoCure's website at www.diagnocure.com, through a link on the Investors page - Presentations. A replay of the webcast will be available on DiagnoCure's website for those unable to participate in the live webcast.

Next annual meeting

At the next shareholders meeting to be held on April 17, 2014, the shareholders of the Corporation will be asked to reconfirm the Corporation's existing shareholder rights plan (the "Shareholder Rights Plan"). The Shareholder Rights Plan was originally ratified by the shareholders of the Corporation at the annual and special meeting of shareholders held on March 11, 2011. The purpose of the Shareholder Rights Plan is to provide adequate time for shareholders to properly assess the merits of a take‐over bid for the Corporation without undue pressure and to provide the Board of Directors with the opportunity to explore and develop alternatives to a take‐over bid that are in the best interests of the Corporation. The Shareholder Rights Plan is set to expire upon the conclusion of the annual meeting of shareholders of the Corporation in 2020, subject to reconfirmation by shareholders in 2014 and 2017. The full text of the Shareholder Rights Plan is available on SEDAR at www.sedar.com.

Update on PCA3

As the field of prostate cancer is moving toward more integrated risk assessment to decide whether a prostate biopsy is necessary, DiagnoCure is pleased to report that many studies continue to examine the role of the urinary PCA3 score in conjunction with other urinary markers to enhance the specificity of screening and reduce unnecessary biopsies. In 2013 alone, DiagnoCure has monitored more than 54 new clinical publications describing PCA3, which brings the total of papers on PCA3 to nearly 250. Among those published in 2013, at least two confirm the utility of PCA3 to predict the outcome of a biopsy in men who have had a prior negative biopsy, while about 16 demonstrate that PCA3 could also be useful in allowing discrimination between indolent and aggressive prostate cancer.

Interestingly, some studies in diverse populations from around the world have also demonstrated that urinary PCA3 scores could predict the presence of prostate cancer prior to an initial prostate biopsy. At least six different studies performed on more than 6,000 men support this outcome, some even providing evidence that a higher PCA3 score correlates with aggressive disease and a high Gleason score. It is also interesting to note that the relationship of PCA3 to disease volume and grade is currently the object of studies in men enrolled in prospective active surveillance programs. For example, the Canary PASS study of prostate cancer patients under active surveillance, provides preliminary evidence that PCA3 allows discrimination between men at risk of aggressive cancer and those who could be placed on less intensive surveillance protocols with fewer repeated prostate biopsies, reducing the risks and costs of invasive procedures.

About DiagnoCure

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.

Forward‐looking statements

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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing be...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory?
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
In recent years, containers have taken the world by storm. Companies of all sizes and industries have realized the massive benefits of containers, such as unprecedented mobility, higher hardware utilization, and increased flexibility and agility; however, many containers today are non-persistent. Containers without persistence miss out on many benefits, and in many cases simply pass the responsibility of persistence onto other infrastructure, adding additional complexity.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
Back in February of 2017, Andrew Clay Schafer of Pivotal tweeted the following: “seriously tho, the whole software industry is stuck on deployment when we desperately need architecture and telemetry.” Intrigue in a 140 characters. For me, I hear Andrew saying, “we’re jumping to step 5 before we’ve successfully completed steps 1-4.”
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...