TORONTO, March 28, 2018
3D Signatures Inc. (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0) (the “Company” or “3DS“), a personalized medicine company with a proprietary software platform (TeloView™) based on the three-dimensional analysis of chromosomal signatures, is pleased to announce that it has signed a collaboration agreement with MDxHealth SA (Euronext: Brussels MDXH.BR) (“MDxHealth”), a world leader in molecular diagnostics for urological cancers, to evaluate 3DS’ prognostic test candidate for prostate cancer (“Telo-PC™”), using 3DS’ proprietary TeloView™ software platform.
3DS and MDxHealth will share the costs of conducting the collaborative study. Pursuant to the agreement, 3DS has also granted MDxHealth an exclusive option to negotiate a license agreement for the Telo-PC™ test.
“This is an excellent opportunity, combining our expertise in urological diagnostics with the innovative 3DS software platform, to evaluate an exciting technology that may improve the clinical management of patients with prostate cancer” said Dr. Jan Groen, CEO of MDxHealth. “MDxHealth is constantly evaluating new opportunities that might allow us to increase our commercial footprint and we look forward to collaborating with 3DS to explore the potential of this partnership.”
There is a significant unmet need for accurate and minimally invasive diagnostic and risk-assessment tools that allow clinicians to make more informed treatment decisions for prostate cancer patients. Traditionally, the diagnosis of prostate cancer has involved repeated invasive tissue biopsies, which can easily miss cancerous cells or misinterpret benign conditions as being dangerous, leading to unnecessary surgeries. This system needs urgent improvement as seen by the sheer number of people across the world affected by prostate cancer. According to the World Health Organization1, there were over 570,000 new cases of prostate cancer in the U.S. and Europe in 2012. The U.S. National Institutes of Health2 estimates there were over 3 million men living with prostate cancer in the United States in 2014. Currently, prostate cancer patients are often faced with the difficult choice of either living with the cancer under active surveillance, or pursuing treatment which has a significant risk of devastating side effects such as erectile dysfunction, incontinence, bowel complications and infection.
“We look forward to expanding the evaluation of our TeloView™ platform in prostate cancer through a collaboration with MDxHealth, as they are recognized world leaders in molecular diagnostic testing for patients with prostate cancer,” commented Jason Flowerday, CEO of 3DS. “We hope this study will continue to build on the evidence observed to date which indicates that our Telo-PC™ test is able to predict the stability and aggressiveness of prostate cancer through three-dimensional nuclear telomeric profile analysis.”
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of urological cancer. The Company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
3DS (TSX-V:DXD; OTCQB:TDSGF; FSE:3D0) is a personalized medicine company with a proprietary software platform, TeloView™, that is designed to predict the course of certain diseases and to tailor treatment options for the individual patient. The technology is based on the three-dimensional analysis of telomeres, the protective caps at the ends of chromosomes. 3DS’ TeloView™ software platform measures the organization of the genome and its correspondence to; the stage of a given disease, the rate of progression of the disease, how different diseases will respond to various therapies, and a drug’s efficacy and toxicity. 3DS’ proprietary imaging software is designed to go beyond identifying whether a patient suffers from a specific disease or condition. Instead, the TeloView™ platform is designed to inform clinicians and patients with respect to how to personalize treatment and best manage an individual’s disease based on their unique TeloView Score™. As healthcare moves increasingly toward better informed, patient-centric approaches, the Company intends for the TeloView™ platform to deliver personalized medicine that allows for better treatments, leading to better outcomes.
The TeloView™ platform is supported by 25 clinical studies involving more than 3,000 patients and 20 different cancers, plus Alzheimer’s disease. 3DS benefits from twenty years of research, $25M of non-dilutive investment into its platform and more than 130 supporting publications, and holds a portfolio of patents related to three-dimensional telomere analysis for proliferative diseases, including (but not limited to) hematological disorders such as Hodgkin’s lymphoma, multiple myeloma, and chronic myeloid leukemia. 3DS’ intellectual property portfolio also covers prostate cancer, breast cancer, lung cancer, melanoma, colorectal cancer, and Alzheimer disease.
For more information, visit the Company’s website at: http://www.3dsignatures.com.
The information concerning MDxHealth contained in this news release has been provided by MDxHealth. Although 3DS has no knowledge that would indicate that any statements contained herein concerning MDxHealth are untrue and incomplete, the directors and officers of 3DS assume no responsibility for the accuracy and completeness for such information.
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Cautionary Note Regarding Forward-Looking Statements
This news release contains forward-looking statements which constitute “forward-looking information” within the meaning of applicable Canadian securities legislation (“Forward-Looking Statements”). All statements included herein, other than statements of historical fact, are Forward-Looking Statements and are subject to a variety of known and unknown risks and uncertainties which could cause actual events or results to differ materially from those reflected in the Forward-Looking Statements. Often, but not always, these Forward-Looking Statements can be identified by the use of words such as “estimates”, “potential”, “open”, “future”, “assumes”, “projects”, “anticipates”, “believes”, “may”, “continues”, “expects”, “plans”, “will”, “to be”, or statements that events “could” or “should” occur or be achieved, and similar expressions, including negative variations. Statements with respect to MDxHealth’s option to negotiate a license agreement for the Telo-PC™ test, 3DS’ future collaboration with MDxHealth and the study’s ability to build on previous evidence in respect of 3DS’ Telo-PC™ test, among others, are Forward-Looking statements.
Such Forward-Looking Statements reflect the Company’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by 3DS as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many risk factors could cause the Company’s actual results, performance, achievements, prospects or opportunities to be materially different from any future results, performance or achievements that may be expressed or implied by such Forward-Looking Statements, including risks related to the failure of 3DS and MDxHealth to execute successfully on the collaboration agreement or at all; the risk that the Telo-HL™ test may not be commercially launched for research use or as an LDT by the first quarter of 2018, or at all; uncertainties related to 3DS’ clinical trials and test development; risks related to the volatility of the price of 3DS’ common shares; risks related to the possibility that 3DS’ shareholders may experience dilution; risks related to 3DS’ requirements for additional financing and future access to capital, including the risk that the proceeds raised under the Private Placement may be insufficient to finance 3DS’ business objectives; the risk that a positive return on an investment in 3DS’ common shares is not guaranteed; risks related to 3DS’ intention to retain earnings and not pay cash dividends on its common shares in the foreseeable future; risks related to 3DS’ early stage of development; the risk that 3DS’ tests will not be successfully deployed; risks related to 3DS’ dependence on third parties, including collaborative partners, licensors and others; risks related to 3DS’ clinical trial recruitment; that there is currently no market for 3DS’ products and that such market may be slow to develop if at all; risks related to 3DS’ reliance on key personnel; risks related to the competitive nature of the biotechnology industry; risks related to 3DS’ limited operating history, lack of revenue, history of losses and inability to assure that it will earn profits in the future or that profitability will be sustained; risks related to government regulation; risks related to rapid technological change; risks related to the fact that 3DS’ software may now or in the future contain undetected errors, bugs or vulnerabilities; the risk that 3DS or its directors and officers may be subject to a variety of civil or other legal proceedings, with or without merit, including product liability claims; risks related to the protection of 3DS’ intellectual property rights; risks related to 3DS’ limited sales, marketing and distribution experience; risks related to the possibility that 3DS’ directors and officers may be placed in a conflict of interest as a result of their employment or affiliation with third parties, risks related to 3DS’ use and storage of personal information and compliance with applicable privacy laws, as well as those risks discussed under the heading “Risk Factors” in the Company’s annual management’s discussion and analysis dated October 23, 2017 and filed on SEDAR. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in the Forward-Looking Statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended.
In making the Forward-Looking Statements, the Company has made various material assumptions including, but not limited to, that 3DS and MDxHealth will collaborate successfully, obtaining positive results from 3DS’ current and planned clinical trials and research and development initiatives, including the study with MDxHealth; that the Telo-HL™ test will be commercially launched for research use or as an LDT by the first quarter of 2018; obtaining regulatory approvals with respect to 3DS’ clinical trials which are now ongoing or may in the future be commenced; 3DS’ ability to successfully develop its tests; assumptions regarding general business and economic conditions; that 3DS’ current positive relationship with third parties will be maintained; the availability of future financing on reasonable terms; 3DS’ ability to attract and retain skilled staff; assumptions regarding market competition and the products and technology offered by 3DS’ competitors; and 3DS’ ability to protect patents and proprietary rights.
3DS believes that the assumptions and expectations reflected in the Forward-Looking Statements in this press release are reasonable, but no assurance can be given that these expectations will prove to be correct. Forward-Looking Statements should not be unduly relied upon. This information speaks only as of the date of this press release, and 3DS will not necessarily update this information, unless required to do so by securities laws.
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.