WINNIPEG, MB--(Marketwired - October 17, 2016) - 3D Signatures Inc. (TSX VENTURE: DXD) (the "Company" or "3DS"), a personalized medicine company developing precision clinical tests using a proprietary software platform based on three-dimensional analysis of chromosomal signatures, is pleased to provide a letter to shareholders providing guidance and insight into the Company's milestones over the coming year. Jason Flowerday, the Company's CEO, is excited to report on the company's early progress and to provide a roadmap to commercialization.
Dr. Sabine Mai, the Company's co-founder, has discovered a new, complex, and dynamic class of biomarker. With strong supporting data for fourteen different cancers and neurodegenerative diseases, in addition to drug development applications, it is imperative that 3DS is focused on core initiatives that will drive value for shareholders and make efficient use of time and resources. Management has prioritized four programs for the coming year: 1) validation and preliminary approval of its lead prognostic test for Hodgkin's Lymphoma, 2) initiation of a major clinical trial for blood-based monitoring tests for Prostate Cancer, 3) strategic engagement with pharmaceutical companies for development of companion diagnostics, and 4) securing the right people and partners to elevate its business.
There are approximately 10,000 new cases of Hodgkin's Lymphoma and an estimated 1500 deaths in the United States and Canada each year. Physicians cannot today predict which patients will respond to standard chemotherapy and enter long-term remission or not respond and relapse, requiring alternative but more aggressive forms of therapy. There is currently no test to predict whether patients will respond to standard chemotherapy or not.
3DS plans to announce a clinical trial for a Hodgkin's Lymphoma precision medicine test in the coming months. The trial seeks to predict, at point of diagnosis, whether patients will respond to standard chemotherapy or not. The company expects to engage a nationally recognized and accredited laboratory partner in the validation and approval of a Hodgkin's Lymphoma Laboratory Developed Test (LDT) for Canada in 2017.
Every year, there are over 3,000,000 existing and new cases of prostate cancer in the United States and Canada. A large proportion of these patients are needlessly over-treated and/or subjected to surgery -- costing the healthcare payers billions of dollars annually and inflicting unnecessary treatment and complications on patients. There is a significant unmet need, at every stage of the disease, for accurate and minimally invasive risk-assessment tools to allow clinicians to make better treatment decisions. 3DS wants to arm physicians with the tools necessary to confidently personalize treatment decisions for each individual prostate cancer patient. No such tests currently exist.
The Company plans to announce a major clinical trial for prostate cancer precision medicine tests in the coming weeks. The trial will seek to predict the most effective treatment plan for the individual patient and would represent a first-in-class minimally invasive (blood-based) risk-assessment tool for prostate cancer patients at various stages of disease and treatment.
Based on published work by Dr. Mai and her collaborators regarding real-time ex-vivo feedback on several new therapeutic candidates and inbound interest from a number of major pharmaceutical companies, 3DS is activating a dedicated strategy to engage industry in discussions around partnership opportunities. 3DS's technology has the potential to identify lead therapeutic candidates through drug-screening, select specific patients for clinical trials, monitor patients during clinical trials, and ultimately work with pharmaceutical companies on the approval of companion diagnostics for precision medicine. There is significant potential value to be realized by pharmaceuticals companies in the form of efficient identification of new drugs, targeted clinical trials, objective real time feedback during clinical trials, and expedited regulatory approval by way of companion diagnostics. We are excited by these potential opportunities.
People and Partners
The 3DS team is an enthusiastic and group of scientific, business, legal and accounting professionals that are working hard to execute on milestones and realize the potential of 3DS' technology. The Company has been fortunate to secure a strong and dedicated board of directors and management team at a relatively early stage of its growth:
- John Swift, Chairman, Board of Directors
- Jason Flowerday, CEO & Director
- Dr. Sabine Mai, Director & Chair, Clinical & Scientific Advisory Board
- Ferenc Somogyvari, Director
- Gordon McCauley, Director
- Bruce Colwill, Director
- Dr. Ian Smith, Director
- Keith Cassidy, CFO
- Oumar Samassekou, VP Clinical Technology
- Hugh Rogers, VP Finance
To learn more about the team's background, please visit: http://www.3dsignatures.com/corporate/.
3DS has formed a Clinical & Scientific Advisory Board ("CSAB"), chaired by its co-founder Dr. Mai, for the purpose of seeking ongoing advice from international recognized clinical and scientific experts on the development of the company's priority biomarkers and its proprietary TeloView™ software platform. The Company continues to add internationally recognized expertise to the CSAB.
Of equal importance to the Company and its commercial success is the formation of a Business Advisory Board ("BAB") comprised of industry veterans and business leaders with international life sciences business success. Their experience and networks are critical to 3DS. The Company's senior management is in active discussions with BAB members to confirm its commercialization strategy, initially focused on Canada and United States, and to assist the company in selecting academic and clinical partners to co-develop its novel class of biomarkers.
Engaging strategic academic and commercial partners, particularly in the United States, is a significant part of the Company's business plan. A number of discussions are underway with potential partners and 3DS will continues to engage new potential partners with a view towards expediting commercialization and maximizing market acceptance and penetration of its products.
About 3D Signatures Inc.
3D Signatures Inc. (TSX VENTURE: DXD) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of telomere organization. The technology is well developed and supported by 16 clinical studies on over 1,500 patients on 13 different cancers and Alzheimer's disease. Depending on the application, the technology can measure the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity. The technology is designed to predict the course of disease and to personalize treatment for the individual patient. For more information, visit the Company's website: http://www.3dsignatures.com.
This news release contains forward-looking information based on current expectations. Statements with respect to objectives and priorities for the remainder of 2016 and beyond, strategies or future actions, research and development, product development, and the effectiveness of the technology, among others, are all forward-looking information. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such information can generally be identified by the use of forwarding looking wording such as "may", "expect", "estimate", "anticipate", "intend", "believe" and "continue" or the negative thereof or similar variations. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, estimates, forecasts, projections and other forward looking statements will not occur. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, and other factors, many of which are beyond the control of the Company. Risk factors that could cause actual results or outcomes to differ materially from the results expressed or implied by forward-looking information include, among other things: market demand; technological changes that could impact the Company's existing products or the Company's ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; the ability to manage operating expenses, which may adversely affect the Company's financial condition; the Company's ability to successfully maintain and enforce its intellectual property rights and defend third-party claims of infringement of their intellectual property rights; adverse results or unexpected delays in clinical trials; changes in laws, general economic and business conditions; and changes in the regulatory regime. The Company cautions the reader that the above list of risk factors is not exhaustive. Important factors that could cause actual results to differ materially from the Company's expectations include, litigation, global economic climate, loss of key employees and consultants, additional funding requirements, changes in laws, technology failures, competition, and failure of counterparties to perform their contractual obligations. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. These statements should not be read as guarantees of future performance or results. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by law.
The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made by, third parties in respect of the matters discussed above.
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