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3D Signatures Inc. Announces Non-Brokered Private Placement to Raise $1,500,000 and Updates Previously Announced Brokered Private Placement
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
TORONTO, Nov. 27, 2017 (GLOBE NEWSWIRE) -- 3D Signatures Inc. (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0) (the "Company" or "3DS") is pleased to announce its intention to raise $1.5 million CAD by way of a non-brokered private placement of 7,500,000 units (the “Units”) at a price of $0.20 per Unit (the “Private Placement”). Each Unit will consist of one common share of the Company and one common share purchase warrant exercisable at $0.35 for 5 years from the date of the closing of the Private Placement.
The Company has agreed (i) to pay a cash finder’s fee of 6% of the aggregate proceeds raised from subscriptions arranged by certain finders and (ii) to issue broker warrants equal to 6% of the aggregate Units subscribed for pursuant to the subscriptions arranged by such finders. Each broker warrant shall be exercisable for one common share at a price of $0.35 for a period of 24 months following the closing date of the Private Placement.
The closing of the Private Placement is expected to occur on or about November 30, 2017, and is subject to the receipt of all necessary regulatory approvals, including the approval of the TSX Venture Exchange. All securities issued pursuant to the Private Placement will be subject to a four month hold period in accordance with applicable Canadian securities laws. There is no material fact or material change regarding 3DS that has not been generally disclosed.
The Company intends to use the net proceeds from the Private Placement to fund clinical trials, and for working capital and general corporate purposes. The Company expects that approximately $750,000 of the Private Placement will be used to fund clinical expenses, including the Company’s test for Hodgkin’s lymphoma, Telo-HLTM, which requires validation of the scoring model as well as analytical validation prior to expected commercial launch as a laboratory developed test (“LDT”) in the first quarter of 2018. The balance of the Private Placement is expected to be used to fund general working capital expenses.
Separately, 3DS announces the termination of a previous agreement, announced on October 25, 2017, pursuant to which Haywood Securities Inc. (“Haywood”) agreed, on behalf of a syndicate of agents including Industrial Alliance Securities Inc., to sell, by way of a brokered private placement on a best efforts basis, units of the Company at a price of $0.25 per unit for aggregate gross proceeds of up to $2,500,000. In accordance with the terms of the engagement letter, the Company agreed to pay all reasonable fees and expenses, including legal fees and disbursements, incurred by the agent or on their behalf.
This press release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “1933 Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the 1933 Act and applicable state securities laws or an exemption from such registration is available.
About 3DS
3DS (TSX-V: DXD; OTCQB: TDSGF; FSE: 3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer’s disease. Depending on the desired application, this platform 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 at: http://www.3dsignatures.com.
For further information, please contact:
Jason Flowerday
CEO & Director
604-428-8842
investors@3dsignatures.com
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. The Forward Looking Statements in this news release include, without limitation, statements about the use of proceeds of the Private Placement, 3DS’ ability to complete the Private Placement, including obtaining the necessary approvals in connection therewith, 3DS’ expected clinical trials and research and development initiatives, the development and commercialization of the Telo-HLTM test as an LDT by the first quarter of 2018, the expected closing date of the Private Placement, the payment of finder’s fees in respect of the Private Placement and the possibility that the Company may increase the size of the Private Placement or allot subscriptions on a pro-rata basis in the event of the Private Placement being oversubscribed. 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.
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 the risk that the Private Placement may not close; the risk that 3DS’ management will have discretion in the actual application of the net proceeds and may elect to allocate proceeds differently from what is described herein; the risk that the Telo-HLTM test may not be commercially launched as an LDT by the first quarter of 2018, or at all; the risk that 3DS’ management may elect to allot subscriptions on a pro-rata basis in the event that the Private Placement is oversubscribed; 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; uncertainties related to 3DS’ clinical trials and test development; 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 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, the timely receipt of regulatory and third party approvals related to the Private Placement; the completion of the Private Placement; obtaining positive results from 3DS’ current and planned clinical trials and research and development initiatives; that the Telo-HLTM test will be commercially launched 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.
Qss..
Have you been reading why TDSGF been basically re-organized their personel lately?
Is that a good sign?
Tia!
-Chaka
3D SIGNATURES REPORTS FINANCIAL RESULTS FOR 2017
3D Signatures Inc (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0)
Shares Issued 46,445,199
Last Close 10/24/2017 $0.28
Tuesday October 24 2017 - News Release
Mr. Jason Flowerday reports
3D SIGNATURES REPORTS FINANCIAL RESULTS FOR 2017
3D Signatures Inc. has released its operational and financial results for its fiscal year ended June 30, 2017.
The Company recorded a net loss of $9,913,401 ($0.21 per Common Share) in the year ended June 30, 2017 and $1,758,719 ($0.07 per Common Share) in the year ended June 30, 2016. In the three months ended June 30, 2017, the net loss was $2,764,895 ($0.05 per Common Share) as compared to $510,877 ($0.02 per Common Share) in the three months ended June 30, 2016. The increase in the net loss was primarily due to an increased wage expense for both clinical staff and management. Stock based compensation, costs associated with the listing of the Company's stock on the TSXV and ongoing expenses relating to the Company's operations as a reporting issuer also contributed to the increased net loss.
"This past year was a transitional one. We stayed on schedule and accomplished a lot, most importantly staying on track with our key clinical trial in Hodgkin's lymphoma," stated Jason Flowerday, CEO of 3DS. "That said we have and continue to reorganize our budget significantly, reducing and prioritizing expenditures to ensure sustainable operations going forward. The Company is extremely focused on initiating the commercial launch of its Hodgkin's lymphoma test as an LDT in Q1 2018," added Mr. Flowerday.
Fiscal 2017 Corporate Highlights,
On September 8, 2016, 3DS (formerly Plicit Capital Corp. ("Plicit") announced the completion of its qualifying transaction and reverse takeover, as that term is defined in the policies of the TSX Venture Exchange ("TSXV"), approved by the TSXV. The shareholders of the acquired company, 3D Signatures Inc., received 4.0376 shares of 3DS for each one of Plicit's shares.
On September 8, 2016, 3D Signatures Inc. (now 3D Signatures Holdings Inc.) became a wholly owned subsidiary of Plicit and Plicit changed its name to 3D Signatures Inc.
On September 13, 2016, 3DS started trading on the TSXV under the symbol DXD.V.
On September 27, 2016, 3DS appointed Jason Flowerday, B.Sc, MBA as the Company's Chief Executive Officer and concurrent appointment to the Company's Board of Directors, to lead the Company's commercialization efforts and capital markets strategy.
On October 19, 2016, 3DS announced its participation in a major clinical trial for prostate cancer diagnosis and management, known as PRECISE.
On October 27, 2016, the Company introduced the Company's Business Advisory Board ("BAB"), consisting of senior biotech industry executives.
On November 14, 2016, the Company introduced the Company's Clinical and Scientific Advisory Board ("CSAB"), comprised of physicians and researchers.
On December 5, 2016, the Company announced the appointment of Mr. Nigel Terrett to the BAB.
On December 6, 2016, 3DS presented the preliminary results of an important collaborative initiative between the Company and the Institut universitaire de cardiologie et de pneumologie de Quebec, exploring the possibility of identifying a biological marker to distinguish between two forms of lung cancer.
On December 9, 2016, the Company announced that Helen Stevenson was appointed to the Board of Directors, replacing Dr. Ian Smith, who stepped down from the Board of Directors and joined the Company's CSAB.
On December 16, 2016, 3DS announced the closing of a private placement for 5,187,618 units sold at a price per unit of $0.75 for total gross proceeds to the Company of $3,890,714, including the partial exercise of the over-allotment option, granted in connection with the private placement.
On December 22, 2016, 3DS announced that it had issued an additional 215,300 units pursuant to the second tranche of the private placement, which were sold at $0.75 per unit for gross proceeds to the Company of $161,475 pursuant to the partial exercise of the over-allotment option.
On December 22, 2016, 3DS also announced that it had retained Kilmer Lucas Inc. to provide Canadian and U.S. investor relations and strategic advisory services.
On January 4, 2017, 3DS announced that its common shares (the "Common Shares") had started trading on the OTCQB Venture Market ("OTCQB") in the United States under the symbol "TDSGF" and on the Frankfurt Stock Exchange in Germany under the symbol "3D0". As well, the Company announced that it had secured Depository Trust Company ("DTC") eligibility for its Common Shares listed on the OTCQB, which made the securities eligible to be electronically cleared and settled through the DTC, speeding up the receipt of stock and cash and accelerating the settlement process for investors.
On January 6, 2017, 3DS announced the issuance of an additional 597,082 units pursuant to the third tranche of the Company's previously discussed private placement, which were sold at $0.75 per unit for gross proceeds to the Company of $447,812 pursuant to a further partial exercise of the over-allotment option.
On January 6, 2017, the Company appointed Joost van der Mark, as its Chief Business Officer. Mr. van der Mark brought more than two decades of executive experience to 3DS, having worked with several major international healthcare companies, as well as earlier stage biotechnology and healthcare firms.
On February 21, 2017, 3DS' co-founder and principle inventor, Dr. Sabine Mai, presented at the 24th International Molecular Medicine Tri-Conference in San Francisco, CA, on the results of a prospective blood-based prostate cancer pilot study using the Company's TeloView{A } software platform. Based on blinded blood samples, TeloView{A } correctly predicted the stability and aggressiveness of disease for each of the study's 50 intermediate risk prostate cancer patients.
On February 23, 2017, 3DS announced that the validation program for its Hodgkin's Lymphoma ("HL") test ("Telo-HL"), a five-stage program aimed at the development of a commercially marketable LDT within the next twelve months, is underway. On March 29, 2017, the Company announced the successful internal analytical assay validation, referred to as Stage 2 of the validation program.
On March 14, 2017, 3DS announced that it had made the final payment to CancerCare Manitoba ("CCBM") for the purchase of intellectual property. CCMB previously assigned this intellectual property to 3DS on June 26, 2014. CCMB retains a 1.5% royalty on all gross revenues derived from the commercialization of these patent rights and related products.
On March 21, 2017, 3DS announced the clinical study results which confirmed that, based on a swab of a patient's cheek, the Company's TeloViewTM software platform has the ability to identify patients with Alzheimer's disease and distinguish between mild, moderate, and severe forms of the disease. The results of this study have been accepted for publication in the peer-reviewed Journal of Alzheimer's Disease.
On April 11, 2017, the Company announced the appointment of Dr. Kevin Little as its Chief Scientific Officer. Dr. Little provides the Company with a successful track record of clinical and executive experience with life sciences firms, including those who are focused on growth.
On April 18, 2017, the Company announced the relocation of its corporate office to the MaRS Discovery District located in Toronto. Management completed the relocation on April 30, 2017.
On April 27, 2017, the Company announced that it had received the first batch of blood samples for PRECISE. The samples were received for processing and analysis at the Company's laboratory.
On May 5, 2017, the Company announced the resignation of Ferenc Somogyvari from the Board of Directors. Mr. Somogyvari joined the Company's CSAB.
On June 8, 2017, the Company announced the commencement of the clinical trial component of the Telo-HL validation program. The process was Stage 3 of the validation program.
The Company's financial statements and management's discussion and analysis are available on www.sedar.com.
About 3D Signatures Inc
3DS (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer's disease. Depending on the desired application, this platform 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.
Investor Relations
Terry Bramhall
1-604-428-8842
© 2017 Canjex Publishing Ltd.
I'm in this GEM NOW.
I will continues to load till it the LAUNCH DATE ensues.
It's going to be hard chasing TDSGF later imo.
My guess is we have 3-6 months LEFT.
Huge biotech technology we have here.
glta.
Chaka
3D SIGNATURES ANNOUNCES COMPLETION OF STAGE 3 OF HODGKIN’S LYMPHOMA TEST VALIDATION PROGRAM
TORONTO, Oct. 10, 2017 (GLOBE NEWSWIRE) — 3D Signatures Inc. (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0) (the “Company” or “3DS”), is pleased to announce that, on September 30, 2017, the Company completed the clinical trial component (the “Clinical Trial”), or Stage 3, of its Hodgkin’s lymphoma (“HL”) test (“Telo-HLTM”) validation program. Data from the Clinical Trial has been submitted to the Company’s statistics consulting partner for analysis.
“We are excited to accomplish this critical milestone on schedule, and we remain on track for the expected commercial launch of Telo-HLTM as an LDT by the end of Q1 2018,” commented Jason Flowerday, CEO of 3DS.
Powered by the Company’s proprietary TeloViewTM software platform, Telo-HLTM is designed to stratify HL patients at the point of diagnosis into patients with aggressive or non-aggressive disease. Patients with aggressive disease may then be considered for alternative treatments at the time of diagnosis rather than waiting until they have failed multiple rounds of standard chemotherapy. There is currently no known biomarker available that can predict patient response to standard chemotherapy in HL patients. The Company expects Telo-HLTM to benefit patients seeking personalized treatment and to provide significant cost savings to payors and insurers that are currently burdened with expensive treatments and procedures that may not be necessary if patients could be considered for more targeted and effective therapies at the outset of treatment.
Stage 3 of the Telo-HLTM validation program, as set out in the Company’s news release dated February 23, 2017, included the analysis of over 400 retrospective HL cases to generate a quality controlled data set of 200 patients. The analysis comprised performing a wet lab co-immuno-telomeres FISH assay, 3-dimensional imaging, Hodgkin and Reed-Sternberg cell selection and TeloViewTM software analysis. The assay was performed on the diagnostic lymph node tissue from HL patients. A minimum of 30 Hodgkin’s cells and 30 Reed-Sternberg cells were analyzed from each of the 200 patient specimens. The Clinical Trial was multicentre with HL tissue sourced from three national and international university hospitals.
“I was impressed with the technical proficiency displayed in performing the assay and the overall concordance of HL cell identification,” noted Dr. Hans Knecht, 3DS advisor, Professor of Medicine and Chief, Division of Hematology at Jewish General Hospital, and Director, Division of Hematology, Department of Medicine, McGill University, Montreal. “Most important was the notable quality control and quality assurance standards that were employed during the cell identification process,” Dr. Knecht added.
Stage 3 data has been submitted to the Company’s statistics consulting partner, BioStat Solutions Inc., Maryland, USA (“BSSI”). BSSI will carry out statistical evaluation of the data and develop a scoring model to distinguish patients with non-aggressive disease from patients with aggressive disease that may relapse within 12 months of treatment with standard first-line chemotherapy. BSSI’s statistical analysis will generate Telo-HLTM’s characteristics including positive predictive value, negative predictive value, specificity and sensitivity, with a target performance of greater than 90% on all characteristics. The 3DS clinical development team has started processing an independent patient cohort of over 100 HL cases that will be used to validate the scoring model from BSSI.
3DS also announced today that the United States Patent and Trademark Office has recently issued the Company two new patents governing key aspects of its technology platform. US Patent 9,784,666, entitled “Methods for Assessing Cancer Cells Using Granulometry”, covers a high-resolution imaging technology for assessing cancer progression. US Patent 9,758,830, entitled “Methods for Evaluating Alzheimer’s Disease and Disease Severity”, covers the stratification of Alzheimer’s patients using 3DS technology.
About 3DS
3DS (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer’s disease. Depending on the desired application, this platform 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 at: http://www.3dsignatures.com.
About BSSI
BioStat Solutions, Inc. (BSSI) is a privately held professional service corporation providing statistical and bioinformatics expertise to pharmaceutical and biotech companies as well as to the government and its contractors. BSSI’s diverse team of statisticians, bioinformaticists, epidemiologists and geneticists provides answers to complex and challenging analytical questions. Whether the client is facing big data or machine learning problems, or is looking for new biomarker or diagnostic device strategies, BSSI provides solid results towards effective decision-making. For more information, visit BSSI’s website at: http://www.biostatsolutions.com.
Forward-Looking Information
This news release includes forward-looking statements that are subject to risks and uncertainties. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of the Company to be materially different from the historical results or from any future results expressed or implied by such forward-looking statements. All statements within, other than statements of historical fact, are to be considered forward looking. Although 3DS believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in forward-looking statements. 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. There can be no assurances that such statements will prove accurate and, therefore, readers are advised to rely on their own evaluation of such uncertainties. We do not assume any obligation to update any forward-looking statements.
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.
For further information, please contact:
Terry Bramhall
Investor Relations
604-428-8842
terry.bramhall@3dsignatures.com
Petunia1..
Are you still in TDSGF?
I am HEAVILY keeping tap of this GEM.
IYO..
What's the prognosis success of this TELE-platforms?
Thoughts?
Tia!
Have to be PATIENCE here.
Canada is the NEXT HOTSPOTS in pharmaceuticals sector.
glta:)
Paraceratherium..
I've been reading and doing some DD with 3DSIGNATURES overall company.
Very impressive with the SCIENTISTS people behind the technology.
I also see KNIGHTS THERAPEUTICS is also involve as well.
HUGE POTENTIAL here.
I intend to buy 3DSIGNATURES stock sometimes next month.
Also, some BIO EXPERTS already keeping tap of TDSGF.
glta.
3D Signatures Inc. Announces Short Form Prospectus Offering to Raise Up to C$5 Million
TORONTO, ONTARIO--(Marketwired - July 19, 2017) -
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
3D Signatures Inc. (TSX VENTURE:DXD)(OTCQB:TDSGF)(FRANKFURT:3D0) (the "Company" or "3DS") is pleased to announce that is has entered into an agreement with a syndicate of agents led by Haywood Securities Inc. ("Haywood"), as sole book-runner, and including Industrial Alliance Securities Inc. (collectively, the "Agents") to sell, by way of a short form prospectus, on a best efforts agency basis, up to 12,500,000 common shares in the capital of the Company (the "Common Shares") at a price of C$0.40 per Common Share (the "Offering Price"), for aggregate gross proceeds of up to C$5,000,000 (the "Offering"). In addition, the Company has granted to the Agents an option (the "Over-Allotment Option") to purchase up to an additional 1,875,000 Common Shares at the Offering Price, to cover over-allotments, if any. The Over-Allotment Option is exercisable by the Agents, in whole or in part, at any time up to 30 days following the closing date.
The Company has filed a preliminary short form prospectus dated July 18, 2017 (the "Preliminary Prospectus") with the securities regulatory authorities in the provinces of British Columbia, Alberta, Manitoba and Ontario pursuant to National Instrument 44-101 - Short Form Prospectus Distributions. The Common Shares will be offered for sale in the United States on a private placement basis pursuant to exemptions from the registration requirements of the United States Securities Act of 1933, as amended (the "U.S. Securities Act"). This press release is not an offer to sell, or a solicitation of an offer to buy, any of the securities in the United States. The Common Shares have not and will not be registered under the U.S. Securities Act or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from such registration. Subject to agreement between Haywood and the Company, each acting reasonably, the Common Shares may also be offered in other international jurisdictions pursuant to the appropriate exemptions and registration requirements in such jurisdictions.
In connection with the Offering, the Company has agreed to pay to the Agents a cash commission equal to 8.0% of the gross proceeds from the Offering, except in respect of any subscriptions by eligible purchasers under the Offering on a list provided by the Company and accepted by Haywood (the "President's List"), for which the Agents will only receive a cash commission equal to 2.0% of the gross proceeds from the Offering raised from such purchasers (the "Agents' Compensation"). The Company has also agreed to reimburse the Agents for reasonable expenses incurred in connection with the Offering, including the reasonable legal fees, up to a maximum amount of C$50,000 plus disbursements and taxes, of the Agents' legal counsel and reasonable out of pocket expenses, and will pay to the Haywood a corporate finance fee of C$40,000 plus tax (the "Corporate Finance Fee" and, together with the Agents' Compensation, the "Agents' Fee"). In addition to the the Agents' Fee, the Company has agreed to issue to the Agents broker warrants (the "Broker Warrants"), exercisable at the Offering Price to purchase such number of Common Shares as is equal to 8.0% of the aggregate number of Common Shares sold to purchasers not listed on the President's List, and 2.0% of the aggregate number of Common Shares sold to purchasers listed on the President's List. Each Broker Warrant shall be exercisable into one Common Share at any time prior to 5:00 p.m. (Vancouver time) on the date that is 24 months after the closing date.
In addition to the Agents' Fee and the Broker Warrants, the Company may be required to compensate certain finders (the "Finders") in relation to non-Canadian subscriptions secured by these Finders. To the extent that purchasers who have been introduced to the Company through these Finders participate in the Offering, cash commissions may be payable to these Finders and the Company may be required to issue to these Finders compensation warrants (the "Compensation Warrants"). In the case of any such subscriptions, the gross commissions payable to these Finders, including any Compensation Warrants issued to these Finders, shall not exceed the limitations set out in TSXV Policy 5.1 - Loans, Loan Bonuses, Finder's Fees and Commissions.
Subject to the amount of net proceeds ultimately received by the Company from the Offering, the Company intends that the net proceeds of the Offering in the following manner:
Hodgkin's Lymphoma - The Company plans to employ approximately 40% of the net proceeds from the Offering to complete the validation program for the Company's Telo-HL test and to commercially launch this test as a laboratory developed test.
Myeloma and Lung Cancer - The Company plans to employ approximately 20% of the net proceeds from the Offering to undertake pilot studies to determine the applicability of the Company's proprietary TeloView™ software platform to the lung cancer and myeloma diseases.
Clinical Wages and Laboratory Expenses and General Working Capital Expenditures - The Company will use approximately 40% of the net proceeds from the Offering to fund clinical wages and laboratory expenses related to the Company's ongoing research and development activities and for general working capital purposes.
For a complete description of the Company's anticipated uses for the proceeds from the Offering, potential investors should make reference to the Preliminary Prospectus.
Closing of the Offering is expected to occur on August 31, 2017 and is subject to certain conditions including, but not limited to, the receipt of all necessary approvals including the approval of the TSX Venture Exchange and the securities regulatory authorities.
About 3DS
3DS (TSX VENTURE:DXD)(OTCQB:TDSGF)(FRANKFURT:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. 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 desired application, the technology can measure the stage of disease, the rate of progression of the disease, drug efficacy, and drug toxicity. The technology is designed to predict the course of the disease and to personalize treatment for the individual patient. For more information, visit the Company's new website at http://www.3dsignatures.com.
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. The Forward Looking Statements in this news release include, without limitation, statements about the use of proceeds of the Offering, the expected closing date of the Offering, the ability to obtain the necessary approvals to complete the Offering and the compensation of the Agents and the Finders, including whether compensation will be payable to the Finders and the form and extent of any such compensation. 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.
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 volatility of the price of the Common Shares; risks related to the possibility that 3DS' shareholders may experience dilution; that 3DS' management will have discretion in the actual application of the net proceeds, and may elect to allocate proceeds differently from what is described herein; risks related to 3DS' requirements for additional financing and future access to capital, including the risk that the proceeds raised under the Offering may be insufficient to finance 3DS' business objectives; the risk that a positive return on an investment in the 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; uncertainties related to 3DS' clinical trials and test development; 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; risks associated with 3DS' international operations; 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 information form dated January 31, 2017 and filed on SEDAR, the Preliminary Prospectus and the Company's filing statement dated August 22, 2016 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 the timely receipt of regulatory and third party approvals related to the Offering; the completion of the Offering; obtaining positive results from 3DS' current and planned clinical trials; obtaining regulatory approvals with respect to 3DS' clinical trials which are now ongoing or may in the future be commenced; assumptions regarding general business and economic conditions; 3DS' ability to successfully develop its tests; 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.
Stephen Kilmer
Investor Relations
647-872-4849
stephen@kilmerlucas.com
Hugh Rogers
VP Corporate Finance
204-582-0922
investors@3dsignatures.com
Terry Bramhall
Investor Relations
1-604-428-8842
terry.bramhall@3dsignatures.com
Company highlights to date
3D Signatures is developing a technology to diagnose 14 different diseases with unprecedented accuracy, from prostate cancer to Alzheimer's, all with a simple blood test, cheek swab, or tissue sample. This work is supported by over 130 peer reviewed papers and 2000 patients. Our short video HERE will explain better than I can.
Recently, our software platform has attracted partnership discussions from major biopharma companies. You can catch quite a few additional company highlights in the investor section of our website
We anticipate our first clinical product for commercial use by the end of 2017
I expect news next week. We are overdue for the financing. Lets get the show on the road.
Some of the bigger investors are selling shares of other companies to buy shares of DXD. Explains the volume. Financing should be done around this price. Should explode any day now.
Looks like a good entry point for this stock.
Looking for a financing around this level any day now. Once secured, the stock should move quickly to the dollar level.
http://bit.ly/2sxoIMc
Exciting Digital Health Company to Keep an Eye On
Startup Spotlight by PM360 Staff on June 17th, 2017
Bioinformatix Datablend Wearables 3D Signatures Epilen GalileoMD Spring
3D Signatures
Jason Flowerday, CEO and Director
jason.flowerday@3dsignatures.com
www.3dsignatures.com
About:
3D Signatures Inc. has developed proprietary software that analyzes a patient’s chromosomal arrangement—or signature—through a non-invasive blood test or tissue sample, measuring disease stage and genomic stability, as well as drug efficacy and potential side effects. Unlike most diagnostic companies, the platform tells doctors how to personalize treatment and best manage the disease for each individual patient.
Transformational:
3D Signatures is preparing to market its imaging technology once late-round clinical trials fully confirm its reliability for Hodgkin’s disease. Currently, no biomarker is available that can predict patient response to standard chemotherapy in Hodgkin’s lymphoma patients and thereby help guide treatment decisions on the individual basis.
Offering:
3D Signatures’ validation program for its Hodgkin’s lymphoma (“HL”) test (“Telo-HL”) validation program consists of five stages which aim to develop a commercially marketable laboratory-developed test (LDT) within the next 10 months. In parallel to this, the company is working on validating four more products to address lung cancer, prostate cancer, multiple myeloma, and Alzheimer’s disease.
Big Picture:
The global cancer diagnostics market is expected to reach $13.1 billion by 2020, according to MarketsandMarkets, one of the world’s largest research firms. What sets 3D Signatures apart is that it’s the only company in the world conducting 3D telomere analysis. Unlike 2D analysis, 3D Signatures is able to accurately measure genomic instability. This technology harnesses the predictive power of the telomere as a dynamic biomarker. The company can determine how a disease will progress and enables clinicians to measure the appropriateness and effectiveness of different treatments for specific patients—saving time and improving outcomes.
3D Signatures has $2.55M cash at end of fiscal Q3
3D Signatures Inc (C:DXD) (OTCBB:TDSGF
Shares Issued 46,445,199
Wednesday May 31 2017 - News Release
Mr. Jason Flowerday reports
3D SIGNATURES INC. REPORTS THIRD QUARTER 2017 FINANCIAL RESULTS
3D Signatures Inc. has released its operational and financial results for its fiscal third quarter ended March 31, 2017.
Third quarter highlights:
On January 4, 2017, 3DS announced that its common shares had started trading on the OTCQB Venture Market ("OTCQB") and on the Frankfurt Stock Exchange under the symbols "TDSGF" and "3D0", respectively. The Company also announced that it had secured Depository Trust Company eligibility for its common shares listed on the OTCQB.
On January 6, 2017, the Company announced the appointment of accomplished healthcare industry veteran, Joost van der Mark, as its Chief Business Officer. On January 6, 2017, 3DS announced the closing of the third and final tranche of a fully subscribed brokered private placement. The Company issued a total of 597,082 units pursuant to the third tranche of the private placement, which were sold at $0.75 per unit for gross proceeds to 3DS of $148,800, pursuant to the exercise of the Agent's over-allotment option.
On January 9, 2017, the Company announced that new data from a study published in Urologic Oncology suggested that the use of its proprietary TeloView{A } technology platform may be a promising blood-based treatment-response biomarker in prostate cancer patients who are undergoing combined (hormonal) androgen deprivation therapy and radiation therapy.
On January 18, 2017, the Company announced that it had awarded 253,125 incentive stock options (the "Options") to its CEO, Jason Flowerday, at an exercise price of $0.79 per share. The Options are exercisable for a ten-year period from the date of grant (January 17, 2017) and will vest in four tranches of 63,281 each, every six months from October 1, 2017 to April 1, 2019.
On February 15, 2017, 3DS announced the appointment of medical diagnostics expert, Harry Glorikian, to its Business Advisory Board ("BAB").
On February 21, 2017, 3DS announced a presentation at the 24th International Molecular Medicine Tri-Conference in San Francisco, CA, by its co-founder and principle inventor, Dr. Sabine Mai, on the results of a prospective blood-based prostate cancer pilot study using its TeloView{A } software platform. Based on blinded blood samples, TeloView{A } correctly predicted the stability and aggressiveness of disease for each of the study's 50 intermediate risk prostate cancer patients.
On February 23, 2017, the Company announced the initiation of the validation program for its Hodgkin's lymphoma test, "Telo-HL".
On March 14, 2017, 3DS announced that it had made the final payment to CancerCare Manitoba ("CCBM") for the purchase of intellectual property, all of which had been assigned from CCMB to 3DS on June 26, 2014.
On March 21, 2017, the Company announced clinical study results which confirm that, based on a swab from the inside of a patient's cheek, its proprietary TeloView{A } software platform has the ability to identify patients with Alzheimer's disease and, furthermore, distinguish between mild, moderate, and severe forms of the disease. The results of this confirmatory study have been accepted for publication in the peer-reviewed Journal of Alzheimer's Disease.
On March 29, 2017, 3DS announced that it had successfully completed internal analytical assay validation for its Telo-HL test pursuant to FDA guidelines. This process is referred to as Stage 2 of the validation program as set out in the Company's news releases dated February 23, 2017.
"The fiscal third quarter was another period of meaningful progress for 3DS, and builds on our accomplishments to both increase awareness of 3D telomere analysis as a disruptive technology and to advance the TeloView{A } platform toward commercialization," said Jason Flowerday, CEO.
Summary Third Quarter Results
For the three months ended March 31, 2017, the Company reported a net loss of $2,171,822, or $0.04 loss per common share, as compared to a net loss of $570,449 or $0.02 loss per common share for the three months ended March 31, 2016. The increase in net loss is primarily due to increases in salaries, wages, benefits and stock-based compensation as a result of the Company's hiring of additional employees, as well as the appointment of a new BAB member, to support its global growth strategy. Additional increases in professional fees and investor relations costs are the result of 3DS becoming a publicly traded company in September 2016.
As at March 31, 2017, the Company's cash amounted to $2,552,822.
The Company's financial statements and management's discussion and analysis are available on www.sedar.com.
About 3DS 3DS (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer's disease. Depending on the desired application, this platform 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 new website at http://www.3dsignatures.com.
We seek Safe Harbor.
Danny Deadlock Recommendation
4) 3D Signatures (DXD.TSXV 46 cents)
http://www.3dsignatures.com/
I have been monitoring this unique genomics company since March (80 cents). This past week a heavy-handed seller started dumping paper in the 0.40's and it has crushed them. I have no idea why, but this isn't uncommon in May. If there is nothing wrong from a company perspective (which I doubt there is), this could be a great bottom fishing opportunity in the mid 0.40's while this seller exists.
Read through their website for more information, but the potential here may be significant. I like "unique" companies and this is definitely unique in the genomics space.
http://www.3dsignatures.com/science/#page-section-11
http://www.3dsignatures.com/corporate/
3D Signatures is a novel personalized medicine company with proprietary software that can analyze a patient's chromosomal arrangement - or signature - through a simple non-invasive blood test or tissue sample, measuring disease stage and genomic stability, as well as drug efficacy and potential side effects.
Unlike most diagnostic companies, our proprietary imaging software goes beyond identifying whether a patient suffers from a specific disease or condition. Our analytics platform tells doctors how to personalize treatment and best manage the disease for each individual patient.
THE CAPITAL GAINS CLUB TOP PICK May 12th 2017
OUR TOP BIOTECH PICK: 3D SIGNATURES INC.
(TSXV:DXD and OTCQB: TDSGF)
Predicting the course of diseases and personalizing treatment for the individual patient
“If successful, this could represent a first-in-class blood test which would specifically identify clinically significant prostate cancer. Such a tool does not currently exist for prostate cancer patients” said Dr. Laurence Klotz, the Chairman of the Canadian Urology Research Consortium
Executive Summary: 3D Signatures is a personalized medicine company with a proprietary software platform based on the three-dimensional (3D) analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer’s disease. Depending on the desired application, this platform 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.
Dr. Sabine Mai, is the founder and largest shareholder of the company and is an internationally known researcher who has more than one hundred publications related to research on Genomics and Genomic Instability. Most recently she has contributed to a library of patents related to her work on 3D Genomic Analysis. She is the recipient of several academic awards including the Braidwood Jackson Memorial Award; the Dr. Saul Highman Memorial Award; the Rh Award (Basic Science); the J&J Cognition Challenge (2013). She was recognized in 2015 as one of the Top 100: Canada’s Most Powerful Women.
Dr. Mai has been instrumental in the development of innovative 3D analysis of genomic instability, which will help in diagnosing more specifically and earlier several forms of cancer. This will allow physicians to personalize treatment and improve the quality of outcomes. During the course of more than twenty years of research she has contributed to a portfolio of patents protecting her discoveries. Her vision is to use her discoveries for the benefit of patients everywhere.
Jonathan Goodman, the CEO of Knight Therapeutics Inc. (over $1 billion market capitalization biotech company) is a key advisor to 3D Signatures. In addition, Knight Therapeutics invested in 3D Signatures and has signed definitive licensing and distribution agreements with the company.
One of the main reasons we like 3D Signatures and the stock is because of its proprietary technology that analyzes a specific part of an individual’s unique DNA (their telomeres) to determine how a disease will progress and if a patient will respond to treatment. This information enables clinicians to measure the appropriateness and effectiveness of different treatments for specific patients.
3D Signature’s technology has over 20 years of research and over $25 million in non-dilutive research & development funding.
No wonder the board and management own approximately 35% of the company!
This is not an early stage biotech company with an undeveloped drug or technology platform – this is a company with an innovative technology and a dedicated team that only makes millions of dollars and saves countless lives if they continue to develop the technology with a view to selling the company to a much larger biotechnology company. We believe the company is poised for exponential gains and we have never sold a share. As the company progresses through various trials and continues to enter into partnerships with other companies, we believe the stock will perform well and the company will attract analysts and large fund managers.
The best way to make large sums of money in a stock is being positioned in a take-over target and that is what we believe 3D Signatures is.
Why a big Pharmaceutical company would acquire 3D Signatures
Hodgkin lymphoma
There are approximately 10,000 new cases of Hodgkin lymphoma and an estimated 1,500 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.
Prostate cancer
Every year, there are over three million existing and new cases of prostate cancer in the United States and Canada. A large proportion of these patients are needlessly overtreated and/or subjected to surgery -- costing the health care 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. 3D Signatures wants to arm physicians with the tools necessary to confidently personalize treatment decisions for each individual prostate cancer patient. NO SUCH TESTS CURRENTLY EXIST.
Drug development
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, 3D Signatures is activating a dedicated strategy to engage industry in discussions around partnership opportunities. 3D Signatures' 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.
3D Signature’s plan over the course of 2017:
Validation and preliminary approval of its lead prognostic test for Hodgkin lymphoma;
Initiation of a major clinical trial for blood-based monitoring tests for prostate cancer;
Strategic engagement with pharmaceutical companies for development of companion diagnostics; and
Securing the right people and partners to elevate its business.
The Team:
Dr. Sabine Mai: Founder and Major Shareholder
Professor of Physiology and Pathophysiology, Biochemistry and Medical Genetics, Human Anatomy and Cell Science, University of Manitoba.
Director of The Genomic Centre for Cancer Research and Diagnosis (GCCRD) at University of Manitoba.
She was recognized in 2015 as one of the Top 100: Canada’s Most Powerful Women.
Jason Flowerday: CEO and Director
over a decade of business development and marketing work for two of the world’s largest pharmaceutical companies, Germany’s Bayer AG and US-based Johnson and Johnson.
Jonathan Goodman: Business Advisor
CEO of Knight Therapeutics (investor and partner with 3D Signatures)
The co-founder, President and CEO of Paladin Labs Inc. which was acquired by Endo for $3.2 billion. Under his leadership, $1.50 invested in Paladin at its founding was worth $142 nineteen years later.
The Potential: 3D Signatures is in discussions with multiple pharmaceutical companies, with candidate compounds in all phases of clinical trials, about potentially incorporating 3D Signature’s three-dimensional telomere analysis and proprietary software into their trials. The company can offer these organizations significant insight into the efficacy of their compounds and possibly provide information on dose dependent response, as well as toxicity related to each compound.
On December 7, 2016, 3D Signatures presented the preliminary results of an important collaborative initiative between the company and the Institut Universitaire de Ariologie et de Pneumologie De Quebec (“IUCPQ”) exploring the possibility of identifying a biological marker to distinguish between two deadly forms of lung cancer, multiple synchronous lung adenocarcinoma (“AC”) and metastatic lung AC, which is a significant unmet clinical need in the management of patients with multiple lung lesions. In every blinded patient sample the company analyzed, 3D Signature’s technology was able to distinguish between the two respective types of deadly lung cancer. The acquisition of 3D telomere images and analysis was performed in the company's reference lab using the company’s proprietary software platform, TeloView™. A poster was presented at the International Association for the Study of Lung Cancer (“IASLC”) 17th World Conference on Lung Cancer (“WCLC”) which took place in Vienna, Austria from December 4 to December 7, 2016.
3D Signature’s technology has over 20 years of research and over $25 million in non-dilutive research & development funding.
No wonder the board and management own approximately 35% of the company!
The upside potential is huge and there are many catalysts to shoot the stock a lot higher. The company has laid out its business plan and if they continue to execute on time and on budget then we see our exit through a takeover. We hold shares in this company. Will you?
Enjoy the Gains,
Capital Gains Club
C. Sargent, Managing Editor
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TICKERS: DXD; TDSGF; 3D0
3D Signatures' Platform Taps into the Power of the Genome
Source: The Life Sciences Report (5/10/17)
TDSGF:OTCBB DXD:TSX-V
How fast is my cancer progressing? Does this treatment present my best option for a cure? These two big questions, which determine outcomes for patients with serious diseases such as Hodgkin's lymphoma, prostate cancer and Alzheimer's disease, are addressed by the platform technology in development by 3D Signatures Inc. In this interview with The Life Sciences Report, 3DS's new Chief Scientific Officer, Dr. Kevin Little, describes the TeloView platform, its utility in the marketplace and what makes it a compelling investment.
Management Q&A: View From the Top
The Life Sciences Report: Thank you for joining us today, Kevin. Can you describe, in layman's terms, 3D Signatures Inc.'s (DXD:TSX.V; TDSGF:OTCQB; 3D0:FSE) TeloView platform and how it works?
Kevin Little: 3D Signatures has a proprietary platform technology that is able to use telomeres, which are the DNA sequences that cap the ends of chromosomes, to establish distinctive profile differences when we look at cells. For example, in the case of cancer, the differences can tell us which cells are going to respond to traditional therapies. In other indications, the pattern of organization of those telomeres tells us whether a patient is likely to progress more quickly down the path of disease. By labeling the telomeres and then using our proprietary technology and software analytics, we're able to build out a panel of different profiles that show us what's going on in terms of the biology within these cells.
TLSR: How is this technology differentiated from other diagnostics on the market?
KL: If we talk about genomics, a lot of companies play in that space. Think about a sort of classical Mendelian genetics, such as what we teach kids in high school about pea plants. We talk about the difference between the genotype, which is the sequence of DNA bases, and the phenotype, which is what the thing ends up looking like. Genotype is the genetics; phenotype is how big a plant grows, what color the flowers are.
I think a lot of technologies seek to get better at linking genotype to phenotype—looking at what's happening at the level of changes in DNA sequence and linking that to biological outcomes like disease or tumor aggressiveness. What I find really compelling about what 3D Signatures' technology does is that we're using these telomeres as a direct biomarker for the phenotype—a pattern that we can immediately show has biological significance.
TLSR: Can you explain the value of targeting the phenotype versus the genotype?
KL: For me, the proof is in the pudding. I think people can spend a lot of time trying to analyze a gene mutation or trying to track how mutations at the genome level actually translate into something you see in a person. To me, what's more relevant is what we see in the patient, what we see that has a clinical significance for people.
Our assay is a way of capturing the instability that goes on as a cell moves from a normal state to something else, something other, and we can monitor these changes dynamically over time. We take that as a snapshot in time, and can say clearly, "Something is happening in terms of the biology here." I've really always been drawn to this question of outcomes—that is what's drawn me into 3D Signatures. The platform can have very profound impacts quite quickly in what it's able to assess at the genetic level in terms of the activity in the cell, and what we see in phenotype, in the outcome with the patient.
The science is quite profound, and Dr. Sabine Mai, 3D Signatures' cofounder and principal inventor, has been able to demonstrate that it applies across many different disease states in a lot of different indications, primarily in the cancers and now also in the neurosciences. The technology has the ability to profile genomic instability, and that gives us a real-time readout of what's happening in that cell within that patient. I think that is profoundly different than what other companies and technologies are trying to do in terms of health outcomes.
TLSR: Are you talking about personalized medicine here?
KL: Absolutely. Running a 3D Signatures test on a patient sample produces a pattern of the organization of the telomeres in each cell that we analyze from that patient. This gives us the ability to inform clinicians how that specific person is likely to respond to traditional chemotherapy (in the case of Hodgkin’s lymphoma), or how aggressively their disease is likely to progress (in the case of prostate cancer). We are empowering patients and doctors to choose treatment options based on their individual status, not a population-wide probability.
TLSR: You're exploring applications in prostate cancer, blood cancers and Alzheimer's disease. Can you explain your methodology for each of these different indications and where they stand in terms of development?
KL: What's really important here is that we have a repeatable platform. By that, I mean we're not reinventing the process for each of the different disease areas we're investigating.
We have a variety of options available to us in terms of capturing the inputs, whether from a cheek swab in neurological indications, or from blood to isolate the circulating tumor cells, or from diagnostic tumor biopsies. But the next steps—in our laboratory processing and then our proprietary analysis software—is really where we've shown refinement, reproducibility and the ability to generate distinct telomere profile differences for many indications and conditions. The robustness and the reproducibility of the platform, time and time again, are really impressive.
So as far as the development time frames, our Hodgkin's lymphoma test is the one that we are focused on right now in a large clinical trial, with the goal to bring that through to market as a laboratory developed test (LDT) in Q1/18.
In prostate cancer, we're involved in the PRECISE trial, and are processing samples from PRECISE recruitment sites as they're coming online. That's going to be a very important trial for us, to be able to benchmark against on a large scale. The next couple of years, as results come out around PRECISE, will be very informative as to the impacts we can have in terms of clinical decisions around screening and monitoring of prostate cancer. We already have plans to engage in a shorter-term look at more aggressive forms of prostate cancer—late stage—and the need for surgical intervention and our ability to predict which patients are suitable candidates, again through a simple blood-based, a liquid biopsy test that we expect to develop over the next one to two years.
TLSR: When can we expect the readout for the prostate trial?
KL: I believe PRECISE goes on for about 24 months. We'll have some evidence along the way, and that's where we see the opportunity to engage in a second, shorter time window.
TLSR: Where is your technology in terms of the approval process? Do you have a timetable as to when you'll begin to start filing applications or marketing products?
KL: With the LDT work in Hodgkin's lymphoma, discussions are underway right now with potential clinical lab partners to bring that test to market. We have quite an impressive group in terms of our business advisory board, which is exploring the regulatory frameworks for that test. We're engaging early on in discussions with regulators to make sure we anticipate things ahead of time.
TLSR: If you were to tell us what the endgame is, can you describe prospects in terms of a partnership or acquisition? Or does 3DS want to take its products all the way to the market on its own?
KL: From a strategy standpoint, the great thing is that all are options, and they're not mutually exclusive. The fact that we have a platform enables us to choose the business models and relationships we believe will best suit the clinical utility of the platform for each indication.
Bringing the test through as an LDT in Hodgkin's ourselves may be the best way to get the product into clinicians' hands to help people. Prostate may be a different market opportunity for us, and if the partnership opportunities are different, we have that kind of flexibility. That is the advantage of having a platform with a lot of different avenues to pursue. Speaking from the scientific and clinical development side, it's a really nice position to be in—to be able to engage in dialogue with potential partners around the best way to move forward together, or to be able to take something to market on our own as the best way to get the product to where it can have the best outcome.
TLSR: What makes 3DS a compelling investment at this point?
KL: There have been some great news stories out there about the company, and we've certainly been growing and bringing on new people, myself included. I've been absolutely amazed by the depth of talent at 3DS. Yes, it's a relatively small team, but in terms of the scientists and clinical lab technologists, I'm not sure I've ever seen this kind of depth and breadth of experience.
I would also point out that we have so much evidence across different indications that demonstrates the effectiveness of the platform, which is exciting. From a clinical impact standpoint, our ability to affect decisions around people's health is incredibly compelling. This isn't just early stage, or theoretical. There's a wonderful breadth of evidence that already shows how this platform has clinical relevance and I think that makes it very compelling for anyone, whether investor, scientific partner or industry partner.
My undergraduate work was in ecology and evolutionary theory, and my graduate work in genetics and genomics—I was even part of a start-up company during my graduate training, where we were trying to develop tests that could characterize how the genome is organized in cells and use that for biomarkers. I went on to do postdoctoral work in translational neurosciences, and looked at the impact of things like the damage chemotherapy can do to cognition. Starting from that sort of ecology-evolutionary background, my perspective has been shaped by time frames and how networks of things interact. The things that really get me excited about what 3D Signatures can do are from that big picture view. 3DS has a big picture view as to what's going on in terms of biology and genomic instability, and how this platform has the ability to have significant impact in so many areas.
And it's moving fast. The people are driven. 3DS really is a wonderful, exciting place to be, and a wonderful opportunity for the stakeholders and partners who are involved with it.
TLSR: Thank you so much, Kevin.
Dr. Kevin Little is the chief scientific officer of 3D Signatures, overseeing the design, development and implementation of the company's research and clinical programs. Prior to his position at 3DS, Little worked as an independent consultant, offering strategic advisory services to help facilitate new life sciences collaborations for public and private sector clients, including Thomson Reuters, Illumina, Janssen, McGill University and the Global Alliance for Genomics and Health. Little previously led the PERFORM Centre, a $36 million health research and community services complex, as the founding chief administrative officer. Before returning to Canada to lead the start-up of the PERFORM Centre, Little spent several years leading the New Zealand government's economic development efforts to build strategic investment relationships across the biotechnology industry sector. Little holds a Bachelor of Science degree in biology from the University of Victoria, and earned his Ph.D. in experimental medicine from McGill University, specializing in DNA repair and functional human genomics.
Read what other experts are saying about:
3D Signatures Inc.
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Disclosure:
1) Tracy Salcedo conducted this interview for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She owns, or her family owns, shares of the following companies mentioned in this interview: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
2) 3D Signatures Inc. is a sponsor of Streetwise Reports. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclaimers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) 3D Signatures Inc. had final approval of the content and is wholly responsible for the validity of the statements. Opinions expressed are the opinions of Kevin Little and not of Streetwise Reports or its officers.
4) Kevin Little: I was not paid by Streetwise Reports to participate in this interview. I had the opportunity to review the interview for accuracy as of the date of the interview and am responsible for the content of the interview. I or my family own shares of the following companies mentioned in this interview: 3D Signatures Inc.
5) Interviews are edited for clarity. Streetwise Reports does not make editorial comments or change experts' statements without their consent.
6) This interview does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
7) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article, until one week after the publication of the interview or article. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own shares of 3D Signatures Inc., a company mentioned in this article
Pittsburg Post-Gazette Features 3D Signatures May 8th, 2017
http://bit.ly/2pwj8HC
Ok so what's the deal E O on this. I like what I see and can't believe its so low right now. This stock should be trading way higher considering if even half of what they say is true. Any how, thanks in advance and I'll share any thing that I might dig up. I've a small position now here n may expand that sooner than latter.
Thanks.
Tailwinds Research Group LLCTailwinds Research Group
3D Signatures: Disruptive Technology with an Attractive Business Model
By Daniel Carlson - April 21, 2017
At Tailwinds, we are focused on finding future leaders. Companies that fit our model bring new technologies to growing markets. The combination of disruptive technologies with expanding end markets gives our portfolio companies the opportunity to grow at multiples of the overall economy and command premium valuations. 3D Signatures (3DS) is one of those companies.
Genomic Analysis for Personalized Medicine
In 2003, after more than a decade of research, the Human Genome Project was completed by the U.S. Department of Energy and the National Institutes of Health.
The goals of the Human Genome Project were to learn the order of the 3 billion units of DNA that go into making a human genome, as well as to identify all of the genes located in this vast amount of data. By 2003, almost all of the pairs of chemicals that make up the units had been put in the correct sequence—enough for a pronouncement of success.
The information garnered from the genome project has the potential to forever transform healthcare. Many believe that genome-based medicine, frequently called personalized medicine, is the future of healthcare—the next logical step in a world in which more is known about human genetics, disease, and wellness than ever before.
Personalized medicine is a young but rapidly advancing field of healthcare that is informed by each person’s unique clinical, genetic, genomic, and environmental information. Because these factors are different for every person, the nature of diseases—including their onset, their course, and how they might respond to drugs or other interventions—is as individual as the people who have them.
Personalized medicine is about making the treatment as individualized as the disease. It involves identifying genetic, genomic, and clinical information that allows accurate predictions to be made about a person’s susceptibility of developing disease, the course of disease, and its response to treatment.
In order for personalized medicine to be used effectively by healthcare providers and their patients, these findings must be translated into precise diagnostic tests and targeted therapies. This is where 3D Signatures comes into the picture.
With their unique diagnostics centered around Telomeres, a protective structure that safeguards chromosomes and insures genomic stability, 3DS has discovered a platform with the potential to provide advanced diagnostic results for many diseases, allowing personalized therapies to be delivered to the patients.
“Our novel, proprietary technology analyzes a specific part of an individual’s unique DNA (their telomeres) to determine how a disease will progress and if a patient will respond to treatment. This information enables clinicians to measure the appropriateness and effectiveness of different treatments for specific patients.”
This is groundbreaking research with the potential to provide both better patient outcomes and significant savings to the healthcare system. As an example of how this works, examine the results from 3DS’s recent assay validation study related to Hodgkin’s Lymphoma, a disease for which the standard of care is chemotherapy and in which 20% of patients suffer a relapse.
Powered by the Company’s proprietary TeloView™ software platform, the test stratifies HL patients at the point of diagnosis into non-relapsing and relapsing patients. Relapsing patients may then be considered for alternative treatments at the time of diagnosis rather than waiting until they have failed multiple rounds of standard chemotherapy.
Avoiding multiple failed chemo treatments not only is of obvious benefit to the patient, but can result in savings of over $90,000 per treatment that is avoided. At this time, there is currently no biomarker available that can predict patient response to standard chemotherapy in HL patients. 3DS is hoping to change this and will launch their clinical trial soon, in an effort to be first to market with a successful diagnostic.
And, it’s not just Hodgkin’s Lymphoma. TeloView™ is a platform that has potential applications in many diseases. The above chart shows 3DS’s progress in discovering biomarkers in several forms of cancer as well as Alzheimer’s; as you can see, they are already progressing on multiple fronts and this is just a partial list of potential applications. The Company already believes the technology has potential in 12 kinds of cancer, and expects that number to only increase.
Diagnostics With a SaaS Model
To date, 3D Signatures has demonstrated success in many early stage trials. This has enabled them to obtain financing, not only in the public markets, but through significant, non-dilutive, grants as well. It has also sparked the interest of many large pharmaceutical companies, which, according to the Company’s recent press release, might fund them “through non-dilutive or independent financing arrangements, such as a joint venture.”
Joint ventures would make a lot of sense for 3DS as they could partner on many diseases, thereby increasing their pipeline, without diluting investors. However, the broad applicability of their platform would make an acquisition less likely, in my opinion, as their technology could help assay a far broader swath of diseases than any one pharma company would be attacking.
Thus, I fully expect 3DS to be coming to market with their own assays in the future. Which brings up another very positive aspect of their business. Besides being potentially able to assay many different diseases, the model is incredibly high-margin, scaleable, and protected on the IP. This is due to their SaaS model of performing assays.
The assays analyzed by 3D Signatures are all collected elsewhere, at outpatient centers or in the hospital labs. Once prepped, they are shipped to 3DS for analysis. 3DS has a very intense three dimensional imaging program that examines each sample and returns back the data needed to diagnose diseases, their stage, progression, etc., with those results then returned to the patient’s physician.
The important part, from the business model perspective, is that 3DS is simply running a software diagnosis on samples that are collected and prepped elsewhere. It’s kept in house to control the proprietary nature of the program, but the majority of the labor is external. This creates a very high margin and scalable Software-as-a-Service (SaaS) model for 3DS.
This high margin, scalable model is a key differentiator for 3DS. As they grow the number of assays performed, the company’s bottom line will expand rapidly. The SaaS model is one that typically gets rewarded with a much higher multiple by the market, due to the upside potential, as well as the high margins which limits losses should business slow for any reason.
A Disruptive, Scalable Platform
The bottom line here on 3D Signatures is that this company represents everything that we at Tailwinds are looking for in our Select Portfolio companies. They have a highly disruptive business, being able to (hopefully) perform diagnostics on diseases that haven’t been accurately diagnosed, from a personalized medicine perspective, in the past. By doing so, the Company provides a benefit to patients and a much needed cost savings to the whole healthcare system.
Meanwhile, they are doing this with a high margin, scalable software model that will allow them to be highly profitable if and when their business takes off. And, finally, their technology is a platform with broad applications within the medical field; a platform which has yet to fail in a clinical trial. Put together, 3D Signatures represents a compelling investment opportunity.
3D Signatures to relocate to MaRS Discovery District
3D Signatures Inc (C:DXD)
Shares Issued 46,445,199
Last Close 4/17/2017 $0.68
Tuesday April 18 2017 - News Release
Mr. Jason Flowerday reports
3D SIGNATURES ANNOUNCES RELOCATION TO MARS DISCOVERY DISTRICT IN TORONTO
3D Signatures Inc. will relocate its corporate offices to the MaRS Discovery District in Toronto this spring. Following a rigorous screening process, 3D Signatures was selected by MaRS Venture Services to join a growing list of promising Canadian health care companies that are moving to one of the world's largest innovation hubs.
"3D Signatures is thrilled to become a member of the MaRS community, working alongside other like-minded companies in a state-of-the-art complex designed to cultivate innovation and entrepreneurship," commented 3D Signatures' chief executive officer, Jason Flowerday. "This move offers us immediate access to a broad range of corporate and clinical resources, affordable and flexible laboratory space, and a network of potential collaborators and mentors to help us grow our business, all in one of the most desirable locations in Canada."
MaRS supports promising companies tackling key challenges in the health, clean tech, finance and commerce industries, as well as work and learning sectors, as they start, grow and scale.
As part of the MaRS community, 3D Signatures will not only have access to a state-of-the-art facility, co-working and laboratory space, but also key opinion leaders, potential collaborators and financing partners, and a wide range of business and venture services to support the company's growth.
"The move to MaRS offers 3D Signatures a number of benefits that go beyond conventional lab and office space, and we expect this relocation to pay off immediately as we work towards validation and commercialization of our diagnostic pipeline, starting with our Hodgkin's lymphoma and prostate cancer tests," added Mr. Flowerday.
The company is expected to complete the relocation to MaRS by April 30, 2017.
About 3D Signatures Inc.
3D Signatures is a personalized medicine company with a proprietary software platform based on the 3-D of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer's disease. Depending on the desired application, this platform 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 further information, please contact:
Terry Bramhall
Investor Relations
604-428-8842
clearcutcanada@gmail.com
Hugh Rogers
VP Corporate Finance
604-428-8842
investors@3dsignatures.com
OR
Stephen Kilmer
Investor Relations
647-872-4849
stephen.kilmer@3dsignatures.com
Primary Logo
© 2017 Canjex Publishing Ltd.
3D Signatures appoints Chief Scientific Officer
3D Signatures Inc (C:DXD)(OTCQB:TDSGF)
Shares Issued 46,445,199
Last Close 4/10/2017 $0.72
Tuesday April 11 2017 - News Release
Mr. Jason Flowerday reports
3D SIGNATURES ANNOUNCES APPOINTMENT OF DR. KEVIN LITTLE AS CHIEF SCIENTIFIC OFFICER
3D Signatures Inc. has appointed, subject to approval of the TSX Venture Exchange, Dr. Kevin Little, a leading biomedical scientist and corporate executive, as its new chief scientific officer, effective immediately. In this role, Dr. Little will oversee the design, development and implementation of the Company's clinical programs.
Dr. Little is an accomplished industry executive with a strong history of success in leading life sciences ventures through the creation of collaborative business ecosystems. Prior to his position at 3DS, Dr. Little worked as an independent consultant, offering strategic advisory services to help facilitate new life sciences collaborations and research-related ecosystems for public and private sector clients, including Thomson Reuters, Illumina, Janssen, McGill University and the Global Alliance for Genomics and Health. Dr. Little previously led strategic planning for the PERFORM Centre, a $36 Million health research and community services complex, as the Founding Chief Administrative Officer. There, he established and oversaw all operations across nine business units. Before returning to Canada to lead the start-up of the PERFORM Centre, Dr. Little spent several years leading the New Zealand government's economic development efforts to build strategic investment relationships across the biotechnology industry sector.
Dr. Little holds a Bachelor of Science degree in Biology from the University of Victoria, and earned his Ph.D. in Experimental Medicine from McGill University, specializing in DNA repair and functional human genomics. During his Ph.D. studies, he was part of a biotech start-up developing clinical assays to map the functional organization of the human genome. Dr. Little went on to complete a postdoctoral fellowship in translational neuroscience and clinical gene therapy at the University of Auckland in New Zealand, and is a Certified Strategic Alliance Professional.
"With his unique combination of clinical and executive expertise, Kevin is exceptionally well-qualified to lead our clinical development programs as Chief Scientific Officer, and we are thrilled that we attracted a candidate of his caliber to this key position," said Jason Flowerday, CEO of 3D Signatures. "Kevin has an outstanding track record in helping life sciences companies grow, and we look forward to working with him to bring 3DS' transformational technology to market."
"I'm thrilled to join 3DS, an innovative personalized medicine company with a potentially game-changing technology, at such an exciting stage," commented Dr. Little. "3DS' platform is fundamentally different from conventional diagnostic methods, and represents an entirely new diagnostic paradigm. This disruptive technology has the potential to dramatically improve patient outcomes, something I'm very passionate about, while, at the same time, reducing costs and improving resource use across the healthcare system. I look forward to working with everyone at 3DS to maximize the clinical and commercial potential of this exciting new technology."
In connection with Dr. Little's appointment as CSO, and pursuant to 3DS' stock option plan, the Board of Directors of the Company granted Dr. Little 25,000 stock options (the "Options"), exercisable at $0.74, the closing price of the Company's shares on the TSX Venture Exchange on April 7, 2017. The Options will vest in two tranches, 10,000 on April 10, 2018 and 15,000 on April 10, 2019. Once vested, the Options are exercisable for ten years from the date of grant.
3DS also announced that it has granted 23,000 incentive stock options (the "Incentive Options") to recently hired employees of its subsidiary, 3D Signatures Holdings Inc., at an exercise price of $0.74. The Incentive Options are exercisable for a ten-year period from the date of the grant and will vest 50% in April 2018 and 50% in April 2019, respectively.
About 3DS
3DS (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer's disease. Depending on the desired application, this platform 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 new website at http://www.3dsignatures.com.
We seek Safe Harbor.
© 2017 Canjex Publishing Ltd.
3D completes validation of Hodgkin's lymphoma test
3D Signatures Inc (C:DXD) (OTC-TDSGF)
Shares Issued 46,445,199
Last Close 3/28/2017 $0.71
Wednesday March 29 2017 - News Release
Mr. Hugh Rogers reports
3D SIGNATURES COMPLETES ASSAY VALIDATION FOR HODGKIN'S LYMPHOMA TEST
3D Signatures Inc. has successfully completed internal analytical assay validation for its Hodgkin's lymphoma (HL) test (Telo-HL) pursuant to Food and Drug Administration guidelines. Assay validation of Telo-HL included validating the consistency of key reagents and the reproducibility and repeatability of the locked protocol. This process is referred to as stage 2 of the validation program as set out in the company's news release dated Feb. 23, 2017. Assay validation was completed on schedule.
Powered by the company's proprietary TeloView software platform, Telo-HL stratifies HL patients at the point of diagnosis into non-relapsing and relapsing patients. Relapsing patients may then be considered for alternative treatments at the time of diagnosis rather than waiting until they have failed multiple rounds of standard chemotherapy. There is currently no biomarker available that can predict patient response to standard chemotherapy in HL patients.
The company expects Telo-HL to benefit patients seeking personalized treatment while also providing significant cost savings to payors and insurers that are currently burdened with expensive treatments and procedures that may not be necessary if patients could be considered for more targeted and effective therapies at the outset.
"The data collected during this validation stage confirms that the Telo-HL assay is reproducible according to FDA guidelines for clinical quantitative assays," stated Dr. Oumar Samassekou, 3D's vice-president of clinical technology. "We are ready and excited to launch the clinical trial to develop and finalize the scoring model for Telo-HL. This will establish a score to delineate relapsing from non-relapsing patients at the time of diagnosis, before they begin first-line chemotherapy."
The clinical trial will commence in the coming weeks and include the analysis of 250 to 300 retrospective HL patient samples that match the targeted prognostic criteria for the test. A statistical scoring model will also be developed and finalized from the data collected during the clinical trial. The clinical trial is expected to be complete in less than five months.
About 3D Signatures Inc.
3D Signatures is a personalized medicine company with a proprietary software platform based on the 3-D analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer's disease. Depending on the desired application, this platform 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.
Investor Relations
1-604-428-8842
We seek Safe Harbor.
© 2017 Canjex Publishing Ltd.
3D's TeloView can identify Alzheimer's patients
3D Signatures Inc (OTCQB:TDSGF)(C:DXD)
Shares Issued 46,445,199
Last Close 3/20/2017 $0.67
Tuesday March 21 2017 - News Release
Mr. Hugh Rogers reports
3D SIGNATURES' TELOVIEW SOFTWARE IDENTIFIES AND STAGES PATIENTS WITH ALZHEIMER'S DISEASE FROM A CHEEK SWAB
3D Signatures Inc. has provided clinical study results which confirm that based on a swab from the inside of a patient's cheek, its proprietary TeloView software platform has the ability to identify patients with Alzheimer's disease (AD) and, furthermore, distinguish between mild, moderate and severe forms of the disease. The results of this confirmatory study have been accepted for publication in the peer-reviewed Journal of Alzheimer's Disease.
AD is the most common form of dementia affecting approximately five million Americans age 65 and older, as well as an estimated 200,000 Americans under the age of 65 who are afflicted with early-onset AD. AD is clinically defined as a progressive neurodegenerative disorder that involves cognitive impairment, memory loss, visual-spatial retrogression and language impairment. AD is the fifth leading cause of death for people age 65 and older.
"Current diagnostic methods are not highly specific," commented Dr. Sabine Mai, 3DS co-founder and principal inventor. "In addition, AD is only confirmed postmortem pathologically. There is a significant need for an accurate, non-invasive biomarker that can diagnose AD and indicate disease progression, and we believe TeloView{A } has the potential to answer that important call."
In agreement with previous research, the current study demonstrated that TeloView{A } software platform clearly distinguished between AD and non-AD individuals, and between mild, moderate and severe AD, and is, therefore, a promising candidate as a non-invasive AD biomarker and monitoring tool. The current confirmatory study involved a cohort of 44 age- and gender-matched healthy non-caregiver controls and 44 AD study participants. 3D telomeric profiles of buccal cells of AD patients and their non-AD controls were examined with participant information blinded to the analysis.
The Company is currently exploring opportunities to expand the scope of its AD related work with further clinical studies and to fund that work through non-dilutive or independent financing arrangements, such as a joint venture.
About 3DS
3DS (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer's disease. Depending on the desired application, this platform 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 new website at http://www.3dsignatures.com.
We seek Safe Harbor.
© 2017 Canjex Publishing Ltd.
STREETWISE REPORTS covers 3D Signatures Inc.
https://www.streetwisereports.com/pub/na/3d-signatures-disruptive-technology-moving-ahead-for-prostate-cancer-and-hodgkins-lymphoma
http://bit.ly/2m3pyMt
Here is an informative 3D Signatures Inc. video clip
http://bit.ly/2n2VvFQ
http://www.3dsignatures.com/wp-content/uploads/2017/03/3dtt_3ds001_animation_en_1080p_high.webm
3D's TeloView can predict cancer stability, says study
3D Signatures Inc (C:DXD)OTC-TDSGF
Shares Issued 46,445,199
Last Close 2/21/2017 $0.88 CDN $.67 USA
Tuesday February 21 2017 - News Release
Mr. Jason Flowerday reports
3D SIGNATURES TO PRESENT POSITIVE RESULTS FOR PROSTATE CANCER LIQUID BIOPSY
Later today Dr. Sabine Mai, 3D Signatures Inc. co-founder and principal inventor, will present the results of a prospective blood-based prostate cancer pilot study using the company's proprietary TeloView software platform. The results will be presented at the 24th International Molecular Medicine Tri-Conference in San Francisco, CA. Based on blinded blood samples, TeloView correctly predicted the stability and aggressiveness of disease for each of the study's 50 intermediate risk prostate cancer patients.
A prospective prostate cancer patient cohort was assessed to evaluate TeloViewTM's potential to blindly stratify 50 intermediate risk prostate cancer patients (Gleason 7, PSA <20) and monitor their disease progression or stability. Patients were recruited after informed consent, blood was drawn and circulating tumor cells ("CTCs") were isolated prior to radical prostatectomy. CTCs were isolated from blood samples from each of the 50 patients.1 Surgery results correlated with the observed three-dimensional nuclear telomeric profiles from CTCs and indicated that the TeloView platform correctly identified each patient with stable vs. progressive disease (p=0.0175).
"These results are extremely encouraging," stated Jason Flowerday, CEO of 3DS. "We believe that the TeloViewTM software platform is a disruptive technology. It is based on a universal structural biomarker, 3D telomere organization, that has generated impressive results across a number of diseases, with prostate cancer being one of our highest priorities." In previous clinical research, TeloViewTM has also demonstrated the ability to identify and profile multiple CTC clones within a single patient (heterogeneity)1,2 as well as the ability to monitor and quantify changes to 3D telomere profiles as a result of treatment (before and after).3 Based on clinical data produced by Dr. Mai and her colleagues, 3DS believes that TeloViewTM is a promising candidate for development as an accurate, blood-based risk-assessment and monitoring platform for prostate cancer. As announced on October 19, 2016, TeleViewTM will be included in a multicenter Canada-wide prostate cancer clinical trial, known as PRECISE, to identify and monitor prostate cancer patients suitable for active surveillance.
About 3DS
3DS (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer's disease. Depending on the desired application, this platform 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.
1 Adebayo Awe J, Saranchuk J, Drachenberg D, Mai S. Filtration-based enrichment of circulating tumor cells from all prostate cancer risk groups. Urol Oncol. 2017 Feb 12. pii: S1078-1439 (16) 30415.
2 Awe JA, Xu MC, Wechsler J, Benali-Furet N, Cayre YE, Saranchuk J, Drachenberg D, Mai S. 3D telomeric analysis of isolated circulating tumor cells (CTCs) defines CTC subpopulations. Translational Oncology. 2013 2013 Feb; 6(1):51-65.
3 Wark L, Thomas Klonisch T, Quon H, Mai S. Three dimensional telomere signature dynamics in circulating tumor cells of early follow-up high-risk prostate cancer patients undergoing androgen-deprivation and radiation therapy. Urol Oncol. 2016 Dec 9. pii: S1078-1439 (16) 30332-5.
© 2017 Canjex Publishing Ltd.
3D SIGNATURES INC.
ANALYTICS AT THE FOREFRONT OF PERSONALIZED MEDICINE
3D Signatures Inc. is a cutting edge diagnostic company that has developed over 20 years a proprietary software program that:
1. Diagnosis what kind of disease/cancer the patient has.
2. Gives a Prognosis of how stable or aggressive the disease is.
3. Determines how a patient will respond to a specific treatment.
4. Monitors whether the patient is stable during treatment.
5. The precise and predictive nature of 3D Signatures platform will generate huge savings for both the health care providers
as well as the patient all leading to speedier and better patient outcomes.
6. $20 million in successful R&D built into the company thus far.
7. 16 Clinical trials completed on over 1,500 patients.
8. 20 years of research.
9. 13 Cancers and Alzheimer's studied.
10. Several Big Pharma companies are monitoring 3D Signatures Inc
I wondered when other folks would start checking this one out....
3D Signatures A New Class of Biomarkers
http://www.equedia.com/3d-signatures-new-class-of-biomarkers/
3D Signatures: An Entirely New Class of Biomarkers
EQUEDIA NOVEMBER 6, 2016 19.7K 6
I wrote a check for $50,000 into this Company.
That’s because I believe that this $50,000 could soon be worth many times that.
In fact, in just a bit, I’ll show you why a 15,700% potential return is possible from here.
And it all starts with a very special situation that could soon propel the shares of this Company.
It’s one that involves one of the smartest scientists in North America and her breakthrough in a multi-billion dollar, life-changing industry.
It’s why she was named one of the most powerful women last year.
Yet, very few investors know about this Company – but I believe very strongly that many soon will.
This isn’t just a random breakthrough.
This Company has over 20 years of research, more than $25 million spent on R&D, and patents in both N. America and Europe for its breakthrough discovery.
This technology is a first-of-its-kind and has the potential to change an industry worth billions upon billions of dollars.
And it’s about to transition from the lab to the real world.
That could mean serious profits for a company with a market cap of barely over CDN$30 million – incredible considering the amount of research and money already poured into this technology.
It also means shareholders could soon be rewarded as well.
It’s no wonder why big names are already jumping at the chance to get involved.
In fact, one big pharmaceutical company just invested $1 million into this tiny junior and has already signed an exclusive license and distribution agreement to lock down this tech in certain parts of the world.
But big profits are just a small benefit to what this Company could soon achieve.
This Company has the potential to change lives.
Serious as Cancer
Chances are you or someone you know is going to get cancer.
I don’t mean to sound harsh, but 40% of us will be diagnosed with cancer at some point during our life.
In the U.S. alone, The National Cancer Institute estimates that about 595,690 Americans will die of cancer this year. That’s more than one every minute.
But this should come as no surprise.
I am sure many of you have already gone through a very difficult time in dealing with cancer – whether it was your own or someone you love.
I know I did.
A Most Difficult Decision
That brings me to a very difficult subject.
Anyone who has had to deal with cancer knows that one of the most difficult decisions we can make is how we deal with it.
That’s because after a cancer diagnosis, patients and their families have to make a number of decisions about treatment.
How do we know what treatment is right?
Do we need radiation?
Do we need surgery?
Do we need chemotherapy?
How do we know if one treatment is better than another?
How do we know if a treatment is actually working?
There isn’t a simple answer for any of these questions because there is no “one size fits all” treatment for any cancer.
Unfortunately, that means many diagnosed with cancer are often mistreated, or worse, over-treated.
According to the Prostate Cancer Foundation:
“…current estimates indicate that 30% more men are aggressively treated for prostate cancer than is necessary to save a life from the disease.”
This not only costs healthcare payers billions of dollars every year, but it often inflicts unnecessary treatment and complications on patients.
For example, chemotherapy and radiation are often used to fight cancer – both of which can take a serious toll on a patient.
Here is just one story of a women named Hazel…
Via Cancer Tutor:
“Two years ago, Hazel was diagnosed with breast cancer. She described her chemotherapy as the worst experience of her life.
“This highly toxic fluid was being injected into my veins. The nurse administering it was wearing protective gloves because it would burn her skin if just a tiny drip came into contact with it. I couldn’t help asking myself, ‘If such precautions are needed to be taken on the outside, what is it doing to me on the inside?’
“From 7 p.m. that evening, I vomited solidly for two and a half days. During my treatment, I lost my hair by the handful, I lost my appetite, my skin color, my zest for life. I was death on legs.”
She is not alone in her experience. Nearly everyone who undergoes such harsh treatments has similar stories.
Now imagine if it turned out that after the chemotherapy, her cancer didn’t die.
Imagine if we later found out that another treatment would have been the better option?
That’s just the tip of the iceberg:
“…Some 67 percent of people who die during cancer treatment do so through opportunistic infections arising as a direct result of the immune system failing because of the aggressive and toxic nature of the drugs.”
In other words, some cancer treatments can even lead to death.
Yet, despite all of this, there hasn’t been an accurate way to tell what treatment is best for those diagnosed with cancer. Nor have there been ways to determine how a patient is reacting to treatment in real time.
That’s why one of the biggest challenges for cancer physicians is recommending the right treatment.
No physician wants to be responsible for mistreating a patient.
But what if it didn’t have to be this way?
What if there was a technology that could more accurately inform you about treatment?
What if there was a technology that could not only determine how your disease is progressing, but also how you’re responding to treatment in real time?
Why go through the perils of radiation, chemotherapy, or surgery if it might not work?
Anyone who has ever had to deal with cancer knows just how significant this could be.
After 20 plus years of research, more than $20 million in R&D, more than 100 peer-reviewed papers, and 16 clinical studies, one of 2015’s most powerful Canadian woman is about to bring such a technology to the world.
Her name is Dr. Sabine Mai and her breakthrough research is finally moving from the bench to the bedside to enable better treatment and monitoring options for patients.
That’s why she co-founded the company I am about to introduce.
And that’s why the value of this Company could soon soar.
3D Signatures Inc.
Canadian Trading Symbol: TSX-V: DXD
US Trading Symbol: OTCQB: TDSGF
German Trading Symbol: FSE: 3D0
An Entirely New Class of Biomarkers
3D Signatures Inc. (3DS) has discovered an entirely new class of biomarkers for diagnosis, assessment, and monitoring of major diseases, with a current focus on Cancer and Alzheimer’s Disease.
The discovery of a new biomarker alone represents a major breakthrough.
A biomarker is “a measurable substance in an organism whose presence is indicative of some phenomenon such as disease, infection, or environmental exposure.”
According to a new report by Grand View Research Inc., the global biomarkers market is expected to reach over US$78.2 billion by 2024.
And according to market research firm Kalorama, the cancer biomarker is expected to reach over US$7.4 billion by 2020.
But 3DS has gone far beyond just identifying a new biomarker.
Using this new biomarker, 3DS has developed precision clinical tests that are powered by a proprietary software platform that can measure:
the stage of disease
the rate of progression of a disease
drug efficacy
and drug toxicity
That means instead of “guessing” what treatment to use based on “guessing” the stage of disease and “guessing” how it’s progressing, we no longer have to “guess.”
It potentially means once we select a treatment, we can know right away if it’s working, see if there are any adverse side effects, and know if the treatment is doing more harm than good – all in near real-time.
In fact, the technology is designed to predict the course of a disease and customize treatment for each individual patient.
This has never been done before.
All of this is backed by more than 20 years of research and has already been validated in numerous papers, supported by 16 successful clinical studies on over 1,500 patients on 13 different cancers (including prostate, breast, lung and multiple myeloma), and Alzheimer’s disease.
This type of personalized treatment is truly groundbreaking and could soon be adopted by clinics everywhere.
For a company worth just over CDN$30 million, the upside could be tremendous.
I’ll get back to this in a bit.
But before I do, it’s important to understand how it works.
How 3DS Technology Works
Every human has DNA that is packaged into chromosomes.
At the tip of each chromosome are protective regions of DNA called telomeres.
3d-telomeresBy using fluorescent markers and high-resolution microscopes, we can see the location of each telomere within a cell nucleus and digitally analyze it.
3DS patented software platform then analyzes an individual’s three-dimensional chromosomal structure or “Signature” and specifically analyzes the patient’s telomeres in a three-dimensional manner.
This three-dimensional organization of telomeres within a cell nucleus is highly predictive with respect to the health of that individual cell.
In other words, we can tell a lot just by looking at the health and shape of these telomeres.
So how does that help us?
Screening – Who has a particular disease?
Diagnosis – What kind of disease/cancer?
Prognosis – How stable or aggressive is the disease/cancer?
Predicting – How will the patient respond to a particular treatment?
Monitoring – Stability/progress of patient over course of treatment
Drug Development – Identification/development of better drugs
Real-Life Scenario
Depending on the disease, a clinic takes a tissue, blood, or a cheek swab sample.
This sample is then preserved and labeled.
Pictures of these samples are then taken from multiple 3D perspectives, which are then exported to a centralized 3D Signatures analytics centre.
Once at the centre, the images are analyzed and then given a scoring model based on the parameters generated by 3DS technology.
A personalized report is finally generated and sent back to the clinic with clear information for the patient.
It’s a super simple, non-invasive process.
With 3DS, we can now accurately provide a host of predictive medical information in real-time, using nothing more than blood, cheek swab or tissue samples.
The impact and benefits of this technology are truly significant.
Helping medical professionals deliver the best care protocols for each patient will not only benefit patients immensely, but it could save health care providers billions of dollars by reducing ineffective, improper, and unnecessary treatments.
Imagine what it could save for insurance companies.
The potential market for this alone is staggering.
But just how big is the market?
Creating Beachhead
As of right now, 3DS trials include 14 diseases and 16 clinical trials on over 1500 patients.
3ds-current-market-studies
Here is the pipeline and stage of each niche for 3DS technology:
3ds-current-progress
As you can see, 3DS works on a wide spectrum of diseases, with many of them already moving into the development and validation stage. In fact, there is potential to work on even more diseases and cancers.
But for now, let’s focus on the two that are closest to market.
3ds-hodgkins
Hodgkin’s Lymphoma
For almost all patients with Hodgkin disease, cure is the main goal.
The 2 main ways of treating Hodgkin disease are chemotherapy and radiation therapy. Depending on the situation, one or both of these treatments might be used.
However, these treatments can have side effects that often don’t show up for many years. Because of this, doctors try to choose a treatment plan with the lowest risk of possible side effects.
But since physicians can’t predict whether a patient will respond to standard chemotherapy and enter long-term remission or not respond and relapse, treatment choices become even more difficult to make.
It also means that patients have no way of knowing if the treatments are working until long after it’s over.
By that time, the treatments could have done more harm than good.
There simply is no test capable of providing clinicians with the type of information for proper treatment in real-time.
Except for 3D Signature’s platform.
3DS is designed to determine whether an individual will respond to standard chemotherapy almost immediately.
Once a treatment is selected, it can also determine if the treatment is working in real time.
Those who are shown to not respond to chemotherapy can then receive optimized alternative treatments resulting in:
New treatment options
Reduced secondary complications
Significant cost savings
This is truly groundbreaking when it comes to treating those diagnosed with Hodgkin’s Lymphoma.
But as significant as this is, Hodgkin’s Lymphoma is a small market when compared to other cancers.
Such as prostate cancer…
3ds-prostateProstate Cancer
One in seven men will be diagnosed with prostate cancer during his lifetime.
And one in 39 men will die from it.
In fact, there are over three million existing and new cases of prostate cancer in the United States and Canada alone.
As I mentioned earlier, many diagnosed with prostate cancer are often mistreated because of the dangers that might arise if left untreated.
If we could avoid over-treating the 80% of men with low-grade disease who will never die of prostate cancer, we would save billions of dollars every year.
More importantly, thousands of men may not have to suffer some of the dangerous treatments involved in treating prostate cancer.
Right now, there is no test to accurately determine which intermediate-risk patients will progress to an advanced cancer and require immediate aggressive treatment.
But 3DS technology is designed to stratify patients into several risk categories and predict the most effective treatment plan.
And best of all, the test is a non-invasive risk assessment and monitoring platform based on a blood sample, and not a prostate biopsy.
US$9 Billion-Dollar Prostate Cancer Market
Based on an estimated retail price of US$3,000 per 3DS Telo-PC test, the total market revenue could be over US$9 billion per year!
Let’s put that into perspective.
If 3DS captures just 10% of the prostate test market, that’s nearly US$1 billion in revenue.
3DS is worth barely over CDN$30 million as I write this.
The average price to sales ratio of those in the healthcare information and technology space is 3.54.
Using back-of-the-napkin math, based on the 3.54 ratio, the current US-CDN exchange rate of 1.34, current 3DS share structure, and assuming 3DS captures 10% of the prostate test market, it means 3DS could be worth over CDN$96 per share!
That’s a potential return of more than 15,700%!
3ds-prostate-test-market-sizeOf course, take the back-of-the-napkin calculation with a grain of salt.
It will take time for 3DS Telo-PC to fully come to market and there are other risks along the way. The Company will likely dilute further as they raise more money to progress, and going to market involves time and risks.
I am also not saying that once 3DS technology comes to market in full for prostate cancer that everyone will take the test, nor will it be fully adopted by every clinic – that would be very optimistic thinking.
prostate-biopsyBut if you’re a man reading this, would you rather take a non-invasion blood sample or a very invasive prostate biopsy?
I wouldn’t think twice about which one I prefer.
And while there are other tests one can do for prostate cancer, 3DS is a dynamic biomarker that can be used throughout the course of the disease and treatment(s).
All of the other tests are static, meaning each test is only relevant for a particular piece of information/stage.
But that’s not all.
3ds-prostate-competitorsAll of the other tests are statistically based, meaning they will provide a probability of progressing within a period of time.
In other words, the other tests are practically a guessing game.
3DS, on the other hand, is a real-time assessment of what stage you’re at and what treatment you need the day you take the test.
It’s a one test fits all.
Lastly, all of the other tests are focused on “the cancer” versus the capacity of dealing with tumour heterogeneity.
Essentially, if you have prostate cancer, you have more than one type of cancer within that tumour.
3DS looks at many circulating tumour cells and can identify and assess multiple tumour subpopulations with the same test.
The implications are significant with respect to understanding the disease and appropriate treatment.
In short, there simply is nothing like 3DS.
That’s precisely why just last week, 3D Signatures Inc. announced that it was one of the few invited to participate in the first randomized, multicenter study focused on biopsy naive patients with clinical suspicion of prostate cancer, known as PRECISE.
3DS Included in One of the Most Significant Clinical Studies in North America for Prostate Cancer
Even more important is what Principal Investigator, Dr. Laurence Klotz, the Chairman of the Canadian Urology Research Consortium and a renowned uro-oncologist and prostate cancer thought leader had to say about 3DS:
“We have an opportunity to test a new blood-based biomarker to accurately stratify patients into risk groups. If successful, this could represent a first-in-class blood test, which would specifically identify clinically significant prostate cancer. Such a tool does not currently exist for prostate cancer patients.”
SUCH A TOOL DOES NOT CURRENTLY EXIST FOR PROSTATE CANCER PATIENTS.
It’s no wonder why 3DS involvement in this study is being funded by the Ontario Institute for Cancer Research and the Movember Foundation Canada:
“Awarded by way of a rigorous peer review process run by Prostate Cancer Canada, this multimillion dollar project is funded by the Ontario Institute for Cancer Research (OICR) and the Movember Foundation Canada. To support its participation in PRECISE and the development of related clinical tests, 3DS’ projected budget is approximately $2.4M over a two-year period which represents at least 50% savings over an independently run study.”
First to Dollar, Then to Regulator
Now here’s the kicker: unlike a drug treatment, 3DS doesn’t have to go through all of the hurdles before it can make money.
It can begin to have clinics using the technology long before full validation of each individual disease – and that means it can begin making money almost immediately.
The best part is that 3DS is just at the beginning stages of roll out to the medical community, which means this is ground-floor investing for a platform that could completely change the way diseases are diagnosed and treated.
But that’s just the tip of the iceberg.
Aside from just clinical tests for patients, which could lead to saving billions of dollars and thousands of lives, there could be something even bigger.
And I am not talking about the billions of dollars in potential revenue for the tests.
In fact, it’s so big and unique that I am not sure how to value it just yet. But I am betting Big Pharma might have an idea.
Let me explain.
Drug Development
Drug development is one of the most costly, time-consuming, and riskiest businesses in the world.
According to a report published by the Tufts Center for the Study of Drug Development (CSDD) back in 2014, the cost of developing a prescription drug that gains market approval is a whopping US$2.6 billion.
Source: Tufts Center for the Study of Drug Development via Scientific American
Source: Tufts Center for the Study of Drug Development via Scientific American
Add in post-approval development – studies to test new indications, formulations, and dosage strengths – and costs spike up to nearly US$3 billion.
And, as you can see, the costs have been exponentially rising, year after year.
More importantly, the costs of clinical trials have not only surpassed the costs of preclinical trials but is becoming increasingly more expensive.
That’s because, on average, it takes over a decade to bring a new drug to market.
According to Medicine Net:
“In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet. That is if it makes it.
Only 5 in 5,000 drugs that enter preclinical testing progress to human testing.
One of these 5 drugs that are tested in people is approved.
The chance for a new drug to actually make it to market is thus only 1 in 5,000.”
So not only is it expensive, it’s extremely time-consuming and extremely risky.
But what if we could shorten this time during the most expensive part of the drug approval, the clinical trial?
You see, a lot of the time spent on the drug approval process is during clinical trials – which is one of the reasons it costs a lot of money.
Clinical trials have many phases, starting with a small group of patients and then more and more as we move through the phases.
During each phase, volunteer patients are monitored to see how they react to the drug.
In other words, wait and see.
But what if drug companies didn’t have to wait and see?
What if they could know in real-time if the drug was working?
What if they could know in real-time if the drug was toxic?
What if they could know in real-time how certain drugs reacted with different individuals?
That’s precisely what 3DS could soon do for Big Pharma.
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, 3D Signatures is already in discussions around partnership opportunities with some very big names.
That’s because 3DS 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.
Which is precisely why 3DS is focusing on already approved products and late-stage drug trials to commercialize companion diagnostics.
In fact, as I just mentioned, discussions are already underway with several major pharmaceutical companies.
Don’t be surprised to see 3DS announce a major partnership with a big-name pharma company in the near future.
The potential for what 3DS real-time ex-vivo feedback can do for both patients and Big Pharma is massive.
It’s precisely why the Company has attracted some of the top minds in the industry.
I could write a full report on the list of who’s who involved in 3DS, but here’s a brief example of the credentials from the management, board, and advisors – together, they combine decades of experience in diagnostics, healthcare, pharmaceutical and business.
Business development and marketing work at some of the world’s largest pharmaceutical companies, including Germany’s Bayer AG and US-based Johnson and Johnson.
Professor of Physiology and Pathophysiology, Biochemistry and Medical Genetics, Human Anatomy and Cell Science, University of Manitoba. Director of The Genomic Centre for Cancer Research and Diagnosis (GCCRD) at University of Manitoba. Internationally known researcher with more than one hundred publications related to research on Genomics and Genomic Instability. Recipient of several academic awards including the Braidwood Jackson Memorial Award; the Dr. Saul Highman Memorial Award; the Rh Award (Basic Science); the J&J Cognition Challenge (2013).
Chairman of the Centre for Imaging Technology Commercialization. Former Director General of the NRC Institute for Biological Sciences, Ottawa, ON, and founder and Director General of the Institute for Biodiagnostics, Winnipeg, MB. 2008 Outstanding Achievement Award of the Public Service of Canada. Awarded the Queen’s Gold (2002) and Diamond (2012) Jubilee Medals for contributions.
Internationally recognized for contributions to the treatment of prostate cancer, notably for pioneering the adoption of Active Surveillance as a standard aspect of patient care. Widely published uro-oncologist and a Professor, Department of Surgery, University of Toronto, past Chief of Urology, Sunnybrook Health Sciences Centre, Toronto, and Chairman, World Uro-Oncology Federation. Awarded the Order of Canada in 2016 for his contribution to prostate cancer treatment.
How about business advisor Jonathan Goodman, Director & CEO of Knight Therapeutics Inc., who just put CDN$1 million into 3DS?
Then there’s advisor Dr. Heiner Dreismann who is Past President and CEO of Roche Molecular Diagnostics.
I could go on but you get the point. If you want to learn more about the 3DS team, I’ve included it at the bottom of this Letter.
The people backing 3DS is why I believe in this Company, its platform, the science behind it, and the upside it could provide for early shareholders.
Near-Term Catalysts
As you can imagine, such a profound new technology and research has not gone unnoticed by industry experts – even if its under the radar of financial institutions.
As hinted by 3DS, a steady stream of positive news flow is expected including talent acquisition, clinical trial progress, and new business developments.
All of this means that we could witness some big announcements as early as next year that could significantly propel the Company to new heights.
I confidently believe that once the 3DS business strategy rolls out, institutions will want a piece of the pie.
Conclusion
Based on Dr. Sabine Mai’s groundbreaking research, 3D Signatures is the first and only company to understand and quantify normal versus disease state telomere arrangement, turning this into usable, predictable, reliable, and highly valuable information that can improve patient outcomes.
Highly promising and unconventional software platform is already attracting attention from multinational healthcare companies relatively early in the product development process.
What 3DS is doing is truly remarkable.
We rarely see this type of talent, bandwidth, and opportunity in a junior with such a small market cap.
That’s because few people really know about 3DS. The management team aren’t promoters – they’re business operators and science professionals with incredibly deep backgrounds and a track record of success.
They’re doctors who other doctors ask for advice.
This may be a small company now with a small retail investment market, but I don’t expect it to be for long.
Which means the window of opportunity is closing for early investors.
3DS is right on the brink of not only numerous milestones, but it could also soon begin to generate revenue.
It’s why I invested in this Company and why I think many smart people will too.
3D Signatures Inc.
Canadian Trading Symbol: TSX-V: DXD
US Trading Symbol: OTCQB: TDSGF
German Trading Symbol: FSE: 3D0
Seek the truth,
Ivan Lo
The Equedia Letter
www.equedia.com
Disclosure: We’re biased towards 3D Signatures Inc. because the Company is an advertiser. We currently own shares purchased in a private placement. You can do the math. Our reputation is built upon the companies we feature. That is why we invest in every company we feature in our Equedia Special Report Editions, including 3D Signatures Inc. It’s your money to invest and we don’t share in your profits or your losses, so please take responsibility for doing your own due diligence. Remember, past performance is not indicative of future performance. Just because many of the companies in our previous Equedia Reports have done well, doesn’t mean they all will. Furthermore, 3D Signatures Inc. and its management have no control over our editorial content and any opinions expressed are those of our own. We’re not obligated to write a report on any of our advertisers and we’re not obligated to talk about them just because they advertise with us.
3ds-captial-structure
3DS Board, Management, and Advisors
JOHN SWIFT, LLB, CHAIR, BOARD OF DIRECTORS
Past Principal Secretary in the Prime Minister’s Office and Chief of Staff, Office of the Leader of the Opposition, Government of Canada. Past board member of GenXys Health Care Systems, Inex Pharma, Ultrasonix Medical Corp. and Neuromed Technologies Inc. Past Chairman of Central City Foundation.
JASON FLOWERDAY, CEO & DIRECTOR
Mr. Flowerday has extensive life sciences leadership experience including over a decade of business development and marketing work for two of the world’s largest pharmaceutical companies, Germany’s Bayer AG and US-based Johnson and Johnson. Other notable positions include executive leadership and entrepreneurial roles with Knight Therapeutics and Pro Bono Bio Inc. Mr. Flowerday was also co-founder and co-owner of both Orphan Canada and RxMedia Healthcare Communications. He is an independent Director of Aequus Pharmaceutical
SABINE MAI, PHD, DIRECTOR AND CHAIR, CLINICAL AND SCIENTIFIC ADVISORY BOARD
Dr. Sabine Mai is currently Professor of Physiology and Pathophysiology, Biochemistry and Medical Genetics, Human Anatomy and Cell Science, University of Manitoba. She is also Director of The Genomic Centre for Cancer Research and Diagnosis (GCCRD) at University of Manitoba. She is an internationally known researcher who has more than one hundred publications related to research on Genomics and Genomic Instability. Most recently she has contributed to a library of patents related to her work on 3D Genomic Analysis. She is the recipient of several academic awards including the Braidwood Jackson Memorial Award; the Dr. Saul Highman Memorial Award; the Rh Award (Basic Science); the J&J Cognition Challenge (2013). She was recognized in 2015 as one of the Top 100: Canada’s Most Powerful Women.
FERENC SOMOGYVARI, DIRECTOR
Co-founder and former GM of Carl Zeiss Microscopy with more than 38 years in the optical medical and biology industries. Former CEO of 3D Signatures.
IAN SMITH, PHD, DIRECTOR
Dr. Smith, OC, PhD, DSc, FRSC, is currently the Chairman of the Centre for Imaging Technology Commercialization. His past research and commercialization achievements include significant success in the field of magnetic resonance imaging. Dr. Smith is a former Director General of the NRC Institute for Biological Sciences, Ottawa, ON, and founder and Director General of the Institute for Biodiagnostics, Winnipeg, MB. He is a passionate advocate for the advancement of diagnostics for the early detection and treatment of disease.
He was appointed Officer of the Order of Canada in 2008 for his leadership in the advancement, development and commercialization of Canada’s diagnostic technologies, notably magnetic resonance imaging, in the field of health care. In addition, Dr. Smith received the 2008 Outstanding Achievement Award of the Public Service of Canada, presented to individuals who have displayed long-term excellence throughout their careers in Canada’s public service. He was awarded the Queen’s Gold (2002) and Diamond (2012) Jubilee Medals for his contributions.
BRUCE COLWILL, DIRECTOR
Bruce Colwill is a strategic finance professional with over 25 years of experience in start-up and entrepreneurial companies. As the CFO of multiple public and private companies, Bruce has been responsible for fundraising in excess of US$400 million including private and public financing, debt and other structured financings.
GORDON MCCAULEY, DIRECTOR
President and CEO of Viable Healthworks Corp. and Chairman of Life Sciences BC. Co-founder and former President and COO of Neuro Discovery Inc. (NDI Capital). Past President and CEO of Allon Therapeutics.
KEITH B. CASSIDY, CFO
Keith Cassidy is an accountant with significant experience in professional services management (legal), as well as health care and education, at strategic and leadership levels. Keith Cassidy has served as VP Finance and CFO for the Royal Victoria Hospital.
He has held Executive Director positions with several major law firms including Davies Ward Phillips & Vineberg LLP; McMillan LLP; and Bennett Jones LLP. He has also lectured in Business Administration at John Abbott College in Montreal.
OMAR SAMASSEKOU, MD, PHD, VP, CLINICAL PROGRAMS
Oumar Samassekou, PhD, is trained in medical genetics, cytogenetics and other molecular genetics. During his Ph.D. and post-doctoral trainings, Dr. Samassekou developed expertise on prenatal diagnosis and cancer genomics. He has worked on the development of a non-invasive diagnostic procedure to detect fetal chromosomal abnormalities from maternal peripheral blood.
In regards to his background in cancer genomics research, Dr. Samassekou has studied the length of individual telomeres, telemetric nuclear architecture, and genomic instability in leukemia and breast cancer. In addition to his competencies in research, he has been trained in a clinical laboratory examining both molecular genetics and cytogenetics. Dr. Samassekou was the supervisor of a molecular pathology unit in one of the largest laboratories specializing in clinical pathology of breast cancer in Canada. Dr. Samassekou has also developed competency to supervise analytical and clinical validation of different clinical diagnostic, prognostic and predictive tests.
HUGH ROGERS, LLB, VP FINANCE
Mr. Rogers is an entrepreneur and lawyer with broad private and public company experience in business management, regulatory compliance, finance and investor relations. Recent work includes corporate finance advisory positions in a range of industries from health sciences and agribusiness to mining and oil and gas. Recent experience also includes corporate restructuring under the Companies’ Creditors Arrangement Act and disposition of distressed assets. Mr. Rogers holds a B.Sc. and LLB. He is a member in good standing of the Law Society of British Columbia.
CLINICAL AND SCIENTIFIC ADVISORY BOARD
Laurence Klotz – MD, FRCS(C)
Dr. Klotz is internationally recognized for his contributions to the treatment of prostate cancer, notably for pioneering the adoption of Active Surveillance (or “Watchful Waiting”) as a standard aspect of patient care. Dr. Klotz obtained his medical degree and residency training from the University of Toronto with a special fellowship in uro-oncology and tumour biology at Memorial Sloan Kettering Cancer Centre, New York. He is a widely published uro-oncologist who serves on the board or heads many medical/scientific organizations. He is a Professor, Department of Surgery, University of Toronto, past Chief of Urology, Sunnybrook Health Sciences Centre, Toronto, and Chairman, World Uro-Oncology Federation. Dr. Klotz was awarded the Order of Canada in 2016 for his contribution to prostate cancer treatment.
Hans Knecht – MD, FRCPC, FMH, FAMH
Dr. Knecht established himself as a prominent haematologist through his ground-breaking translational research on lymphoma biology. His current focus is on the molecular events leading to the transition from the mononuclear Hodgkin to the multinuclear Reed-Sternberg cell and the impact of 3D nuclear telomere organization on this transformation. Dr. Knecht received his medical degree from the University of Zurich, Switzerland with post-graduate work under both Maxime Seligmann (Haematology) and Karl Lennert (Haematopathology) in Paris and Lausanne, respectively. Dr. Knecht is currently a Professor of Medicine and Chief, Division of Haematology at McGill University and Jewish General Hospital, Montreal.
Darrel Drachenberg – BSc, MD, FRCS(C)
Dr. Drachenberg is a urologic oncologist and researcher and strong proponent of Active Surveillance for prostate cancer patients. Dr. Drachenberg attended medical school at the University of British Columbia and urology residency at Dalhousie University. He is an American Foundation of Urology Scholar with fellowship training in urologic oncology at the National Cancer Institute in Bethesda, Maryland. He founded the laparoscopic urology program and prostate brachytherapy, cryotherapy, and HIFU programs at the University of Manitoba where he works as assistant professor of surgery and director of research for the Manitoba Prostate Center and Section of Urology and Chair of the Genito-Urinary disease site group, CancerCare Manitoba.
Dr. Thomas Cremer – Professor emeritus of Anthropology and Human Genetics, Ludwig Maximilians University, Munich, Germany, Independent Expert
Dr. Cremer is an internationally-recognized scientist specializing in the studies of nuclear architecture. He is one of the pioneers of interphase cytogenetics and comparative genomic hybridization (CGH). These methods have become widely used tools for cytogenetic analyses of chromosomal imbalances.
He is a corresponding member of the Heidelberg Academy for Sciences and Humanities since 2000, a member of the Leopoldina since 2006, a honorary member of both the European Cytogenetics Association (ECA) and the German Society of Human Genetics since 2011, as well as the recipient of the medal of Honor of this Society.
Kenneth C. Anderson, MD
Program Director, Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics Institute Physician, Kraft Family Professor of Medicine, Harvard Medical School
Dr. Anderson graduated from Johns Hopkins Medical School, trained in internal medicine at Johns Hopkins Hospital, and completed hematology, medical oncology, and tumor immunology training at Dana-Farber Cancer Institute.
He serves as chief of the Division of Hematologic Neoplasia, director of the Jerome Lipper Multiple Myeloma Center, and vice chair of the Joint Program in Transfusion Medicine at Dana-Farber.
BUSINESS ADVISORS
Jonathan Goodman, Director & CEO, Knight Therapeutics Inc.
Prior to Knight, Mr. Goodman was the co-founder, President and CEO of Paladin Labs Inc. which was acquired by Endo for $3.2 billion. Under his leadership, $1.50 invested in Paladin at its founding was worth $142 nineteen years later. Prior to co-founding Paladin in 1995, Mr. Goodman was a consultant with Bain & Company and also worked in brand management for Procter & Gamble. Mr. Goodman holds a B.A. with Great Distinction from McGill University and the London School of Economics with 1st Class Honours. Additionally, Mr. Goodman holds an LL.B. and an M.B.A. from McGill University.
Dr. Heiner Dreismann, Past President and CEO, Roche Molecular Diagnostics
Dr. Dreismann is a seasoned executive with more than 24 years experience in the healthcare industry, and is regarded as a pioneer in the early adoption of the polymerase chain reaction (PCR) technique, one of the most ubiquitous technologies in molecular biology and genetics research today. He had a successful career at the Roche Group from 1985 to 2006 where he held several senior positions, including President and CEO, Roche Molecular Systems, Head of Global Business Development, Roche Diagnostics and Member of Roche’s Global Diagnostic Executive Committee. Dr. Dreismann currently serves on the boards of several public and private health care companies. He earned a master of science degree in biology and his doctor of philosophy degree in microbiology/molecular biology (summa cum laude) from Westfaelische Wilhelms University (The University of Munster) in Germany.
John Lindsay, Founder, SciPartners
Mr. Lindsay began his career at Millipore Corporation, Merck KGaA, and quickly advanced to become the youngest Vice President in the history of the company. He was promoted to Executive Vice President of several divisions, including the Analytical Group and Milligen Biosearch Divisions. In 2000, he founded SciPartners, with the objective of building a platform for development of early stage European and North American firms. His focus is the Life Science market, and over the past 14 years he has successfully built up sales and marketing that led to rapid growth and increased revenues for many companies, and the acquisition of ProXeon by ThermoFisher and the acquisition of Halo Genomics by Agilent.
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