Todos Medical CEO Presented Corporate Update And Roadmap at The LD Micro Conference
June 17, 2019 08:30 ET | Source: Todos Medical Ltd.
REHOVOT, Israel, June 17, 2019 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro-diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, today announced that CEO Herman Weiss, MD, MBA, FACOG, provided a corporate update and roadmap at LD Micro International Annual Invitational in Los Angelos, California.
Link to webcast with Dr. Herman Weiss, CEO at the 9th annual LD Micro Invitational
Following is a synopsis of the presentation:
Todos Medical CEO Presents Corporate Update
I would like to personally welcome all those who have been following Todos Medical and supporting us through our mission to bring important innovation to patients worldwide. Our vision at Todos is simple; to provide physicians and their patients the earliest and most accurate screening and diagnostic information to help treat disease when it is in its earliest and most treatable stages. From our flagship TBIA platform, our TM-B2 test is a blood test for breast cancer initially focused on replacing the current battery of tests performed on patients with dense breasts who have inconclusive mammogram results, a significant unmet medical need.
Our TM-B2 test is a simple blood test for breast cancer diagnosis targeting women 25 years and older. TM-B2 can be a valuable lifesaving test for women under 40 years old where mammography is not efficient as a screening tool. We are also developing additional blood tests for other aspects of breast cancer, as well as colon cancer and other cancers.
This update, the first one under my watch as CEO, outlines the tremendous progress we have made in the last year, and provides the roadmap for upcoming milestones to track our progress against the big plans we have for the year ahead.
Here are notable highlights from the last 12 months:
Completed internal restructuring where I stepped in as CEO in August of 2018, and our immediate past CEO, Rami Zigdon, MBA, moved to the role of Chief Business Officer to focus on international partnerships for the cancer platform. This transition was made to prepare for the commercial launch of our TM-B2 breast cancer blood test due to my experience in bringing new products to market when I served as Global Head of Women’s Health while at Teva Pharmaceuticals from 2012 to 2017. I want to thank Rami for leading the company to where it was when I took over, affording me the opportunity to step in and take the Company forward towards growth.
Presented results from clinical studies at major meetings:
TM-B2 San Antonio Breast Cancer Conference (SABCS)
ASCO
Received several patent issuances from international patent offices, significantly strengthening our cancer intellectual property position
Israel
United States TM-B2
Received regulatory approval to market our tests in Europe and Israel
Commercial distribution agreements for our TM-B2 test in Austria, Romania and Israel
Entered into a fundraising agreement with an experienced New York-based investment banking firm to underwrite the listing of the Company’s common shares onto the Nasdaq Capital Markets
Raised more than 1.5 million USD in financing from existing and new investors who are buying into our vision and plan of action for the Company
Entered into a Joint Venture with Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS) to fund clinical studies of their neuro-diagnostics subsidiary Breakthrough Diagnostics, Inc. that is developing the Alzheimer’s blood diagnostic LymPro Test.
LymPro was originally developed by Prof. Thomas Arendt a world leader in Neurodegenerative diseases at Leipzig University who believes that Alzheimer’s and cancer share certain critical biological mechanisms. The scientific synergy between our existing platform and the Breakthrough platform is significant as we are focused on the immune’s system role in disease, whether it be cancer or Alzheimer’s;
The funding we provided allowed for the completion of a 20-patient clinical trial at Leipzig University under Dr. Arendt’s supervision, which was a follow-up study to a 140 subject study conducted by Amarantus and presented at Alzheimer’s Association International Conference in July 2015
Based on the positive Leipzig clinical study results we received in May of 2019 from Dr. Arendt, Todos exercised its option to acquire Breakthrough entirely and is now preparing for the underwritten offering required to close the acquisition
For the next 12 months the Company is preparing to:
Complete the underwritten offering, acquisition of Breakthrough and Nasdaq listing
Provides the Company with 18 months capital
Primary use of funds to drive international launch for TM-B2
Conduct trials in support of US FDA approvals in US CLIA lab
Commercialize TM-B2 in Europe and Israel
Evaluate additional international partnerships for commercial launch
Complete ongoing colorectal cancer studies for TM-C1
Complete ongoing confirmatory clinical trial for LymPro at Leipzig University
Re-validate LymPro in US CLIA lab based on new clinical trial data
Identify Pharma Services clients based on new clinical trial data
To summarize, our proprietary TBIA cancer screening platform continues to develop on schedule and we believe LymPro is scientifically quite synergistic, thereby adding significant value to Todos as a whole as we look at the continued migration of failed cancer drugs being moved into Alzheimer’s clinical development. We have successfully signed partners in pilot countries in Europe as well as Israel, and are in discussions of widening the roll out with further regional partnerships. As we execute on the TM-B2 initial launch, we will initiate and complete enrolling patients in the European and Israel-based lab method validation studies necessary to support full commercialization launch by our partners in the second half of 2019. We hope to sign additional international commercialization partnerships in the months ahead while also completing additional clinical trials. These are both areas of high unmet need and will serve a valuable tool in the treatment and screening more patients and helping identify patients who need further testing and catching cancer much earlier. Exact Sciences has shown successful adoption for their colon cancer stool test and we believe we can replicate their roadmap to success with with a simple blood test. The LymPro Test is a fascinating, potential game-changing, biomarker in neurological disease that could help physicians take care of patients and potentially aid in the development of life saving therapies allowing drug companies to target patients who are earlier in the disease process than they are currently able to recruit. This fits exactly with our cancer platform profile and we believe the main benefit is for pharma companies looking to identify and monitor patients with Alzheimer’s disease prior to the initiation of symptoms.
I look forward to continuing to update the community as we hit our milestones and bring meaningful innovation to patients around the world.
Thank you,
Herman Weiss, MD, MBA, FACOG
http://www.globenewswire.com/news-release/201...rence.html
June 17, 2019 08:30 ET | Source: Todos Medical Ltd.
REHOVOT, Israel, June 17, 2019 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro-diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, today announced that CEO Herman Weiss, MD, MBA, FACOG, provided a corporate update and roadmap at LD Micro International Annual Invitational in Los Angelos, California.
Link to webcast with Dr. Herman Weiss, CEO at the 9th annual LD Micro Invitational
Following is a synopsis of the presentation:
Todos Medical CEO Presents Corporate Update
I would like to personally welcome all those who have been following Todos Medical and supporting us through our mission to bring important innovation to patients worldwide. Our vision at Todos is simple; to provide physicians and their patients the earliest and most accurate screening and diagnostic information to help treat disease when it is in its earliest and most treatable stages. From our flagship TBIA platform, our TM-B2 test is a blood test for breast cancer initially focused on replacing the current battery of tests performed on patients with dense breasts who have inconclusive mammogram results, a significant unmet medical need.
Our TM-B2 test is a simple blood test for breast cancer diagnosis targeting women 25 years and older. TM-B2 can be a valuable lifesaving test for women under 40 years old where mammography is not efficient as a screening tool. We are also developing additional blood tests for other aspects of breast cancer, as well as colon cancer and other cancers.
This update, the first one under my watch as CEO, outlines the tremendous progress we have made in the last year, and provides the roadmap for upcoming milestones to track our progress against the big plans we have for the year ahead.
Here are notable highlights from the last 12 months:
Completed internal restructuring where I stepped in as CEO in August of 2018, and our immediate past CEO, Rami Zigdon, MBA, moved to the role of Chief Business Officer to focus on international partnerships for the cancer platform. This transition was made to prepare for the commercial launch of our TM-B2 breast cancer blood test due to my experience in bringing new products to market when I served as Global Head of Women’s Health while at Teva Pharmaceuticals from 2012 to 2017. I want to thank Rami for leading the company to where it was when I took over, affording me the opportunity to step in and take the Company forward towards growth.
Presented results from clinical studies at major meetings:
TM-B2 San Antonio Breast Cancer Conference (SABCS)
ASCO
Received several patent issuances from international patent offices, significantly strengthening our cancer intellectual property position
Israel
United States TM-B2
Received regulatory approval to market our tests in Europe and Israel
Commercial distribution agreements for our TM-B2 test in Austria, Romania and Israel
Entered into a fundraising agreement with an experienced New York-based investment banking firm to underwrite the listing of the Company’s common shares onto the Nasdaq Capital Markets
Raised more than 1.5 million USD in financing from existing and new investors who are buying into our vision and plan of action for the Company
Entered into a Joint Venture with Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS) to fund clinical studies of their neuro-diagnostics subsidiary Breakthrough Diagnostics, Inc. that is developing the Alzheimer’s blood diagnostic LymPro Test.
LymPro was originally developed by Prof. Thomas Arendt a world leader in Neurodegenerative diseases at Leipzig University who believes that Alzheimer’s and cancer share certain critical biological mechanisms. The scientific synergy between our existing platform and the Breakthrough platform is significant as we are focused on the immune’s system role in disease, whether it be cancer or Alzheimer’s;
The funding we provided allowed for the completion of a 20-patient clinical trial at Leipzig University under Dr. Arendt’s supervision, which was a follow-up study to a 140 subject study conducted by Amarantus and presented at Alzheimer’s Association International Conference in July 2015
Based on the positive Leipzig clinical study results we received in May of 2019 from Dr. Arendt, Todos exercised its option to acquire Breakthrough entirely and is now preparing for the underwritten offering required to close the acquisition
For the next 12 months the Company is preparing to:
Complete the underwritten offering, acquisition of Breakthrough and Nasdaq listing
Provides the Company with 18 months capital
Primary use of funds to drive international launch for TM-B2
Conduct trials in support of US FDA approvals in US CLIA lab
Commercialize TM-B2 in Europe and Israel
Evaluate additional international partnerships for commercial launch
Complete ongoing colorectal cancer studies for TM-C1
Complete ongoing confirmatory clinical trial for LymPro at Leipzig University
Re-validate LymPro in US CLIA lab based on new clinical trial data
Identify Pharma Services clients based on new clinical trial data
To summarize, our proprietary TBIA cancer screening platform continues to develop on schedule and we believe LymPro is scientifically quite synergistic, thereby adding significant value to Todos as a whole as we look at the continued migration of failed cancer drugs being moved into Alzheimer’s clinical development. We have successfully signed partners in pilot countries in Europe as well as Israel, and are in discussions of widening the roll out with further regional partnerships. As we execute on the TM-B2 initial launch, we will initiate and complete enrolling patients in the European and Israel-based lab method validation studies necessary to support full commercialization launch by our partners in the second half of 2019. We hope to sign additional international commercialization partnerships in the months ahead while also completing additional clinical trials. These are both areas of high unmet need and will serve a valuable tool in the treatment and screening more patients and helping identify patients who need further testing and catching cancer much earlier. Exact Sciences has shown successful adoption for their colon cancer stool test and we believe we can replicate their roadmap to success with with a simple blood test. The LymPro Test is a fascinating, potential game-changing, biomarker in neurological disease that could help physicians take care of patients and potentially aid in the development of life saving therapies allowing drug companies to target patients who are earlier in the disease process than they are currently able to recruit. This fits exactly with our cancer platform profile and we believe the main benefit is for pharma companies looking to identify and monitor patients with Alzheimer’s disease prior to the initiation of symptoms.
I look forward to continuing to update the community as we hit our milestones and bring meaningful innovation to patients around the world.
Thank you,
Herman Weiss, MD, MBA, FACOG
http://www.globenewswire.com/news-release/201...rence.html
