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 released a letter to shareholders:
Thank you for continuing to support the Company as we embark on this effort to transform into a US-focused blood diagnostics company preparing to embark on a clinical utility study with a view towards obtaining our own CPT code to allow for value-based, consistent reimbursement of an actionable blood test for breast cancer. I was asked by the Company’s Board of Directors to step in as CEO in early January, in large part, due to the prospective acquisition of Provista Diagnostics, which is a US-based blood testing company that has received over $50 million in investment to develop the Videssa® blood test for breast cancer.
Please find here a link to the Company’s updated corporate presentation: http://investor.todosmedical.com/static-files/815190c5-2c1f-4e21-9309-dd5aab5802d1 . The Company is staying strategically focused in the area of breast cancer, while continuing to develop our Alzheimer’s diagnostic platform.
Over the past several weeks, as we have begun to put the infrastructure in place to re-domicile Todos from Israel to the US, I have been repeatedly asked why a company that owns TM-B2, a breast cancer blood test for the dense breast population (BI-RADS III/IV), would buy a competitor that owns Videssa, a competing breast cancer blood test for the dense breast population. Is it because you don’t believe in TM-B2? To be clear, we unequivocally believe in TM-B2. Our rationale for the business combination is as follows:
- Videssa has been prospectively tested in over 1,100 subjects, vs. over 400 subjects for TM-B2;
- As Videssa has significantly more prospective clinical validation data, it has achieved a level of clinical validation that allows it to progress to a clinical utility (reimbursement) study;
- Videssa has shown very strong negative predictive value (NPV) for breast cancer, but poor positive predictive value (PPV), whereas TM-B2 has shown strong NPV and PPV;
- We have the opportunity to dramatically accelerate the acquisition of data for TM-B2 by ‘piggybacking’ its development onto the clinical utility study for Provista, i.e. we will collect data for both Videssa and TM-B2 during Videssa’s clinical utility study:
• This will have the benefit of true ‘head to head’ data comparing Videssa and TM-B2;
• Due to the extremely low cost of running the TM-B2 assay, the incremental cost to the Videssa clinical utility study is expected to be relatively insignificant;
• The study is being designed to define the value of NPV in breast cancer for Videssa, and would have the upside potential of demonstrating the value of TM-B2
• The data obtained could potentially support the value of PPV in breast cancer for TM-B2, but at a minimum will provide us with significant analytical and clinical validation data for TM-B2;
- The market opportunity for a blood test that can triage subjects who have dense breast is so large that regardless of which technology is ultimately the best, Todos shareholders stand to benefit substantially from any positive clinical results;
- The underlying Todos Total Biochemical Infrared Analysis (TBIA) platform can be leveraged by virtue of the data collected in the Videssa clinical utility study to create additional exploratory and proof of concept data for other cancers, and potentially other diseases.
Todos is also preparing to receive confirmatory data from the second half of an ongoing clinical trial of the Alzheimer’s blood diagnostic LymPro Test through our joint venture, Breakthrough Diagnostics. The importance of this milestone cannot be overstated by virtue of the initial data that we received that demonstrated a very strong correlation with amyloid PET imaging ( p = 0.000002, r = .849). We strongly believe that Alzheimer’s disease is effectively cancer of post-mitotic brain cells (cells that are physiologically no longer able to complete the cell division process), and this upcoming data will provide further evidence of the immune system’s importance in Alzheimer’s disease. Recent data published in the Journal of Experimental Medicine hypothesize that signaling molecules linked to the immune system immune cells in the brain have the potential to alleviate age-related cognitive decline. We believe this provides further evidence that LymPro is on the right track in terms of understanding the role of the immune system in Alzheimer’s disease. A breakthrough in this area could have significant implications for health systems worldwide, especially identifying a peripheral biomarker that could identify individuals at the earliest stages of disease.
In light of the significant market opportunity the Company has in the areas of cancer and Alzheimer’s, we believe there is tremendous value to be unlocked from the underlying technologies to which Todos has rights. Going forward, the Company will be focused on bridging the gap to allow the Company to achieve interim milestones on its way to a proposed listing on Nasdaq in the first half of 2020.
I would like to sincerely thank you for your continued support of the Company, and I look forward to providing further updates in the near future.
About Todos Medical Ltd.
Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer’s disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer’s influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company’s two cancer screening tests, TM-B1 and TM-B2, have received the CE mark. Breakthrough Diagnostics is developing the LymPro Test®, a blood test for diagnosing Alzheimer’s disease. Todos has also entered into an exclusive option to acquire breast cancer blood testing company Provista Diagnostics, Inc. that is commercializing the Videssa® breast cancer blood test.