NEW YORK, NY, ALPHARETTA, GA and TEL AVIV, ISRAEL – (NewMediaWire) – September 26, 2023 – Todos Medical, Ltd. (OTCQB: TOMDF), an innovative healthcare solutions company, today provided a corporate update to its stakeholders centered on the Company’s efforts to retool and focus primarily on addressing the Long COVID epidemic that is affecting over 15 million Americans, over 6% of the adult US population, according to the US Centers for Disease Control. Todos intends to deploy medical foods to aid physicians in the dietary management of Long COVID, optimize immune support with nutritional supplements targeting the 3CL protease, and precision diagnostic panels to assist in the diagnosis and monitoring of Long COVID patients. A recent report by David Cutler of Harvard University estimates the annual Long COVID cost to the US economy is $3.7 trillion.
3CL Pharma USA, Inc.: Tollovid™, Tollovir™ and TolloTest™
Todos has finalized a new agreement with NLC Pharma, Ltd., our partner on the development and commercialization of 3CL protease-related products, to license dietary supplement Tollovid, therapeutic candidate Tollovir and biomarker assay TolloTest. Tollovid is currently marketed online direct to consumers through Amazon and MyTollovid.com, Tollovir has completed a Phase 2 clinical trial in hospitalized COVID, and biomarker assay TolloTest has completed analytical and clinical validation in hospitalized COVID, and initial proof of concept as a tool to quickly diagnose COVID in outpatients.
Under the terms of the new license agreement, wholly-owned subsidiary 3CL Pharma USA, Inc. (3CL Pharma) licensed rights for the manufacture and distribution of Tollovid, Tollovir and TolloTest in the United States, Canada, Mexico, Ghana and the Caribbean (the “Territories”). Todos can continue to serve international online customers outside the Territories through its MyTollovid.com website. Todos is required to complete license fees payments to NLC Pharma within 90 days of execution of the agreement for exclusivity in the Territories, a per bottle royalty on dietary supplement and medical food sales, and fees to expand rights to include key jurisdictions beyond the Territories. Todos retains 100% ownership of the equity in 3CL Pharma. The companies expect to complete all the closing conditions of the agreement on or before December 15, 2023, subject to earlier termination under certain conditions.
With this signed agreement now in place, the Company is now able to swiftly implement our strategy of crowdfunding within the 3CL Pharma entity to fund a Long COVID clinical trial. We expect to have announcements about the crowdfunding details, as well as product updates for Tollovid and business plan updates for 3CL Pharma in the coming weeks.
Provista Diagnostics, Inc.: Long COVID Testing
With the ending of the public health emergency (PHE) in the United States, there has been a substantial drop off in demand for the COVID PCR testing that was responsible for the majority of Provista’s revenue from 2021 to 2023. As a result of significant work we did during the PHE with Amerimmune on Long COVID after establishing the Post COVID Immune Test, we now have immune testing available that falls in line with a recent key publication in Nature from the Putrino Lab and the Yale School of Medicine describing various important Long COVID biomarkers. Provista will also establish the cardiovascular, metabolic and hormonal panels relevant for Long COVID patients. Our objective is to become the go to lab for Long COVID diagnosis and monitoring, including for clinical trials and investigational biomarkers, to support the Long COVID community health journey.
As a result of increased risk of cancer and Alzheimer’s among Long COVID patients, we believe that our proprietary Videssa™ breast cancer and LymPro Alzheimer’s blood tests will help arm Long COVID patients and all patients with additional tools to be proactive with their healthcare. We intend to initially bring these tests to market through Laboratory Developed Tests (LDTs).
The Company intends to create value for its shareholders through its equity ownership in 3CL Pharma that will allow it to offset its outstanding liabilities and capture the full value of the 3CL Pharma product offering for the Long COVID community via crowdfunding and subsequent listing of 3CL Pharma.
For more information, please visit todosmedical.com. For more information on the Company’s dietary supplement that provides immune support with 3CL protease inhibition, please visit www.mytollovid.com.
About Todos Medical Ltd.
Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company’s state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that examines cancer’s influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally developed cancer-screening tests, TMB-1 and TMB-2 have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing, Long COVID Panel analyses, and Provista’s\ proprietary commercial-stage Videssa® breast cancer blood test. More information on Provista is available at www.provistadx.com.
Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer’s disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Todos formed 3CL Pharma USA, Inc. 2022 to consolidate the intellectual property surrounding 3CL protease–based diagnostic testing and development of 3CL protease botanical and pharmaceutical inhibitors that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’ brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid™ in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovir™, while also developing the 3CL protease diagnostic TolloTest™.
For more information, please visit https://todosmedical.com/.
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
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President & CEO