New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - February 23, 2023 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today provided a corporate update for shareholders.
CLIA/CAP Clinical Lab Provista Diagnostics
With the recent surge in respiratory viruses throughout the United States, there has been renewed interest in PCR testing to help physicians identify patients infected with COVID, Flu A/B, RSV and/or Strep A. As a result of this trend, certain private schools recently reestablished their COVID screening programs and are aggressively pursuing test-to-treat models which recently demonstrated that treatment with antivirals was associated with a lower risk of post-acute sequelae of COVID – currently the greatest COVID threat for schoolchildren. Todos believes it has capitalized on this emerging market trend at its CLIA/CAP clinical lab Provista Diagnostics by signing new reference lab agreements with CLIA labs that service urgent care centers and schools in the New York / New Jersey area, allowing it to generate record testing volumes of over 30,000 tests billed to date for the month of February. We have decided to wind down our pilot urinary tract infection, wound, gastrointestinal, respiratory pathogen and sexually transmitted disease PCR program in Dunnellon, Florida after a successful pilot launch with several strong case studies, after we were unable to scale the sales effort sufficiently to justify further investment. We have reprioritized our sales resources towards our core urban markets of Atlanta and New York / New Jersey where we have our deepest relationships and where the data from the Dunnellon pilot launch can be translated into more substantial commercial opportunities. Additionally, we are preparing to expand our testing panels to include toxicology testing, routine blood testing, cancer genetics (CGx) and pharmacogenomics (PGx) in order to be able to offer full service lab testing that will bolster our commercial opportunities.
Our Long COVID Panel partnership with Amerimmune Diagnostics is starting to produce intriguing data for the identification of biomarkers associated with severe COVID and Long COVID that can be translated into definitive Long COVID diagnostic and disease monitoring panels. Combined with new markers being developed to monitor viral persistence, protease persistence, immune system integrity and cardiovascular risk post-COVID, we believe being able to monitor the key pathophysiological markers underpinning Long COVID disease progression and treatment response will be crucial in developing the right cocktail of interventions unique to each patient. The Long COVID Panel sample collection is available through the Quest Diagnostics collection network in all states with the exception of New York and California and can be ordered through a patient’s primary care physician or specialist. We believe the Long COVID Panel will help patients seeking conclusive evidence for a Long COVID diagnosis and related access to disability benefits through the American Disabilities Act that recognizes Long COVID as a cause of disability.
We remain committed to bringing to market our proprietary suite of diagnostic tests that will initially be launched as Laboratory Developed Tests (LDTs) in the United States through Provista, as well as bringing on additional unique tests that will further distinguish Provista from other testing labs. We expect our Videssa breast cancer blood test, our LymPro Alzheimer’s blood diagnostic and our Total Biochemical Infrared Analysis (AI) AI immune system blood testing platform, to allow us to address the $8 billion dollar US breast cancer testing market, the $7B Alzheimer’s disease testing market, and the $168 billion cancer global testing market. We believe that COVID and Long COVID will both drive significant increases in cancer and dementia in the years ahead, making the diagnostics Todos is developing even more important for patients and physicians.
3CL Pharma majority-owned subsidiary
The Company is now in the final stages of preparing to launch the crowdfunding campaign for its majority owned subsidiary 3CL Pharma. 3CL Pharma will be investing proceeds from this funding campaign to expand the marketing efforts for our dietary supplement Tollovid™, as well as launching clinical development programs for our dual-mechanism drug candidate NLC-V (Tollovir®) 3CL protease inhibitor and CCR5 antagonist, our protease persistence diagnostic test TolloTest™ and our dietary supplement Tollovid in Long COVID. We believe 3CL Pharma is uniquely positioned to become the most compelling Long COVID investment opportunity. 3CL Pharma is addressing the $132 billion immune support with Tollovid, the $16 billion COVID treatment market with Tollovir, and the $97 billion COVID diagnostics market with TolloTest™.
Tollovir generated strong data from a Phase 2 trial in hospitalized patients completed in early 2022 that showed benefits in mortality, time in the hospital, oxygen saturation levels and immune biomarkers. The regulatory landscape for hospitalized COVID treatments is extremely challenging in the current politicized environment, where the US government has recently indicated that it would end the Public Health Emergency (PHE) on May 11, 2023 and is attempting to assure biopharmaceutical product developers that the Emergency Use Authorization pathway will remain available after that date. After a thorough review with our regulatory attorneys, the risk of investing to develop a hospitalized treatment is too great under the current circumstances. As a result, we have our hospitalized COVID program on pause.
We have begun to receive significant interest from fundamental institutional investors and not-for-profit organizations in trials for Tollovir in Long COVID, largely based on its dual-mechanism, safety profile and the strength of the hospitalized on key biomarkers. We have a plan in place to initiate a Tollovir Phase 2 development program largely as a result of the strong positive feedback patients have provided on the supplement version, Tollovid, which is being used by Long COVID patients. Concurrently, we have made significant inroads with physician groups in the United States using Tollovid with their Long COVID patients, and we expect these initial efforts to be rolled out through key patient advocacy and functional medicine groups in the US in the months ahead.
We are continuing to pursue strategic options for the further development of the TolloTest as a point-of-care viral persistence test and intend to first bring the technology to the United States for validation at Provista and for inclusion in our Long COVID Panel partnership with Amerimmune.
The Company recently formed Todos Botanicals to serve as the long-term solution for manufacturing of our 3CL Pharma subsidiary’s Tollovid product(s). With these manufacturing capabilities now in-hand, we are also able to manufacture other botanical products, including CBD products. The Company is working on launching the first automated retail locations. We have been delayed in rolling out these machines as our previous partners Nerd Hemp were unable to secure the funding needed to drive that business on an exclusive basis, and as a result we entered into a direct agreement with our partners at Smart Automated Retail Network who control the intellectual property and relationships underpinning the rollout. As a result, we have been working with them to refine the products going into these machines, as well as working with the retail locations themselves where these machines will be initially rolled out to optimize marketing materials and messaging. The retail locations that we currently have access to include over 40 international airports and 21,850 grocery store locations. The CBD market is expected to reach over $20B in the United States by 2026.
New York Stock Exchange listing
The Company is now pursuing a national stock exchange listing with the New York Stock Exchange through the NYSE American Exchange. We are hopeful to be able to provide updates to the marketplace in the months ahead as we make progress on the business fundamentals in order to be able to achieve the initial listing standards.
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 the Israeli-based majority-owned joint venture 3CL Pharma Ltd with NLC Pharma in March of 2022 to consolidate all of 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™.
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 the 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.
Todos Corporate Contact:
Gerald Commissiong CEO
917-983-4229 x 104
Todos Press Contact: