New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - May 27, 2022 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today released a corporate update from CEO Gerald Commissiong on the Company’s CLIA/CAP-certified lab Provista Diagnostics, an update on the Company’s 3CL Pharma majority-owned subsidiary progress and plans to take the Company onto a national stock exchange.
CEO Gerald Commissiong commented:
“Todos’ CLIA/CAP certified laboratory Provista Diagnostics is getting further entrenched in the PCR testing business by expanding beyond COVID PCR testing to also test for other pathogens such as Urinary Tract Infection (UTI) with PCR, which we believe provides significantly more value over the previous standard of cell culture assays by enabling faster turnaround time, 24h-48h for PCR vs. 3-7 days for cell culture, in addition to precision medicine treatment decision-enabling pharmacogenomic data to make better antibiotic prescribing decisions. The Company’s test menu expansion will continue as we expand our customer base in preparation for the commercial readiness of the Company’s proprietary testing pipeline products such as the Videssa® breast cancer blood test and the LymPro Alzheimer’s blood test. We expect Videssa to be launched in the first half of 2023 and recently completed enrollment in the second part of the LymPro vs. amyloid beta clinical trial for which preliminary positive results were announced in the third quarter of 2019.
“On the therapeutic front, earlier this morning we announced that we will be presenting final data for the Company’s majority-owned subsidiary 3CL Pharma’s Phase 2 clinical trial for Tollovir™ in the treatment of hospitalized COVID-19 at the Precision Medicine World Conference on June 30, 2022 at 1:30 pm PT. In light of recent developments in COVID-19 therapeutics in the hospital setting, the Company is updating its Phase 2/3 clinical trial planning to account for any potential changes in therapeutic approaches to hospitalized COVID-19 and has retained the top regulatory law firm in the United States with a strong history of working with the FDA to help the Company navigate the regulatory process for Tollovir, and provide oversight over the Company’s 3CL protease inhibitor immune support dietary supplement product Tollovid®.
“As the full scope of the COVID transmission-enabling policy of removing mask mandates nationwide comes into focus, the US Center for Disease Control and Prevention (the “CDC”) recently acknowledged that approximately 1 in 5 adults infected with COVID under the age of 65 have developed Post-Acute Sequalae of COVID (“PASC” or “Long COVID”), a chronic post-viral syndrome that often involves long-term disability, including an inability to work or attend school. For the age group 65 and older, 1 in 4 infected persons develop the condition. The advent of Long COVID is potentially the single largest mass disabling event in human history. A Bank of England monetary committee recently acknowledged that Long COVID is the primary driver behind a 440,000 worker decrease in the British Workforce between 2019 and 2022, while also disclosing a record high of 4.5% of adults who responded they could not work due to long-term sickness. In the United States, the statistics are potentially even more sobering with 22 million U.S. adults living with Long Covid (~7% of the population) and 7 million experiencing Disabling Long Covid (DLC) representing 2.3% of the population with a cumulative cost estimated at more than $386 billion as of January 2022. The world needs solutions for Long COVID as the full weight of the pandemic’s impact on human health comes into focus. Here at Todos Medical we believe we are ready to deliver those solutions.
“3CL Pharma has developed a novel set of assets around the SARS-CoV-2 3CL protease (3CLpro, Main Protease, Mpro, Nsp5) that has positioned it to help address some of the core challenges affecting the Long COVID community, namely appropriate supplementation, therapeutic drug candidates and novel diagnostic tools. In the area of supplementation, several case studies have been reported that describe the potential immune-support benefits of the Company’s dietary supplement product Tollovid®, and we now have a loyal base of Long COVID customers who are providing us with information on how best the community can see immune support benefits. Tollovid has been positioned as a 3CL protease cleanse to help reduce and maintain low 3CLpro body content. We have now gained insights that we wish to share with customers that will drive our future packaging decisions, dosing recommendations and marketing plans as we continue to do research with Long COVID clinics to better understand how customers can get the most out of Tollovid.
· Customer feedback indicates Long COVID symptoms that started within 6 months of ordering Tollovid generally see sustained results more quickly than those who have had Long COVID for 1 year. Patients who have had Long COVID for 1 year generally see sustained results more quickly than patient who have had Long COVID for 2 years. Based upon this consumer feedback, we will look to create new bottle packs of 2, 3, and 4 bottles that will allow consumers to more easily identify the level of immune support recommended for them based upon feedback from similar types of customers. The single bottles are still a great way to achieve the needed support dosing over 5, 10 or 15 days followed by a gradual shift towards maintenance dosing of as little as 2 pills per day, depending on how the customer responds. Over the summer we intend to submit new certificates of free sale that will include 120 pills/bottle, 180 pills/bottle and 240 pills/bottle to allow for 1 (60 pills over 5 days), 2 (120 pills over 10 days) or 3 (180 pills over 15 days) support dosing cycles followed by a reduction towards daily maintenance consumption. We expect that as customers successfully transition from support to maintenance that we will continue to see strong customer loyalty, as evidenced by Tollovid’s significant increases in returning customers rate and subscriptions. The Long COVID community has quickly embraced Todos and we hope to help them with respect to product pricing following the 50% off promotion pricing that reduced the per bottle price of Tollovid from $299/bottle to $149/bottle that runs through May 30th, 2022. As such, we will be launching new pricing packages for Tollovid that align with the needs of our customer base starting on Memorial Day as follows:
o $199 for one (1) bottle
o $299 for two (2) bottles (avg cost $149.50/bottle)
o $399 for three (3) bottles (avg cost of $133/bottle)
o $499 for four (4) bottles (avg cost of $125/bottle)
o $599 for five (5) bottles (avg cost of $120/bottle)
· Adequate biomarker testing and monitoring for Long COVID sufferers does not exist in the United States, and given our proprietary position with Tollovid, Todos’ CLIA/CAP-certified diagnostic lab Provista Diagnostics is well positioned to establish a Long COVID biomarker panel to monitor the key markers for Long COVID patient health, and potentially identify novel companion diagnostic biomarkers that could be used to flag patients for potential therapeutic intervention. Provista is in the process of establishing relationships with lab partners that offer validated Long COVID biomarker testing, as well as preparing to add specialized 3CL protease (“TolloTest”) and fecal PCR testing that will allow patients to monitor the degree to which Long COVID sufferers continue to exhibit viral persistence that could be driving disease pathology.
· The data being gathered from Tollovid dietary supplement customers is helping inform our clinical trial plans for both Tollovid and Tollovir in Long COVID. 3CL intends to initially conduct observational clinical studies for Tollovid while advancing randomized, double-blind, placebo-controlled trials for Tollovir in Long COVID. We expect Tollovir Long COVID trials will initially be conducted in Israel early in the summer while the Company establishes an Investigational New Product (IND) designation and gains authorization to proceed with the pivotal Tollovir hospitalized trial in United States and Europe as well as an IND for European trial authorization for Tollovir in Long COVID.
“One of the key concerns we hear from customers and shareholders is regarding the ability of Todos Medical to fund the development of 3CL Pharma. After significant debate, the Company has retained counsel to help 3CL Pharma file to raise capital using crowdfunding Regulation CF (“Reg CF”) from non-accredited investors and Regulation D06C (“506C”) from accredited investors. Todos recently received a third party valuation for 3CL Pharma of over $1.9 billion, and as a result, we believe we can raise capital at attractive valuation for both investors and Todos that will allow 3CL Pharma to maximize its potential. We expect the offerings to be in the market in late June 2022 and we are currently preparing a Tollovid manufacturing run to be used to reward 3CL Pharma investors with supply of Tollovid. By raising funding for 3CL Pharma in this way we are providing investors who believe in Tollovid, Tollovir and Tollotest with an opportunity to directly impact 3CL Pharma’s ability to widely distribute Tollovid, while also limiting Todos’ cash burn going forward.
“The Company has completed an S-1 draft that it anticipates using to execute a capital raise in conjunction with an uplisting to a major exchange at some point in the second half of 2022 centered around the further advancement of our PCR and Long COVID testing business at Provista and the commercialization of our Videssa breast cancer blood test in 2023. As stated earlier in this update, the Company has a crowdfunding capital raising strategy for unlocking the $1.9 billion third party valuation we recently received for the first two 3CL Pharma’s three key assets. We believe initiating capital raising directly into 3CL Pharma via crowdfunding will represent a major valuation inflection event for Todos as the fear of significant dilution will be reduced while the value of 3CL Pharma’s development will still be captured by the Company and eventually passed along in some form to shareholders.”
About Tollovid® and Tollovid Daily™
Tollovid and Tollovid Daily are dietary supplement products made from natural ingredients that help support and maintain healthy immune function and also have potent 3CL protease inhibition properties based upon in vitro functional assays that show strong inhibition of 3CL protease activity. Tollovid's 3CL protease IC50 binding affinity is at least ten times (10x) as strong as Ivermectin’s published 3CL protease IC50 binding affinity. Tollovid Daily’s 3CL protease IC50 binding affinity is at least two and a half times (2.5x) as Ivermectin. Tollovid and Tollovid Daily bind to the active site (receptor binding domain) of the 3CL protease. Tollovid has a 5-day dosing regimen, with 4 doses of 3 pills taken each day that provides maximum immune support. Tollovid Daily is a daily immune support product with a dosing regimen of twice daily.
Tollovir® is a 3CL protease inhibitor and anti-cytokine therapeutic candidate for the treatment of the nidovirus subcategory of coronaviruses that includes SARS-CoV-2, COVID-19, SARS-CoV-1, MERS and 229E. Tollovir is made from all natural ingredients that are qualified to ensure strong inhibition of the 3CL protease in vitro, as well as strong anti-cytokine activity. Tollovir has successfully completed a Phase 2 clinical trial in Israel for the treatment of patients hospitalized with COVID-19. Tollovir will be developed for the treatment of hospitalized COVID-19 (severe and critical), moderate COVID-19, long-haul COVID and potentially pediatric COVID-19. Todos has licensed rights for Tollovir to T-Cell Protect Hellas S.A. for the Greek market.
TolloTest® is a 3CL protease diagnostic fluorescence platform technology that has demonstrated clinical proof of concept in hospital setting and outpatient settings in correctly identifying patients infected with COVID-19, including within 1-3 days of first exposure. TolloTest diagnostic tools are being developed to address key deficiencies with current SARS-CoV-2 rapid antigen and PCR technologies. TolloTest can provide results in less than ten (10 minutes), and potentially in as little as two (2) minutes. Data generated from two studies conducted with TolloTest demonstrate that: (1) it can identify SARS-CoV-2 infected patients earlier than rapid antigen testing (potentially earlier than PCR testing), (2) it can identify patients who are likely no longer infectious, but still test positive by PCR and (3) it can identify patients that are still likely infectious, but who have been released from quarantine based on time from positive PCR test. TolloTest assay formats are being developed for (1) point-of-care/at-home market and (2) rapid mass screening in community settings (airports, schools, offices).
About Videssa® Breast Cancer Blood Test
Videssa Breast is the only simple blood test to provide early and accurate detection of active breast cancer. In those women who present with suspicious mammography results, the decision whether to order additional imaging or biopsy can be difficult. With a simple blood draw, Videssa Breast can help guide further diagnostic procedures or provide assurance that the patient does not have breast cancer. When used in combination with imaging, Videssa Breast offers the healthcare provider additional data leading to increased confidence and clarity when clinical assessment is challenging.
About LymPro Alzheimer’s Blood Test
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.
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 deploys deep examination into 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 and Provista's proprietary commercial-stage Videssa® breast cancer blood test.
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 has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Additionally, Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses.
For more information, please visit https://www.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 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.
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