Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, announced that its President & CEO Gerald Commissiong today issued a letter to shareholders outlining the Company progresses towards a national exchange listing expected in the first half of 2022.
Dear Valued Shareholder,
I would like to thank you for joining us in our journey here at Todos to transform the course of the COVID-19 pandemic and help patients with cancer and Alzheimer’s get better access to diagnostic tools that could dramatically impact their health. I’m going to touch on the key themes of great interest to our shareholders and hopefully set out the key plans we have that we believe will drive shareholder value in the months ahead.
Acquisition of NLC Pharma Assets and Formation of 3CL Sciences
We continue to make good progress to complete the acquisition of NLC Pharma’s assets, and have updated the timeline expected to close the transaction to this month January 2022. As a reminder, Todos and NLC Pharma are currently operating under our active joint venture with NLC Pharma called COVID Antigen Test Killer (CATK) established in Q2/2020 where Todos has been funding the development and commercialization of 3CL protease biology-related products that include Tollovid®, Tollovid Daily™, Tollovir™ and TolloTest™. As a reminder, Dr. Dorit Arad of NLC Pharma is a pioneer in the field of 3CL protease biology whose lab was the first to purify the 3C and 3CL proteases in the early 2000s and is slated to become the Chief Scientific Officer of 3CL Sciences.
Tollovid and Tollovid Daily are dietary supplements products that have received Certificates of Free Sale (CFS) from the US Food & Drug Administration (FDA) with 2 allowed claims:
1) Support and maintain healthy immune function
2) 3CL protease inhibitor (based on in vitro data)
These are important products available for purchase now on Amazon, Alibaba and our own website www.MyTollovid.com that empower people to make decisions now to support their immune system. We have seen record sales of Tollovid in the last month as increasing awareness of the significant benefit of 3CL protease inhibitors has gained international attention, and we believe we are uniquely positioned to meet that demand given that we have 3CL protease inhibitor products with authorized FDA claims on the market now in the United States and a partner in Europe via T Cell Protect Hellas that is preparing to distribute Tollovid Daily throughout Europe.
In parallel, we are developing botanical drug candidate Tollovir for the treatment of COVID-19 in hospitalized patients. Tollovir is a combination of herbal ingredients that have two specific compounds (NLC-EXT-1 and NLC-EXT-2) discovered by Dr. Arad through research under the joint venture that have 1) potent 3CL protease inhibition via sub nanomolar binding affinity activity and 2) anti-cytokine activity. We believe the dual mechanisms of Tollovir are critical in the hospitalized setting because they are synergistic in reducing the hyper-inflammation that likely drove the patient to the hospital and stopping the replication of the virus that likely created the hyper-inflammation in the first place.
The virus can maintain its activity at low levels for at least 3 months and research has shown it can persist for up to 8 months 1. Efforts aimed at reducing the hyper-inflammation and stopping the replication of the virus that created the inflammation feedback loop should be able to quell the cycle that causes hospitalized symptoms and death. It is very important to stabilize patients in order to get them out of the hospital faster so we can reduce the COVID burden on hospital systems. This time to stabilization is actually our primary endpoint in the current study. We believe we can produce in the tens of millions of treatment courses of Tollovir in 2022 to meet the demand for drug-grade 3CL protease inhibitors. We will be working with our European partners T-Cell Protect Hellas S. A. to gain Emergency Use Authorization (EUA) in Greece, and of course 3CL Sciences itself, as an Israel-based company, will be looking to advance EUA in Israel. We also expect we could receive EUA in other jurisdictions depending on the need in those jurisdictions. Given that we do not know which variant may emerge next, the variant-independent nature of the 3CL protease inhibitor products we are bringing forward will be a critical part of the fight against COVID-19 going forward.
We continue to believe that 3CL protease diagnostics could represent a sea-change in the COVID diagnostics market and TolloTest is uniquely positioned to meet that demand. On average, lateral flow antigen tests show evidence of disease 9 days after infection well after symptoms appear, but we expect our TolloTest to significantly cut that time and show evidence as early as 1 to 3 days before symptoms appear. The 3CL protease develops in the body 70 times faster than a virion, making detection easier. We have developed prototype models for mass screening systems for point-of-entry access to airports, schools, offices, sports arenas and other areas where large groups of people will interact indoors and will be building the prototype in the first half of 2022, and intend to partner the single use point of care intellectual property to a group currently in the market looking to differentiate their current nucleocapsid antigen testing kits by having an additional unique marker that could identify the virus earlier than currently available antigen tests.
We have seen record demand for PCR testing at our CLIA/CAP lab Provista Diagnostics in recent weeks, and we are ramping up hiring to meet the substantial demand we expect will continue in the months ahead for COVID testing. With this demand increasing, we are seeing increasing sample flow from our reference lab clients and have received a number of new contracts to support new testing sites that are being established throughout the New York City area and the Atlanta area.
COVID testing at our client labs through our Corona Diagnostics subsidiary are also seeing increasing demand and we are looking at ways to more closely align with our labs to our mutual benefit so we can help them further scale to meet the demands of their local communities.
Proprietary testing: Videssa breast cancer test and LymPro Alzheimer’s test
Todos was founded to bring proprietary tests for immune-related disorder to market beginning with breast cancer. To that end, our Videssa breast cancer test is the priority product candidate to bring into the market because it will differentiate our CLIA lab and allow us to provide a comprehensive suite of testing that will be ‘stickier’ with ordering physicians. Women with dense breasts or those who are at high risk of cancer, will view our CLIA lab as a next generation cancer testing lab that can screen for both breast cancer and COVID. Building on this concept will allow us to tie together COVID testing, including monitoring for Long COVID biology that we intend to bring online later this year, with testing for Cancer which will also need to be monitored closely, especially cancer patients who are post-COVID. To this end, we intend to launch a clinical study in 2022 to meet the criteria to bring this important test into the market and gain initial reimbursement that will allow us to drive sales in 2023. We will be giving more detail on our Videssa strategy in the weeks ahead as Dr. Jorge Leon, our Chief Scientific Officer of Oncology and Infectious Diseases, makes progress in getting the study started.
In addition, we have the second half of an ongoing clinical trial for our LymPro Alzheimer’s blood test at the University of Leipzig in Germany that we expect to readout in the first half of 2022. As a reminder, this clinical study is evaluating the correlation between LymPro scores and amyloid concentrations in the brain as measured by SUVR, and the first half of the study showed a strong statistical significance of the correlation with p = 0.00000216 and r = 0.85. We are very hopeful that LymPro, a dynamic functional assay that measures immune response in the blood that mimics ongoing pathology in the brain, will become an important tool to qualify patients who are most likely to benefit from amyloid treatment. LymPro measures the fundamental underlying biology of Alzheimer’s disease that we believe can be identified at the pre-symptomatic phase given that key LymPro markers appear to be stage-independent even at the mild cognitive impairment (MCI) stage.
Corporate Plans for Uplist to Nasdaq
The Company has engaged an underwriter to support our uplisting to the Nasdaq in the first half of 2022 and we expect to file the S1 needed to complete the transaction in the near future. The S1 is already drafted, and its filing will be a major step forward towards that objective. We expect the clinical data from the Phase 2 clinical trial of Tollovir to be released on January 26th, 2022 and will provide further details around the data’s release in the weeks ahead given that we are extremely close to completing the data lock that will trigger the analysis and data report back to the Company from the statistical analysis group our key clinical advisor Dr. Jules Mitchel retained to execute the analysis. We believe the data will be a revaluation event for Todos and thereafter we will strategically plan on the best path to achieve the Nasdaq listing that has been a key stated objective for some time.
We are very excited about our positioning in the marketplace at the beginning of this new year. We believe the combination of COVID testing and Tollovid/Tollovid Daily sales that are currently driving revenues will serve as a bridge to the transformational revenue of Tollovir. The potential of Emergency Use Authorization (EUA) in one or more jurisdictions in the first quarter of 2022 exists and could be a boon to revenues should we receive it. If this happens, we plan to complete the necessary studies to expand the number of jurisdictions in which Tollovir receives EUAs. This would have an impact in the second half of 2022 that would multiply sales, and position the Company financially at the same point where we expected to be in the beginning of 2023 from launching our proprietary diagnostics initiatives. We believe this short-term (PCR Testing / Tollovid / Tollovid Daily), medium-term (Tollovir) and longer-term (Videssa and LymPro) revenue strategy could layer in key revenue and provide the funding needed to drive the next leg in revenue generation.
We are very excited about the future for Todos, and we thank you for sharing in our vision as a shareholder of the Company.
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. In 2021, Todos completed the acquisition of 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. 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 is focused on the commercialization of Videssa and will bring the TBIA tests to market thereafter.
Todos has entered into a joint venture with NLC Pharma targeting diagnostic and testing solutions to address the COVID-19 pandemic. The Joint-Venture is pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses. The Company’s proprietary therapeutic candidate Tollovir™ is currently in a Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, and is preparing to initiate Phase 2/3 clinical trials for both hospitalized and non-hospitalized patients in Israel.
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 is also distributing certain (COVID-19) testing materials and supplies to CLIA-certified labs in the United States. The products cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits.