TODOS MEDICAL LTD. Dear Shareholder,
We would like to thank you for continued support as we execute on the vision we laid out in the first half of 2020, transitioning the Company from a cancer and Alzheimer’s-focused R&D diagnostics company into a commercial organization focused on providing comprehensive solutions to address the United States’ biggest challenges in testing, tracing and immune support in response to the COVID-19 pandemic. Going forward as the newly created business lines mature, each at their own pace, we are seeking to adjust expectations in light of the market’s response to our progress and address some of the limiting factors to value creation.
Nasdaq Uplisting Timing
Given where the Company’s common stock is currently trading, we do not believe it is realistic to uplist to Nasdaq in 2020, but rather look to achieve that milestone in the first half of 2021. We are focused on creating value for our common shareholders and, given where our common stock is currently trading, we believe it is prudent to remove the risk of a significant reverse split from market concerns until we have demonstrated several more months of growing sales and commercial execution. Given that the Company is now generating revenue that we expect to continue to grow significantly into 2021, we now believe that our common equity can significantly increase in value on the OTC Markets™ because we believe we are well positioned as a growing commercial organization with the upside of several attractive research & development programs with patent protected development-stage programs addressing large market opportunities. While we are disappointed the market is not currently recognizing our fundamental value, we now have a significant opportunity to begin to educate the marketplace with regards to our overall business, and specifically our COVID-19 business.
COVID-19 Testing
Todos has positioned itself as a ‘one stop shop’ for all things COVID testing related. We understand that there is significant confusion with regards to COVID testing, and therefore we are outlining here exactly what we offer in the different types of testing products we make available to clients:
Polymerase Chain Reaction (PCR) Testing
PCR testing is now the gold-standard in COVID-19 testing. Definitive diagnoses are almost exclusively confirmed by PCR. As such, screening and surveillance testing of any kind will ultimately lead to a confirmatory PCR test.
Equipment to create workflows capable of conducting over 20,000 PCR tests per day per lab include:
1. RNA automated extraction machines
2. RT-PCR machines (96 well and 384 well)
3. Liquid handler machines
4. Automated and semi-automated pipettes
Reagents and consumables include:
1. Extraction reagent kits
2. COVID and COVID + influenza a/b qPCR reagent kits
3. Swab and Viral Transport Medium kits
4. Robotic and manual pipette tips
5. PCR plates
6. Validation Samples
Todos has optimized a workflow with Tecan liquid handlers currently being implemented at our
Rapid Antigen Testing
Antigen testing allows for testing at lower accuracy rates than PCR, but with much faster turnaround times because the results are provided at the point of care. As such, it screens more people faster and take immediate action if a positive test leads to a suspected case of COVID-19 that needs to be confirmed by PCR. The Company has entered into several agreements with companies focused on bringing antigen tests into the marketplace. While our sales have been focused on PCR testing, we believe rapid antigen testing will become routine in
Rapid Antibody Testing
As schools, employers and other constituents begin to implement comprehensive COVID-19 surveillance programs, one of the key questions emerging is whether individuals have previously been infected with COVID-19. We have secured rights to the FDA Emergency Use Authorization (EUA) FaStep rapid SARS-CoV-2 antibody test and have added this to our offering to our sub-distribution partners.
Emerging COVID-19 Testing Technologies
The Company has also secured rights to several tests that are currently awaiting EUA approval from the FDA. These tests include point-of-care PCR tests that will compete with the Abbott ID Now™ and Cepheid point of care molecular tests. We also expect to enter into an agreement to secure distribution rights to lab-based tests to more comprehensively evaluate COVID-19 immune-status that we believe will become paramount as vaccines enter the marketplace and testing for immunity becomes more widespread in 2021.
Additionally, we are continuing to make significant progress with our 3CL protease rapid saliva/buccal test, being developed via our joint venture,
One of the most innovative programs Todos has been working on is the biosafety level 3 (BSL3) mobile labs solution that has been making steady progress and has now completed all of the instrument and clinical sample validation required to be able to receive CLIA certification for PCR testing. The mobile labs are now awaiting CLIA inspection in the days ahead, after an unexpected postponement of the inspection date occurred earlier this week. Upon receiving final certifications, several contracts are well into the negotiation phase and we expect revenues to begin to flow from this project in December. The mobile labs have the ability to conduct over 2,000 PCR tests per day, have been equipped with rapid antigen testing machines as well as lateral flow point of care antigen tests that will allow our implementation partners to conduct testing on large groups and confirm suspected COVID-19 cases by PCR, as well as do large scale PCR testing onsite with turnaround times of as little as 6 hours. We currently have 2 mobile labs in the final stages of authorization and have secured 10 additional mobile lab units that we will begin to build-out upon certification of the first unit. We expect to reach a production capacity of 100 mobile units per month in the first quarter of 2021.
We believe this initiative is innovative and timely because it addresses many of the key logistical challenges surrounding COVID-19 testing, and opens the possibility of also being used as the basis for added healthcare services around testing that will become increasingly important heading into 2021.
Tollovid™ – Immune Boosting Dietary Supplement
We believe the 3CL protease is an important drug development target for COVID-19 largely based on work Pfizer has published. Our joint venture with NLC Pharma has gained exclusive rights to bring to market the dietary supplement Tollovid, a 3CL protease inhibiting formulation of plant extracts designed to support and maintain healthy immune function. We believe Tollovid has a first-mover advantage in the 3CL protease inhibition space because it has received a Certificate of Free Sale by the FDA based largely on the data that has been generated by NLC in understanding how 3CL protease inhibition impacts the replication of coronaviruses generally. Our proprietary Tollovid formulation has been optimized to maximize 3CL protease inhibition using natural products, and we believe the current capsule formulation will become the basis of a line of products based on Tollovid’s active, 3CL protease-inhibiting ingredients. NLC recently completed certain experiments with Tollovid against actively circulating coronaviruses, and NLC expects to make that data available to the public in
Todos is now focused on the commercial launch of Tollovid at The Alchemist’s Kitchen™ in
Summary
The focus of the Company is now squarely focused on COVID-19 for the immediate term. We expect the revenues we generate from sales of COVID-19 testing solutions to drive the business in the near-term and position the Company to capitalize on the very significant programs we have in cancer and Alzheimer’s diagnostics. We are looking to ensure that we create value for our shareholders by executing on this plan and as such are taking a measured approach to our uplisting timelines because we believe the market is fundamentally not understanding the progress the Company has made to date.
We look forward to continuing to update you on our progress as we reach additional milestones and thank you for your continued support.
President & CEO
For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com
For testing and PPE inquiries, please email sales@todosmedical.com.
About Tollovid™
Tollovid is an orally administered proprietary blend of plant extracts that includes a powerful 3CL protease inhibitor that helps support and maintain healthy immune function.
About The Alchemist’s Kitchen
The
About
Headquartered in Rehovot,
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.
Additionally, 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
For more information, please visit https://www.todosmedical.com/.
Forward-looking Statements
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 Investor Contact:
LHA Investor Relations
Senior Vice President
(212) 838-3777
kgolodetz@lhai.com
Todos Corporate Contact:
(917) 983-4229 ext. 103
priyanka@todosmedical.com
2020 GlobeNewswire, Inc., source
