Todos Medical Provides Corporate Update

Todos Medical Provides Corporate Update




Todos Medical Provides Corporate Update

  • PCR COVID lab sales strengthening as the US prepares to implement serial COVID testing programs to further re-open the economy
  • Scaling molecular lab business by deepening COVID offering and preparing to expand into complementary testing verticals aligned with Todos’ cancer and Alzheimer’s IP Testing
  • Novel 3CL protease biomarker theragnostic offering being positioned for actionable COVID PCR reflex testing and complementary inhibitor solutions potential
  • Strengthened balance sheet and catalysts positioning Todos for national exchange listing

NEW YORK, NY, REHOVAT, ISRAEL, March 17, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Todos Medical, Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening, diagnosis and immune support, as well as developing blood tests for early detection of cancer and Alzheimer’s disease, today provided a corporate update following the achievement of certain key sales and financial milestones.

“The second half of 2020 and the beginning of 2021 has been an incredibly exciting time for Todos,” said Gerald E. Commissiong, President & CEO for Todos Medical. “We took on the significant task of commercializing a new lab testing business with uncertain international supply chains and stiff competition, and we were able to carve out a niche of being able to timely provide labs with comprehensive lab-based COVID testing solutions that can scale to meet the requirements of local, state and federal contracting demands. Our focus on automation has created a commercial infrastructure able to deploy integrated solutions for labs looking to scale lab services for their core clients, and we believe the growing need for regional lab solutions in the United States will only make Todos’ turnkey solutions more attractive to existing and prospective clients.”

PCR COVID Lab Testing Business

The PCR COVID lab testing business is currently undergoing a rapid transformation, as the US begins to move toward serial testing programs to further reopen the economy and a return to in-person education for children. This places labs that were unable to automate testing processes at a severe competitive disadvantage in acquiring new clients as well meeting increasing demands for faster turnaround times from payers. The only solution to this growing problem is to automate lab PCR testing processes in order to improve efficiency and scale. Given Todos’ position of enabling labs to cost-effectively scale capacity in order to meet these new requirements for optimal reimbursement, we are now able to focus our new client acquisition strategy on those clients with strong demand from pre-existing and emerging relationships for COVID testing. We believe this will allow Todos to springboard our offering beyond PCR COVID Testing into new areas of molecular testing that are enabled by the automation Todos provides, and we intend to stay on the cutting edge of actionable tests with strong clinical utility that will enable physicians to provide improved patient outcomes with a lower overall cost of care.

Additionally, the Company is preparing to expand its offering into genomic sequencing in order to position its clients as Centers of Excellence in COVID testing, able to quickly reflex test confirmed PCR positive patients for variant determination. This capability will become increasingly important, especially as new variants emerge and as infected vaccinated individuals continue to spread the virus leading to evolutionary pressures to produce variants that will overcome current traditional receptor binding domain (RBD) antibodies. While the current focus is on the B.117 variant originally identified in the UK, the more troubling variants are those that seem to be able to evade existing vaccine immune response, such as the B.135 variant originally identified in South Africa. New variants have been discovered in New York City, California and most recently in Brittany, France, and we expect the proliferation of new variants to become an emerging theme as the pandemic enters a new phase alongside state-sponsored mass vaccination plans globally. The ability of high-capacity labs to become regional reference labs for COVID variant surveillance will become paramount as economies re-open, social interactions increase dramatically and domestic and international travel re-emerge as a normal way of life.

Further, Todos has made significant investments in helping to develop a novel mobile biosafety level 3 molecular laboratory infrastructure capable of doing high capacity (3,000+ tests/day) housed in a 20-foot container, able to be deployed anywhere in the world. This product offering was recently featured in the Wall Street Journal. We intend to focus on initially deploying in the New York City area before scaling deployment to other areas and we are working with prospective partners to bring this forward. This will allow for 6h or less turnaround times that will be suitable to cater to sporting events, theatre shows, international travel, nightlife, as well as several other industries where impulse decision making is critical for business. Whereas most ‘mobile labs’ really are sample collection sites that then have to send specimens for PCR testing at traditional brick and mortar labs, Todos’ solution actually performs that PCR testing on-site, thereby dramatically cutting down logistical issues that lengthen the reporting of results.

Todos intends to leverage its position in helping to build regional Centers of Excellence in COVID testing by focusing on monitoring of ‘long-hauler’ COVID patients and building testing menus that cater to the emerging areas of concern that could become more important for patient stratification and monitoring. These areas include hereditary cancer (CGx) testing combined with actionable biomarker monitoring where Todos has significant IP, including Todos’ TBIA platform and our pending acquisition of Provista Diagnostics for its Videssa Breast Cancer screening test, pharmacogenomic (PGx) testing designed to improve pharmaceutical prescribing success by improving patient outcomes as well as dementia screening, where Todos has intellectual property surrounding the LymPro Test™, a novel biomarker test monitoring cell cycle checkpoint integrity that drives the inappropriate attempts at cell division by post-mitotic neurons, a potentially actionable therapeutic target in Alzheimer’s disease.

Todos intends to focus on ways to leverage its existing testing business and its client base to deliver actionable high value testing that will improve outcomes while lowering cost of care.

3CL Protease Biology and Commercial Opportunities

Since the beginning of the pandemic, the primary focus of public health efforts has been on the development of vaccines in order to facilitate the process of creating herd immunity among the population. To date, this has led to major scientific achievements with several novel vaccines being granted emergency use by national and international regulatory authorities and the initiation of a mass vaccination campaign that is racing against the spread of potential new variants able to escape these vaccines’ immunological signature. With that said, one of the areas where significantly less progress has been made is in the area of antivirals, where new products aim to cripple the virus’ ability to replicate and thus provide the body with more time to mount an innate and/or acquired immune response.

In response to this emerging area of need, Todos partnered with NLC Pharma to advance a theragnostic program targeting the 3CL protease, a key enzyme required for coronaviruses to replicate and exit cells to infect other cells.

We have funded the development of a novel enzymatic 3CL protease diagnostic test that determines whether a coronavirus is actively replicating vs. inactively being cleared from the body by the immune system, as well as 3CL protease inhibitors that aim to slow the replication of the virus in order to be able to further support the body’s ability to be able to overcome a potential coronavirus exposure or infection.

We expect to soon be reaching critical clinical development milestones surrounding our lab-based 3CL protease test, as well as milestones surrounding the development of the related point-of-care or at-home diagnostic test. Concurrently, we are beginning to get commercial traction with the launch of our dietary supplement Tollovid™ that received a certificate of free sale from the US FDA in the third quarter of 2020, as well as a more concentrated version named Tollovir™, which Todos is advancing together with NLC Pharma through a more traditional regulatory pathway in Israel and eventually worldwide. We are hopeful this combined approach of testing and monitoring the 3CL protease and in parallel intervening to reduce its activity will yield improved clinical outcomes for consumers and patients.

Improved Financial Position and Path to National Exchange

The Company recently announced sales for January and February 2021 of $5.2M and $7.2M, respectively, and disclosed that it has retired approximately $3.2M in convertible notes. This increasing revenue base, coupled with significant debt reduction, is strengthening the Company’s financial position at a time where we see increasing demand for our automated lab solutions that will allow labs to become key players in their region. We intend to continue to look to expand our client base, as well as continue to strengthen our balance sheet through debt reduction and improved financial performance in preparation for a proposed listing of the Company’s shares onto a national stock exchange.

Conclusion

We remain focused on driving revenue growth and complementing our existing product offering with natural extensions. We believe that our establishment of a strong commercial infrastructure is the key to unlocking the value of our  intellectual property portfolio for our Company and its stockholders. We are excited about the path in front of us as we continue to build Todos Medical into a world class company and thank all of our shareholders for their ongoing support.

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 Todos Medical Ltd.

Headquartered in Rehovot, Israel, 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 entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista’s proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

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. Todos has formed a strategic partnership with Integrated Health LLC to deploy mobile COVID-19 testing 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 the reproductive mechanism of coronaviruses.

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 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 Investor Contact:

Richard Galterio

Ascendant Partners LLC

Managing Partner

732-642-7770

rich@ascendantpartnersllc.com

Todos Corporate Contact:

Priyanka Misra

Todos Medical

(917) 983-4229 ext. 103

priyanka@todosmedical.com