Todos Medical Announces Exclusive License & Distribution Agreement with T-Cell Protect Hellas S.A. for Tollovid® Products Covering 30 Countries in Europe

Rhea-AI Summary

Todos Medical, Ltd. (OTC-PINK:TOMDF) has secured an exclusive licensing and distribution agreement with T-Cell Protect Hellas S.A. for its Tollovid® and Tollovid Daily™ products across Europe. The agreement ensures a minimum of 500,000 bottles sold over 18 months, with an initial order of 50,000 bottles for Greece. Concurrently, T-Cell Protect is investing €1 million in Todos to aid the development of Tollovir, its antiviral candidate targeting coronaviruses, and seeks emergency use authorization for the product. Revenue generation from this agreement is expected to commence in the current quarter.

Positive

• Exclusive agreement with T-Cell Protect for European distribution of Tollovid products.
• Initial purchase order of 50,000 bottles from T-Cell Protect supports strong market entry.
• Investment of €1 million by T-Cell Protect to advance the development of Tollovir.
• Anticipated revenue generation from the agreement starting this quarter.

Negative

• None.

• The agreement calls for a minimum of 500,000 bottles in sales over 18 months
• T-Cell Protect to invest 1 million euros in Todos to support development of Tollovir, the Company’s 3CL Protease Inhibiting Antiviral Drug Candidate

NEW YORK & TEL AVIV, Israel--(BUSINESS WIRE)-- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, together with its joint venture partner NLC Pharma, Ltd., today announced that it has entered into an exclusive European licensing & distribution agreement with T-Cell Protect Hellas S.A. (T-Cell Protect or T-Cell) for a product based on its Tollovid® and Tollovid Daily™ 3CL protease inhibitor and immune support dietary supplements. The product will be marketed under the T-Cell Protect brand throughout 30 countries in Europe with the agreement calling for a minimum of 500,000 bottles in sales over 18 months. T-Cell has placed an initial purchase order for 50,000 bottles of the Tollovid Daily product that is expected to meet the demand of an initial rollout to a subset of the 11,000 stores located throughout Greece. More information about the product can be found at www.tcellprotect.com. Under the terms of the agreement, T-Cell Protect will purchase finished product at wholesale from Todos until such time as T-Cell Protect establishes manufacturing capabilities at a facility it currently operates in Greece to support the European market. At such time, Todos will then receive double-digit royalties on the sales of the licensed product manufactured by T-Cell Protect. The Company anticipates revenue to be generated from this agreement beginning in the current quarter.

Concurrent with this announcement, T-Cell Protect has made an investment of 1 million euros in Todos Medical to support the clinical development of Tollovir, the Company’s 3CL protease inhibiting antiviral drug candidate, and has also received exclusive marketing rights for Tollovir in Greece. T-Cell Protect intends on initiating the process for conditional Emergency Use Authorization of Tollovir to meet the increasing demand for the prevention and treatment of Coronaviruses, including COVID-19.

“We are very excited to introduce and launch this new daily dietary supplement to the European Market based on the Tollovid dietary supplement formulas for people looking for additional targeted immune support,” said Themis Filippopoulos, President & CEO of T-Cell Protect. “It was clear to us that we should focus on natural supplements because it's an area that we are aligned with and where we believe we can make a real difference to people's lives across the world. With consumers becoming increasingly more focused on immune support products that utilize natural ingredients, we believe that the formulations utilized in the Tollovid products will ideally position our new T-Cell Protect supplement products to capture a significant market share for the rising class of 3CL protease inhibitors. We are also excited to invest in the development of Tollovir, especially with the recent significant increase in interest in 3CL protease inhibitor antiviral products. We intend to work diligently with the team at Todos to secure market authorization as quickly as possible.”

Mr. Filippopoulos continued, “We expect to see very strong demand in Greece and the rest of the European market as people are looking for additional layers of immune support heading into the winter. Moving forward, we will be using this initial period for the rest of 2021 and early 2022 to prepare for a larger European rollout, initially in the 8 largest countries in Europe that have been equally impacted by the Coronavirus pandemic, where we have our strongest retail footprint after Greece, and thereafter the rest of Europe. We believe that the Tollovid family of products marketed under the T-Cell Protect brand will be extremely well received in Europe where people are focused on more natural ways to support and maintain healthy immune function. The potential for Tollovid and Tollovid Daily in Europe is quite significant and we are excited to bring them to market.”

“We believe this distribution agreement & related investment validates our commercial approach for our Tollovid and Tollovid Daily products,” said Gerald E. Commissiong, President & CEO of Todos Medical. “As we continue to make significant progress with our Tollovir 3CL protease inhibiting biology programs, we believe this promising therapeutic will have a significant impact on human health going forward.”

“We look forward to working with T-Cell Protect to bring our game-changing therapeutic product candidate Tollovir to market to treat patients with COVID-19 in Greece,” said Dr. Dorit Arad, Founder & Chief Scientific Officer of NLC Pharma, Todos’ 3CL biology joint venture partner.

For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.

About Tollovid® & Tollovid Daily™

Tollovid and Tollovid Daily are dietary supplement products, made from natural ingredients, that helps support and maintain healthy immune function, and are also 3CL protease inhibitor products based upon in vitro functional assays that show inhibition of 3CL protease activity. Tollovid’s 3CL protease inhibition activity release criteria is at least twice as stringent as Tollovid Daily’s 3CL protease inhibition release criteria. 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 twice daily immune support product that is designed to provide ongoing daily immune support for the person on the go.

About Tollovir®

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 is currently in 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.

About T-Cell Protect Hellas S.A.

T-Cell Protect Hellas (www.tcellprotect.com), based in Athens, Greece, is a European nutraceutical manufacturer and supplier of immune support dietary supplement products that is led by a world-class management team. The company has 11,000 stores throughout Greece. Mr. Filippopoulos, the founder of the company, has been in the natural supplement industry for over 35 years and has launched some of the most well-known products in Europe with his vast retail network relationships. T-Cell Protect is rolling out the Tollovid family of Products under the T-Cell brand throughout Europe.

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/.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211123006250/en/

Todos Corporate and Investor Contact:

Richard Galterio

Todos Medical

732-642-7770

rich.g@todosmedical.com

Source: Todos Medical, Ltd.

FAQ

What is the significance of the agreement between Todos Medical and T-Cell Protect for stock TOMDF?

The agreement secures an exclusive distribution of Tollovid products across Europe, promising a minimum sale of 500,000 bottles over 18 months, which is significant for revenue growth.

How much is T-Cell Protect investing in Todos Medical for Tollovir development?

T-Cell Protect is investing €1 million in Todos Medical to support the clinical development of Tollovir.

When is revenue expected to be generated from Todos Medical's agreement with T-Cell Protect?

Revenue generation from the agreement is expected to begin in the current quarter.

What are Tollovid and Tollovid Daily products marketed by Todos Medical?

Tollovid and Tollovid Daily are dietary supplements designed to support healthy immune function and are based on 3CL protease inhibition.