· 3CL Pharma prepares to crowdfund for Long COVID trials of Tollovir™ and Tollovid™
· CEO to Present at Emerging Growth Conference on Wednesday, October 12, 2022 at 2pm ET
New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - October 11, 2022 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today provided a corporate update for shareholders. The company will give a presentation at the Emerging Growth Conference on Wednesday, October 12, 2022 at 2:00pm EST.
Event: Emerging Growth Conference
Presentation Date: Wednesday October 12, 2022
Time: 2:00pm Eastern Time (ET)
Register to Attend: https://goto.webcasts.com/starthere.jsp?ei=1571724&tp_key=4274f13b29&sti=tomdf
Commercial PCR Testing Business
The Company’s CLIA/CAP-certified clinical testing lab Provista Diagnostics recently completed a successful launch of its suite of PCR testing services for Urinary Tract Infection (UTI), Wound, Respiratory Pathogen (RP), Gastrointestinal (GI) and Sexually Transmitted Infections (STI), COVID and MonkeyPox in Dunnellon, Florida where it onboarded multiple providers including urgent care centers, specialty care practices such as podiatry, skilled nursing facilities and hospitals. The focus of Provista’s commercial operations has transitioned beyond high volume COVID testing towards integrated genetic testing solutions with fast turnaround time and more insightful treatment recommendations. This empowers providers with a PCR biomarker data toolkit that improves patient outcomes and reduces the overall cost of care. Our soft launch was successful and we learned a number of lessons which enable us to prepare marketing collateral for the full-scale launch in the broader rural area around Dunnellon which is also underserved by the major lab testing companies. Once this full-scale launch is complete, we intend to duplicate this effort in other strategic rural underserved areas around the United States where we expect our program can provide similar results. The Company expects the new PCR testing business to become material to the Company’s financials in the fourth quarter of 2022 and will initiate protocols to add cancer genetics and pharmacogenomic testing to further improve its genomics offering.
The Company intends to remain on the leading edge of pandemic preparedness with its high-capacity PCR COVID and MonkeyPox offerings. We are now preparing to submit an Emergency Use Authorization application to the US FDA for a saliva-based MonkeyPox diagnostic test, as well as continue to build towards wastewater testing capabilities for COVID, MonkeyPox, Polio, and other pandemic pathogens which we expect to become more common in public wastewater settings, as well as septic tank settings for homes and edifices not connected to sewer systems.
Long COVID is a poorly quantified heterogenous disease that requires in depth testing and analysis to help manage the significant symptoms and underlying viral persistence driving the disease pathophysiology. Our Long COVID Panel partnership with Amerimmune Diagnostics was established to monitor immune system markers relevant to T cell exhaustion, B cell activation, and neutralizing antibody production. Profiling Long COVID via biomarkers empowers clinicians to more closely monitor the outcomes from treatment and supplement recommendations. As our understanding of Long COVID improves we plan to add key markers related to cardiovascular (CV) risk assessment and viral persistence. Sample collection is available through Quest Diagnostics collection network in all states with the exception of New York and California, and can be ordered through a patient’s primary care physician. As we begin to raise awareness for this key tool for Long Haulers, we expect they will become more aware of our antiviral supplement Tollovid.
Development-stage Proprietary Testing
The Company intends to commercialize the Videssa breast cancer blood test in 2023. We have collected the first 40 blood samples from an up to 750 patient study from participants being enrolled in a clinical trial in Mexico. These samples should allow us to complete the analytical and clinical validation for Videssa as a laboratory-development test (LDT) and launch at Provista. The blood work will also allow for ex-US regulatory authorization and set the stage for a pivotal study for Videssa to achieve clinical utility data in the United States for Videssa in breast cancer.
Upon the launch of Videssa, the Company will be positioned to generate patient-matched data for its Total Biochemical Infrared Analysis (TBIA) artificial intelligence (AI) cancer blood testing platform. This will allow TBIA to generate matched relevant patient datasets to perfect its algorithms and produce sufficient data to allow for submission to the US FDA. While in development alongside Videssa, we believe that TBIA will be able to rapidly accelerate its path to market for all cancers, including breast cancer. Additionally, the Company’s Alzheimer’s blood testing platform LymPro expects to read out on key data related to correlation with amyloid PET scan in the fourth quarter of 2022.
The Company recently formed Todos Botanicals to serve as the long term solution for manufacturing of our 3CL Pharma subsidiary’s Tollovid product(s). With these manufacturing capabilities now in-hand, we are also able to manufacture other botanical products, including CBD and other 0% THC products, that could ultimately prove complementary to Tollovid in terms of immune support dietary supplements. We recently entered into an agreement with Nerd Hemp to supply Tollovid and white-labeled CBD products under a $50M supply agreement. The products are being deployed through Nerd Hemp’s automated retail machines, initially contracted to be deployed into 5,500 locations throughout the United States. The Company is now finalizing its first purchase order under the agreement and is also steadily building up its CBD white-label customer base.
3CL Pharma majority-owned subsidiary
The Company is now in the final stages of preparing the crowdfunding campaign for its majority owned subsidiary 3CL Pharma that is developing the dual-mechanism 3CL protease inhibitor and CCR5 antagonist drug candidate Tollovir™, the 3CL protease inhibitor dietary supplement Tollovid™ and our protease persistence diagnostic test TolloTest™.
Tollovir has generated data from a Phase 2 trial in hospitalized patients that showed benefits in mortality, time in the hospital, oxygen saturation levels and immune biomarkers. The Company is preparing for an extension of its current Phase 2 study to gather sufficient data to engage with regulators related to an Emergency Use Authorization for hospitalized COVID patients to reduce death. Concurrently, we have received significant interest from institutional investors and not-for-profit organizations in trials for Tollovir in Long COVID and we have a trial plan in place to initiate Phase 2 development largely as a result of the positive feedback patients have provided on the supplement version, Tollovid, which is being used by Long COVID patients. A Phase 2 trial is also planned for Tollovid. We have also seen an increased interest in the use of Tollovid as an herbal remedy for settings where Pfizer’s drug Paxlovid is not authorized to be used, including in younger vaccinated individuals, after Paxlovid 5-day treatment period has ended and in pediatric cases under pediatrician supervision.
We are continuing to pursue strategic options for the further development of the TolloTest as a point-of-care viral persistence test and intend to first bring the technology to the United States for validation at Provista and for inclusion in our Long COVID Panel partnership with Amerimmune.
New York Stock Exchange listing
The Company is now pursuing a national stock exchange listing with the New York Stock Exchange through the NYSE American Exchange. We expect to provide further details in the weeks ahead.
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 examines 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, Long COVID Panel analyses, and Provista's proprietary commercial-stage Videssa® breast cancer blood test. More information on Provista is available at www.provistadx.com.
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 formed the Israeli-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March of 2022 to consolidate all of the intellectual property surrounding 3CL protease–based diagnostic testing and development of 3CL protease botanical and pharmaceutical inhibitors that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’ brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid™ in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovir™, while also developing the 3CL protease diagnostic TolloTest™.
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.
Todos Corporate Contact:
Daniel Hirsch CFO
917-983-4229 x 104
Todos Press Contact: