Todos Medical in the business of saving lives with early disease detection

Develops proprietary technology for blood-based disease testing Offers a comprehensive suite of coronavirus (COVID-19) testing solutions Developing significant programs in cancer and Alzheimer’s diagnostics What Todos Medical does: Todos Medical Ltd (OTCQB:TOMDF) is in the business of saving lives by providing the tools necessary for the early detection of life-threatening diseases such as cancer and coronavirus (COVID-19). The Israel-based company believes blood-based tests are the future of cancer screening, using its core proprietary technology centers on testing blood cells using a Fourier-transform infrared (FTIR) spectrometer to turn biological information into data, and then using its patented Total Biochemical Infrared Analysis (TBIA) deep learning data analytics platform to mine the data in order to develop algorithms that are indicative of the presence of cancer, and the tissue of origin in the body where the cancer is located. The TBIA detection method is based on cancer’s influence on the immune system that triggers biochemical changes in peripheral blood. Todos Medical believes the primary advantages of the TBIA platform are the high accuracy (sensitivity and specificity) and low costs of goods sold (COGS), due to the biological information being captured using spectroscopy versus biological antibody capture methods that require the manufacture of multiple antibodies to capture a biological signature. The company and its academic partners at Ben Gurion University have also published research suggesting FTIR has the potential to be used to identify the presence of viral and bacterial infections, and it is currently evaluating how best to pursue its technology as it relates to the early detection of COVID-19. Todos Medical has established a comprehensive suite of testing solutions for addressing the COVID-19 crisis that includes its proprietary qPCR (quantitative polymerase chain reaction testing) testing kits, which amplifying a virus’ genetic material to a level where it can be detected in even the smallest of amounts, as well as its Point of Care (POC) Antibody Tests to determine if someone has antibodies from a past COVID-19 infection.   In addition, Todos Medical has decided to expand into the detection of Alzheimer’s disease, as it views Alzheimer’s as cancer of neuronal cells that are incapable of completing cell division due to their post-mitotic nature. How is it doing: Todos Medical has been making smart progress so far in 2021. On June 29, Todos revealed that it continues to make progress with enrollment of its Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, with its TolloTest biomarker being used for the first time as a surrogate biomarker to monitor patient response to treatment. In a second-quarter 2021 corporate update, the medical diagnostics and related solutions company also said its partners at NLC Pharma have identified an anti-inflammatory mechanism of action for its Tollovir dietary supplement to complement its 3CL protease inhibiting mechanism. Tollovid, a mix of botanical extracts, is being targeted to support healthy immune function against circulating coronaviruses.  Todos also said it has seen interest from several potential international distribution partners for Tollovid and expects to build a significant international distribution footprint in the second half of 2021 as it begins its initial roll-out of the dietary supplement. The company added it will seek distribution partnerships in jurisdictions where high-value dietary supplements are distributed by reputable pharmacies and other high-end wellness stores that can engage with consumers directly on the value and underlying science of their products. A month earlier, Todid announced that the US Food and Drug Administration (FDA) had granted it a new certificate of free sale for a second dosing regimen for Tollovid as a dietary supplement. Under the new certificate of free sale, the company is authorized to market Tollovid with a dosing regimen of 60 pills over a five-day period, equivalent to 12 pills per day. Tollovid, a mix of botanical extracts, is being targeted to support healthy immune function against circulating coronaviruses.  At the same time, Todos said it planned to use a portion of the proceeds from a $3.3 million fixed-price crossover investment with Yozma Group, a venture capital firm from South Korea, to launch Tollovid. With Yozma’s recent investment, Todos has raised $9.7 million in the crossover round since January 2021, said the company. On the M&A front, in April Todos unveiled the acquisition of Provista Diagnostics Inc, a US-based medical diagnostics that owns the intellectual property rights to proprietary breast cancer blood test Videssa and has a diagnostic lab currently performing coronavirus (COVID-19) PCR testing.  Under the terms of the agreement, Todos said it has acquired Provista from its private equity owner for $7.5 million, consisting of an initial cash payment of $1.25 million, the issuance of $1.5 million in Todos shares priced at $0.0512 each, the issuance of a $3.5 million convertible promissory note, and payment on for before July 1, 2021, of $1.25 million. The company said Videssa was developed to provide physicians with actionable information regarding breast cancer risk in women following an inconclusive mammogram result (BI-RADS III or IV), which primarily occurs in women with dense breasts.  Todos said it intends to build Provista into a highly automated lab capable of running multiple platforms in parallel to offer clients comprehensive testing solutions, especially in cancer, infectious disease, immune monitoring, and Alzheimer’s disease. Provista’s lab already has ELISA and PCR testing capabilities onsite. Away from coronavirus, in April Todos revealed that it had received a notice of allowance from the European Patent Office covering the use of the company’s proprietary Total Biochemical Infrared Analysis (TBIA) platform to diagnose cancers. The TBIA method uses blood - plasma and/or peripheral blood mononuclear cells (PBMCs) - to distinguish between patients with benign tumors versus malignant tumors in contrast to no tumors (healthy controls). The Todos patent application specifically covers methods for capturing consistent data from infrared spectroscopy readers, as well as the application of various artificial intelligence algorithm development methods to the data. Inflection points: Expect PCR COVID-19 testing kits to drive sales  Anticipates $60 million in revenue by the end of 2H 2021 Distribute Aditx’s immune-related AditxtScore COVID-19 scoring system Further news on acquisition of Provista Diagnostics What the boss says: “In light of the emerging Delta variant circulating widely in the US, there is now a clear need for novel COVID-19 antiviral therapies to protect the unvaccinated and those for whom authorized vaccines do not confer immunity, which includes a large portion of the elderly and those taking immune suppressants, against COVID-19 infection,” Todos Medical CEO Gerald E. Commissiong said in the company's June 29 statement. “The Biden administration recently underscored this need by pledging to invest $3.2 billion into research for COVID-19 antiviral therapies, similar to the US government’s investments into COVID-19 vaccines in 2020 at the beginning of the pandemic. “We believe this government recognition of the need for antivirals will provide a significant tailwind for the development of our Tollovir antiviral that is currently undergoing a Phase 2 clinical trial in Israel with plans progressing rapidly to expand the clinical development program to India," he added. Contact the author: jon.hopkins@proactiveinvestors.com