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Sunday, September 25, 2022

Todos Medical (OTCMKTS: TOMDF) Interviews Reveal Major Testing Plans

Todos Medical Inc.(OTCMKTS: TOMDF) has been extremely resourceful in the past couple of weeks winning the Monkeypox testing business through a focused customer outreach.  On Monday they announced their first two contracts for Monkeypox testing. Proactive Investors did an interview with the CEO and revealed a very deliberate plan of action to have the test validated within a couple of weeks and onboard new and existing customers. Their plan was to canvas the New York and New Jersey locations and get reference agreements from the small testing labs that have the demand but don’t want to scale up the infrastructure for Monkeypox. Todos’ Provista Diagnostics laboratory is highly automated and can accept this kind of demand.

https://www.youtube.com/watch?v=1QnDxWUfhqs

Local Monkeypox testing rival Applied DNA Sciences Inc. (NASDAQ: APDN) has also secured some significant relationships with the New York State Department of Health (“NYSDOH”) for a validated lesion-based Monkeypox test.  Yesterday RushNet, Inc. (OTCMKTS: RSHN) rushed into the Monkeypox diagnostic race expanding its infectious disease panel with a PCR test for Monkeypox. The stock rose 82% on a reference lab agreement rumored to be Ipsum Diagnostics which is also located in Georgia. The irony of the situation is that Todos Medical’s testing lab Provista Diagnostics is located approximately 5 miles from Helios Dx, RushNet’s lab.

Provista Diagnostics (OTCMKTS: TOMDF) – Best in Breed

In the early days of the COVID-19 testing, there was a big difference in the quality of the test and the type of test. The winners of the COVID-19 battle tended to be established names that had the testing capacity and the ability to turn it around quickly. Todos spent the past year building up its testing capacity.  Provista is a fully automated lab with a daily testing capacity of 25,000 PCR tests.  In comparison, Ipsum Diagnostics has a testing capacity of 10,000 tests per day. The potential revenues could be up to $100 per test—similar to COVID test reimbursements—once the government settles on a reimbursement price.  The revenue numbers are staggering for investors that believe in the narrative that Monkeypox can be spread via respiratory droplets, touch, touching infected clothing and objects instead of just the CDC’s main talking point of gay sex. Todos has an in-house testing capacity and is likely to have its test validated sometime next week. This positions it for another leg higher.

Saliva-Based vs Lesion Testing  – A Better Mousetrap

There are close to 10,000 Monkeypox cases in the United States and the majority of cases are in New York and California. There are also reports that kids have contracted it making it vital before kids go back to school.  There is likely to be a stampede of demand for community testing for back-to-school and Todos is perfectly positioned with their saliva-based test because it can pick up people before they are symptomatic, as opposed to lesion-based tests which are the standard. Obviously, lesion-based tests can only be taken once someone has developed lesions, which can start appearing 3-17 days after infection.  The value of early identification is being able to distribute the vaccine and potentially deliver therapies like Siga Technologies’ (NASDAQ: SIGA) TPOXX antiviral which was FDA-approved for Smallpox in 2018.

Advantage Todos

All these Monkeypox labs are going to have a lesion test but Todos will likely be only one of the few labs in the United States with the coveted saliva-based test.  Flow Health based in California launched its saliva-based test for Monkeypox. Applied Diagnostics and Roche (OTCMKTS: RHHBY) is also working with Monkeypox PCR tests, with the former initiating analytical validation and the latter rolling out a trio of tests already. However, it’s unclear whether these PCR tests are saliva-based. With an incubation period of a matter of weeks and certain studies suggesting asymptomatic spread is possible, saliva-based PCR testing (as opposed to anorectal PCR testing) would be the optimal way to noninvasively screen for Monkeypox.

First Long-COVID Panel

There is currently a dearth of diagnostic tests to prove that they have Long-COVID or to figure out what pharmacological interventions they could take to help their condition. The only lab with a comprehensive panel of cytokine tests besides Todos Medical is Bruce Paterson’s Incell DX.   From the beginning of Long COVID it has been difficult to assess what therapy to give as what give to which patients at which time is difficult without biomarkers. Todos has aggregated the most comprehensive set of biomarkers that have been associated with Long-COVID and as they receive more patient samples will whittle the biomarkers down to key ones to drive the long-COVID assay test.

Even Big Pharma is struggling to commercialize its neutralizing antibody therapies among the Long-COVID sufferers. Todos’ long-COVID panel would enable patients to characterize their disease as an active chronic infection while lacking endogenous neutralizing antibody production. This in turn would enable these patients to either pursue Tollovid supplementation if they have intact immune systems or to pursue neutralizing antibody treatments such as AstraZeneca’s (NASDAQ: AZN) Evusheld (potentially in addition to Tollovid supplementation or Pfizer’s (NYSE: PFE) Paxlovid) to help clear the disease if they are truly immunocompromised and cannot mount an immune response.

Investment Summary

There are 3 pure-play Monkeypox diagnostic companies.  There is a lot of excitement for APDN because they are NASDAQ listed and had quarterly revenues of $6.1 million and a $45 million market cap.  They also have a massive contract win with NYDOS and have a team that looks like they can get wins. RSHN is the new kid on the block and really all they have is a reference agreement with a Georgia lab with about $2.0 million in quarterly revenues and a $25 million market cap.

TOMDF is ideally positioned to run the table with its low $39 million market cap.  They have about $2.2 million in quarterly sales and expect a ramp into year-end.  Their saliva-based Monkeypox test is clearly superior to lesion-based testing giving them a niche in a market that is about to explode and become commoditized. School demand is set to skyrocket and TOMDF is squarely positioned to capture it all.  They also have a proprietary breast cancer test called Videssa and an Alzheimer’s test (Lympro) that can really avoid bad outcomes with early detection. The newest innovation is the Tollotest which could arguably replace or augment PCR with early COVID-19 detection of 1 – 3 days from exposure and before symptoms.  The elephant in the room is the $1.9 billion Tollovir asset that came into the company and has not been recognized by the market.  The company’s phase 2 drug Tollovir took dying off the table in the hospitalized setting in a randomized controlled trial that bested Gilead Sciences (NYSE: GILD)  $5.6 billion remdesivir. They are also actively pursuing Long Covid with a Long Covid Panel test and have reported on a number of case studies for active Tollovid users.

TOMDF stock has been depressed for months before the recent excitement for Monkeypox testing labs came into focus.  The toxic noteholder was active in the market on a daily basis for the better part of a year and never let the stock price breathe.  In a recent tweet, the CEO confirmed that the toxic noteholder was gone.  As soon as the size disappeared from the ask the stock started its march higher.  Given the Company’s Phase2 status of development, the pharma assets could be conservatively valued at $500 million and act as a great catalyst.  TOMDF is the best of breed in testing and has a pharmaceutical product that rivals Pfizer’s (NYSE: PFE) world record Covid-19 drug, Paxlovid.

Disclosure: we hold no position in TOMDF either long or short and we have not been compensated for this article.

Image by Gerd Altmann from Pixabay

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