With the FDA approval of the Pfizer-BioNTech vaccination many biotech stocks moved higher. Leading the microcaps was Todos Medical (OTCMKTS: TOMDF). Shares of leading vaccines makers Pfizer (NYSE: PFE), BioNTech (NASDAQ: BNTX), and Moderna (NASDAQ: MRNA) moved higher on the news due to anticipation of future approvals. The White House immediately took advantage of this approval to pitch the vaccine after hours in a press conference with President Biden claiming that COVID-19 was now a pandemic of the unvaccinated. President biden said
“Those who have been waiting for full approval should go get your shot now.” – Pres Biden
All this attention on vaccines trickled down to some promising therapeutics drug developers. One of the most interesting plays of the day was COVID-19 diagnostics and pharmaceutical maker Todos Medical (OTMKTS: TOMDF) which surged on record volume of 74 million shares and ended the day up a whopping 103%. Before the market opened the company announced that their lab in Georgia had a fully validated neutralizing antibody test called cPass which can help in quantifying a person’s current level of immunity to the Delta Variant. Their cPass test has an EUA and their lab is the only fully automated lab which can do up to 1500 tests daily. However, what really moved the stock was an interview on FOX Business with Stuart Varney.
Volume before the interview was a brisk 10 million but shortly after the interview volume started surging. Investors appeared to connect the dots that the recent debate over the policy to administer the booster shots was coming under heavy fire and testing may be the saving grace. The Biden administration is trying to walk a fine line between encouraging new people to get a shot and protecting those who were vaccinated from the delta variant. They also unleashed a new program to make booster shots widely available to those who reach the 8 month mark. In the interview the CEO of Todos Medical let out a bombshell that studies in Israel where the Delta Variant already surged found out the immunity from the virus wanes after 6 months and that there is potentially this 2 month window where people may be lacking protection. The debate on boosters was further complicated by a WHO announcement recommending a delay on boosters to prioritize under-vaccinated countries.
What is clear is that testing is making its way into the narrative and since TOMDF appears to be the largest lab with neutralizing antibody tests they would be the direct recipient. Speculation seems to be brewing that since cPass is the only EUA approved test capable of medically determining if a booster is appropriate the Biden Administration may have to compromise. This means that booster shots may only be allowed with a cPass test that confirms the need. This could be a game changer for the diagnostics company.
Provista Diagnostics is the name of the testing company, and it is a subsidiary of Todos Medical. In their latest press release, Provista indicated that they have the capability to do up to 20,000 PCR tests daily which equates to $2 million in sales daily or $60 million monthly. With respect to the cPass Neutralizing Antibody test it appears that they can do up to $3.6 million in sales monthly. Investors need to keep in mind these estimates assume maximum utilization. The company closed the day with a market cap of approximately $25 million which represents about 10% of its fair value using comparable drugs.
Todos has a diagnostics business that is slated to do $50 million in revenues this year and the stock barely trades at a multiple of projected sales including the massive bump today. Todos also has joint venture agreement with NLC Pharma for Tollovir which is a phase 2/3 oral antiviral which by many estimates would be valued in the range of $250 – $400 million. Last year Roche Holdings (OTCMKTS: RHHBY) licensed the ex-US rights of Atea Pharmaceuticals (NASDAQ: AVIR) for an oral antiviral for $350 million. The value gap on the pharmaceutical side is enormous.
If investors are curious about the reason for the massive valuation gap that currently exists, it can be traced back to a restructuring done in January 2021. The company consolidated legacy convertible notes into one primary holder who has been trickling out his investment over the past 6 months. These stock sales have been weighing heavily on the shares, but the price action today indicates that he has finished his conversion. The stock is back up to the price point where their strategic South Korean investor Yozma Global Genomic Fund put in a sizable investment in January and April 2021. Both investments were at $.06 and represented a premium to the market price at the time.
While TOMDF is more of a pure play in COVID-19 Enzolytics (OTCMKTS: ENZC) is more of a focused play in HIV with exposure to COVID-19 as a potential label expansion in the future should they get their HIV drug approved. Most of the excitement surround ENZC is coming from an initiation of their HIV trials. One of the things that makes their drug ITV-1 stand out from the pack is the drugs safety profile. ITV-1 is really a form of immunotherapy that strengthens the immune system. Most of the HIV drugs are part of the Highly Active Antiretroviral Therapy (HAART) which does its best to use chemotherapy in multiple ways to disrupt the proliferation of the HIV virus. The point to make is all the drug has to do is keep the viral load at bay and the safety profile will be what drives the approval process forward.
There are some major catalysts that have impacted ENZC. The letter of intent with Creative Biolabs to license anti-HTLV-1 was a major step forward in advancing the clinical trials by completing the commercial manufacturing of the drug. ENZC was able to leverage the financial balance sheet of Creative Biolabs in order to get the production manufacturing ready for sale. In addition, the LOI provided for Artificial Intelligence to screen for conserved sites on the virus and potentially use them in the development of a compound. They have identified these conserved targets for HIV, COVID-19, HTLV-1, Influenza-A, Influenza-B, H1N1 influenza, Herpes Zoster, and many more.
The value proposition of ENZC can be found in its platform technology which has the capability to produce monoclonal antibodies that can target the conserved regions of various viruses. According to their last press release they have a partner willing to fund the initial round of production. Clinical trials in HIV are due to start shortly in the European Union. The key
The market cap is $357 million and there are 2.8 billion outstanding shares out of 3.0 billion authorized. The potential dilution at this point is minimal which means the stock could run if a small amount buying hits the tape.
Therapeutic Solutions International (OTCMKTS: TSOI) has been on a tear after the FDA gave it the go ahead to start its pivotal Phase 3 trial for COVID-associated lung failure using its JadiCell universal donor stem cell treatment. Since that kickoff announcement it has been a news bonanza that keeps building on the story. They are also planning on filing an EUA which is a very bold initiative given the past failures of other COVID-19 companies like CytoDyn Inc. (OTCMKTS: CYDY) which appears to have a drug that works but was denied due to their lack of data. The treatment is called Jadi Cell and they had excellent clinical trial data supporting their EUA application. In a randomized controlled clinical trial the JadiCell treatment showed 100% effectiveness in saving COVID-19 ICU patients under age 85. This was the rationale for the application.
The story continued to build with the all encompassing Mechanism of Action (MOA). At the heart of the MOA are the CD73 expressing T-Cells. They were able to show that a small dose of IL-2 had a noticeable effect in expanding the class of this type of cell. Many stem cell therapies have been struggling for years to overcome the body’s natural suppressor function and the stem cell desire to differentiate quickly. Donor stem cells simply don’t last long in the body due to suppression so by expanding the colony of stem cells it allowed for a durable response in these studies.
The company has a market cap of $270 million with 3.5 billion authorized shares. There are 2.2 billion shares issued and outstanding. The company made a statement in a blog post that dilution was something that they were going to try to avoid by going after government funding. Sticking to this mindset could allow the stock to continue its run higher unimpeded.
The rising tide in COVID is managing to lift many COVID stocks. These focus stocks have tremendous potential to outperform the rest of the market. At the core of their story is a platform technology. When looking at biotech investments it is essential that the underlying science that underpins the company is sound. Having this fundamental element in place derisks the stock in the long run. These biotech runners are set to scale new heights so make a place in your portfolio for them. Investors should pay special attention to TOMDF because that stock was depressed due to structural reasons and NOW it’s poised for an epic run with a short term target price of $.34 which represents a $250 million market cap now that the overhang of the seller is gone.
Disclosure: we hold no position in TOMDF ENZC TSOI either long or short and we have not been compensated for this article.