CEO on Twitter - 7/1/21

Todos Medical Update Unveils Plan to Take on Pfizer and $3.2 Billion Antiviral Prize




https://emerginggrowth.com/todos-medical-update-unveils-plan-to-take-on-pfizer-and-3-2-billion-antiviral-prize/

By Chris Long - June 29, 2021

Todos Medical, Ltd. (TOMDF) just released a corporate update of what amounts to a very credible plan to take on pharma giant Pfizer (PFE) in a race for Biden’s $3.2 billion quest for an antiviral. Since their clinical trial is in Israel the recent surge of the Delta variant has increased hospitalization which would trickle down to increased enrollment in their trial. Supplementing their trial is a collaboration with India that has “near-immediate access to 6 clinical sites that have previously enrolled patients” which could also mean an acceleration of enrollment that ultimately lands them in a position to start recruiting for a phase 3 in India and to seek an Emergency Use Authorization (EUA). For a company with a 1 in 4 shot at a $3.2 billion prize the market is grossly undervaluing it at $20 million.

Tollivir Approval Trajectory

Not far off message from the recent CNBC remarks of Pfizer’s CEO Albert Bourla was the CEO of Todos Medical, Gerald Commissiong, who said “we believe that Tollovir may ultimately represent a new standard of care in the treatment and management of COVID-19.” We have never seen this type of warning shot against big pharma and Albert Bourla whose employees are “treated almost like a hero” for being the first to come to market with a vaccine. This bold statement, however, was backed up by more color on the Mechanism of Action (MOA) that seems to indicate there is a dual mechanism. While Pfizer’s drug just targets the antiviral part of the disease Tollvir also has an anti-inflammatory component which in theory makes it superior in the sense that it can treat people over a larger course of the disease. In a head to head comparison against Pfizer’s drug, Tollovir would be effective on a much larger patient population. The company explained their evidence of this was in the reduction of the biomarker C Reactive Protein (CRP) which cannot be explained by a reduction in only viral load. Pfizer is one clinical trial phase behind Todos, and expects an approval on their 3CL protease inhibitor by the end of this year. If Tollovir is to beat Pfizer then a phase 3 clinical trial would need at least their interim readout before the end of the year.

Immune Supplement – FDA Approved

Todos also has an immune supplement called Tollovid which represents about 1/3rd of the active ingredient in Tollovir. Tollovid, the supplement, earned the certificate of free sale for a 5-day dosing regimen from the FDA in May. The active ingredient in Tollovid is the same as Tollovir which dramatically increases the likelihood of approval from a regulatory perspective assuming there is no dose limiting toxicity that has not already been discovered. The company opined

“WE BELIEVE THIS AUTHORIZATION UNDERSCORES THE EMERGING NEED IN THE MARKETPLACE FOR IMMUNE SUPPORT SUPPLEMENTS SUPPORTED BY STRONG SCIENTIFIC AND SAFETY DATA, AS WELL AS PROVIDES INTERNATIONAL REGULATORY AUTHORITIES WITH A HIGH DEGREE OF COMFORT OF TOLLOVID’S SAFETY PROFILE.”

The company also announced their launch of a retail website called www.myTollovid.com which allows the purchase of the immune boosting supplement directly from the company. They also are expanding their footprint internationally and these distribution partners would likely fund the expansion to overseas markets. Expected distribution deals should be within the current quarter.

Diagnostic Business Revamped

It’s already clear that both PFE and TOMDF believe that 3CL protease inhibitors are safe and effective against COVID-19 and variants. Investors that want to wrap their heads around why, need to look no farther than the Tollotest that Todos developed to measure 3CL protease enzymes. The reason 3CL protease is such a powerful biomarker is because it is only present in the body if the person has an active coronavirus. Now that can mean any coronavirus but in this day and age COVID-19 is prevalent and this test could tell if you are still infectious because without the 3CL protease there is no active infection. This also might eventually replace the real time PCR tests that measure spike protein regardless if they are attached to an infective virus or a viral fragment that has been destroyed. This is a very big part of their strategy going forward with the diagnostics business

There was also an update on the CLIA lab that they acquired called Provista. The salient news was that they invested in throughput and screening allowing them to be much more efficient at processing samples. This should allow them to get more lucrative contracts based on volume. The schools are a prime example of potential business as tests would be required for admittance. This move also positions themselves to test for the presence of the neutralizing antibody. Those that took the vaccine 6 months ago will want to know if they still have protection or need a booster shot as the delta variant prevalence rises which is expected to be at over 50% by mid July. These are a few of the trends that will push the testing business back into the spotlight. The bottom line is that the moves they made position them to double their reimbursement revenues.

8-K Overreaction to NASDAQ Uplisting Planning

This morning the market reacted very negatively toward an 8-K filing last night that laid the foundation for an uplisting to the NASDAQ. While an increase in the authorized shares is almost always taken as a negative because it allows the company to get extremely loose in diluting shareholders interests, the CEO was quick to dismiss that idea in the comment of the update. Commissiong said:

“IT IS IMPORTANT TO NOTE THAT UNDER ISRAEL LAW, THERE CAN ONLY BE A PROPORTIONAL SPLIT OF ISSUED AND AUTHORIZED SHARES, MEANING THAT IF THERE IS A REVERSE SPLIT OF THE OUTSTANDING SHARES 1:10, THEN THERE MUST BE A PROPORTIONAL REVERSE SPLIT OF THE AUTHORIZED SHARES BY THE SAME 1:10 RATIO.”

The purpose of the reverse split and increase in authorized shares is to eventually achieve compliance in obtaining an uplisting to the NASDAQ. Having this latitude to reverse split the stock gives them a better negotiating position with NASDAQ. A shareholder meeting is to be held on July 26th, which means an uplisting could happen in the August time frame that seems to correspond with their launch of a clinical trial in India.

Investment Summary

Todos Medical has a credible plan to get the drug to market or at least get it to the stage that Merck’s (MRK) drug Molnupiravir got to when it was awarded a $1.2 billion dollar purchase order from the government. The biggest risk is Todos Medical is their ability to raise money in a quick and efficient manner to capitalize on the market opportunity. The uplisting looks like it’s on track and should have investor backing. Most of the programs they have in place seem to be self funding like the crowdfunding initiative with Tollovid which could do really well thanks to all the publicity that PFE is giving to its 3CL protease inhibitor which in theory might be an early cure to COVID-19.

The company is very cognizant of dilution when you look at the statements surrounding the stock split and efforts to “mitigate potential dilution.” The stock has a $20 million market cap and is frustratingly low to current shareholders that understand the potential. The overhang seems to be from convertible note holders that really don’t understand the true value of what they are holding. These noteholders might be very close to finishing their liquidation based on a volume analysis of the shares traded over the past quarter. Their conversion price basis is at the current market cap which is why the stock volume tends to eventually dry up after a sell off. Investors that understand there is limited downside and the only reason for the depressed stock price is a structural investor myopically interested in liquidation will be well served buying shares. Investors who capitalize on this structural inefficiency could see TOMDF stock price vaulting in the near future as investors who understand that investment in TOMDF is akin to a lottery ticket where you get your money back if you lose. The government backed race to find an antiviral represents a $3.2 billion prize and there are only 4 tickets currently in circulation , MRK, PFE, Atea Pharmaceuticals (AVIR), and TOMDF.

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Todos Medical Provides End of Second Quarter 2021 Corporate Update

https://investor.todosmedical.com/news-events/press-releases/detail/115/todos-medical-provides-end-of-second-quarter-2021-corporate

• Tollovir™ COVID-19 anti-viral scientific and clinical development progressing in Israel with plans progressing rapidly to expand into India in non-hospitalized setting

• Tollovid™ dietary supplement focusing on international distribution partnerships

• Videssa™ breast cancer and LymPro™ Alzheimer’s blood tests are being prioritized as key proprietary diagnostic programs and are the centerpiece of Nasdaq listing strategy

• Company to leverage Provista Diagnostics CLIA lab by focusing on sales of COVID-19 PCR and neutralizing antibody testing services to increase margin on revenues

NEW YORK, NY, and TEL AVIV, ISRAEL, June 29, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today provided a corporate update to the marketplace following the filing of its quarterly financials for the first quarter of 2021.

“The first half of 2021 has seen a dramatic shift in the COVID-19 marketplace in the United States,” said Gerald E. Commissiong, President & CEO of Todos Medical. “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. 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. We are also optimistic about the interest we have seen from several potential international distribution partners for our dietary supplement Tollovid that provides immune support as a protease inhibitor. We expect to build a significant international distribution footprint in the second half of 2021 as we begin our initial roll-out of this important product.

“As the COVID-19 pandemic remains very fluid, the US has focused its efforts on vaccination in the first half of 2021, which has largely been successful in bringing down daily COVID-19 case numbers and has given confidence to state governments to re-open economies with limited COVID-19 restrictions. We see this vaccination focus creating a significant new opportunity for our recently acquired CLIA/CAP certified lab, Provista Diagnostics. Through Provista we are focusing our COVID-19 diagnostic testing strategy to prioritize delivering diagnostic services, including PCR and neutralizing antibody testing, thereby expanding beyond simply distributing testing supplies. This expansion into testing services serves to diversify our business into higher margin revenue in the COVID-19 space, as well as help us to expand our business development opportunities with the labs we work with by providing reference lab testing services as we increase Provista’s automated testing capabilities. We are especially excited to begin our expansion into COVID-19 neutralizing antibody testing that receives nearly double the reimbursement vs. traditional COVID antibody testing (~$79 vs. ~42). We believe neutralizing antibody testing will become more critical to help determine robust COVID-19 immunity.”

Mr. Commissiong continued, “Going forward, the Company is concentrating its extensive investment in automated lab equipment to the benefit of Provista. We have begun working to substantially expand Provista’s lab sales team to build relationships with healthcare providers prescribing tests to patients, as well as provide reference lab testing services to CLIA labs who are looking to deprioritize internal COVID-19 testing. Due to our lab automation infrastructure and distributor pricing for our reagents, we believe that we can compete for large volume COVID-19 testing business, and we expect to see a resurgence in this testing in the fall as schools seek to re-open in classroom learning for K-12 and college-aged students who are the least likely groups to have been vaccinated, as well as among employers. We believe that the significant strides we have made at Provista will position the Company to accelerate growth into 2022 and build significant long-term value for the benefit of our stockholders.”

Tollovir™ Phase 2 Scientific and Clinical Development Programs

We are continuing to make progress with enrollment of our Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, with our TolloTest™ biomarker being used for the first time as a surrogate biomarker to monitor patient response to treatment. The recent resurgence of COVID-19 in Israel, driven by the Delta variant, has increased hospitalizations in both the vaccinated and unvaccinated, and has led to a reimposition of indoor mask mandates to help curb the spread. While the total number of hospitalized patients remains relatively low, we see the Israel program as critical to our overall clinical development strategy because the clinical investigators we are working with in Israel have tremendous international collaborators who think quite highly of the science emerging from Israel, making them willing to collaborate on broader international clinical development programs that will likely be needed for the ultimate regulatory approval of Tollovir.

As part of the ongoing scientific effort to further elucidate the mechanisms that have enabled Tollovir to achieve its very positive early clinical results, our partners at NLC Pharma identified an anti-inflammatory mechanism of action of Tollovir to complement its 3CL protease inhibiting mechanism. This dual mechanism of action helps more readily explain the significant reduction in symptoms and the biomarker C Reactive Protein (CRP) that was documented in the earliest clinical COVID-19 data sets produced in Israel, which could not be explained by a reduction in viral load alone likely caused by Tollovir’s 3CL protease inhibiting mechanism. As a result of these quite complementary 3CL protease inhibiting and anti-inflammatory mechanisms, given that we are in a race with Pfizer to get to market with the first 3CL protease inhibiting COVID-19 antiviral for which therapeutic claims could be made, we believe it is critical to rapidly expand our clinical development programs to gather additional data in multiple clinical settings to demonstrate Tollovir’s ability to help patients suffering from COVID-19.

As part of that effort, our Israel-based Principal Investigators have introduced us to physician clinical collaborators in India who work with a highly-respected local Clinical Research Organization (CRO) with extensive experience in running COVID-19 clinical trials. This CRO has near-immediate access to 6 clinical sites that have previously enrolled patients into clinical trials for hospitalized COVID-19 patients and 5 clinical sites that have previously enrolled patients into clinical trials for non-hospitalized COVID-19 patients. We believe this CRO relationship will allow for the rapid expansion of enrollment for Tollovir’s clinical data acquisition, and allow us to quickly prepare for a Phase 3 international clinical development program to support regulatory approval under Emergency Use Authorization. We are working closely with NLC Pharma to finalize the agreements needed to bring these clinical programs forward, with the expectation that we will be in a position to begin dosing patients in India in August 2021. We do not expect significant expenses to be associated with the clinical program in India at least through the completion of Phase 2 studies.

We believe that Tollovir may ultimately represent a new standard of care in the treatment and management of COVID-19 patients, and we are working diligently to make certain its clinical development execution will lead to the creation of clinical data that will be extremely valuable for regulators seeking to approve the product’s use, as well as potential partners who may become further interested in the program as additional clinical and scientific data emerges.

Tollovid™ distribution plans

We are very pleased that the Company’s dietary supplement Tollovid received FDA authorization for a new 5-day dosing regimen in April 2021. We believe this authorization underscores the emerging need in the marketplace for immune support supplements supported by strong scientific and safety data, as well as provides international regulatory authorities with a high degree of comfort of Tollovid’s safety profile. We also recently launched the website www.myTollovid.com where Tollovid can be purchased online directly from Todos Medical in the United States, creating a new distribution channel beyond The Alchemist’s Kitchen initial retail footprint for the product.

Going forward, the Company sees two critical areas of expansion in the advancement of Tollovid:

1. International 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; and

2. US marketing campaign to dramatically expand awareness of Tollovid for consumers and distribution partners who are looking for products to further support immune function.

The Company is making steady progress in identifying international distribution partners for Tollovid, and we expect to begin to make announcements on this front in the third quarter of 2021.

With regards to a significant US marketing campaign, the Company is evaluating the best path forward to utilize our resources and create demand in both the investor and consumer community for Tollovid. As part of that effort, we believe that independent funding to support sales and marketing for a Tollovid-focused entity, potentially through crowdfunding, may be the best use of the existing Tollovid commercial material and the best financing path forward in order to mitigate potential dilution of using Todos resources on a marketing campaign. The Company expects to make progress towards independent funding for Tollovid in the third quarter of 2021.

Todos Corporate Profile: Videssa™ Breast Cancer, LymPro Alzheimer’s blood tests and Revenue

As the Company engages with the investor community and NASDAQ as part of a potential listing process, it is important that we crystalize our corporate profile and begin to prioritize our resources towards the areas that will create long-term value for shareholders. For this reason, we are moving in the direction of packaging Tollovir, TolloTest, and Tollovid, three extremely exciting programs that Todos Medical has incubated as part of its push into COVID-19 at the height of the pandemic, into a separate unit of programs that will be ultimately be self-financed, spun-off, partnered and/or sold in order to create maximum shareholder return on the investment made as they make their way through their development and commercialization cycle.

Going forward, the Company will be focused on bringing forward the crown jewel from its recent Provista Diagnostics acquisition: the Videssa Breast Cancer blood test. We believe Videssa could ultimately represent a new standard of care in certain areas for breast cancer screening, a marketplace that remains dramatically underserved both domestically in the US as well as internationally, and for which Todos Medical is extremely well positioned to disrupt. Because of the extensive peer-reviewed clinical data already published on Videssa, the next key milestone is to analytically revalidate the assay at Provista and engage with Key Opinion Leaders on the best intended use to initially launch the product based on the data we have already gathered. Our Chief Medical Advisor Dr. Jorge Leon has become much more heavily involved in the Videssa test over the last several weeks as we have been making key decisions on the corporate profile Todos is presenting to NASDAQ. He has become a very strong advocate for focusing the Company on Videssa where we can begin to generate significant clinical utility data for Videssa in the next 6-12 months and potentially significantly disrupt the $7 billion breast cancer screening market.

Additionally, the recent approval of Biogen’s Aduhelm™ amyloid beta antibody has significantly increased the value of the Company’s proprietary LymPro Alzheimer’s blood test, that has shown to extremely strong correlation data (p=0.000002) with amyloid beta PET imaging SUVR scores in preliminary studies performed by our partners at Leipzig University in Germany under the direction of Dr. Thomas Arendt. We believe that payers will require patients to undergo amyloid PET imaging prior to prescribing Aduhelm. In the effort to identify those patients who are likely to be positive for PET imaging, and mitigate the negative side effects of the radioactive materials used in the conduct of amyloid PET imaging testing for those unlikely to be amyloid positive, payers will want to pre-screen patients with minimally invasive tools that could give them a higher degree of confidence that a patient will be amyloid beta positive by PET imaging. LymPro could fill this emerging need for physicians and payers, as well as fulfill this area of need for pharmaceutical companies seeking to enrich their screening for clinical trials. Given the $250 billion marketplace for Alzheimer’s that is expected to grow rapidly as new treatment options continue to get market authorization in the US, we believe LymPro could also help drive mid-term value for Todos as progress is made.

In support of the Company’s proprietary Videssa and LymPro tests, Todos will continue to be focused on generating revenue through the sale of diagnostic tests, with a greater emphasis being placed on expanding diagnostic testing services provided to the marketplace through Provista’s CLIA/CAP certified lab due to the increased margins vs. the reagents sales business. The reason why lab services represents a much more attractive business than reagents sales is because the margins per test are 10-15x higher per test on revenues that are 4-10x higher per test than selling regents. From a financial forecasting standpoint, free cash flow generated from $10M in sales from lab sales of COVID-19 testing services would be close to $7M on the sale of 100,000-125,000 tests, whereas free cash generated from $10M in sales of reagents would be $4M on sales ~500,000 tests. As such, we see the acquisition of samples for Provista as the next natural evolution in our CLIA testing strategy in order to support the ultimate commercialization and market acceptance of our proprietary Videssa and LymPro blood tests.

Long-term, we expect Todos core TBIA artificial intelligence testing platform that currently has a CE Mark for Breast Cancer and Colon Cancer to be able to replace Videssa and LymPro, while substantially reducing our costs of goods sold (COGS), however because of the data-hungry nature of AI/machine learning in healthcare, we will be focusing TBIA for the foreseeable future on creating equivalency data to Videssa and LymPro as those products are commercialized. We believe TBIA could ultimately represent an entirely new blood testing platform that has the potential disrupt the marketplace when it has achieved the level of data necessary to overcome current AI-driven biomarker objections.

NASDAQ Listing Plans and Corporate Profile

On June 28, 2021, the Company disclosed the agenda for the Annual General Meeting of its stockholders that will be held on July 26th, 2021. As part of the agenda for the meeting, several proposals were put forward to shareholders to vote on by proxy to allow the Company to be positioned to achieve a Nasdaq listing in the third quarter of 2021, depending on market conditions. Two of the key proposals for shareholders to vote on in the proxy are an increase in authorized Ordinary Shares, as well as a reverse split of Ordinary Shares. It is important to note that under Israel law, there can only be a proportional split of issued and authorized shares, meaning that if there is a reverse split of the outstanding shares 1:10, then there must be a proportional reverse split of the authorized shares by the same 1:10 ratio.

The Company is working closely with its Nasdaq listing consultants, and as part of that process, management and the Board of Directors was given the advice that in negotiations for a potential listing with Nasdaq it is critical that the Company has stockholder authorization to execute whatever corporate actions are necessary to allow its common stock to meet the initial Nasdaq listing standards. This in no way means that the Company is required to execute a maximum reverse split to achieve those listing standards. Given that market forces in the OTC marketplace, it is important that the market is aware that the Company is able to achieve a Nasdaq listing under any circumstances in order to protect the Company and its shareholders.

Management continues to believe the Company is substantially undervalued and we see important corporate milestones being achieved in the third quarter of 2021 that will ultimately drive fundamental value, especially driven by our Tollovir clinical development program. We are excited about the path forward for Todos given the consolidation of all the Company’s programs into a focused strategy centered on our industry leading diagnostics programs that have an emerging revenue base to support their development, with the tremendous potential upside of an antiviral therapy for COVID-19 that could dramatically alter the standard of care for patients worldwide and potential applications beyond COVID-19.

The Board of Directors and management would like to thank our shareholders for their tremendous support as the Company embarks on the next exciting chapter of its progress, and we look forward to communicating with our shareholder on an ongoing basis in the weeks and months ahead as the Company achieves key milestones that will help drive it forward in its mission to help patients.

For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com.

For COVID-19 testing inquiries, please email sales@todosmedical.com.

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.

Todos Corporate and Investor Contact:

Richard Galterio
Todos Medical
732-642-7770
rich.g@todosmedical.com

It hasn't been announced yet. Only referenced in a tweet on 6/23/21:

Conference call will be forthcoming in near future.

I interpreted the 1-for-2 lower range as a way to give false hope of a limited RS before hitting us over the head with the 1-for-500 sledgehammer.

For the 5 Billion shares, which defies logic, the only reason I can fathom for such a drastic increase would be as part of some poison pill measure to prevent a takeover from big pharma, if they succeed in beating Pfizer to market in the ongoing competing trials. At current share price the market cap is only a bit over $20M. Add in up to 5B shares in a poison pill and the buyout price becomes closer to $200M, and that's assuming current share price. With the spike in share price one would expect with positive trial results ahead of Pfizer, that poison pill could raise the buyout price up to several billion dollars.

This is the only thing that makes sense to me. I don't believe even GC could dilute shareholders that much unless he was expecting the share price to go sub-penny and convertible funding would require significantly more shares.

We should learn more in the upcoming corporate update and conference call.

8-K Filing

https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-015368/0001493152-21-015368.pdf

From the filing:

We intend to present the following matters to the Annual General Meeting:

1. To seek the approval of the Company’s shareholders to amend Todos’ Articles of Association: (a) to authorize the creation of 50,000 (fifty thousand) redeemable Preferred A Shares of the Company, that the Company may in the future be entitled to issue in exchange for two outstanding Convertible Notes pursuant to the terms of the Securities Purchase Agreements (the “Yozma Purchase Agreements”), dated as of January 22, 2021 and April 14, 2021, respectively, between the Company and Yozma Global Genomic Fund 1 (“Yozma”), pursuant to which Yozma: has purchased from the Company two convertible notes in the original in the original principal amounts of $4,857,142.86 and $4,714,285.71, respectively (with net proceeds to the Company of $3,400,000 and $3,300,000, respectively) which class of Preferred A Shares shall be allocated entirely for such purpose; (b) to authorize the creation of five thousand (five thousand) redeemable Preferred B Shares of the Company, pursuant to the Company’s exercise of its exclusive option to acquire Provista Diagnostics, Inc.; (c) to increase the Company’s authorized share capital to permit the issuance of a total of up to 5,000,000,000 (five billion) ordinary shares of the Company; and (d) to allow the Company to fulfill relevant provisions of U.S. law in lieu of Israeli law requirements regarding External Directors, if and to the extent allowed to do so under Israeli corporate law and regulations.

2. To seek approval of the Company’s shareholders for the compensation packages recommended by the Compensation Committee and approved by the Board, including compensation for each of the Company’s currently serving Directors and C-level officers, as well as for the External Directors to be elected at the Meeting.

3. To elect Lauren Chung as an External Director of the Company for a term ending on July 26, 2024 and to elect Moshe Schlisser as an External Director of the Company for a term ending July 26, 2024.

4. To re-elect Gerald Commissiong, Dr. Herman Weiss, Daniel Hirsch and Moshe Abramovitz as directors of the Company for a term ending at the Company’s next annual meeting, or their earlier resignation or removal.

5. To extend for an additional year the authority granted to the Company’s Board of Directors to effect a reverse split of the Company’s ordinary shares (as per resolution of the Company’s Shareholders’ Meeting of May 11, 2020), such that the authority so granted shall extend until July 26, 2022, and to expand such authority to include a reverse split of the Company’s entire share capital share at a ratio within the range from 1-for-2 up to 1-for 500, provided that the Company shall not effect reverse share splits that, in the aggregate, exceed 1-for-500.

6. To adopt the Company’s 2021 Equity Incentive Plan.

7. To review the Company’s 2020 Annual Financial Statements.

8. To ratify the appointment of Yarel and Company as the Company’s Auditors for the 2021 financial year.

9. To transact any other business as may properly come before the meeting, or any adjournment or postponement of the meeting.

CEO on Twitter - 6/26/21



https://www.cnbc.com/2021/06/25/delta-who-urges-fully-vaccinated-people-to-continue-to-wear-masks-as-variant-spreads.html?__source=iosappshare%7Ccom.apple.UIKit.activity.PostToTwitter

With such dire predictions, I'd certainly be holding on to my 1.4M shares too. Actions speak louder than words.

Outstanding Shares Update - 6/25/21



https://www.otcmarkets.com/stock/tomdf/security

CEO on Twitter - Merck Desperate To Get Back In Coronavirus Race, With A Pill | Seeking Alpha

https://seekingalpha.com/article/4436693-merck-desperate-to-get-back-in-coronavirus-race-with-a-pill

CEO on Twitter - America's Child Care Sticker Shock

https://www.axios.com/covid-child-care-costs-9fb695f7-6102-40fa-9548-4c472ac70894.html

CEO on Twitter - 6/24/24 (multiple tweets)

CEO on Twitter - 6/23/21 (multiple tweets)

Actually, irony is the wrong word. Hypocrisy is a better word.

Someone has failed to find the irony in a poster who claims I am a shill for posting GC's Twitter responses now asking someone else to post GC's Twitter responses because they want to be informed and yet won't take the time to sign up for their own Twitter account.

I'm once again posting the CEO's Twitter responses. If you're seeing blanks where GC is typing, I guess you should probably sign up for a Twitter account.

You can't make this stuff up. LMAO

CEO on Twitter - 6/24/21

Lots of great info here. I held my shares and purchased more on the extreme over-reaction of the uninformed. That's what makes investing so great. Lots of so-called investors who panic because they don't understand the basics of accounting and financial reporting. Of course, there are those who hate the company and CEO and would like to sell, but they've misplaced their testicles. What a horrible fate to hate your investment and be unable to act. In desperation they claim anyone with a positive outlook is a company shill and paid for posting.

Enjoy the tweets.

CEO on Twitter - 6/23/21

Warning: Posting GC's tweets will get you labeled as a company shill. Anyone can sign up for Twitter to keep themselves informed. They believe GC is a con man anyway and will only use what you post to tear down the company and the value of your investment.

I appreciate your previous comments, Sukyamadda. If you want to continue to communicate outside this board, let me know.

I purchased more shares on the dip.

Yes, I try to find the silver lining as a shareholder.

But, since this board is filled with shareholders who believe the company and CEO are a scam, yet don't have the balls to sell their shares, I will leave you all to trash the company and diminish the value of your own shares by discouraging any potential new investor with your dire predictions the company is trash and the CEO is a liar. Good luck with that.

Maybe one of you can step up and moderate the board. I'm out of here. I will continue as a shareholder as long as I see promise in the story that's unfolding, but I will no longer post or even read this board.

That should satisfy those who believe I am posting lies. I have better uses of my time than discussing with folks who invest in companies they believe are scams. Leslunier will be convinced he was right all along and that I was a plant by the company. Morons everywhere, as I continue to observe.

GLTA

Do you not realize that there are expenses associated with those sales, and when cash does come in it gets rolled back into inventory and trial costs and other business expenses? Clearly if the company was self-sufficient with revenues able to meet all expenses, there would be no need for funding from Yozma.

The cash on hand at the end of the quarter has no direct correlation to revenues or sales. There are expenses that deplete the cash position.

The only thing that doesn't add up is what's between one's ears.

That's your opinion. If I make a mistake, I admit it and own it. Can't say the same for some here.

Perhaps it's time to sell your shares. Oh wait, you already posted you did that. You posted on 4/15/21:

You will be glad to hear I took your advise and sold my interest in TOMDF.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163211940

Or did you? You posted on 5/31/21:

And yes I am, regrettably, a shareholder. Didn't learn my lesson from ambs. All the posts about maybe he learned something from his previous mistakes sucked me in. What he learned was there is a sucker born evry day and some times twice.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164121845

Total BS. Was this just an error, or an outright lie?

CEO on Twitter - 6/22/21



I feel a bit lacking now since I have come across this requirement before regarding quarterly financial statements. Didn't cross my mind until GC reminded me in his reply.

Revenue does not include sales unless those sales are paid for, so why would revenue be higher? Sales are made and the customer has a period agreed upon in the sales contract (30, 45, 60 days, etc.) to pay the company. Only then the sales amounts included in the revenues reported. If $2M in sales to are recorded in a quarter, but payments of only $1M is received during the quarter, then $1M is recorded for revenue and accounts receivable for the quarter.

Regarding the paragraph about the customer who has not yet paid, that's always a risk for any company, and that's why we have the courts to resolve these disputes. Amarantus had multiple lawsuits for unpaid bills, so now GC is on the other end of that issue.

I'm okay with releasing unaudited financials, as this is allowed per SEC rules and stated in the filing. There was a shareholder on Twitter urging GC to post the filings and amend any changes later. Perhaps that's what he decided to do, removing the urgency of the auditors to complete their review this week. We don't know what's going on with the auditor firms that might have caused another delay. I don't automatically believe the company is trying to deceive shareholders when a glitch occur. Some do. Different strokes. Both the CEO and CFO are legally on the hook for the accuracy of this unaudited filing. I expect we will see a fully audited update in the near term.

The company was reporting sales in the press releases, not revenues, which is why the numbers don't seem to align. The 10-Q is reporting revenues.

Todos Medical Announces $7.2M in Sales for February 2021, a 38% Month Over Month Increase From Sales of $5.2M in January 2021

https://investor.todosmedical.com/news-events/press-releases/detail/105/todos-medical-announces-7-2m-in-sales-for-february-2021-a

During my initial review of the 10-Q, I realize the charts I have previously posted had a significant error. I was reporting sales but calling it revenue on the charts. Sales does not equal revenue. While some sales during a period may result in revenues, sales not yet paid for would be added to Accounts Receivable, which is an asset of the company, not a revenue category.

I realized this error when reviewing Q1 2021 revenue figures in the report that didn't match what I had previously reported. I will update the charts accordingly and repost, changing from monthly to quarterly totals to align with how the company is currently reporting sales and revenues.

Todos Medical 10-Q filed

https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-015003/0001493152-21-015003.pdf

Let the gnashing of teeth and the feeding frenzy begin.

Regarding the author, Chris Sandburg, here is what I found on the web site. He writes articles on many biotech companies, including NASDAQ and NYSE-listed biotechs. I believe this tends to give him a bit more legitimacy than someone who only writes about OTC penny stocks. Just my opinion.

https://insiderfinancial.com/author/chris-sandburg/

No guess on the day. Doesn't matter to me as long as they are released this week. I expect to see Form 4 updates after the financials, not before. I'm still not convinced there was insider buying the last few weeks. The site you posted seemed to indicate that, but other sites did not.

There is a disclaimer at the end of the article, but it doesn't provide any info on the author's ownership status.

Disclosure: Insider Financial and its owners do not have a position in the stocks posted and have posted this article for free without editorial input. This article was written by a guest contributor and solely reflects his opinions.

There is another disclaimer for the site that goes into much greater detail at this link:
https://insiderfinancial.com/disclaimer/

I'm not trying to convince you of anything. It makes no difference to me if you invest or not, if you pass on this article or not. Maybe he responds, maybe he doesn't. While I agree we don't know this person and might be suspect of his response (if any), I would assume if he does state he is a shareholder, then why would that be a lie? Yes, it could indicate bias in the article, but being a shareholder doesn't automatically infer bias. The article seems well researched with plenty of links to the companies mentioned and is clearly the author's opinion. I believe the article gives a fair account of current events and there is enough uncertainty stated to indicate this is definitely NOT a sure thing for Todos, or even for Pfizer. No one knows with any certainty how this story will unfold.

To each his own. Every one of us has motives. My motivation is to make money with this investment, but I won't go as far as lying about the company, nor will I pump the stock to get a better price if I'm looking to exit. I continue to tell those who read my posts to invest only what you can afford to lose in the penny stock realm. This is still a high risk investment. Anyone who reads this article and decides they can get rich quick by investing all of their money in Todos is a gambler and not an investor and may live to regret that decision. There's still a good deal of uncertainty here, but in my opinion things are looking better than at any time in the past regarding the company's potential, with is not reflected in the share price. Dilution with fundraising has hurt us there. Let's see what the financial update reveals.

Financials should be out this week according to GC's tweet. Then I expect to start seeing Form 4's filed with the SEC from insider buying.

I emailed Chris Sandburg asking if he was invested in Todos. If I get a reply I will post it here.

I noticed the title of the article changed after the article was published.

Initially it was:
Pfizer Takes On All Coronaviruse

Changed to:
Todos Medical (TOMDF) with a $22 Million Market Cap Taking on Pharma Giant Pfizer for COVID-19 Antiviral

Also, in the article text the market cap of Todos is $16M and in the new title it is $22M, but the text remains unchanged. Share price was rising during the interim.

Todos Medical (TOMDF) with a $22 Million Market Cap Taking on Pharma Giant Pfizer for COVID-19 Antiviral

Insider Financial
OTC Markets Stock News
June 19, 2021

https://insiderfinancial.com/pfizer-takes-on-all-coronaviruses/181664/

Great article. Send this to every investor you know and let's get the word out to those who have never heard of Todos Medical.

CEO on Twitter - 6/19/21

Outstanding Shares Update - 6/18/21

https://www.otcmarkets.com/stock/tomdf/security

Agreed.

The mental process used in forming this "confirmation" is indeed lacking. I found the article, as I have found others posted here, by occasionally reading other investor boards for both AMBS and TOMDF. If you review my posts, I have occasionally mentioned posts found on other boards so there is already precedent for this behavior. I'll leave it to you to find this article mentioned on other boards, if that isn't expecting too much.

I don't communicate with GC, I don't work for GC, and I don't get paid for posting here or for responses. And my name is neither Joe or Joey. Wrong at every turn. I am an investor in Todos (700K+ shares) who moderates this board, and nothing more.

Here's something that may help in future deductive reasoning and conclusions. Amazon has a good price.

CEO on Twitter - 6/17/21

Gerald Commissiong of Todos Medical: 5 Things I Wish Someone Told Me Before I Became a CEO

An Interview With Charlie Katz
AUTHORITY MAGAZINE - June 13, 2021

https://medium.com/authority-magazine/gerald-commissiong-of-todos-medical-5-things-i-wish-someone-told-me-before-i-became-a-ceo-4713037264c8

GC quoted in June 10, 2021 WIJA news story.

https://wjla.com/news/coronavirus-vaccine/white-house-exploring-tentative-plans-to-resume-international-travel

White House exploring tentative plans to resume international travel

WASHINGTON (Sinclair Broadcast Group) — International travel is making a comeback. Dozens of countries are reopening their borders to U.S. tourists and the Biden administration is formulating plans to restart travel with some of America's closest partners.

The world is starting to reopen. That's sparking excitement among stir-crazy travelers and cautious optimism from public health officials who are confident in COVID-19 vaccines but remain concerned about virus variants.

"It is still risky," said Dr. Lin Chen director of the Travel Medicine Center at Mount Auburn. "The risk is just far lower for the vaccinated people."

With nearly 64% of U.S. adults partially vaccinated, the White House announced plans to reopen travel with some of America's closest partners. This week, several working groups made up of public health experts started exploring when and how to resume non-essential travel with Canada, Mexico, the European Union and the United Kingdom.

"The point of these working groups is to share data and set out both milestones and criteria to enable a reopening of travel between our two countries as swiftly as possible, consistent with public health guidance," National Security Adviser Jake Sullivan told reporters Wednesday, referring to the U.K. and E.U. groups.

The effort is being led by the White House Covid-19 Response Team and the National Security Council with representatives from the Centers for Disease Control and Prevention and the Departments of State, Homeland Security, Health and Human Services, and Transportation, according to reports.

The White House signaled that it's not ready to lift restrictions on international non-essential travel yet or announce a timeline to allow foreign visitors into the United States. "At the end of the day this is a process being driven by science and public health guidance," Sullivan said. The United States still has COVID-19 travel bans on the E.U., the U.K., Ireland, China, Brazil, South Africa, India and Iran. U.S. land borders have also been closed to Canadian and Mexican travelers since March 2020.

The U.S. Travel Association celebrated the announcement as "an important step forward in our national recovery from the pandemic."

Even with the United States closed to most foreign tourists, the world is starting to open up again. France and Spain announced they would accept vaccinated American tourists this summer. Many other popular destinations are welcoming travelers with proof of vaccination, a positive serological test for antibodies or a negative COVID test.

Cruises are launching this summer, with some requiring vaccines and others not. Royal Caribbean announced it would sail eight ships from ports in Florida and Texas to international destinations beginning in July. Norwegian and Carnival are also resuming trips.

At the same time, pressure has been growing for governments in countries that are still closed to lessen travel restrictions, particularly as more countries ramp up vaccine distribution.

This week top airline and airport executives in the U.S. and U.K. urged both governments' leaders to establish a travel corridor and lift the mutual travel bans. Both the U.S. and U.K. have vaccinated over 60% of their population. "These are the poster children of good vaccination programs," said John Holland-Kaye, CEO of London's Heathrow Airport at a Monday press conference. "There needs to be a prize for that."

Yet, the emergence of new, highly transmissible variants has led some to question the risks and benefits of resuming international travel.

On Thursday, the World Health Organization urged Europeans to travel "responsibly" over the summer holiday, warning the continent was "by no means out of danger" despite increased vaccinations and lower case counts.

Average daily new cases in the U.K. have spiked 68% over the last week, driven by the Delta variant, first detected in India.

The Delta variant has spread quickly among children and young adults. According to the U.K. health secretary, it is causing 91% of Britain's new COVID cases and has threatened to derail British Prime Minister Boris Johnson's plans to reopen the economy later this month.

Yet, preliminary data from the National Institutes of Health suggest two doses of the Pfizer and AstraZeneca vaccines are likely to provide protection against the Delta variant with minimal loss of efficacy. A single dose of either dramatically reduces efficacy.

Across the board, all the vaccines available in the United States have proven effective against all the variants of concern. Not only do they prevent serious illness in vaccinated people but studies show that they also limit transmission of the virus to others in rare cases of breakthrough infections. The lower risk of illness and transmission bodes well for vaccinated jet-setters and for public health generally.

"Vaccination is going to help us reopen the world," said Dr. Chen."I really see that as the major way of reopening travel."

Additionally, there are layered protections in place around international travel. Passengers are required to wear masks on flights. Anyone flying back to the United States must also present a negative COVID-19 test taken 72 hours before their return flight.

For those who are ready to travel abroad, experts say getting fully vaccinated is the first and most important step. After that, it's critical to understand the landscape before jumping on a plane.

"There's a chaotic mix of different requirements and they're rapidly changing," Dr. Henry Wu, an epidemiologist and director of the Emory TravelWell Center told reporters Thursday. That includes local mask mandates, vaccine requirements, tests and quarantines. "So, do your research and stay flexible."

Countries with high rates of vaccination and low case counts are the safest destination. Those experiencing surges of COVID-19 infections are not a good choice, Wu noted. Not only is the possibility of infection greater but travelers risk becoming a burden on a strained hospital system if they become sick or injured.

The State Department currently advises strongly against traveling to 38 countries. That number is down significantly from April when the State Department issued a widespread travel warning for more than 80% of countries due to COVID-19 infection rates.

The CDC's map of travel recommendations by destination shows much of the world in the "high" to "very high"-risk level for COVID-19.

Compared to lockdown, travel will always increase the risk of spreading the virus. But even with strict limitations in place, the risk of new variants entering the country is always possible. B.1.1.7, or the Alpha variant first detected in the U.K., now accounts for over two-thirds of new U.S. COVID cases. Around 10% of new cases are the highly transmissible P.1 or Gamma variant, that first emerged in Brazil, according to the CDC. The Delta variant, which is driving up cases in Western Europe, has been detected across the United States, making up 6% of new infections.

"The question we've got to ask ourselves is: is this something we can stop or is it inevitable?" said Gerald Commissiong, CEO of Todos Medical, Ltd., a diagnostics company focused on COVID-19 testing, screening and immune support.

By focusing on vaccinating as much of the population as possible, public health officials hope to get a baseline immunity to protect against emerging variants of concern. But it's a race against the emergence of variants in other parts of the world where vaccines are unavailable.

"At the end of the day, there's no denying the biological risk that some of these variants will overcome the vaccines," Commissiong noted. "If we don't help the world get vaccinated ... it's inevitable there's going to be a variant that makes all these vaccines useless."

On Wednesday, the Biden administration announced the U.S. would share 500 million doses of the Pfizer vaccine with low-income countries in Latin America, the Caribbean, Africa, Asia and parts of Oceania. Last month, the U.S. announced it would donate 80 million U.S. vaccines from its excess supply to COVAX, the worldwide vaccine initiative.

The contribution marks the largest single-country donation of vaccines during the pandemic. Beyond protecting millions of people against the virus, the widespread distribution of vaccines also serves U.S. national interests, the White House explained. "COVID-19 knows no borders," a senior White House official told reporters Thursday. "As long as this virus has a hold somewhere in the world, Americans are at risk."

In addition to vaccines, the development of antiviral drugs and therapeutics are also helping win the fight against COVID-19 and improving the prospects of the safe return of international travel. On Wednesday, Merck announced it would supply the U.S. government with 1.7 million doses of molnupiravir, an oral antiviral drug to treat outpatient cases of COVID-19, pending approval by the Food and Drug Administration.

I don't agree that the information you posted indicates insider trading. I have looked at several other insider trading tracking sites and they show no insider trading for Todos Medical. Also, no SEC Form 4's have been filed since January reporting purchases. Your entire hypothesis depends on an assumption for which there is no proof one way or the other.

I can understand why GC was ticked off. You are essentially claiming insiders are illegally buying shares and are manipulating the share price in order to do so by withholding the quarterly filing. Perhaps you haven't been watching the news, but Israel has been under multiple attacks by Hamas, including more attacks in the last 24 hours. GC stated in a tweet that this was the primary reason for the delay, as the CFO is based in Israel.

If your insider data is in fact accurate, it doesn't necessarily mean the activity is illegal. The SEC provides rules that allow legal insider trading. Insider trades could have been pre-planned or conducted in a way to meet these rules. The insider data you presented might be coincidental to the delay in financials, but it doesn't necessarily imply one has anything to do with the other. One can state opinion and list a lot of "facts" but that still doesn't point to conclusive evidence a crime was committed.

I think GC's response was typical of someone being accused of committing a crime. I'd likely respond in similar fashion, but not as polite.

Posting "factual information" that isn't observed on other insider trading sites tends to make me believe there is nothing to this claim. Just my two cents. I own 710K shares and would like to think that insiders are loading up on shares, but legally. We may see Form 4's show up in the near future. It could be Yozma buying shares in the secondary market. They would also be insiders and their purchases would have nothing to do with the delay in financials. It seems unlikely Yozma has access to the financial data about to be released, so their insider purchases would not violate SEC rules. Different rules would apply to company officers. Something to think about... what one person sees as illegal activity another can find a reasonable explanation for it.