Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Share Structure Update - 10/22/21
https://www.otcmarkets.com/stock/TOMDF/security
Well stated. I wish more investors understood that small companies in this position have difficulty finding financing at attractive or what some would even consider reasonable terms. The company is to some degree over a barrel and the financiers know this, which is why they structure the deal more heavily to their favor. It's not like there's a line of financiers standing by with better terms the company can easily turn to.
Perhaps some wouldn't be so unhappy with their investment here with every new financing deal that is announced, but realize it's a reality in the OTC penny stock world they've elected to invest in. It's far different than terms of a traditional business loan a profitable, established company.
There's a high risk to lose one's investment, offset by much higher potential gains if the company succeeds. Most of a person's investments should be in higher quality equities and only the smaller portion they can afford to lose invested here. Unfortunately, I suspect many investing here are taking on much more risk than they're comfortable with because not enough effort was made early enough into the higher quality equities and now they're looking for a Hail Mary pass with this investment to change their reality. And I also suspect some of those who continuously attack this CEO because they lost a lot of money in AMBS were in the same boat, and possibly still are, which is what fuels their continued anger here, lashing out at a CEO who they once saw as their financial savior, and now blame him when those fortunes failed to materialize.
Not preaching... just an observation I suspect is more accurate than most will admit.
Todos Medical Announces Publication in Journal of Clinical Virology Highlighting Clinical Utility of cPass Semi-Quantitative Neutralizing Antibody Test in SARS-CoV-2 Risk Assessment Post-Vaccination or Recovery from Infection
Company hosting cPass webinar on Friday, October 22, 2021 for long-term care facilitiesNew York, NY, and Tel Aviv, ISRAEL, Oct. 21, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced the publication of an article entitled “A Practical Approach to SARS-CoV-2 Testing in Pre and Post Vaccination Era” in the peer-reviewed Journal of Clinical Virology, available online at https://www.sciencedirect.com/science/article/pii/S2667038021000363?via%3Dihub , that highlights the clinical utility of combining the cPass neutralizing antibody test in the vaccinated and COVID-recovered populations with PCR testing in the unvaccinated and not previously infected to reduce COVID-19 transmission. Todos Medical is hosting a webinar entitled “New Paradigm for Measuring Immunity in Pre- and Post-Vaccination Era” on Friday, October 22nd, 2021 at 12:00pm ET for The Society for Post-Acute and Long-Term Care Medicine (“AMDA”), and is available for anyone to attend virtually on Todos’ YouTube Channel at: https://www.youtube.com/channel/UCWsJLl1iB9qlZUSicQ9e-Mg.
The publication concluded, “To minimize the potential for future outbreaks, a revised testing strategy to assure initial and continued protection post-vaccination will likely be required. This could include a combination of qPCR (for non-vaccinated and susceptible people) and nAb (for previously infected and vaccinated people) assays. cPass sVNT could be a useful tool for substantiating individual immunity in a SARS-CoV-2 post-vaccination era.”
Provista Dx offers high-throughput SARS-CoV-2 PCR testing and high-throughput semi-quantitative cPass neutralizing antibody testing as services. For more information on Provista’s testing services, please contact James Doherty, Sr. Director of Business Development at Provista Diagnostics at dohertyj@provistadx.com.
For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.
https://investor.todosmedical.com/news-events/press-releases/detail/143/todos-medical-announces-publication-in-journal-of-clinical
From page 9 of the Q2 10-Q:
Going Concern Uncertainty
Until 2020, we devoted substantially all of our efforts to research and development and raising capital. In 2020, we raised significant capital, but we also generated revenues for the first time as a result of our activities related to Covid-19. There is no certainty as to the continuance of our revenues related to Covid-19. The development and commercialization of our other products, which are necessary for our long term financial health, are expected to require substantial further expenditures. We remain dependent upon external sources for financing our operations. Since inception, we have incurred substantial accumulated losses, negative working capital, and negative operating cash flow, and have a significant shareholders’ deficit. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. We plan to finance our operations through the sale of equity and, to the extent available, short term and long-term loans. There can be no assurance that we will succeed in obtaining the necessary financing to continue our operations.
Regarding the missing sales you keep bringing up, the following statements appear in the Q2 2021 SEC filing. I believe GC also commented on this in a tweet a while back, but I'm not inclined to dig through those. Hopefully the company will collect the unpaid sales revenue from the customer without having to go to court.
From page F-23, Major Customers:
During the year ended December 31, 2020, the Company had one costumer which represents 56.64% of the Company’s total sales. During the Six months ended June 30, 2021, the Company had one costumer which represents 63.43% of the Company’s total sales with which Company’s contractual agreement to supply Covid-19 testing kits to a significant customer expired.
The increase in our revenues is a result of the sales of our COVID-19 testing products through our U.S. subsidiary, Corona Diagnostics, LLC. Revenues for the six and three months ended June 30, 2021 include $4,290,000 of revenues to our significant customer with which Company’s contractual agreement to supply Covid-19 testing kits to a significant customer expired – see Recent Development below
During the first quarter of 2021, the Company’s contractual agreement to supply Covid-19 testing kits to a significant customer expired. At the customer’s request, the Company continued to supply Covid-19 testing kits until such time as the customer requested that the Company stop doing so. The customer has not yet paid for some of the Covid-19 testing kits so supplied, and has not yet renewed its agreement with the Company. The Company believes that ultimately the customer will pay for the Covid-19 testing kits so supplied and will renew its agreement to purchase Covid-19 testing kits from the Company. Should the customer not renew its agreement to purchase Covid-19 testing kits from the Company, it could have a material adverse effect on the Company’s revenues from the sale of Covid-19 testing kits.
I don't know why the company doesn't respond to emails. I have used the means where I have seen others getting responses... Twitter. I signed up for the free account solely to use to communicate with the CEO. Perhaps you could give that a try and have better success.
What's up with the huge volume in AMBS around 3:30 p.m.? Someone catch a rumor of something?
Maybe someone had another "Come to Jesus" talk with the CEO and convinced some "whales" to buy shares. Happened before I heard.... kinda. The talk and the phone calls happened, but not much buying because everyone knew the guy was only interested in conning shareholders to support whatever side of the swing trade he was currently on. Some wannabe investment analyst. Sad, but true. I guess you encounter all types on these boards.
Maybe this time it was different and some whales actually did buy AMBS shares and created enough demand to drive the price 22% higher in the last 30 minutes of the day. The late volume was not typical for this stock.
Your Tollovid question is answered in Gerald's reply to my Twitter question. Scroll down to middle of the post.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166427511
Thanks for the opinion. Could have just advised against investing in penny stocks altogether.
They weren't my friends, as my post stated... friends of a friend. But I have known numerous people who have died from COVID and all were hospitalized getting the best treatment available, which clearly isn't doing the job. You can dismiss Tollovid/Tollovir if you want, but I believe from all the articles I've read that a protease inhibitor will be the most effective treatment. I'll take the 5-day dose of Tollovid if I test positive. I wouldn't get admitted to a hospital at that point anyway, so what can it hurt?
Also, I have plenty of money to buy the product myself, and have purchased it already for several people who are at risk. It's a small price to pay, and even lower with the 10% discount.
I appreciate your comments. Some here dislike the Twitter posts and accuse me of being a paid promoter for the company. I post them because they are relevant to what the CEO is doing and thinking, and it's good for investors to understand that, even if they don't agree. Also, not everyone is on Twitter. I created my Twitter account solely to monitor the CEO's posts. Some here still have anger issues over their Amarantus investment losses, yet they are invested again with the same CEO and continue to be angry about their current investment. Hard to figure that one out. Reminds me of a quote by David Banner in one of the Avengers movies... "That's my secret... I'm angry all the time."
I'm a big fan of the Tollovid/Tollivir product and I recommend it to everything I know as the better alternative to the virus than treatments currently available in hospitals, where patients still die. I have a friend who lost 3 of her long-time childhood friends in the past few weeks to Covid, and all were hospitalized getting the current standard treatment, and all in their 40's. If someone brought in a bottle of Tollivid to the patient I wonder if the doctors and staff would try to prevent the patient from taking it.
I have been vaccinated but if I ever test positive, I'm immediately starting the 5-day Tollovir regimen. I'm not going to depend solely on current treatments to save my life.
Oral Antivirals Poised to Cover the Vaccination and Antibody Blindspots
https://www.linkedin.com/pulse/oral-antivirals-poised-cover-vaccination-antibody-gerald-commissiong
NEWS: Todos Medical to Conduct Webinar Highlighting the cPass SARS-COV-2 Neutralizing Antibody Test for AMDA, The Society for Post-Acute and Long-Term Care Medicine, on October 22, 2021 at 12:00 PM EDT
https://investor.todosmedical.com/news-events/press-releases/detail/142/todos-medical-to-conduct-webinar-highlighting-the-cpass
Dr. Jorge Leone, Chief Scientific Officer of Todos Medical, and Sean Taylor, North American FAS Manager of Genscript, will discuss the importance of the cPass™ SARS-COV-2 neutralizing antibody test as a “New Paradigm for Measuring Immunity in a Pre- and Post-Vaccination Era”
AMDA’s 5,500 members work in skilled nursing facilities, long-term care and assisted living communities, CCRCs, home care, hospice, PACE programs, and other settings
New York, NY, and Tel Aviv, ISRAEL, Oct. 14, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, announced today that its Chief Scientific Officer, Dr. Jorge Leone, and Sean Taylor, North American FAS Manager of GenScript, will conduct a webinar discussing the importance of the cPass™ SARS-COV-2 neutralizing antibody test as a “New Paradigm for Measuring Immunity in a Pre- and Post-Vaccination Era” for members of AMDA – The Society for Post-Acute and Long-Term Care Medicine (“AMDA”).
“Raising the awareness in the medical community of the importance of measuring COVID immunity through cPass, the only emergency use authorized neutralizing antibody test, is a critical part of our marketing efforts for Todos and our Provista Laboratory,” said Jorge Leon, PhD and Chief Scientific Officer at Todos Medical. “AMDA’s membership needs to understand the importance of measuring immunity in order to make informed medical choices, especially in the most at-risk populations. We look forward to this exchange of ideas and the opportunity to expand our reach for providing cPass testing at Provista to this distinguished medical community.”
This talk will explore the key questions associated with how neutralizing antibody testing can provide biomarker-based answers to quantify a key marker of immunity for those previously infected with COVID and those who are vaccinated to determine whether 1) an immune response occurred, and 2) how long it is lasting in order to help physicians make key determinations about when booster shots may be needed. Increasing evidence supports the correlation between neutralizing antibody titers and protection from this dangerous virus. Recent studies show that less than 40% of immunocompromised and less than 70% of elderly (over 80 years of age) people who are fully vaccinated elicit these protective antibodies.
AMDA is the only medical specialty society representing the community of over 50,000 medical directors, physicians, nurse practitioners, physician assistants, and other practitioners working in the various post-acute and long-term care (PALTC) settings. The Society’s 5,500 members work in skilled nursing facilities, long-term care and assisted living communities, CCRCs, home care, hospice, PACE programs, and other settings. The Society has two affiliate organizations. The American Board of Post-Acute and Long-Term Care Medicine runs a certification program for medical directors in PALTC, credentialing Certified Medical Directors (CMDs). The Foundation for Post-Acute and Long-Term Care Medicine oversees awards, community outreach, education, and research with the mission to advance the quality of life for persons in PALTC through inspiring, educating, and recognizing future and current health care professionals.
The webinar will take place on Friday, October 22, 2021 at 12 PM EDT and will be live broadcast on Todos Medical’s YouTube channel at https://www.youtube.com/channel/UCWsJLl1iB9qlZUSicQ9e-Mg.
Presenters
Dr. Jorge Leon, Chief Scientific Officer for Todos Medical, is internationally recognized for his pioneering work in molecular diagnostics. Dr. Leon holds a Ph.D. in cellular and molecular biology from New York University and completed his postdoctoral studies at the German Cancer Research Center in Heidelberg and Columbia University in NYC. Dr. Leon’s subsequent academic research at Columbia University focused on developing monoclonal antibody-based tumor marker assays and radio-immuno imaging devices, which are currently in wide use. In the early 1990s, Dr. Jorge Leon played an integral role in establishing and leading the molecular diagnostics laboratories at Quest Diagnostics. As Director of Molecular Diagnostics, Senior Director of Biotechnology Development, and Vice President of Applied Genomics, Dr. Leon spent twelve years developing Quest’s molecular diagnostics strategy, which is now the world’s largest molecular diagnostics service laboratory. In 2003, Dr. Leon founded Leomics Associates, Inc. a consulting firm committed to helping prestigious, successful companies and academic institutions develop molecular diagnostics and personalized medicine in the United States and globally. Dr. Jorge Leon and his experienced team specializes in identifying breakthrough opportunities and industry trends, and helps start-up businesses, academic centers and established companies successfully build and commercialize innovative business strategies, product pipelines, and test menus.
Sean Taylor holds a Ph.D. and an MBA from McGill University and has spent the past ten years publishing articles, providing seminars, workshops and training videos to help the global scientific community achieve excellent data from western blotting, qPCR and digital PCR experiments. He has managed teams of Field Application Scientists (FAS) in Canada for over a decade who have helped thousands of scientists achieve their research goals. In his current role as North American FAS Manager for GenScript, he leads a dedicated team to continue the tradition of providing pertinent and timely information to help the scientific community overcome research hurdles to accelerate the production of high quality, publishable data, cost-effectively.
For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.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. In 2021, Todos completed the acquisition of 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. 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 is focused on the commercialization of Videssa and will bring the TBIA tests to market thereafter.
Todos has entered into a joint venture with NLC Pharma targeting diagnostic and testing solutions to address the COVID-19 pandemic. The Joint-Venture is pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses. The Company’s proprietary therapeutic candidate Tollovir™ is currently in a Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, and is preparing to initiate Phase 2/3 clinical trials for both hospitalized and non-hospitalized patients in Israel.
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 is also distributing certain (COVID-19) testing materials and supplies to CLIA-certified labs in the United States. The products cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits.
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
Todos Medical gears up to expand its coronavirus testing services and clinical study
Proactive - 10/6/21
by Patrick M. Graham
https://www.proactiveinvestors.com/companies/news/962615/todos-medical-gears-up-to-expand-its-coronavirus-testing-services-and-clinical-study-962615.html#
True, we ain't seen nothing yet... bought this 5 months ago based on your recommendation on another board. Not impressed so far. Company seems to be doing some things but the share price trades in a narrow range. I'm not trading the stock because the general attitude here is that anyone selling is a fool because share price will be much higher very soon. Very soon seems to be a loosely defined term with lots of variables.
Again, not impressed so far, but then again I haven't held this turd for years like some have so my cost basis isn't $0.0001.
The big mystery here that no one seems to want to discuss is with all this financial backing being reported from behind the curtain that has allowed shares to be retired or cancelled, and new acquisitions to be made, what are these funders getting in return? With every other company financiers are issued shares or some other incentives to cause their investment of capital. I haven't seen anything like that reported here, or have I missed it? Lots of posts describing the big money investors who facilitated the cleaning up of the balance sheet, but having read the board since before my investment, no discussion of what these big money financiers are getting in return. Again, what am I missing?
Smells fishy. It seems some believe Alison can do no wrong and has an outstanding reputation and we should trust her implicitly. But Madoff was considered trustworthy based on his extensive Wall Street experience and we saw how that worked out.
Wall Street Journal Interview - 10/6/21
https://www.wsj.com/video/events/medical-testing-is-entering-a-new-era-todos-medical-ceo-says/6E1B4F01-720D-425B-AB48-5191E9627938.html
WSJ subscription required to view
BronxNet Interview - 10/6/21
OPEN Host Daren Jaime sits down with the CEO of Todos Medical Ltd, Gerald Commissiong to discussing the recent patent issued for their inhibitor oral antiviral drug.
Since the bar here has been lowered to regurgitating posts from more than 6 years ago in a continuing agenda to grind the axe, I'll join in. There are many similar posts that can be regurgitated here.
How's that march to $100M and $0.45 share price looking? Gerald and Joe Rubinfeld aren't the only ones making bold claims that never panned out.
Todos Medical Announces Positive Data in Hospitalized and Outpatient Setting for TolloTest™, a Novel SARS-CoV-2 3CL Protease Biomarker Assay
https://investor.todosmedical.com/news-events/press-releases/detail/141/todos-medical-announces-positive-data-in-hospitalized-and
Data demonstrated very high correlation with PCR ct values in positive patients
Data demonstrated 100% sensitivity, as early as 1-3 days post-exposure, in identifying fully vaccinated asymptomatic patients infected with COVID-19
New York, NY, and Tel Aviv, ISRAEL, Oct. 06, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, together with its joint venture partner NLC Pharma, today announced positive clinical validation data for its 3CL protease biomarker assay TolloTest™ in a clinical study evaluating its sensitivity compared with PCR in hospitalized COVID-19 patients, patients hospitalized for conditions other than COVID-19 and individuals exposed to confirmed COVID-19 subjects in the community outpatient setting and healthy controls. The results clinically validated the sensitivity of the 3CL protease biomarker compared with SARS-CoV-2 PCR confirmed positive results in both the hospital and outpatient setting, and provided key insights on the potential role the 3CL protease biomarker could play in assessing the COVID infectivity status of infected patients being released from quarantine and opening the diagnostic window to include earlier diagnosis of individuals from time of time known exposure. The Company sees multiple use cases for the 3CL protease biomarker as an adjunct to both PCR testing and antigen testing for SARS-CoV-2.
The 3CL protease is the main protease found in coronaviruses. When a cell becomes infected with the virus, one of the first viral components made is the 3CL protease, which is an enzymatic saw that cleaves coronavirus polypeptides into usable viral proteins. Since a healthy human body doesn’t contain any traces of 3CL protease it’s an ideal biomarker that will show up only if there is active infection. In theory a 3CL protease test is a much better test for pandemic management because it could identify patients who are capable of spreading the disease and help them.
“We believe that the 3CL protease could become a very important biomarker in the overall COVID-19 diagnostic landscape,” said Jorge Leon, PhD, Chief Scientific Officer at Todos Medical. “To date, the only questions that the widely used PCR and antigen testing tools can answer is whether or not a person has certain fragments of the SARS-CoV-2 virus in their system, not whether that virus is actively replicating and can be spread to others. Neither PCR or antigen tests have the ability to measure infectivity. As we move forward in dealing with this deadly pandemic, key questions about whether an infected person, or someone who continues to test positive by PCR for weeks/months despite recovery from viral infection, is actively infectious are becoming increasingly important if we want to control community spread. We believe a potential solution to address this question is the 3CL protease biomarker. Additionally, it appears the 3CL protease biomarker assay may open the diagnostic window to more accurately reflect the initial presence of SARS-CoV-2, as well as a more accurate measure of when a person is no longer infectious post-diagnosis than mandatory 7-, 10- or 14-day quarantine measures. The length of quarantine should be driven by infectivity biomarkers, not by relatively arbitrary estimates of how long infectivity may last.”
The initial format of the TolloTest assay is immunofluorescence. The TolloTest lab assay performance has been optimized for use with nasal mid-turbinate (NMT) collected samples, consistent with the most widely used specimen collection protocols, with fluorescent reaction occurring within 10 minutes of the sample being applied into the assay. The result yields a quantitative assessment of the activity of 3CL protease, which is highly consistent with PCR cycle time values (ct values). Based upon the data generated, the Company is confident that it can optimize TolloTest for various point-of-care (POC) assay formats that would allow for ease of use similar to current rapid COVID tests, including a qualitative lateral flow assay format that could be used as an adjunct to currently available antigen tests to improve their sensitivity for earlier diagnosis, asymptomatic screening, and release from quarantine, or a quantitative POC test that could provide a non-lab test based tool to monitor the level of viral infection, providing data that mirrors PCR ct values. At-home testing formats are also possible.
In the first part of the clinical study, 58 hospitalized patients and research staff were recruited and evaluated for SARS-CoV-2 infection as measured by PCR, with 30 negative subjects and 28 positive patients enrolled being treated for COVID-19. Of the 30 subjects who tested negative by PCR, 12 were in a subgroup determined to be positive by TolloTest. These 12 individuals may have had SARS-CoV-2 exposure or may have been infected with another coronavirus such as a common cold (HCoV-229E). Of the 28 hospitalized patients who tested positive by PCR, 25 tested positive by TolloTest. Of the 3 PCR positive patients who tested negative by TolloTest, all three had PCR cycle time values (ct values) of 30 of higher, indicating they were likely nearing or at the end of their viral disease process and were likely no longer infectious. As expected, there was a consistent inverse correlation between ct value and 3CL protease activity in both hospitalized and non-hospitalized subjects.
A table of the hospitalized patient set is available below:
Of key interest in the hospitalized patient setting is the fact that 7 of the 25 PCR confirmed positive patients who also tested positive by TolloTest were discharged within 48h of testing positive by TolloTest, indicating patients may have been discharged who still harbored residual active virus even after resolution of their clinical symptoms. This group of potentially infectious people being released to their homes post-quarantine highlights a key failing with the current testing paradigm. Community spread is facilitated when infectious people are cleared back into the community before the actively replicating virus has been fully cleared from the patient.
Following completion of the data gathered in the hospital setting, the Company was able to recruit an additional 17 subjects, all fully vaccinated, into the study from a community event setting held from July 12-17, 2021 in Israel. All 17 enrolled individuals attending the event were notified of close exposure to a known positive COVID-19 patient, with some patients becoming symptomatic several days post-exposure. Beginning on July 15th, 2021 and ending on July 27th, 2021, all 17 patients were enrolled into the study. Of the 17 patients enrolled, 16 were positive by PCR and 1 was negative by PCR. Of the 16 positive patients, TolloTest identified all 16 as being COVID-19 positive and identified the only negative subject as negative. In this very small group of patients the TolloTest performed flawlessly, with a perfect score of 100% sensitivity and 100% specificity.
A table of the COVID-19 community outbreak data is available below:
Todos now intends to evaluate various assay formats to optimize ease of use in the POC setting and turnaround times in the lab setting to address these multiple use cases. The company plans on conducting additional confirmatory studies with the final, optimized POC assay formats with the goal of eventually submitting for an EUA. The Company is in active discussion with potential partners with POC products on the market to help accelerate bringing this critically important biomarker on to the market.
For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.
UPDATE - Todos Medical Announces October Conference Calendar
https://investor.todosmedical.com/news-events/press-releases/detail/140/update---todos-medical-announces-october-conference-calendar
NEW YORK, NY and Tel Aviv, ISRAEL, Oct. 05, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it will be presenting at multiple industry conferences in October. Company CEO Gerald Commissiong will be participating in the following events:
Longwood Healthcare Leaders October 4-5, 2021 Webconference
Role: Gerald Commissiong as Moderator for an industry panel
Title: INCORPORATING NOVEL DIAGNOSTIC APPROACHES
When: Tuesday, October 5th, 2021 at 3:40 pm ET
Registration: https://www.longwoodhealthcareleaders.com/events/longwood-healthcare-leaders-october-2021
Website: https://www.longwoodhealthcareleaders.com/october2021
BioFuture: Reimagine the future of healthcare
Role: Gerald Commissiong giving Todos Medical corporate presentation
When: Wednesday, October 6th, 2021 at 11 am ET
Registration: https://biofuture.com/biofuture-registration/
Website: https://biofuture.com/
Wall Street Journal: Future of Health
Role: Gerald Commissiong as Speaker with Sara Castellanos, WSJ News Editor as moderator
Title: The Testing Industry's New Chapter
When: Wednesday, October 6, 2021 at 1:05 pm ET
Registration: https://foefestival.wsj.com/event/the-future-of-health-2/register/?mod=register_now
Website: https://foefestival.wsj.com/event/the-future-of-health-2/#/agenda
LD Micro Main Event 2021
Role: Gerald Commissiong giving Todos Medical corporate presentation
When: Tuesday, October 12th, 2021 at 4 pm PT (7 pm ET)
Registration: https://www.meetmax.com/sched/event_76871/invitee_login.html?attendee_role_id=IVESTOR
Website: https://www.meetmax.com/sched/event_76871/conference_home.html?bank_access=0&event_id=76871
Todos Medical Provides Update on COVID-19 Oral Antiviral 3CL Protease (Main Protease) Inhibitor Tollovir Clinical Development Program in Light of Molnupiravir Clinical Trial Data from Merck
https://investor.todosmedical.com/news-events/press-releases/detail/139/todos-medical-provides-update-on-covid-19-oral-antiviral
New York, NY, and Tel Aviv, ISRAEL, Oct. 04, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today provided an update on its COVID-19 oral antiviral 3CL protease (“Main Protease”, or “Mpro”) inhibitor Tollovir® clinical development program currently enrolling a Phase 2 clinical trial in hospitalized patients at Shaare Zedek Medical Center in Jerusalem, Israel. In light of the Data Safety Monitoring Board (DSMB) overseeing Merck’s trial in consultation with the US Food & Drug Administration (FDA) stopping enrollment after an interim analysis of 775 patient revealed a 50% reduction in the risk of hospitalization and death in unvaccinated outpatient COVID-19 patients recruited into Merck’s Phase 3 clinical trial within 5 days of symptom onset, Todos has now begun a thorough re-evaluation of outpatient trial designs to provide the fastest path to bring Tollovir to market in the outpatient setting given the now significantly lower than expected patient enrollment threshold required to demonstrate efficacy.
There are currently 27 patients enrolled in the 77-patient Tollovir hospitalized clinical trial in Israel. A pre-specified interim analysis of the safety and efficacy data of Tollovir is scheduled at 33 patients, which the Company expects to enroll in the next several weeks. Upon enrollment completion of the course of treatment for the 33rd patient, the Tollovir DSMB will convene to review the data and decide whether continued enrollment in the clinical study is warranted. Additional clinical trial sites that currently have higher volumes of COVID patients in Israel are expected to be added to the study in order to accelerate enrollment.
Tollovir is a proprietary formulation of key plant extracts that contain potent, highly selective, natural 3CL protease (Mpro) inhibitor & anti-cytokine activities that make Tollovir a strong therapeutic candidate for the treatment of COVID-19. The ingredients contained within Tollovir have been deemed safe for widespread use by multiple regulatory agencies worldwide, including the US FDA, and have been used in over 5,000 human subjects since the beginning of the COVID-19 pandemic, with certain case studies previously shared publicly. Other oral antiviral drug candidates for COVID-19, such as Merck’s Molnupiravir and Pfizer’s PF-07321332, are chemical compounds that have yet to be deemed safe for widespread human use by any regulatory agency. Given the strong safety profile of Tollovir, the Company believes it provides a compelling alternative to newly created or repurposed failed chemical drug candidates that have yet to rigorously demonstrate long-term safety.
“Together with NLC Pharma, our joint venture and co-development partner in Tollovir, we were pleasantly surprised with the Molnupiravir DSMB’s decision to halt enrollment in Merck’s clinical study at the pre-specified interim analysis point after showing a 50% reduction in hospitalization and death based on 775 enrolled patients,” said Gerald Commissiong, President & CEO of Todos Medical. “While it is a tremendous outcome for patients with COVID-19 and the worldwide community at large to have an oral antiviral demonstrate a statistically significant reduction in the most severe outcomes of this devastating disease, it is clear to us from the data we have seen that this decision was likely driven more by the tremendous need in the market for an oral antiviral therapy than by the data itself for this mutagenesis-based drug candidate given the scarcity of available safety data available for Molnupiravir in COVID-19, and the relatively restrictive entry criteria required for its Phase 3 clinical trial.”
On September 30, 2021, Todos announced results from an observational clinical study conducted in Israel by NLC Pharma. Results from this observational study are outlined below:
Dr. Dorit Arad, Chief Scientific Officer of NLC Pharma commented, “Our biggest hurdle in being able to finalize a full development program for Tollovir in the outpatient setting has been trying to decipher what regulators are likely to accept as an approvable endpoint with regards to safety and efficacy. Given the actions of the DSMB in stopping the trials, coupled with the positive comments heard from Dr. Fauci and Dr. Scott Gottlieb with regards to the efficacy demonstrated by Molnupiravir, we are now very comfortable that we have a comparator product against which to build our endpoints for Tollovir. We now intend to engage with regulators in India as well as in Israel, where we are currently enrolling a double blind placebo controlled Phase 2 clinical study in hospitalized patients with a pending interim data readout, to discuss how we can now finalize a pivotal outpatient trial design(s) and begin to move forward rapidly with enrollment as we also prepare for a pre-IND meeting with US FDA that will be followed by a well-defined US clinical development program.”
For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.