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CEO on Twitter - 8/2/21
Linked article: https://edition.cnn.com/2021/08/01/health/uk-scientists-covid-variant-beat-vaccines-intl/index.html
Todos Medical Makes Final Payment to Close Provista Diagnostics Acquisition
Company to ramp up marketing efforts for Provista’s automated capabilities for COVID-19 PCR testing, variant identification, and neutralizing antibody testing
NEW YORK, NY, and TEL AVIV, ISRAEL, Aug. 02, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it has made the final payment of $1.25 million to complete its $10 million acquisition of Provista Diagnostics, Inc. Provista is a medical diagnostics company based in Alpharetta, Georgia that owns the intellectual property rights to the proprietary breast cancer blood test, Videssa®, and has a diagnostic testing laboratory currently performing COVID-19 PCR testing, primarily for the medical and entertainment industries. Over $50 million in research and development was invested since 2012 to develop the Videssa blood test.
Todos is currently expanding Provista’s marketing team as it works to capitalize on its automated capabilities in COVID-19 PCR testing, variant identification, and neutralizing antibody testing. Todos has completed a $2 million investment in order to upgrade the testing equipment in Provista’s lab. Todos believes its EUA approved cPass neutralizing antibody test will become increasingly important as new variants test the effectiveness of the vaccine. The Company is also continuing with its commercialization plans for its proprietary breast cancer blood test, Videssa®, that provides physicians with actionable information regarding breast cancer risk in women following an inconclusive mammogram result (BI-RADS III or IV), which primarily occurs in women with dense breasts. The test has demonstrated specificity of 98%+ in women over and under the age of 50 and addresses a multi-billion market.
“We are pleased to have now fully completed the acquisition of Provista to add the commercialization opportunity of Videssa as well as to centralize our proprietary diagnostic platforms in spectroscopy, flow cytometry, ELISA, PCR and next-gen sequencing,” said Gerald E. Commissiong, President & CEO of Todos Medical. “We believe the acquisition represents an enormous value creation event that will enable us to achieve a high return on investment. We have already begun to expand our marketing team and complete testing automation for a number of tests we believe will drive growth at our lab, including our cPass neutralizing antibody testing. We believe we are on the leading edge when it comes to automated neutralizing antibody testing because we believe this will be the preeminent way to determine COVID immunity levels and the timing of the booster shots if they become necessary. We expect that Provista will be a substantial driver of revenue in the years to come and look forward to executing on our growth plan to build lasting long-term value for our stockholders.”
For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com.
For testing and PPE inquiries, please email sales@todosmedical.com.
https://investor.todosmedical.com/news-events/press-releases/detail/120/todos-medical-makes-final-payment-to-close-provista
CEO on Twitter - 7/30/21
https://twitter.com/i/events/1419889689645912065
Outstanding Shares Update - 7/30/21
https://www.otcmarkets.com/stock/tomdf/security
Todos Medical Retains CRO for COVID-19 Outpatient and Inpatient Phase 2/3 Clinical Trials for Oral Antiviral 3CL Protease Inhibitor Tollovir
• Trials will separately enroll non-hospitalized and hospitalized patients
• Clinical trials in India targeted to be adaptive design to enable expansion into pivotal development upon achieving data milestone
New York, NY, and Tel Aviv, ISRAEL, July 28, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire-- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has retained the services of Innvocept Global Solutions, an Indian clinical research organization (CRO), to manage 2 adaptive design Phase 2/3 clinical trials the Company is preparing to initiate with its joint venture partner NLC Pharma of its proprietary oral antiviral 3CL protease inhibitor drug candidate Tollovir™ for the treatment of non-hospitalized and hospitalized COVID-19 patients in India. Engaging a CRO is the first step of the regulatory process in India. The Company expects enrollment for both trials to begin in the third quarter of 2021 with initial, trial expansion-enabling data expected in the fourth quarter of 2021 that could make each trial become part of the Company’s global pivotal clinical development program for Tollovir that would begin in the fourth quarter of 2021.
“We are pleased to have completed this critical step of retaining a CRO for Tollovir’s clinical development in India and are very impressed with Innvocept’s deep experience in executing rapidly enrolling FDA quality COVID-19 clinical trials with over 10 completed to date, and successfully working with US-based pharmaceutical companies to execute successful clinical trials in India,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Enrollment is also starting to accelerate in our ongoing 77 patient Phase 2 randomized placebo-controlled trial of Tollovir™ at Shaare Zedek Medical Center in Jerusalem, Israel for the treatment of hospitalized COVID-19 patients. This trial opened enrollment in April 2021 and is also evaluating the use of TolloTest™ as a companion diagnostic for antiviral therapy. TolloTest is the Company’s proprietary 3CL protease biomarker assay that is being developed as a more accurate measure of viral infection, load and infectiousness in COVID-19 patients.”
Mr. Commissiong continued, “As we move forward with the clinical development of Tollovir in Israel, we felt it was critical to have a second program recruiting in a larger, less vaccinated jurisdiction that has the potential for faster recruitment. We believe this dual-track clinical development program in Israel and India will have the benefit of showing Tollovir’s clinical efficacy in hospitalized patients when compared to, or in combination with, different standards of care that are emerging internationally. We are also now heavily engaged in planning Tollovir’s US regulatory strategy and planning for a pre-IND meeting with the US Food & Drug Administration ahead of an IND submission we are hopeful to file in the third quarter of 2021. This submission will set the stage for the opening of a US IND and clinical studies intended to ultimately dovetail our global pivotal clinical development program for Tollovir. The expansion of Tollovir’s clinical development into non-hospitalized patients dramatically opens the potential market opportunity for Tollovir, as it is becoming increasingly clear that vaccinated individuals will become infected with COVID-19 in addition to the unvaccinated and those with waning immunity.”
“We continue to compile non-clinical data that includes the Delta variant and is supportive of a regulatory filing for Tollovir. The initial clinical data gathered during a 32 patient Phase 2 open-label, controlled study conducted in Israel in 2020 at the height of the pandemic showed that Tollovir had statistically significantly improved results on key clinical endpoints including death rate, intubation, and mean time to patient discharge,” said Dr. Dorit Arad, PhD, Chief Scientific Officer of NLC Pharma. “Our internal mechanism of action data indicates that Tollovir possesses both exquisitely strong 3CL protease inhibition activity and anti-cytokine activity, based on distinct molecular mechanisms present in its formulation,” Dr. Arad continued. “This dual mechanism makes Tollovir unique among the emerging class of 3CL protease inhibitors currently in development. Researchers are quickly discovering that the fast-replicating Delta variant has shown an improved ability to out-compete neutralizing antibodies for the ACE2 receptors vs. earlier versions of SARS-CoV-2. The Delta variant heightens the call for a safe and effective oral antiviral therapy that can stop an infected person’s viral load from becoming so significant that it triggers cytokine release syndrome, which can lead to hospitalization, death or Long COVID. We believe Tollovir has addressed both viral replication and cytokine storm activity.”
Todos and NLC are currently finalizing study designs for both of its planned Tollovir Phase 2/3 trials in hospitalized and non-hospitalized patients in India, and Innvocept has already identified the clinical trial sites for these important studies. The Company estimates the direct costs to reach interim data for both trials in India will be collectively be approximately $1 million.
https://investor.todosmedical.com/news-events/press-releases/detail/119/todos-medical-retains-cro-for-covid-19-outpatient-and
8-K out on shareholders meeting. All proposals approved.
https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-017856/0001493152-21-017856.pdf
Sorry, that's 7/26/21
CEO on Twitter - 7/23/21
https://www.njonair.com/videos/2021-morning-show/nj-morning-show-july-23-2021/
Interview starts at 9:50
Todos Medical Receives New FDA Certificate of Free Sale for Tollovid Daily™ Including 3CL Protease Inhibitor Claim
• New twice-a-day dosing regimen allows for daily immune system support
• Company intends to create a monthly subscription model for this new product
New York, NY, and Tel Aviv, ISRAEL, July 22, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that the US Food & Drug Administration (FDA) has granted a new Certificate of Free Sale for Tollovid Daily™, the newest member of the Company’s Tollovid™ dietary supplement product line.
The Certificate of Free Sale is for a twice-daily dosing regimen and, critically, a 3CL protease inhibitor claim. Each 60-pill bottle of Tollovid Daily can help support and maintain healthy immune function for 30 days. The Company intends to establish a monthly subscription model as part of its marketing launch campaign for Tollovid Daily immune system support. Tollovid™ and Tollovid Daily are both 3CL protease inhibitor products developed under a joint venture with NLC Pharma.
“We are very excited with the new FDA Certificate of Free Sale for Tollovid Daily™, the newest member of our Tollovid™ dietary supplement product line,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Given our strong belief that in today’s world 3CL protease inhibition is critical to supporting and maintaining healthy immune function, we are extremely pleased that the FDA viewed the in vitro data presented as sufficient to allow this claim. With the global market for immune support supplements expected to grow from $18 billion in 2020 to over $31 billion by 2028 according to Fortune Business Insights, we are confident that our Tollovid products are well positioned to tap into this lucrative, growing market opportunity. Going forward, we are focused on building our infrastructure for a planned US marketing launch of Tollovid Daily now that we have completed building our base www.MyTollovid.com e-commerce infrastructure. We are working on getting Tollovid approved for distribution on large e-commerce platforms that can fulfill rapidly for both individuals and resellers.”
The first commercial production run of Tollovid is now available for purchase at www.MyTollovid.com and Tollovid Daily is expected to be available beginning in late August. The Company expects Tollovid product line revenue to become material for the Company’s earnings in the fourth quarter of 2021.
https://investor.todosmedical.com/news-events/press-releases/detail/118/todos-medical-receives-new-fda-certificate-of-free-sale-for
Outstanding Shares Update - 7/21/21
https://www.otcmarkets.com/stock/tomdf/security
Todos Medical to Launch EUA Authorized cPass SARS-CoV-2 Neutralizing Antibody Kit Through Agreement with Fosun Pharma
• Nature Medicine publication shows that neutralizing antibodies are critical to prevent or reduce the severity of a COVID-19 infection, including infection by emerging COVID-19 variants such as the Delta variant, for both vaccinated and unvaccinated populations
• Todos now validating cPass in its highly automated Provista Diagnostics CLIA/CAP lab to enable antibody quantitation, high throughput and fast turnaround times
• Todos will offer cPass as a service via Provista and distribute kits to client labs
New York, NY, and Tel Aviv, ISRAEL, July 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it has entered into a distribution agreement with Fosun Pharma for the cPass™ SARS-CoV-2 Neutralizing Antibody Detection Kit* that has received Emergency Use Authorization (“EUA”) from the US FDA for the detection of SARS-CoV-2 receptor binding domain (“RBD” or “neutralizing”) antibodies. A recent peer-reviewed paper published in the scientific journal Nature Medicine concluded: “… Here, we show that neutralization level is highly predictive of immune protection, and provide an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic.”
“With the Delta variant posing a significant risk for breakthrough infections based on data from Israel, and fears increasing of a potential third wave nationwide, we see neutralizing antibody testing becoming critical for informed decision making to assess who may be best suited for booster shots, as well as at what point someone previously infected with COVID begins to show waning immunity and may decide to receive vaccination as a result,” said Jorge Leon, Chief Medical Officer for Immunology and Oncology at Todos. “As we begin to learn more about the heterogeneity of immune response to different COVID vaccines, there appear to be subgroups of people who may need an additional dose of the vaccine to be considered fully vaccinated from a neutralizing antibody perspective, and we have now seen the Ministry of Health in Israel just this past week begin to give booster shots to the immunocompromised and certain other at-risk groups who were shown to have low neutralizing antibody titers. Additionally, a recent German study reported that 2% of the general population and over 30% of those over 80 had no detectable neutralizing antibody levels after their second vaccine dose. The cPass test will enable individuals to take charge of their health by making data-driven decisions to protect themselves beyond vaccination, such as masking or avoiding certain higher-risk activities when armed with this crucial information.”
Todos sees a large market opportunity developing for cPass that will begin to encroach on the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020. We believe immune monitoring will be the primary driver of COVID-19 testing growth going forward. To date, 161 million people in the United States have been vaccinated, with the majority of the doses having been administered to older populations who are most likely to show waning immunity the earliest, and will be the first ones for whom booster decisions will have to be made. As time advances, and more and more individuals are 6 months and beyond from their initial vaccine dose, it will become increasingly important for individuals and healthcare providers to asses and monitor neutralizing antibody levels in order to make data-driven decisions with respect to booster shots and behavioral changes.
The Company is currently automating the EUA cPass test at its CLIA/CAP laboratory, Provista Diagnostics (“Provista”), to add high-capacity neutralizing antibody testing to its test menu, and is ramping up its sales and marketing infrastructure. Provista plans to offer cPass as a testing service to other CLIA labs on a reference basis, as well as directly to the public through healthcare professionals. A key differentiator for this novel cPass test is that it detects neutralizing antibodies in patient samples without the use of live virus and with very fast turnaround times, as compared to the conventional method of measuring neutralizing antibodies in patient samples, which requires the use of live cells. Upon completing the automation process, Todos expects Provista to provide high volume results in less than 24 hours. Todos will also make cPass available for client labs to run on their automated equipment.
Todos has also been granted authorization to utilize a high value version of the cPass test at Provista that has been adapted to quantitate neutralizing antibody levels, thereby allowing monitoring of levels over time. Todos sees this modified test as eligible for a higher reimbursement rate than traditional SARS-CoV-2 antibody tests. The Company intends to aggressively market Provista’s new testing capabilities in the coming months in order to begin to capitalize on its investment in automation and drive high margin revenue growth.
* This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the presence of total neutralizing antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
https://investor.todosmedical.com/news-events/press-releases/detail/117/todos-medical-to-launch-eua-authorized-cpass-sars-cov-2
Additional Links:
https://www.fda.gov/media/143584/download
https://www.nature.com/articles/s41591-021-01377-8
https://www.gov.il/en/departments/news/06072021-04
https://www.medrxiv.org/content/10.1101/2021.03.03.21251066v1.full
Outstanding Shares Update - 7/16/21
https://www.otcmarkets.com/stock/tomdf/security
Todos Medical updates on Phase 2 trial progress to treat hospitalized coronavirus patients in Israel
Video Link:
https://www.proactiveinvestors.com/companies/news/955174/todos-medical-updates-on-phase-2-trial-progress-to-treat-hospitalized-coronavirus-patients-in-israel-955174.html
Todos Medical Ltd (OTCQB:TOMDF) CEO Gerald Commissiong updated Proactive on progress of enrollment of its Phase 2 clinical trial to treat hospitalized coronavirus patients in Israel, with its TolloTest biomarker being used for the first time as a surrogate biomarker to monitor patient response to treatment.
Commissiong says recruitment is 'picking up again' due to an increase in coronavirus caseload in Israel.
The medical diagnostics and related solutions company also said its partners at NLC Pharma have identified an anti-inflammatory mechanism of action for its Tollovir dietary supplement to complement its 3CL protease inhibiting mechanism. Tollovid, a mix of botanical extracts, is being targeted to support healthy immune function against circulating coronaviruses.
Outstanding Shares Update - 7/9/21
https://www.otcmarkets.com/stock/tomdf/security
The Form 4 shows shares purchased by GC on line 1. Line 2 shows indirect ownership of shares awarded to Amarantus in the acquisition of the Breakthrough Diagnostics subsidiary and the LymPro test in June 2020.
Line 2 does not indicate shares purchased. Notice there is no transaction date or transaction code. It is included to show the Todos shares owned by Amarantus over which GC has voting rights (in addition to the shares just purchased on line 1).
CEO on Twitter - 7/8/21
https://twitter.com/megtirrell/status/1413305934672244736/photo/1
I'll point you in the right direction.
https://investor.todosmedical.com/news-events/press-releases/detail/62/todos-medical-completes-acquisition-of-breakthrough
Video for Todos Presentation at Emerging Growth Conference - 7/7/21
43 minute presentation
SEC Form 8-K for Securities Purchase Agreement filed
https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-016456/0001493152-21-016456.pdf
SEC Form 4 filed for Gerald Commissiong
https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-016433/0001493152-21-016433.pdf
Biogen Controversy And The Spillover Effect: Actionable Insights
https://seekingalpha.com/article/4438096-biogen-controversy-and-the-spillover-effect-actionable-insights
Todos Medical is mentioned in this article on Alzheimer's treatments. Read the entire article for proper perspective on the excerpts below.
Newer Approaches to AD
For the last few decades, so many attempts have been put on amyloid beta, and more recently, tau. But unfortunately, the amyloid beta angle of attack, besides Biogen’s extremely controversial approval, has been a complete failure. There are many other more interesting theories on Alzheimer’s pathophysiology, and this should not be surprising given the apparent heterogeneity of the disease. For example, Todos Medical (OTCQB:TOMDF), a company with a serum Alzheimer’s diagnostic in development that very closely aligns with the gold standard of Alzheimer’s diagnosis, amyloid PET cSUVR, views Alzheimer’s as “cancer of neuronal cells that are incapable of completing cell division due to their post-mitotic nature,” where neurons are trying to, but mostly cannot undergo mitosis (cell division), and that this dysfunction is mirrored in peripheral lymphocytes. What is interesting is, despite the diagnostic’s excellent correlation with amyloid PET (r = -0.848), their view of the disease is not at all an amyloid beta-driven theory. This is certainly an interesting view, and could be part of the Alzheimer’s puzzle. Personally, I believe there is quite a strong case to be made for neuroinflammation, at least as part of the problem and a good target for solution, even if it's not a primary driver. Todos’ LymPro test is immune-cell based, measuring CD69 in peripheral blood lymphocytes as a marker of entering the cell cycle. An algorithm ties this to a score, diagnosing MCI, and this will provide an extra step before going to get a scan.
The Winners
Mentioned above, Todos Medical Ltd. is developing an Alzheimer’s diagnostic that is blood-based and measures the immune system rather than amyloid or tau. Thus, no cerebrospinal fluid or expensive, costly scan is needed, and this can be done as a proxy before going to get subsequent, confirmatory imaging. Additionally, the expansion of the AD market to Todos represents an outsized opportunity and a potential acceleration of business far more meaningful, relatively, than to an already mature company like Quest Diagnostics.
Todos Medical Appoints Ilanit Halperin, CPA as Corporate Controller
https://investor.todosmedical.com/news-events/press-releases/detail/116/todos-medical-appoints-ilanit-halperin-cpa-as-corporate
NEW YORK, NY, and Tel Aviv, ISRAEL, July 07, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it has appointed Ilanit Halperin, CPA as its Corporate Controller. Ms. Halperin, the principal of Halperin Ilanit, CPA, has over 25 years of financial reporting, accounting and auditing experience.
“We are very pleased to bring Ms. Halperin on Board to help strengthen the Company’s financial controls as we embark on the next stage of growth for Todos,” said Daniel Hirsch, Chief Financial Officer at Todos. “Ilanit has made substantial progress in putting in place the financial infrastructure needed to successfully engage with the investment community going forward.”
Prior to forming Halperin Ilanit CPA in 2018, Ms. Halperin was a partner of Fahn Kanne Grant Thornton Israel, the sixth largest CPA firm in Israel and the Israeli member firm of Grant Thornton International Ltd. From 2011 until 2017, she was head of the firm’s High-Tech and Life Sciences Department. During her tenure at Fahn Kanne Grant Thornton Israel, Ms. Ilanit was the audit engagement partner of several companies listed in the United States.
“I’m very pleased to be able to help Todos in the next stage of growth for the Company,” said Mr. Ilanit Halperin, newly appointed Corporate Controller at Todos. “This is a very exciting time as management continues to build the Company and prepare it for a listing on a US national stock exchange. My role will be to ensure that we stay in compliance with the various financial reporting requirements so that the management team’s focus can be on growing the business.”
Eyes Shift to the Healthcare Industry After the Pandemic Prompts a Reconsideration
https://www.prnewswire.com/news-releases/eyes-shift-to-the-healthcare-industry-after-the-pandemic-prompts-a-reconsideration-301324876.html
I keep arguing semantics? I was answering a question from another poster. Where is the argument in my response? There was none.
The Todos press releases reported sales. So did the tweets.
Clearly, the man-crush continues with Gerald.
GDS: Gerald Derangement Syndrome - where one cannot stop thinking of Gerald, posting about Gerald, or wishing there could be another "Come to Jesus" personal chat with Gerald.
Must be great for a CEO to have such devoted fans.
Posting time is local time of the IH servers, which means it has nothing to do with local time of the person posting. It's a big world connected by the internet, so one shouldn't conclude anything based on message posting time.
My advice to you is to sell Todos and enjoy fewer sleepless nights.
Just stating my expectations that if GC purchased 1M shares or 100M shares, some wouldn't be satisfied.
I don't know how to address your other concerns. I suspect any Tollivid/Tolliver income with be later on, not this early. Mobile test trailers seemed like an area to explore but probably didn't work out as expected. I would be surprised if we see any income from those sources.
Anyone who knows anything about business knows things never go as planned or expected. Some things may work out, others will not. Expectations of revenue in one area and then no revenue produced doesn't mean the company is lying. Even with a company as successful as Apple, I can give you a dozen or more examples of products or ventures that failed for them. It will be the same with Todos. Mobile labs may not pan out, where other ventures might. Lots of risk still, which is one reason the share price is where it is.
Yeah, JP is the one to follow. Look at the track record with AMBS, all over the map with that one, depending on which side of the flip he was on.
I'll continue to post the CEO tweets because some of the readers don't have Twitter accounts. And I post the actual screen shot of the tweet, not select passages as some here post.
The investors can decide what to believe or how to interpret the tweets. Sorry if that rubs your feathers the wrong way.
I'm not defending anyone. Simply stating that investing in penny stocks and having expectations of non-dilutive financing is not being realistic. Any startup with IP has to prove the IP before the street will give it better funding terms. Todos isn't there yet. Amarantus isn't there yet either.
Maybe you should have waited until the IP was proven. Much less risk that way.