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8-K Filing
Item 1.01 Entry into a Material Definitive Agreement.
On April 27, 2021, Todos Medical Ltd. (the “Company”) entered into a Securities Purchase Agreement (the “SPA”) with Yozma Global Genomic Fund (the “Purchaser”) pursuant to which the Company has agreed to issue a promissory convertible note (the “Note”) to the Purchaser in the principal amount of $4,714,285.71 for proceeds of $3,300,000 (the “Transaction”).
https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-010250/0001493152-21-010250.pdf
Todos Medical Emerging Growth Conference 4/28/21
Length of video is 48 minutes.
Form 8-K for Provista Diagnostics acquisition
https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-009515/0001493152-21-009515.pdf
Outstanding Shares Update - 4/23/21
https://www.otcmarkets.com/stock/tomdf/security
Todos Medical Acquires Provista Diagnostics and Its Proprietary Videssa Breast Cancer Blood Test
• Todos plans to commercialize Videssa in late 2021 to reduce unnecessary biopsies in the $7.19 billion mammogram naïve market and integrate it into its TBIA Platform
• Provista Diagnostics’ testing lab in the Atlanta, Georgia area is currently performing COVID-19 testing, that will be automated to significantly increase processing capacity
• Todos expects to employ testing methodologies to expand Provista’s capabilities regarding COVID variant identification
NEW YORK, NY, and REHOVAT, ISRAEL, April 22, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it has acquired 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.
The breast cancer diagnostics market reached a size of over $19 Billion in 2019, according to a September 2020 market report published by Global Market Insights. In many cases, current tools often cannot provide diagnostic certainty in identifying cancerous breast masses that results in an estimated $7.19 billion of additional breast diagnostic testing, according to a 2018 study by ClinicoEconomics and Outcomes Research. Videssa was developed to provide 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 results provided by the test, that has demonstrated specificity of 98%+ in both women over and under the age of 50, arms physicians with a powerful tool to help guide decisions of whether to continue to monitor a low-risk patient intermittently, or whether to advance an at-risk patient immediately into a more expensive and invasive diagnostic assessment that generally includes a breast biopsy. With breast biopsies having been found to show a false-positive rate following diagnostic screening procedures as high as 71 percent in the United States according to the National Cancer Institute, the annual cost in biopsy procedures that might have been avoided is estimated to be $2.18 billion.
Dr. Jorge Leon, Chief Medical and Scientific Officer for Oncology and Infectious disease for Todos Medical, commented, “Videssa is a well-positioned diagnostic blood test for breast cancer with several peer-reviewed publications in well-respected medical journals demonstrating its ability to help physicians triage patients with dense breasts who regularly show inconclusive results on mammogram, a problem affecting well over 20% of women in the United States. The Videssa test offers a novel combination of biomarkers for a cancer detection liquid biopsy by detecting the presence of inflammatory markers linked to cancer with the specificity of tumor pathway biomarkers and auto-antibodies against tumor associated antigens present in breast cancer. As we prepare to launch Videssa as an aid in the diagnosis of breast cancer following an inconclusive mammogram result by the end of 2021, we expect to work with key opinion leaders in the months ahead to expand the clinical validation of additional use cases for Videssa in preparation for launch in order to confirm the accuracy of this panel to detect early stage and recurrences of breast cancer, as well as to prove its clinical utility in the context of the management of high risk patients as well as of patients already treated and in remission.
“Todos’ proprietary TBIA platform will be able to piggyback on the sample volume we anticipate generating from Videssa in order to further refine its algorithms and begin deploying our proprietary TBIA immunosurveillance blood testing assay for breast cancer, colon cancer and other cancers,” continued Dr. Leon. “We believe this strategy will allow us to dramatically accelerate the timeline of bringing TBIA into the market in the United States and allow us to scale that platform more rapidly.”
Todos has already delivered and installed automated extraction systems, Tecan™ and other liquid handler machines, and 384-well PCR machines in order to help position Provista to dramatically ramp up its COVID-19 PCR testing capacity in the second quarter of 2021. The Company intends to build Provista into a highly automated lab capable of running multiple platforms in parallel in order to offer clients comprehensive testing solutions that meet their needs, especially in cancer, infectious disease, immune monitoring and Alzheimer’s disease. Provista’s lab already has ELISA and PCR testing capabilities onsite.
“The acquisition of Provista gives Todos a US-based home for its proprietary diagnostic platforms in spectroscopy, flow cytometry, ELISA, PCR and next-gen sequencing,” said Gerald E. Commissiong, President & CEO of Todos Medical. “As Todos expands from being a supplier of COVID-19 testing automation and reagents to labs into a company also running its own COVID-19 testing lab, the supply chains and relationships we have built in working closely with Provista’s highly competent staff over the last year will serve us extremely well. In the immediate term, we intend to focus on expanding Provista’s COVID-19 PCR testing business and deploying new assays capable of confirming whether the viral strain of a positive COVID-19 sample is from one of the known variants, as well as building assays to help monitor long-hauler COVID-19 patients who are likely at higher risk for other diseases based on the damage inflicted on their immune system. With COVID-19 testing as the initial commercial anchor to our Provista lab strategy, we will also now be able to validate our lab-based TolloTest™ 3CL protease enzymatic assay in the US and begin deploying it to monitor this biomarker of emerging importance in COVID-19, especially in concert with clinical researchers evaluating novel anti-viral therapies for COVID-19. We expect that Provista will serve as the base for all of Todos’ operational activities in the United States going forward, including COVID-19, cancer and Alzheimer’s diagnostic tests we intend to bring into the market.”
Under the terms of the Agreement, Todos acquired Provista from its private equity owner for an aggregate purchase price of $7.5 million consisting of an initial cash payment of $1.25M, the issuance of $1.5M in Todos common shares priced at $0.0512/share, the issuance of a $3.5M convertible promissory note (the “Note”) and the payment on for before July 1, 2021 of $1.25M (the “July Payment”). The Provista shares acquired by Todos shall remain in an escrow account until the July Payment is made. The Note has a maturity date of April 8, 2025 and is convertible beginning on October 20, 2021 into Todos common shares at a conversion price equal to the lesser of $0.05 or the volume weighted average price of the last 20 trading days for the common shares prior to the date of conversion. In the event that Todos uplists its common shares to a national securities exchange, the Note shall automatically be exchanged into preferred stock with a conversion price equal to the lesser of (a) $0.05, (b) the opening price on the day of the uplisting provides there is no transaction associated with the uplisting or (c) the deal price of an uplisiting transaction.
https://investor.todosmedical.com/news-events/press-releases/detail/113/todos-medical-acquires-provista-diagnostics-and-its
I don't know anything about the relationship between Rob Rill, Managing Director of The Strategic Funds, LLC and Todos Medical. He clearly is an investor in Todos, but whether that is working for or against us is uncertain.
On this site: https://www.thestrategicfunds.com.pr/team/robb-rill/ there's a bullet item stating:
• Manages a proprietary fund, Strategic Capital, with an emphasis on short-selling securities and identifying microcap fraud in the market
I don't know why he would be selling 8% of his holdings over the last 6 weeks. There are many reasons one would sell, but only one reason to buy. He may be one of the players who has been shorting the stock recently.
Todos Medical Launches Phase 2 Clinical Trial of Its Antiviral 3CL Protease Inhibitor NLC-V-01 (Tollovir) in Hospitalized COVID-19 Patients
• First 10 patients dosed in 77 patient randomized, double blind, placebo controlled Phase 2 Clinical Trial at Shaare Zedek Medical Center in Jerusalem, Israel
• Data from randomized, placebo controlled, open label Phase 1b trial in 27 hospitalized COVID-19 patients supports dose selection for the Phase 2 Clinical Trial
• Company to include its proprietary 3CL protease enzymatic assay (“TolloTest™) as exploratory theranostic biomarker
NEW YORK, NY, and REHOVAT, ISRAEL, April 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced the initiation of a randomized, double blind, placebo-controlled Phase 2 clinical trial (the “Clinical Trial”) of its antiviral NLC-V-01 (“Tollovir™”), a potent 3CL protease inhibitor, for the treatment of hospitalized COVID-19 patients. The trial, being conducted at Shaare Zedek Medical Center in Jerusalem, Israel, will evaluate the safety and efficacy of Tollovir for the treatment of COVID-19 in hospitalized patients. Tollovir is a patent-pending therapeutic agent being developed through a joint venture between Todos Medical and NLC Pharma. 3CL protease inhibitors are targeted as desirable candidates for development of antiviral therapies against SARS-CoV-2 (the virus that causes COVID-19).
The primary endpoints of the Clinical Trial being examined are:
• Time to discharge from the hospital
• Time to clinical improvement based upon the National Early Warning Score 2 (NEWS2) in Israel
The secondary endpoints of Clinical Trial being examined are:
• Rate of change of measured parameters
• Rate of change in vital signs (blood pressure, heart rate, respiratory rate, saturation, and body temperature)
• Time from the 1st day of receiving NLC-V treatment to negative RT-PCR test result
• COVID-19 related deaths
• Incidence of deterioration and need for mechanical ventilation
• Incidence and duration of time on supplemental oxygen
A synopsis of the Clinical Trial is available on the Israel Ministry of Health’s website at: https://my.health.gov.il/CliniTrials/Pages/MOH_2021-01-20_009687.aspx
Commenting on the Phase II trial, Dr. Dorit Arad, Co-Founder and Chief Scientific Officer of NLC Pharma, stated, “The launch of this Clinical Trial is a critical step towards the clinical validation of our proprietary scientific work that was recently further supported with data from the Dan Peer laboratory at Tel Aviv University in Israel concluding that our proprietary medical grade 3CL protease inhibitor, Tollovir, is an antiviral therapeutic candidate for SARS-CoV-2’s based on its 3CL protease reproduction mechanism. I am glad that my pioneering academic work over the last 30 years on 3CL mechanisms has made such a significant impact, and that it is finally being recognized by leading pharmaceutical companies as a key target in the war against COVID-19 that could yield an easy to administer oral antiviral therapeutic capable of stopping SARS-CoV-2 replication, independent of different mutations that are emerging at the site of spike protein.”
Dr. Arad continued, “In 2020, we enrolled 27 patients who participated in a Phase 1b open-label, placebo controlled observational study in Israel of various formulations of this antiviral therapeutic candidate, and we also received feedback from patients all over the world who used certain dietary supplement formulations of our 3CL inhibitors to combat COVID-19 infection. Based on the data gathered from those two sources, we strongly believe that the further development of the selected formulation, Tollovir, is justified as a potential clinical therapeutic for significantly reducing the severity of a COVID-19 infection, and ultimately may be proven in further studies to be a prophylactic to reduce the risk of getting COVID-19 upon SARS-CoV-2 exposure.”
“The solid peer-reviewed scientific evidence regarding 3CL protease inhibitors as antiviral drugs against coronaviruses, together with recent in vitro data generated at Tel Aviv University that we reviewed in detail showing Tollovir’s activity of inhibiting SARS-CoV-2 replication, and quite importantly, a review of the empirical data from people using the dietary supplement in hospitalized settings all strongly encourage us to perform this Phase 2 study. The goal is to provide results that could have a significant impact on our ability to treat hospitalized patients diagnosed with COVID-19,” said Dr. Rokach, MD Lung Specialist and Principal Investigator of the Clinical Trial at Shaare Zedek Medical Center in Jerusalem.
“We are excited by the initiation of this clinical trial for Tollovir,” said Gerald E. Commissiong, President & CEO of Todos. “Dr. Arad’s history with this therapeutic target is well-known throughout the field of coronavirus research, and Todos is proud to support this very important clinical development program at a time when emerging variants are potentially threatening the progress that has been made in the last year as the field focused on COVID-19 vaccine development. By impacting SARS-CoV-2’s ability to reproduce in the body, we are hopeful to improve hospitalized patients’ clinical outcomes significantly, while also limiting the virus’ ability to mutate by reducing the number of times it is able to replicate in a host. Additionally, our TolloTest™ assay, currently optimized for inpatient settings, could be a valuable biomarker for measuring a person’s contagiousness by quantitatively measuring 3CL protease as a proxy for viral load, which could provide clearer objective data to make end of quarantine decisions when many PCR positive patients are likely inappropriately released from quarantine and able to infect others.”
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/112/todos-medical-launches-phase-2-clinical-trial-of-its
Outstanding Shares Update - 4/16/21
https://www.otcmarkets.com/stock/tomdf/security
I'm not the one spewing false info about the Yozma note, particularly the 30% OID. You continue to claim Yozma realized a 30% profit in a very short time. If one reads and understands the mechanics of the funding agreement, the only way they can realize that profit is to fully convert the entire loan amount and then sell all those shares back into the market. Gerald has stated several times that Yozma is a long-term partner, so if they had sold their holdings to realize the gain you continue to state they made, then they would be out of the game and no longer involved with Todos as shareholders. Another part of the funding agreement you continue to ignore is what happens to the 30% OID funds when the uplist or fundamental transaction (merger or acquisition) occurs. That transaction would invest the funds back into the company and fully negate the 30% discount, so the only discount that would be realized is the 20% maximum discount on the conversion price, and even that would only be realized if Yozma sold all their shares after conversion. Just because you don't understand this doesn't mean I'm spreading false information.
Where did the 135M shares issued go? Some went to Yozma, and a lot went to the existing convertible debt holders who elected to convert vs. being bought out. Gerald even stated this in a recent tweet. Todos was contractually obligated to convert the existing debt holders, and they chose to convert vs. buy out because it was more profitable for them to convert. There is no mystery here about the increase in issued shares and who they went to. I'm fairly certain Yozma has converted all of the debt to shares at this point. Why would they not? The price went lower than the 0.0599 price quoted in the agreement, and they could have achieved the maximum 20% reduction in conversion price as the price drifted lower. I haven't calculated their lowest price, as the adjustment was on a 10-day moving average, and as I've stated before the adjustment would always trail the existing market price a bit, so they may or may not have converted at the lowest price possible, but I agree likely in the 0.04's as you stated. As the share price moved lower, they likely converted some along the way as the conversion price adjusted, converting more as price adjustment moved lower. Given the terms of the agreement, I would have fully converted if I had been the investor. Yozma still have the 16M share warrant they can exercise in the future once the share price moves north of the 0.10-something exercise price.
Do I believe Yozma sold those converted shares? No way. Given what Gerald has stated in press releases and tweets, I believe Yozma is in this investment for the long haul, not for a quick profit as previous funders have done. According to the statements, Todos has found a fundamental investor in Todos, something Amarantus never had, so it seems very likely Yozma probably converted but is holding their shares for the long term gain. They are a strategic investment firm, not a vulture capital firm turning a quick profit and driving the share price in the dirt in the process.
Since you've now sold out of your Todos investment, can we assume the Gerald Derangement Syndrome will keep you posting here telling us about the con man and incompetent CEO he is, warning us to save us from the same kind of losses you experienced investing his GC's companies? Just asking, as I'm sure others here would like to know what to expect.
Where have I praised GC, other than to post an article about successful business leaders learning from their past mistakes to enable them to win, and offering an opinion that GC may have learned from his failures at AMBS and is making different choices with Todos? Not joining the opinions of those who believe he is a crook doesn't mean I'm praising him. I post his Tweets, news and filings, and data on revenue growth and outstanding share growth. Positives and negatives in all of those. That does not equal praise. I am still underwater on this investment and understand it may not work out, but if at some point I feel the potential is no longer there, I will sell and move on, unlike some here who are afflicted with GDS and can't move on.
Some posting here have Gerald Derangement Syndrome. They believe the man is a crook yet continue to follow him and some even invest in his newest venture. Part of the crowd always looking for something to hate or complain about. Making an investment in a company where one believes the CEO is a liar and con man certainly qualifies to enable one to meet that goal.
I don't really care who runs this company. It can be GC or someone else. I'm focusing on the growing revenues and expanding business model. I expect Todos to be acquired at some point.
I've tried explaining how the OID works and how the amount of the discount will be returned to the company as an investment when the uplist or a fundamental transaction occurs (which is also explained in the filings, meaning they wouldn't really have a 30% profit) but it falls on deaf ears. You seem to be convinced Yozma has converted the entire debt amount and sold those shares to make a quick profit. I posted your own words about how you were no longer going to post, yet you continue to post about how the CEO is incompetent and a scam artist, and continue to have no balls to take any action to do anything about it, other than hope this investment works out. Best of luck. Maybe the losses won't be $275K here as they were with AMBS. I still don't understand how someone could risk that much in a penny stock in a company with no revenues.
Because we disagree on several aspects of this company, I did take a look at your other posts made in other investments, and it seems like you are pretty much unhappy with every investment you're in. Seems to be a pattern of staying invested long term in companies where the leadership is inept in your view. That's why I suggested growing a pair. Or just continue to make bad investments and do nothing but complain about them. That will work out well, I'm sure.
And the best you can come up with is that I'm either GC or working for GC. Pathetic.
I am debt-free and invest over half of my income. I have an amount invested in this penny stock (with growing revenue) that I can afford to lose. This is the ONLY penny stock I own. My other investments are spread across mutual funds and listed companies that are all doing very well. I don't bitch and moan about the fund managers or the management of those companies. I don't invest hoping things work out. I don't invest in companies where I have no respect for management or how they are performing. If I discover I've made a bad investment and management isn't meeting my expectations, I have the good sense to get out and look for better investments. Clearly some investors haven't grasped that basic concept of investing. So it appears we disagree on much more than just the 30% OID issue. But whatever, it's your money to lose investing in penny stocks run by, in your view, inept management. Good luck. Hope that works out for ya.
I have explained the 30% Original Issue Discount but you continue to post about Yozma having made a 30% profit. That is not correct. The maximum discount Yozma received on the conversions is 20% as per the post I previously made. The 30% OID part of the funding is only converted if the company completes the Nasdaq uplist or completes a fundamental transaction (typically merger or buyout). At that time Yozma can convert the OID amount at the 0.0599 price and the company receives the remaining $1,457,142.
Yozma has NOT made a 30% profit in a few months as you continue to falsely claim. Read and understand the filings, please.
From my previous posts with applicable excerpts from the funding agreement, with my comments in red.
Outstanding Shares Update - 4/9/21
https://www.otcmarkets.com/stock/tomdf/security
Gerald was asked via Twitter when Q1 earnings would be posted. There are no Q1 earnings to be posted, that's my point. Q1 earnings will be disclosed in the upcoming 10-K due 4/30/21 (due 5/15 with late filing). I don't see that he sidestepped the question at all. Clearly the person who made that tweet was not aware there would be no Q1 earnings report. Perhaps he meant March revenue, since Jan and Feb numbers are already out.
Those who are pre-dispositioned to see the Todos glass as half empty based on their AMBS experience will never trust Gerald, yet some have invested in Todos with Gerald as CEO. Still scratching my head over that one Or was your investment prior to him taking the CEO position?
If Gerald doesn't answer an irrelevant question, he must be hiding something. Yeah, I see that now. I'll start unloading my shares in the morning.
weren't you the one who has stated that you can't judge from past mistakes?
I referenced an article from Business Insider in post #2379 titled Most every successful person has a story of excruciating failure in their past -- and for good reason
Why don't you address the issue of over 137.5 shares issued since yozma ? Where did they go? That's more than 6.8 million at an average of .05 per share. There wasn't that much convertable debt without including Yozma.
Once again I will answer your "concern" that has already been address here in my posts.
See post #2338 regarding the minimum and maximum number of shares Yozma could convert given the maximum of 20% discount from the initial conversion price of $0.0599. Yozma could convert debt to shares in a range of 81M to 101M shares. Given the share price dropped below the $0.04792 price by the other convertible debt holders converting and dumping their shares, Yozma converted at the discounted price, so they very likely received the maximum of 101,357,409 shares.
I suggested Yozma may be converting already (but not selling) in posts #2340 and #2345.
Gerald stated in his Twitter posts on 3/13/21 (see post #2553) that convertible note holders had a contractual period to convert prior to being bought out and most chose to convert because it was more profitable, and that was disclosed in the 8-K filing. He also stated on Twitter on 3/16/21 (see post #2575) that he didn't know if the vulture funds were still holding shares post-conversion, but that they were out of the Todos capital structure. Since the heavy selling pressure pushed the price down, which would allow Yozma to convert their entire debt holding at the 20% discounted price per the agreement, why would they not convert? They would never get a better price. This also means Todos could have little to no debt remaining after all the conversions... a great time to start the share buybacks the CFO stated was an option after profitability.
In the same tweet, Gerald stated "We have one fund who has a different horizon in the market, and a VC who put into crossover round on the cap table now." He's referring to Yozma as the fund and Leviston Resources LLC as the VC. Gerald has stated numerous times in his tweets that Yozma is focused on Nasdaq listing. As such, it seems highly likely that while Yozma has converted, they are NOT selling. Since the selling pressure seems to have dried up, news is now starting to push the share price higher. Given this turnaround in events over the last few months, I would think you would have a better outlook instead of posting the same concerns over this turning into another Amarantus.
By the way, I thought you were done for a while, per your post #2342.
There is no quarterly report with a foreign company. Todos is based in Israel, not the USA. They are only required to file an annual 10-K report with the SEC. I can't believe people are invested in this company and have done so little DD to not understand this.
See post 2608 regarding the 10-K filing.
Perhaps you should sell your shares and recover whatever you can before this goes sub penny, since you have so much doubt in the CEO this time around. Why the hell did you invest here with your jaded view of the CEO's past record? I fail to comprehend why someone remains invested hoping this time around will be different, yet continues to post serious doubts. Life is too short to be miserable worrying over an investment. Find some companies that you believe in and invest there.
Sorry, I disagree. Even with their discounted purchases, at the current price they would have to sell a majority of their shares to recover their initial investment. Why would they do that if they are focusing on Nasdaq as the CEO states? Much more money to be made if they stay the course.
By your own admission you were burned in the AMBS disaster and that was largely driven by vulture financiers dumping their shares to take their instant profit and driving the price into the dirt. That doesn't seem to be the Yozma business model as they have a very good reputation with the companies they invest in. Yozma is referred to in the Tweets as a fundamental investor, something AMBS never had. So I don't believe they are behaving as you suggest and unloading their shares for recovery of their initial investment. I doubt they did the amount of due diligence necessary to invest in Todos to reap a small gain in a few months. A fundamental investor is here for the long game... Nasdaq uplist, helping Todos grow the business, and share price appreciation.
From the CEO's Twitter posts on 3/13 and 3/14/21...
See my post #2335. The details of the Yozma agreement are included in the 8-K filing on 1/26/21.
https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-001831/0001493152-21-001831.pdf
Outstanding Shares Update - 4/2/21
https://www.otcmarkets.com/stock/tomdf/security
Gerald looking like a CEO should look. Excellent marketing video. Also take notice Gerald is hands-on with setting up the equipment. I am liking the way this story is unfolding. Share price will be moving higher, I have no doubt. Looking forward to March figures and upcoming annual 10-K report. GLTA
https://vimeo.com/529139115/9d3166bcc0
NT 10-K: Notice under Rule 12b25 of inability to timely file all or part of a Form 10-K, 10-KSB, or 10-KT
If the subject report could not be filed without unreasonable effort or expense and the registrant seeks relief pursuant to Rule 12b-25 (b), the following should be completed.
The subject annual report, semi-annual report, transition report on Form 10-K, 20-F, 11-K or Form N-SAR or Form N-CSR, or portion thereof will be filed on or before the 15th calendar day following the prescribed due date or the subject quarterly report or transition report on Form 10-Q or subject distribution report on Form 10-D, or portion thereof, will be filed on or before the fifth calendar day following the prescribed due date.
State below in reasonable detail the reasons why Form 10-K, 11-K, 20-F, 10-Q, N-SAR, N-CSR, or the transition report portion thereof, could not be filed within the prescribed time period.
The compilation, dissemination and review of the information required to be presented in the Form 10-K for the relevant fiscal year has imposed time constraints that have rendered timely filing of the Form 10-K impracticable without undue hardship and expense to the registrant. The registrant undertakes the responsibility to file such annual report no later than 15 days after its original due date.
Have all other periodic reports required under Section 13 or 15(d) of the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such shorter period that the registrant was required to file such report(s) been filed? If the answer is no, identify report(s).
[X] Yes
Is it anticipated that any significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings statements to be included in the subject report or portion thereof?
[X] Yes
If so: attach an explanation of the anticipated change, both narratively and quantitatively, and, if appropriate, state the reasons why a reasonable estimate of the results cannot be made.
During the year ended December 31, 2020, Todos Medical Ltd. generated revenue as compared to the year ended December 31, 2019 which had no revenue. Todos Medical Ltd. estimates that associated additional expenses increased by approximately $5,000,000 in 2020 from 2019.
https://investor.todosmedical.com/sec-filings/all-sec-filings/content/0001493152-21-007593/0001493152-21-007593.pdf
Todos Medical Completes Automation Equipment Installation and Training for Meadowlands Diagnostics
• Minority-owned lab now well positioned to attract and expand institutional contracts with skilled nursing facilities, ambulatory surgery centers, schools & first responders
• Automation solution increases processing capacity to 6,000 PCR tests per day, expandable to 12,000 daily tests with minor upgrades
• Todos expects to see a progressive increase in sales to this client in the second half of 2021 through exclusive PCR supply agreement
NEW YORK, NY, and REHOVAT, ISRAEL, April 01, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening, diagnosis and immune support, as well as developing blood tests for early detection of cancer and Alzheimer’s disease, today announced the successful installation of automated lab equipment and completion of training for Wood-Ridge, NJ-based lab client Meadowlands Diagnostics (“Meadowlands Diagnostics”).
“With the completion of automation at Meadowlands Diagnostics, we have brought two new client labs online in March and now have three fully automated laboratory clients in operation, with a fourth on the way,” said Gerald E. Commissiong, President & CEO of Todos Medical. “We have received their initial sales orders for stocking COVID testing supplies in February and expect to see sales orders from these new labs progressively increase in the second half of 2021 as they ramp up operations. Furthermore, we believe our growing family of lab clients will provide Todos with a more diversified revenue base and greater future sales potential. As the Todos solution continues to gain traction in the space, we are confident that our future growth in this business will be fueled by adding additional laboratories seeking a cost-effective way to meet the needs of COVID testing customers in the markets they service. We are excited to welcome the team at Meadowlands Diagnostics to the Todos family and look forward to helping them build their business as a trusted partner for years to come.”
The Todos automation solution is expected to be instrumental in helping Meadowlands Diagnostics with new contracts entered into with skilled nursing facilities, ambulatory surgery centers, local schools and first responders. As the provider of PCR testing supplies to Meadowlands Diagnostics, Todos expects to see a progressive increase in sales to this client in the second half of 2021 and into 2022 as the lab seeks to grow its PCR testing business.
By implementing the Todos automation solution, Meadowlands Diagnostics now has a capacity of 6,000 PCR tests per day, with the potential to quickly expand to up to 12,000 PCR tests per day. Additionally, the lab could potentially increase processing capacity to in excess of 40,000 PCR tests per day through the future implementation of pooling at a 4:1 ratio.
A video of Todos’ automated PCR solutions is available here: https://vimeo.com/529139115/9d3166bcc0
“When we opened Meadowlands Diagnostics at the beginning of the pandemic, we quickly realized that we were unable to meet the needs of the community,” said Reginald Samuels, President & CEO of Meadowlands Diagnostics. “Now that we’ve partnered with Todos Medical, we have the capacity we need to be able to serve the needs of our community.”
For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com.
https://investor.todosmedical.com/news-events/press-releases/detail/110/todos-medical-completes-automation-equipment-installation
Todos Medical Completes Automation Equipment Installation and Training for a Laboratory Client in Brooklyn, NY
• Automation solution increases processing capacity to 6,000 PCR tests per day, expandable to 12,000 daily tests with minor upgrades
• Client entered into contract with the State of Kentucky to provide PCR testing for nursing home facilities
NEW YORK, NY, and REHOVAT, ISRAEL, March 29, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening, diagnosis and immune support, as well as developing blood tests for early detection of cancer and Alzheimer’s disease, today announced the successful installation of automated lab equipment and completion of training for a lab client in Brooklyn, NY. The implementation of the Todos automation solution has expanded the lab’s processing capacity to 6,000 PCR tests per day from 500 PCR tests per day, with the potential to quickly expand to up to 12,000 PCR tests per day. The lab will be implementing EUA approved PCR testing for COVID-19 testing, as well as COVID + influenza A & B PCR testing upon request for select clients. Additionally, through the future implementation of pooling, the lab could potentially increase processing capacity to in excess of 40,000 PCR tests per day at a 4:1 ratio.
The Todos automation solution is expected to be instrumental in helping this lab client service a new contract recently entered into with the State of Kentucky to conduct testing for nursing home clients. The Company expects nursing homes to continue to conduct surveillance testing for COVID-19 for at least the next several years.
“After considerable work helping to complete the installation process, our Brooklyn lab client has successfully completed training and is now able to report PCR testing results utilizing our process,” said Gerald E. Commissiong, President & CEO of Todos Medical. “We are now focused on continuing to serve our lab clients, with a hyper-focus on helping them upgrade their saliva PCR testing capabilities to meet the needs of new testing populations that we expect will be conducting COVID testing for the foreseeable future, such as schools, skilled nursing facilities and sports & entertainment venues.”
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/108/todos-medical-completes-automation-equipment-installation
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Todos Medical Enters Into Automation and Reagent Supply Agreement with MAJL Diagnostics
https://investor.todosmedical.com/news-events/press-releases/detail/107/todos-medical-enters-into-automation-and-reagent-supply
NEW YORK, NY, REHOVAT, ISRAEL, and ATLANTA, GA, March 23, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening, diagnosis and immune support, as well as developing blood tests for early detection of cancer and Alzheimer’s disease, today announced that it has entered into an automation and reagent supply agreement with MAJL Diagnostics (“MAJL”). Under the terms of the agreement, Todos will implement its automation solution, including Tecan™ liquid handlers, automated RNA extraction machines, as well as a 384-well PCR machine capable of conducting COVID, cancer genetics and pharmacogenomics testing, in order to become the provider of all COVID-19 PCR testing reagents and supplies. Upon completion of the automation process, MAJL will be capable of processing approximately 1,500 PCR COVID-19 tests per day.
“We are very excited to work with MAJL as they look to increase their capacity for COVID-19 testing and we continue to expand the geographic footprint of our install-base,” said Gerald E. Commissiong, President & CEO of Todos. “Our automation solution will enable MAJL to scale their testing capacity significantly and give them the ability to actively engage with larger business opportunities, including school districts in the Atlanta area. As MAJL increases its testing capacity, we look forward to helping with their growth, providing additional automation as needed.”
“We were very impressed with the system Todos has been able to put together,” said Lisa Cloud, President & CEO of MAJL Diagnostics. “We look forward to growing our COVID-19 PCR testing business in the months ahead and believe Todos’ scalable solution provides us with the flexibility to expand our capabilities proportionately with our marketing efforts.”
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.
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 entered into an exclusive option agreement to acquire 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 transaction is expected to close in the third quarter of 2020.
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. Todos has formed a strategic partnership with Integrated Health LLC to deploy mobile COVID-19 testing 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 the 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 Investor Contact:
Richard Galterio
Ascendant Partners LLC
Managing Partner
732-642-7770
rich@ascendantpartnersllc.com
Todos Corporate Contact:
Priyanka Misra
Todos Medical
(917) 983-4229 ext. 103
priyanka@todosmedical.com