Announcement • Aug 31
Todos Announces Notice of Allowance from Uspto for Patent Application Covering Use of Compositions in Tollovid™? and Tollovir™? Ingredients Todos Medical Ltd. announced that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance for NLC Pharma’s patent application entitled "Compounds for Treating a Coronavirus Infection” prosecuted from the groundbreaking work of Dr. Dorit Arad. The Notice of Allowance covers the use of key compounds contained in the ingredients in Tollovid™ and Tollovir™ (NLC-V-01, NLC-001 or 3CL-001). The allowed claims are directed, among other things, to the administration of compounds to a subject to inhibit activity of the 3CL protease, inflammation and autophagy, and to treat coronavirus infection. The USPTO's assessment pertains solely to patentability, while approvability as a disease treatment falls solely within the jurisdiction of the United States Food & Drug Administration (US FDA). Tollovid, a unique 3CL protease inhibition dietary supplement, is not approved by the US FDA for the diagnosis, treatment, prevention or cure of any disease including COVID, acute and/or chronic coronavirus infections, or Long COVID. Tollovir, an anti-cytokine and 3CL protease inhibitor therapeutic candidate that has successfully completed a Phase 2 clinical trial in the treatment of hospitalized COVID-19 patients, is not approved by the US FDA to diagnose, treat, prevent, or cure any disease including COVID, acute and/or chronic coronavirus infections or Long COVID. Tollovid and Tollovir are manufactured with distinct raw materials, such that the key ingredients of Tollovir are separate and distinct from the key ingredients in Tollovid, resulting in separate end products from different key raw materials that contain patent pending compounds. Announcement • May 17
Todos Medical Ltd. announced delayed 10-Q filing On 05/16/2023, Todos Medical Ltd. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Feb 15
Todos Medical Initiates Validation Plan for PCR-based Avian Influenza A (H5N1, Bird Flu) Test at CLIA/CAP Testing Lab Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP-certified laboratory Provista Diagnostics has initiated a validation plan for PCR-based Avian Influenza A (H5N1, bird flu) human testing. Under the plan, the Company will validate commercial and internally developed H5N1 PCR reagents and launch the most sensitive test. The H5N1 PCR test is being developed as a Laboratory Developed Test (LDT). The currently circulating strain of H5N1, which has been the most transmissible and most deadly to date, has successfully crossed over from birds to mammals, with various land and sea animals, including skunks, foxes, raccoons, bears, minks, mountain lions, sea lions, seals and dolphins having confirmed H5N1 infection at death. Over 58 million poultry birds have been affected, and cases in birds have been reported in every state in the US. There is concern among leading scientists that the current strain of H5N1 could mutate to become more transmissible towards humans. Ecuador reported the first human case of H5N1 for 2023 in a 9-year old girl in January. When H5N1 does infect humans, historical data gathered shows it has a 56% mortality rate. Announcement • Oct 15
Todos Medical CLIA/CAP Lab Provista Submits Emergency Use Authorization Application for Monkeypox PCR Test to US FDA Todos Medical Ltd. announced that its CLIA/CAP-certified clinical laboratory Provista Diagnostics has filed an Emergency Use Authorization (EUA) application with the US Food & Drug Administration (FDA) for its PCR MonkeyPox Test. The EUA application was submitted for lesion-based PCR. The sensitivity achieved for the currently available lesion-based laboratory-developed test (LDT) is 0.95 viral copies per reaction (0.095 copies/ul). Announcement • Sep 28
Todos Medical Announces USPTO Trademark Notice of Allowance for 3Cl Protease Biomarker Diagnostics Tollotest™ Todos Medical Ltd. announced that its majority-owned joint venture 3CL Pharma Ltd. received a Notice of Allowance issued by the USPTO for the Company’s proprietary SARS-CoV-2 3CL protease (Main protease, Mpro, Nsp5) diagnostic TolloTest™ that was developed to detect and quantify the presence of 3CL protease in human tissue samples. TolloTest has been initially validated in upper respiratory tract (swab) samples and can provide PCR-like accuracy with convenience similar to that of a rapid antigen test. The Company previously announced positive data on TolloTest in hospitalized and outpatient settings such as skilled nursing facilities and schools. The test is designed to quantify 3CL protease, which is being measured for correlation with infectiousness and potentially a key feature of the SARS-CoV-2 viral persistence pathology in Long COVID. TolloTest is a potential companion biomarker test for the Company’s 3CL protease inhibitor dietary supplement Tollovid and a companion diagnostic for its Phase 2 asset Tollovir for hospitalized COVID. TolloTest can be commercialized as a rapid point-of-care test in single use and mass screening formats, as an at-home test for single use, and as a laboratory developed test (LDT) for use in high complexity CLIA labs and mobile labs for patient monitoring. The global COVID-19 diagnostics market size is expected to reach USD 50.1 billion by 2030, according to a new report by Grand View Research Inc. The market is expected to expand at a CAGR of 7.7% from 2022 to 2030. The Company expects significant innovation will be required to improve the accuracy of point of care diagnostics and TolloTest could play a key role in area. Announcement • Sep 15
Todos Medical Initiates Validation Plan for PCR-Based Polio Testing at CLIA/Cap Laboratory Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP-certified laboratory Provista Diagnostics has initiated a validation plan for PCR-based polio testing. The Company intends to validate multiple PCR assays for polio, including wastewater testing with ultra-high sensitivity. Low viral load diagnostic tests will be developed for early diagnosis and will be available for multiplexing with other PCR panels. The global bioinformatics market was valued at $13.2 billion in 2021 according to Precedence Research and is expected to grow at a CAGR of 16.3% to $45.6 billion by 2030. This market includes data management and production, data warehousing, and data mining for life sciences, academia, and applied testing. A much smaller subset of this market is the Wastewater-based epidemiology (WBE) which surveils large population clusters in an unobtrusive manner. The routine testing can be used to capture data on underreported viral illnesses, enabling the early detection of pathogens in a community. There are 58 countries gathering this data in order to enact policy decisions. During the COVID-19 surges, wastewater patterns were analyzed and became predictive of the subsequent outbreaks. The average site typically screens weekly or twice weekly and gets reimbursed up to $940 per site per week according to some recent awards from the CDC. Announcement • Aug 27
Todos Medical Announces Saliva-Only Monkeypox Testing At Clia/Cap Clinical Lab Provista Diagnostics Todos Medical Ltd. announced that its Atlanta-area CLIA/CAP-certified clinical laboratory Provista Diagnostics Inc. is now offering saliva-only MonkeyPox testing. The saliva-based samples collected must be stored in the refrigerator within 1 hour of collection and be shipped with cold packs to arrive at the lab within 72 hours of sample collection. The lab has a result turnaround time of 24-48h from the time the sample arrives at the lab. The sensitivity achieved for the saliva-based MonkeyPox laboratory-developed test (LDT) is 1.2 viral copies per reaction (0.12 copies/ul). The saliva test is intended to be used primarily in suspected cases of MonkeyPox without lesions. In cases where patients with suspected MonkeyPox present with lesions, it is still recommended to test both lesions and saliva to determine whether the lesions contain virus and whether saliva is representative of systemic active infection. The Company’s sales representatives have begun reaching out to school districts in the Atlanta, Georgia area to make them aware of Provista’s saliva testing capabilities. The Provista saliva MonkeyPox test is available in all states, with the exception of New York. The Company expects to be able to offer MonkeyPox testing in New York following a late September inspection by the New York Department of Health (NYDOH). Provista is now also preparing to validate blood testing for MonkeyPox IgM/IgG antibodies, including collection using finger prick collection devices, as well as validating MonkeyPox fecal samples to identify potential viral persistence after resolution of acute MonkeyPox symptoms. Announcement • Aug 26
Todos Medical, Ltd. Enrolls Female Long COVID Patient Unable to Secure Testing While Symptomatic for MonkeyPox into Provista Diagnostics Case Study Series Todos Medical Ltd. announced that its Atlanta-area CLIA/CAP-certified clinical laboratory Provista Diagnostics Inc. has enrolled a female Long COVID who was unable to secure MonkeyPox testing while severely symptomatic into diagnostic case study series. The patient was denied testing while symptomatic for MonkeyPox and has now been prescribed TPoxx. Provista has received patient samples collected prior to TPoxx administration and will assess MonkeyPox effect on the Amerimmune Long COVID Panel pre and post TPoxx intervention. The data could provide valuable information on the risk of MonkeyPox to Long COVID patients. The Company believes it is important for schools to plan for PCR-based COVID surveillance testing and MonkeyPox testing and contract tracing programs in order to be able to effectively respond to the threat of viral outbreaks in their schools. With a prevalence of Long COVID among children previously infected with COVID at between 10% according to an article in JAMA and 25% according Nature, there is significant risk that if MonkeyPox outbreaks become routine in schools immune-compromised children, including those with Long COVID, may suffer an outsized impact as a result of impaired immune response. There are currently over 30 million children enrolled in elementary and middle schools in the United States and over 16 million children enrolled in high schools. Announcement • Aug 24
Todos Medical, Ltd Initiates MonkeyPox Diagnostic Case Studies After Being Approached by 4 Patients, Including 3 Women Todos Medical Ltd. announced that its Atlanta-area CLIA/CAP-certified clinical laboratory Provista Diagnostics Inc. has initiated a MonkeyPox diagnostic case study series evaluating the potential for missed diagnosis among suspected MonkeyPox among non-gay male patient groups who have been unable to secure adequate testing to confirm their diagnosis, and who remain symptomatic up to 10 weeks. The first four enrollees in the case study series include three women and one man. The Company intends to work closely with the patients to evaluate multiple test articles for potential MonkeyPox viral reservoir and hopes to enroll sufficient numbers of patients to be able to ultimately validate different sample types as laboratory developed tests (LDTs). The Company remains open to accepting additional patients into its MonkeyPox case study series. The Company also intends to work closely with Amerimmune to measure effects of MonkeyPox on the immune system. This data is expected to uniquely position Provista in the MonkeyPox testing space by providing not only insight on potential active and recent infection, but also in the area of potential viral reservoir driving longer-term symptoms and the development of immunity from infection, and potentially Jynneos vaccination. The Company will use data gathered from these patients to support the launch of a planned blood-based IgM/IgG laboratory developed to determine active or recent infection through blood, as well as a measure of immunity status. Announcement • Aug 23
Todos Medical Ltd. to Report Q2, 2022 Results on Aug 22, 2022 Todos Medical Ltd. announced that they will report Q2, 2022 results at 4:05 PM, US Eastern Standard Time on Aug 22, 2022 Announcement • Aug 16
Todos Medical Ltd. announced delayed 10-Q filing On 08/15/2022, Todos Medical Ltd. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Aug 13
Todos Medical Ltd. Completes Trial Design for Tollovid™ Long Covid Clinical Study in Adults Todos Medical Ltd. announced that its majority-owned subsidiary 3CL Pharma Ltd. has finalized plans for a proposed safety and efficacy clinical trial for its 3CL protease inhibitor immune support dietary supplement Tollovid™ in patients with Long COVID. The 45-patient Part A of the study will be conducted as a 3-arm, randomized, controlled, observer-blinded clinical study evaluating Tollovid’s effects on the structure/function of the immune system as measured by the presence of neutralizing antibodies, total anti SARS-CoV-2 antibodies (IgG, IgA, IgM) and VEGF cytokine levels. Participating subjects will be randomized into three cohorts: 1) a 15-patient cohort to receive 30-day treatment regimen of 12 capsules per day; 2) a 15-patient cohort to receive a 15-day treatment regimen of 12 capsules per day, followed by 15-day treatment regimen of 6 capsules per day; and 3) an untreated control group who will be eligible to receive Tollovid at the conclusion study. All three groups will be allowed to continue taking their standard of care medications while on study, with the exception of other 3CL protease inhibitors. 3CL Pharma intends to initiate this clinical study in early fourth quarter of 2022. Two Long COVID clinics are in the process of finalizing contracts to participate in the study. It is the intention that study participants can enroll and be evaluated both virtually via remote monitoring, as well as in person. The primary endpoints of Part A of the study are the numbers and severity of adverse events, serious adverse events (SAEs), clinical laboratory abnormalities and changes in vital signs after administration of Tollovid at day 30 following enrollment. The secondary structure/function endpoints of Part A of the study are changes in the Amerimmune/Provista Long Covid Panel, CRP and VEGF after administration of Tollovid at day 30 following enrollment. The exploratory objectives of Part A of the study are to evaluate time to improvement over time in the Post-COVID-19 Functional Status Scale scores and in COVID-19 symptoms after administration of Tollovid at day 30 after enrollment. Biomarker data will be gathered at baseline upon enrollment prior to treatment, midway through the study and at the conclusion of the 30-day treatment regimen for all three groups. The Company expects Part A of the study to complete in the fourth quarter of 2022. If successful, a Part B of the study will be opened to rapidly expand patient enrollment, and potentially extend into pediatric patients, with a yet to be determined clinical design based upon the results of Part A and discussions with regulatory agencies. Announcement • Aug 11
Todos Medical Announces PCR Validation of Wound and Respiratory Pathogen Panels At CLIA/CAP Lab Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP-certified laboratory Provista Diagnostics has completed validation of its PCR-based Wound and Respiratory Pathogen panels. The Wound Panel (WP) is a 31-pathogen multiplexed PCR panel, including antibiotic resistance, taken from swab samples of a wound or lesion that will assist physicians in determining which combinations of drug therapies prescribed to the patient will result in the best patient outcomes. The Respiratory Pathogen Panel (RPP) is 24-pathogen multiplexed PCR panel taken from nasal or saliva samples that will assist physicians in making better treatment decisions for patients presenting with respiratory illnesses. Both the WP and RPP tests can be run on Provista’s Tecan and 3D Med liquid handling automation systems that improve efficiency, safety and capacity, allowing Provista to currently perform up to 25,000 PCR tests per day. With nine (9) liquid handling systems currently onsite at Provista from former Todos PCR testing lab clients, the Company expects Provista to soon be able to run up to 50,000 PCR tests per day. Provista now has 7 Thermo Fisher PCR systems (2 QuantStudio 12k Flex, 2 QuantStudio 7 Flex, 3 QuantStudio 5) and 1 Biorad (CFX) system providing an ability to run over 2,400 patient samples at a time. The Company will continue to redeploy automation and equipment assets towards Provista as 3rd party lab testing contracts wind down. Additionally, the Company provided an update on the validation of its MonkeyPox lesion and saliva-based assays that validation is on track to be completed in the second half of August. The Company intends to wait until the MonkeyPox validation is complete in order to commercially launch its WP and RPP tests, as it is the Company’s intention to also make MonkeyPox testing available on those samples. Given that MonkeyPox is spread primarily through skin-to-skin contact, contact with open wounds (lesions), as well as through respiratory droplets and aerosols, both with WP and RPP assays will have important clinical value for differential diagnosis. While lesion-based testing is the current standard of care according to CDC guidelines, prospective clients have expressed eagerness to gain access to saliva-based sample collection as a means of improving the safety of frontline healthcare workers screening suspected MonkeyPox cases. Flow Health in Los Angeles, CA, a leader in MonkeyPox testing, has already reported successfully assisting in the diagnosis of asymptomatic MonkeyPox patients using saliva samples, proving saliva testing’s clinical usefulness in the current MonkeyPox outbreak. Provista MonkeyPox tests are being developed as Laboratory Developed Tests (LDTs). Announcement • Aug 09
Todos Medical, Ltd. Announces First Two Contracts for PCR-based MonkeyPox Testing at CLIA/CAP Clinical Testing Laboratory Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP-certified laboratory Provista Diagnostics has entered into two contracts to provide PCR-based MonkeyPox testing services. Under the first agreement, Provista will be providing MonkeyPox-related testing to a New Jersey-based medical group that specializes in routine screening of patients presenting with dermatologic complaints. Under the second agreement, the Company is expanding a reference laboratory agreement with a New Jersey-based CLIA lab that is already sending COVID testing samples to add MonkeyPox testing. While lesion-based testing is the current standard of care according to CDC guidelines, the clinic and laboratory clients have both expressed they are eager to offer the saliva-based sample collection method Provista is currently validating alongside the lesion-based testing as a means of improving the safety of the frontline healthcare workers screening suspected MonkeyPox cases, given the recent report of a healthcare worker in Israel being infected with MonkeyPox after screening a suspected case. The saliva-based testing is undergoing intense research that the Company expects will open up the potential for testing of asymptomatic or very early-stage patients at high risk of severe disease (such as immunocompromised patients) that could result in earlier diagnosis and early intervention with therapeutic drugs such as Tecovirimat (TPOXX). TPOXX is an investigational drug candidate, and currently only available under an expanded access Investigational New Drug (EA-IND) protocol. Flow Health in Los Angeles, CA has already reported successfully diagnosing asymptomatic MonkeyPox patients and referring patients for TPOXX. The Provista MonkeyPox tests are being developed as Laboratory Developed Tests (LDTs). Announcement • Aug 07
Todos Medical Ltd., Annual General Meeting, Sep 15, 2022 Todos Medical Ltd., Annual General Meeting, Sep 15, 2022. Announcement • Aug 06
Todos Medical Announces First Long COVID Clinic Laboratory Services Agreement for Long COVID Panel Biomarker Partnership with Amerimmune Diagnostics Todos Medical Ltd. announced the first commercial patient samples have been received for its Long COVID Panel biomarker partnership between its CLIA/CAP certified lab Provista Diagnostics and Amerimmune Diagnostics, a CLIA/CAP certified laboratory with expertise in immune diagnostics and a leader in the field of clinical immunology and immune assessment of acute and long-COVID. The patient samples received were requisitioned by Long COVID Clinic RTHM (Real Time Health Monitoring), the partnership’s first Long COVID Clinic client, collected at a Quest Diagnostics service center in the United States and shipped to Amerimmune’s lab in McLean, Virginia for processing. The cPass neutralizing antibody and total antibody portion of the panel is being subcontracted to Provista in Atlanta, GA and the data sent back to Amerimmune to include in their report back to the RTHM physician. The various biomarker tests included in the Long COVID Panel are covered by commercial insurance and Medicare. Additionally, RTHM physicians are now working with Todos’ subsidiary 3CL Pharma on its Tollovid™ 3CL protease inhibitor immune support supplement case study series, and will now begin to monitor biomarker data with the Long COVID Panel. The objective is for Long COVID Panel data to be included in Todos’ ongoing Tollovid case study series going forward to corroborate perceived patient benefit. Todos intends to use data gathered during the case study series and its ongoing IRB-waived market research study to inform Tollovid dosing recommendations for clients. Additionally, Todos is planning a controlled Tollovid Phase 2 study. Announcement • Jul 01
Todos Medical Ltd. Announces Positive Biomarker Data from Phase 2 Trial of Tollovir in Hospitalized COVID-19 Patients Todos Medical Ltd. announced biomarker data from its majority-owned joint venture 3CL Pharma Ltd.'s Phase 2 clinical trial of Tollovir in hospitalized COVID-19 patients. The data showed a positive correlation between the clinical data announced for Tollovir on January 27, 2022 and biomarkers associated with acute phase immune response, inflammation, blood clotting and immune response to COVID-19. Additionally, renal and hepatic biomarker data showed no signals of treatment-associated risk with Tollovir therapy. Announcement • Jun 24
Todos Medical Releases Preliminary Data from Irb-Waived Tollovid® Market Research Study in Acute and Long Covid Todos Medical Ltd. announced preliminary data from its majority-owned joint venture 3CL Pharma Ltd.’s ongoing IRB-waived sponsored market research study of the commercial use of Tollovid® as a dietary supplement. Among the first 41 respondents, of whom 78% were fully vaccinated against COVID-19, 13 reported that they began to use Tollovid when they were diagnosed with active COVID infection, whereas 28 respondents reported that they used Tollovid to address their Long COVID symptoms. 15 of the Long COVID respondents had experienced symptoms for up to 9 months (‘Short’ Long COVID), and 12 of the Long COVID respondents reported having symptoms for over 9 months (‘Chronic’ Long COVID). 18 of the 24 respondents who answered the question “Who diagnosed your Long COVID?” indicated that they were diagnosed by a medical professional. The preliminary results of the market research study are marked in the table below: Respondents to the market research survey generally followed the directions on the Tollovid label, taking 12 capsules per day for 5 days among Acute COVID respondents, and taking at least 2 bottles of Tollovid according to the directions among Long COVID respondents. This market research study is not designed to assess optimal Tollovid dosing. No negative effects from interactions with other concomitant medications or supplements were reported by survey respondents. Announcement • Jun 14
Todos Medical Ltd. Completes Validation of 27 Pathogen UTI PCR Panel at its CLIA/CAP Laboratory Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP-certified laboratory Provista Diagnostics has completed validation of a 27-pathogen urinary tract infection (UTI) PCR precision medicine panel. The assay is now in production, and the Company is preparing to launch it commercially. Provista intends to target skilled nursing facilities, ob/gyn and women’s health specialists as primary customers. The primary benefit of UTI testing using PCR, as compared with current standard methods of cell culture testing, is that PCR is much more sensitive in identifying all of the key bacterial pathogens involved in a UTI, as compared with cell culture that identifies primarily the most prevalent upon cell culture expansion (primarily e.coli). This e.coli pathogen overrepresentation leads to inappropriate therapy selection that results in poor outcomes for patients, including prolonged and worsening symptoms. The second benefit of PCR testing vs. cell culture for UTI, is the rapid turnaround time for (24h-48h) vs. cell culture (3-7 days). For caregivers in skilled nursing facilities, in particular, the rapid identification and resolution of UTI is paramount to avoid potentially significant side effects including incontinence, agitation, lethargy, falls, urinary retention, decreased mobility, decreased appetite, fever, flushed skin, back pain, nausea and vomiting. Announcement • May 05
Todos Medical Ltd. Receives New FDA Certificate of Free Sale for Tollovid® Max Strength Including 5 Day Dosing, 30 Day Dosing and 3CL Protease (3CLpro, Mpro, Nsp5) Inhibitor Claim Todos Medical Ltd. announced that its majority-owned subsidiary 3CL Pharma Ltd. has received a new certificate of free sale (CFS) from the US Food & Drug Administration whose label provides for both a 5-day support dosing regimen and a 30-day maintenance dosing regimen of Tollovid® Maximum Strength and reiterates the 3CL protease (3CLpro, Mpro, NSP5) in vitro inhibitor language allowed on prior labels for Tollovid®. The Company believes this new CFS will help customers more easily navigate using the product given the recent increase in interest for Tollovid®. The new label for the 60-pill bottle provides for: Support to reduce 3CL protease levels of 12 pills per day over 5 days; and Maintenance of low protease levels of 2 pills per day. The Company will be working to add a packaging supplement to future sales of Tollovid with a pamphlet that provides additional information. The Company will continue to sell bottles from inventory manufactured in the first half of 2021 prior to receiving its first CFS with the 3CL protease inhibitor language in June of 2021. Tollovid and Tollovid Daily are dietary supplement products made from natural ingredients that help support and maintain healthy immune function and also have potent 3CL protease inhibition properties based upon in vitro functional assays that show strong inhibition of 3CL protease activity. Tollovid's 3CL protease IC50 binding affinity is at least ten times (10x) as strong as Ivermectin’s published 3CL protease IC50 binding affinity. Tollovid Daily’s 3CL protease IC50 binding affinity is at least two and a half times (2.5x) as Ivermectin. Tollovid and Tollovid Daily bind to the active site (receptor binding domain) of the 3CL protease. Tollovid has a 5-day dosing regimen, with 4 doses of 3 pills taken each day that provides maximum immune support. Tollovid Daily is a daily immune support product with a dosing regimen of twice daily. Announcement • Apr 01
Todos Medical Ltd. Contemplates Bankruptcy Todos Medical Ltd. is contemplating filing for bankruptcy, as of March 31, 2022. According to SEC filing, Company said that it is need to raise additional funds to operate business and continue its operations, if unable to raise funds as and when we need, it may be required to curtail, or even to cease, its operations. The company’s management is attempting to secure additional required funding primarily through additional equity or debt financings. It may also seek to secure required funding through sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions. However, there can be no assurance that the company will be able to obtain required funding. If it is unsuccessful in securing funding from any of these sources, it will defer, reduce or eliminate certain planned expenditures in its research protocols. If the company fails to raise sufficient funds to continue operations, it could be required to seek bankruptcy protection or other alternatives that could result in shareholders losing some or all of their investment in the company. Announcement • Jan 28
Todos Medical and Nlc Pharma Announces Primary and Secondary Endpoints Met in Nlc-V-01 Phase 2 Clinical Trial of Oral Antiviral 3Cl Protease Inhibitor Tollovir in the Treatment of Hospitalized Covid-19 Patients Todos Medical Ltd. together with its 3CL protease theranostic joint venture partner NLC Pharma Ltd. announced positive interim data for its Tollovir™ oral antiviral 3CL protease inhibitor Phase 2 clinical trial for the treatment of hospitalized (severe and critical) COVID-19 patients. Tollovir met its primary endpoint of reducing time to clinical improvement as measured by the National Emergency Warning System 2 (NEWS2) and met several key secondary clinical endpoints, including complete reduction in COVID-19 deaths. The Company has now formally closed the Phase 2 clinical trial due to positive interim efficacy data. Lead clinical site share Zedek Medical Center now permits the use of Tollovir™ in hospitalized COVID-19 patients on a compassionate use basis. Study NLC-V-01 was a double blinded randomized placebo-controlled study designed to evaluate the safety and efficacy of NLC-V (Tollovir™) in adult patients with a confirmed diagnosis of SARS-CoV-2 infection, who are hospitalized due to the infection. Approximately 78 patients were set to be randomized using a 1:1 ratio (approximately 39 per arm) and stratified by weight group (<70 kg, 70-100kg, and >100kg) to receive Tollovir or placebo, in addition to standard of care. Patients who need mechanical ventilation received the randomized treatment using Liquid Syrup. The Company paused enrollment of the NLC-V-01 clinical trial after enrollment of 31 patients to perform an interim-analysis to evaluate the safety and efficacy profile of Tollovir. Primary Objective: To evaluate the safety and efficacy of Tollovir in addition to Standard of Care (SOC) in adult patients hospitalized due to infection with a confirmed diagnosis of SARS-CoV-2. Endpoints: Time to clinical improvement, defined as a National Early Warning Score 2 (NEWS2) of = 2 maintained for 24 hours, in the treatment group (Tollovir) compared to the control group. Time elapsed from hospitalization (1st day) until hospital discharge in patients receiving Tollovir treatment. COVID-19 - related death(s) in the treatment group (Tollovir) compared to the control group. Incidence of deterioration and need for mechanical ventilation in both treatment group (Tollovir) and control group. Incidence and duration of time on supplemental oxygen in both treatment group (Tollovir) and control group. Number of Patients: 31 participants (adult patients with a confirmed diagnosis of SARS-CoV-2 infection, who are hospitalized due to the infection) were enrolled in the Tollovir Phase 2 clinical trial. The study was executed in two cohorts (parts) as follows: Part 1: Tollovir Clinical Trial Part 1 (TCTP1) (N=11): Tollovir formulation 1 (TLVR1) + SOC (N=6) vs. Placebo + SOC (N=5). This part of the study enrolled patients from December 2020 through February 2021 primarily during the Third COVID Wave (Alpha and Beta variants). Part 2: Tollovir Clinical Trial Part 2 (TCTP2) (N=20): Tollovir formulation 2 (TLVR2) + SOC (N=11) vs. Placebo + SOC (N=9). This part of the study enrolled patients from May 2021 through November 2021 primarily during the Fourth COVID Wave (Delta variant). All study design features were identical in Part 1 and Part 2, including enrollment criteria and statistical analysis plan. The only difference between Part 1 and Part 2 cohorts was a change in formulation of the Tollovir botanical drug formula: in TCTP1 the active drug was TLVR1 and in TCTP2 the active drug was TLVR2. TLVR1 primarily consisted of the botanical extract identify as NLC-EXT-2, discovered by Dr. Dorit Arad in 2004 as a 3CL protease inhibitor with potent anti-cytokine activity. TLVR2 consists of a formulation that includes NLC-EXT-2 and NLC-EXT-1, a newly isolated compound first identified in January 2021 as part of raw material qualification experiments that was confirmed in April 2021 to have significantly more potent 3CL protease inhibitor than NLC-EXT-2. NLC-EXT-2 has a 3CL protease ICD50 binding affinity of 20mM vs. NLC-EXT-1 that has a 3CL protease ICD50 binding affinity of 0.8mM. Going forward for the next phase of clinical trials and commercialization, Tollovir will consist exclusively of the TLVR2 formulation that contains both NLC-EXT-1 and NLC-EXT-2 in the proprietary ratio used in Part 2 of the study (TCTP2). The data was analyzed by independent biostatistical service contractor InCSD using SAS 9.4, and the data tables below were prepared by InCSD’s President Dr. Luis Rojas. Dr. Jules Mitchel, a key clinical advisor to the Company, oversaw the analysis. Announcement • Jan 13
Todos Medical to Announce Topline Results from Tollovir™ Phase 2 Clinical Trial from the Treatment of Hospitalized COVID-19 Patients on January 27th, 2022 Todos Medical Ltd. announced that topline results from the Tollovir™ Phase 2 clinical trial for the treatment of hospitalized COVID-19 patients will be announced the morning of January 27th, 2022, with a conference call follow-up that will occur after market close. The Company will provide further details regarding the conference call during the week ending January 17, 2022 when it announces the data lock for the trial. Announcement • Dec 08
Todos Medical Ltd. Announces 2 New COVID-19 PCR Testing Reference Lab Agreements for CLIA/CAP Lab Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP lab Provista Diagnostics has won two (2) new reference lab testing contracts from laboratories collecting samples in Georgia and New Jersey. In the last two weeks both labs referring have experienced a marked uptick in testing demand, primarily from schools, that has caused them to exceed their small testing capacity and required them to identify additional testing capacity available to meet their needs, making them ideal lab clients for Provista. Provista Diagnostics is Todos Medical’s wholly-owned CLIA/CAP certified lab that offers comprehensive, fast, automated COVID-19 testing solutions that help referring labs keep their clients by allowing them to deliver fast turnaround time (TAT) at scale. Provista currently has the automation setup and in place to conduct over 20,000 COVID-19 PCR tests per day. The lab also has the automation in place to conduct over 1,500 cPass semi-quantitative neutralizing antibody tests per day, over 5,000 COVID variant tests per day (including testing for the Omicron variant that is being implemented now by PCR variant kit) and over 5,000 respiratory panel tests per day. Announcement • Dec 03
Todos Medical with Its Joint Venture Partner NLC Pharma Announces All 31 Patients Enrolled to Date in Tollovir® Phase 2 Clinical Trial in Hospitalized Covid-19 Patients Have Completed Study Participation Todos Medical Ltd. together with its 3CL biology-focused joint venture partner NLC Pharma, announced that all 31 patients enrolled to date in Tollovir® Phase 2 clinical trial in hospitalized COVID-19 patients have completed study participation and the data are now being entered into the database for analysis. Dr. Jules Mitchel, a strategic advisor retained by Todos to assist with the analysis, is now leading preparation for data lock and statistical analysis. The Company expects data analysis to be completed in December 2021. Tollovir® is a 3CL protease inhibitor and anti-cytokine therapeutic candidate for the treatment of the nidovirus subcategory of coronaviruses that includes SARS-CoV-2, COVID-19, SARS-CoV-1, MERS and 229E. Tollovir is made from all natural ingredients that are qualified to ensure strong inhibition of the 3CL protease in vitro, as well as strong anti-cytokine activity. Tollovir is currently in a Phase 2 clinical trial in Israel for the treatment of patients hospitalized with COVID-19. Tollovir will be developed for the treatment of hospitalized COVID-19 (severe and critical), moderate COVID-19, long-haul COVID and potentially pediatric COVID-19. Todos has licensed rights for Tollovir to T-Cell Protect Hellas S.A. for the Greek market. TolloTest® is a 3CL protease diagnostic fluorescence platform technology that has demonstrated clinical proof of concept in hospital setting and outpatient settings in correctly identifying patients infected with COVID-19, including within 1-3 days of first exposure. TolloTest diagnostic tools are being developed to address key deficiencies with current SARS-CoV-2 rapid antigen and PCR technologies. TolloTest can provide results in less than ten (10) minutes, and potentially in as little as two (2) minutes. Data generated from two studies conducted with TolloTest demonstrate that: (1) it can identify SARS-CoV-2 infected patients earlier than rapid antigen testing (potentially earlier than PCR testing), (2) it can identify patients who are likely no longer infectious, but still test positive by PCR and (3) it can identify patients that are still likely infectious, but who have been released from quarantine based on time from positive PCR test. TolloTest assay formats are being developed for (1) point-of-care/at-home market and (2) rapid mass screening in community settings (airports, schools, offices).Tollovid and Tollovid Daily are dietary supplement products, made from natural ingredients, that help support and maintain healthy immune function, and are also 3CL protease inhibitor products based upon in vitro functional assays that show inhibition of 3CL protease activity. Tollovid's 3CL protease inhibition activity release criteria is at least twice as stringent as Tollovid Daily's 3CL protease inhibition release criteria. Tollovid has a 5-day dosing regimen, with 4 doses of 3 pills taken each day that provides maximum immune support. Tollovid Daily is a twice daily immune support product that is designed to provide ongoing daily immune support for the person on the go. Announcement • Sep 24
Todos Medical Launches Tollovid Daily™ via Subscription at MyTollovid.com Todos Medical Ltd. announced an expansion of its Tollovid® dietary supplement 3CL protease (MPro) inhibitor immune support product line with the launch of Tollovid Daily™ via subscription. The subscription model takes the hassle out of remembering to order Tollovid Daily on a monthly basis. Both Tollovid and Tollovid Daily are 3CL protease inhibitors for immune support that have 60 caplets per bottle. Tollovid Daily was designed as a twice-daily dosing schedule for people on the go that provides one month of daily immune support. Tollovid was designed as a 12 pills/day, 5-day dosing schedule for when a person is seeking maximum immune support over a short period of time. Announcement • Aug 27
Todos Medical’s CLIA/CAP Lab Provista Completes Validation of High-Capacity SARS-CoV-2 Variant Testing Service Capable of Identifying Known Variants Todos Medical Ltd. announced that its CLIA/CAP certified lab Provista Diagnostics has successfully completed the validation studies required to put the Kogene Biotech PCR Variant Test Kit (‘Kogene Variant Kit’) into production and expects to launch variant testing in September 2021. The Kogene Variant Kit is a PCR kit capable of identifying the key mutations associated with specific SARS-CoV-2 variants, including the key P681R mutation identified in the Delta variant, that allows Todos to categorize the lineage of the strain responsible for a positive test result. The test can be completed in as little as one hour, significantly faster than genome sequencing, and is highly scalable with the Tecan® liquid handling automation currently onsite at Provista. Todos sees a large market opportunity developing for variant testing that will further expand upon the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020. Provista Diagnostics has the automation in place to do up to 20,000 PCR tests, over 1,500 cPass tests per day and can complete over 5,000 variant tests per day when at full capacity. The CMS reimbursement rate per PCR test is $100, and best practices indicate that labs can bill for an additional PCR test to confirm the variant associated with a positive when using the Kogene Variant Kit. To date, over 37 million people in the United States have tested positive for COVID-19, and with the rate of breakthrough infections rapidly increasing, tracking variants of interest and of concern is now urgently needed. Announcement • Aug 17
Todos Medical Ltd. announced delayed 10-Q filing On 08/16/2021, Todos Medical Ltd. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Aug 04
Todos Medical Ltd. (OTCPK:TOMD.F) acquired Provista Diagnostics, Inc. from Ascenda BioSciences LLC for $10 million. Todos Medical Ltd. (OTCPK:TOMD.F) agreed to acquire Provista Diagnostics, Inc. from Ascenda BioSciences LLC for $7.5 million on April 19, 2021. Under the terms of the transaction, Todos acquired Provista for an aggregate purchase price of $7.5 million consisting of an initial cash payment of $1.25 million, the issuance of $1.5 million in Todos common shares, the issuance of a $3.5 million convertible promissory note and the payment on for before July 1, 2021 of $1.25 million.
Todos Medical Ltd. (OTCPK:TOMD.F) completed the acquisition of Provista Diagnostics, Inc. from Ascenda BioSciences LLC for $10 million on August 2, 2021. As of August 2, 2021, Todos Medical, Ltd. made the final payment of $1.25 million to complete its $10 million acquisition of Provista Diagnostics, Inc. Announcement • Jul 24
Todos Medical, Ltd. Receives New FDA Certificate of Free Sale for Tollovid Daily™ Including 3CL Protease Inhibitor Claim Todos Medical Ltd. announced that the US Food & Drug Administration 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. The Company expects Tollovid product line revenue to become material for the Company’s earnings in the fourth quarter of 2021. Announcement • Jul 20
Todos Medical to Launch EUA Authorized cPass SARS-CoV-2 Neutralizing Antibody Kit Through Agreement with Fosun Pharma Todos Medical Ltd. 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. 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. Announcement • May 18
Todos Medical Ltd. announced delayed 10-Q filing On 05/17/2021, Todos Medical Ltd. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Apr 03
Todos Medical Ltd. announced delayed annual 10-K filing On 04/01/2021, Todos Medical Ltd. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Jan 26
Todos Medical Ltd. announced that it has received $3.4 million in funding from YOZMA GROUP KOREA Co.,Ltd. Todos Medical Ltd. (OTCPK:TOMD.F) announced a private placement of convertible promissory note for gross proceeds of $3.4 million on January 25, 2021. The transaction included participation from new investor YOZMA GROUP KOREA Co.,Ltd. The note mature on one year from the closing date. The note is convertible into common shares at a fixed price of $0.0599 per share. Announcement • Dec 25
Todos Medical Announces Agreement to Supply Natural Wellness Clinics with COVID-19 Testing Products to Support Initiatives in the Commonwealth of Kentucky Todos Medical announced that it has entered into a preferred vendor agreement to supply COVID-19 related testing products and services to Natural Wellness Clinics (NWC) for use in its efforts in testing the uninsured population in the Commonwealth of Kentucky. NWC is a US military veteran owned health care provider that offers communities a holistic and integrative approach and is establishing a niche in implementing large-scale testing programs and logistics for state governments that it hopes may dovetail into vaccine distribution logistics. Natural Wellness Clinics recently signed a COVID-19 testing contract for up to approximately $93.4 million with the Commonwealth of Kentucky to test uninsured citizens of Kentucky. Continued funding was anticipated; however, budget concerns have impacted the initiative. In light of the changes in funding for COVID-19 testing for states governments across the United States, Todos is working with the Commonwealth of Kentucky to identify the appropriate funding mechanisms that will allow this testing program to move forward. Announcement • Nov 21
Todos Medical Ltd. Announces Positive in Vitro Data for Tollovid™ Confirming 3CL Protease Inhibition Mechanism of Action Todos Medical Ltd. announced positive in vitro data by its joint venture partner NLC Pharma for the Company’s dietary supplement Tollovid™, demonstrating its ability to inhibit the 3CL protease. The 3CL protease is an enzyme that is required for the intracellular replication of coronaviruses. Tollovid received a certificate of free sale from the FDA in August 2020 and is being launched commercially into the US market initially at botanical wellness store The Alchemist’s Kitchen™ in New York City. As part of NLC Pharma's development activities for Tollovid, a joint study was conducted in the laboratory of Professor Dan Farr, Vice President of Research and Development at Tel Aviv University. During the study, the ability to inhibit the activity of enzyme 3CL was examined. The researchers believe the 3CL protease plays a key role in coronavirus activity and is critical to allow for processing of the proteins encoding viral RNA. Inhibition of this activity could stop the ability of coronaviruses to replicate, and thus inhibit their ability to spread in the body. During the study it was shown that Tollovid, which is an extract of a botanical substance, was able to successfully inhibit the 3CL protease activity. Since the beginning of 2020, over 1,000 patients suffering from diseases caused by circulating coronaviruses in Israel have received various dosing regimens of Tollovid, including both hospitalized and non-hospitalized patients. There has been overwhelmingly positive customer feedback on their experience with the product, including significant positive feedback from physicians. Based on the results of this market research study conducted in Israel, as well as the pioneering research advanced by Dr. Dorit Arad on the entire coronavirus family of viruses for over the last 20 years, NLC Pharma is preparing to initiate a randomized clinical trial in Israel in December 2020 to evaluate the potential for Tollovid to treat patients suffering from actively circulating coronaviruses. Announcement • Nov 19
Todos Medical Announces Positive Initial Clinical Proof-Of-Concept Data for A Rapid SARS-CoV 2 3Cl Protease Detection Assay Todos Medical announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2 3CL protease diagnostic assay in collaboration with its COVID Antigen Test Killer LLC joint venture partner NLC Pharma. The data generated by NLC Pharma in Israel produced 100% sensitivity and 100% specificity in PCR-confirmed positive and negative COVID-19 patient samples. The team is now gathering additional clinical data to submit an emergency use authorization (EUA) to the United States Food & Drug Administration (FDA) for its lab-based test to be distributed through Todos’ existing lab distribution channels. Todos is evaluating the best option for the commercialization of its rapid point-of-care version of the 3CL protease assay for the screening and diagnosis of symptomatic and asymptomatic COVID-19 carriers, based on recent updated guidance from the FDA for COVID-19 diagnostic point of care tests. Announcement • Nov 18
Todos Medical Announces Clinical Validation and National CLIA Certification for Moto+Para Mobile High Complexity Labs Todos Medical Ltd. announced the completion of clinical validation and CLIA certification for MOTO+PARA’s mobile lab. The company’s mobile CLIA lab partner, Integrated Health LLC, has fully validated the clinical performance of the proprietary COVID-19 RT-PCR laboratory testing process performed in MOTO+PARA’s Mobile High Complexity Labs built to biosafety level 3, and has received the approval needed to begin offering COVID-19 screening and analysis as a service to clients anywhere in the United States. Rapid antigen and antibody testing also have been validated and are now ready to be deployed. MOTO+PARA is prepared to accept contracts from prospective clients immediately. Announcement • Oct 08
Todos Medical Enters into Exclusive COVID-19 Testing Supply Agreement with Moto+PARA’s National Mobile CLIA Lab Partner Integrated Health Todos Medical Ltd. announced that it has entered into an exclusive supply agreement with U.S. national mobile CLIA laboratory company Integrated Health LLC operating MOTOPARA Foundation’s mobile biosafety level 3-built laboratories (the “Mobile Labs”) developed to address the global COVID-19 pandemic. The Mobile Labs are initially capable of running 1,000 PCR tests per 8-hour shift and can scale to 3,000 PCR tests per 8-hour shift upon proper process implementation, and capable of processing Rapid Antigen Tests and Rapid Antibody Tests as screening tools as part of overall testing protocols designed to improve testing capacity and reduce positivity rates. MOTO+PARA expects to be able to scale production by end of Fourth Quarter 2020. MOTOPARA Foundation is a non-profit organization managing well-trained retired service veterans from all branches of the military encompassing site operations, physicians, paramedics, and nurses in coordination to provide disaster relief solutions. MOTO+PARA has designed its Mobile Testing and Lab Solution to provide comprehensive services for large scale screening and surveillance, diagnostic triage and confirmatory PCR testing to provide a complete risk assessment that supplies better information to decision makers for threat assessment and possible courses of action. Integrated Health is guiding the first Mobile Lab through CLIA laboratory validation, providing leadership and direction for laboratory policy and practice adherence. MOTO+PARA owns and operates the Mobile Labs, vehicles, vessels, and aircraft, as well as technical staff, healthcare staff and logistics personnel required to administer secured testing and laboratory services. Announcement • Oct 04
Todos Medical Enters into Exclusive Branding and Distribution Agreement with Melbourne Biotech for 96 and 384 Well RT-PCR Machines in the United States Todos Medical Ltd. announced that it has entered into an exclusive branding and distribution agreement with Australia-headquartered Melbourne Biotech, a US FDA-registered manufacturer, to supply high complexity CLIA laboratories in the United States with 96 and 384 well Real Time Polymerase Chain Reaction (RT-PCR) machines. Melbourne RT-PCR machines come with 4, 5 or 6 channels to be able to identify multiple genes in the same well. Todos intends to focus the initial deployment of these RT-PCR machines towards its ongoing mobile high complexity CLIA lab project that it expects to reach the commercialization stage early in the fourth quarter of 2020. Announcement • Sep 26
Todos Medical Enters Into COVID-19 PCR Testing Implementation and Equipment Financing Partnership with AID Genomics Medical Ltd. announced that it has entered into an implementation and equipment financing partnership with AID Genomics, a multi-national genomic R&D company and solution provider focusing on precision medicines for cancers and infectious diseases. AID Genomics recently completed a contract with the Ministry of Health in Israel to build and scale-up 6 HMO laboratories in Israel. In addition, AID Genomics has entered into a worldwide partnership with Tecan Group for delivery of liquid handler machines. AID has sent key staff from Israel to the United States to assist Todos in its current US implementation projects. Under the terms of the agreement, AID Genomics will finance the purchase of the equipment necessary to allow Todos’ clients to scale to meet their capacity requirements and will assist Todos in the implementation of best practices to speed time to scale and optimize sample accessioning and data reporting software. In return, AID Genomics will participate in the net profit of each contract. Additionally, AID Genomics will assist Todos with validating and commercializing its proprietary tests in Israel. Announcement • Sep 23
Todos Medical Expands Existing Contract for COVID-19 PCR Testing Equipment & Supplies with Wisconsin-based Laboratory to $47.5 Million Todos Medical Ltd. announced that it has rapidly expanded its agreement with a Wisconsin-based laboratory to supply it with the necessary testing equipment and supplies to ramp up to 12,000 tests a day, for a total contract value of $47.5 million in reagent sales by Todos Medical over the next seven months. Todos will be supplying automated extraction machines, liquid handlers and PCR machines. Todos has also been granted a priority right to supply the lab with up to 100,000 COVID PCR tests per day in the event the laboratory sees significant additional testing demand. Announcement • Sep 18
3CL Protease Inhibitor NLC-001 Added to COVID-19-focused Joint Venture Between Todos Medical and NLC Pharma Todos Medical Ltd. announced that NLC Pharma has added the dietary supplement NLC-001 to its joint venture with Todos Medical. NLC-001 is an orally administered proprietary blend of plant extracts that includes a powerful potential 3CL protease inhibitor that could help support and maintain healthy immune function. The 3CL protease plays a vital role in the intracellular replication of coronaviruses, and 3CL protease inhibition is being evaluated as a potential therapeutic target for coronaviruses. Under the terms of the agreement, Todos has been granted exclusive worldwide distribution rights for various formulations of NLC-001, excluding Israel, as well as a right of first refusal to develop pharmaceutical drugs based on the NLC technology. Todos is responsible for all commercial activities, including manufacturing, clinical testing, marketing and distribution outside of Israel. NLC will be responsible for the commercialization of NLC-001 in Israel. NLC-001’s active ingredient is on the Israel Ministry of Health’s authorized dietary supplement import list. The U.S. Food & Drug Administration (FDA) granted a Certificate of Free Sale for NLC-001 to the Joint Venture’s U.S.-based contract manufacturer on August 28, 2020. NLC-001 has not received FDA approval as a prophylactic or as a therapeutic intervention for COVID-19. The companies will work together to meet the remaining regulatory requirements to distribute branded versions of NLC-001 as a dietary supplement to help support and maintain healthy immune function in the United States. NLC Pharma has filed multiple patent applications covering the NLC-001 program worldwide.