Todos Medical Releases Corpora – GuruFocus.com

New York, NY, and Tel Aviv, ISRAEL, Could 27, 2022 (GLOBE NEWSWIRE) — through NewMediaWire —Todos Medical, Ltd. ( TOMDF), a complete medical diagnostics and associated options firm, immediately launched a company replace from CEO Gerald Commissiong on the Firm’s CLIA/CAP-certified lab Provista Diagnostics, an replace on the Firm’s 3CL Pharma majority-owned subsidiary progress and plans to take the Firm onto a nationwide inventory alternate.

CEO Gerald Commissiong commented:

“Todos’ CLIA/CAP licensed laboratory Provista Diagnostics is getting additional entrenched within the PCR testing enterprise by increasing past COVID PCR testing to additionally check for different pathogens equivalent to Urinary Tract An infection (UTI) with PCR, which we consider supplies considerably extra worth over the earlier commonplace of cell tradition assays by enabling quicker turnaround time, 24h-48h for PCR vs. 3-7 days for cell tradition, along with precision drugs therapy decision-enabling pharmacogenomic knowledge to make higher antibiotic prescribing selections. The Firm’s check menu enlargement will proceed as we increase our buyer base in preparation for the business readiness of the Firm’s proprietary testing pipeline merchandise such because the Videssa® breast most cancers blood check and the LymPro Alzheimer’s blood check. We count on Videssa to be launched within the first half of 2023 and lately accomplished enrollment within the second a part of the LymPro vs. amyloid beta medical trial for which preliminary optimistic outcomes have been introduced within the third quarter of 2019.

“On the therapeutic entrance, earlier this morning we introduced that we are going to be presenting last knowledge for the Firm’s majority-owned subsidiary 3CL Pharma’s Part 2 medical trial for Tollovir™ within the therapy of hospitalized COVID-19 on the Precision Drugs World Convention on June 30, 2022 at 1:30 pm PT. In gentle of current developments in COVID-19 therapeutics within the hospital setting, the Firm is updating its Part 2/3 medical trial planning to account for any potential adjustments in therapeutic approaches to hospitalized COVID-19 and has retained the highest regulatory legislation agency in the USA with a powerful historical past of working with the FDA to assist the Firm navigate the regulatory course of for Tollovir, and supply oversight over the Firm’s 3CL protease inhibitor immune help dietary complement product Tollovid®.

“As the total scope of the COVID transmission-enabling coverage of eradicating masks mandates nationwide comes into focus, the US Heart for Illness Management and Prevention (the “CDC”) lately acknowledged that roughly 1 in 5 adults contaminated with COVID underneath the age of 65 have developed Submit-Acute Sequalae of COVID (“PASC” or “Lengthy COVID”), a continual post-viral syndrome that usually includes long-term incapacity, together with an incapability to work or attend faculty. For the age group 65 and older, 1 in 4 contaminated individuals develop the situation. The appearance of Lengthy COVID is probably the only largest mass disabling occasion in human historical past. A Financial institution of England financial committee lately acknowledged that Lengthy COVID is the first driver behind a 440,000 employee lower within the British Workforce between 2019 and 2022, whereas additionally disclosing a report excessive of 4.5% of adults who responded they might not work attributable to long-term illness. In the USA, the statistics are probably much more sobering with 22 million U.S. adults dwelling with Lengthy Covid (~7% of the inhabitants) and seven million experiencing Disabling Lengthy Covid (DLC) representing 2.3% of the inhabitants with a cumulative value estimated at greater than $386 billion as of January 2022. The world wants options for Lengthy COVID as the total weight of the pandemic’s affect on human well being comes into focus. Right here at Todos Medical we consider we’re able to ship these options.

“3CL Pharma has developed a novel set of property across the SARS-CoV-2 3CL protease (3CLpro, Fundamental Protease, Mpro, Nsp5) that has positioned it to assist deal with among the core challenges affecting the Lengthy COVID group, specifically acceptable supplementation, therapeutic drug candidates and novel diagnostic instruments. Within the space of supplementation, a number of case research have been reported that describe the potential immune-support advantages of the Firm’s dietary complement product Tollovid®, and we now have a loyal base of Lengthy COVID clients who’re offering us with data on how greatest the group can see immune help advantages. Tollovid has been positioned as a 3CL protease cleanse to assist scale back and keep low 3CLpro physique content material. We’ve got now gained insights that we want to share with clients that can drive our future packaging selections, dosing suggestions and advertising and marketing plans as we proceed to do analysis with Lengthy COVID clinics to higher perceive how clients can get probably the most out of Tollovid.

· Buyer suggestions signifies Lengthy COVID signs that began inside 6 months of ordering Tollovid typically see sustained outcomes extra shortly than those that have had Lengthy COVID for 1 12 months. Sufferers who’ve had Lengthy COVID for 1 12 months typically see sustained outcomes extra shortly than affected person who’ve had Lengthy COVID for two years. Primarily based upon this client suggestions, we’ll look to create new bottle packs of two, 3, and 4 bottles that can permit shoppers to extra simply establish the extent of immune help advisable for them based mostly upon suggestions from comparable varieties of clients. The one bottles are nonetheless a good way to realize the wanted help dosing over 5, 10 or 15 days adopted by a gradual shift in the direction of upkeep dosing of as little as 2 capsules per day, relying on how the shopper responds. Over the summer time we intend to submit new certificates of free sale that can embody 120 capsules/bottle, 180 capsules/bottle and 240 capsules/bottle to permit for 1 (60 capsules over 5 days), 2 (120 capsules over 10 days) or 3 (180 capsules over 15 days) help dosing cycles adopted by a discount in the direction of each day upkeep consumption. We count on that as clients efficiently transition from help to upkeep that we are going to proceed to see sturdy buyer loyalty, as evidenced by Tollovid’s vital will increase in returning clients charge and subscriptions. The Lengthy COVID group has shortly embraced Todos and we hope to assist them with respect to product pricing following the 50% off promotion pricing that diminished the per bottle value of Tollovid from $299/bottle to $149/bottle that runs by Could thirtieth, 2022. As such, we can be launching new pricing packages for Tollovid that align with the wants of our buyer base beginning on Memorial Day as follows:

o $199 for one (1) bottle
o $299 for 2 (2) bottles (avg value $149.50/bottle)
o $399 for 3 (3) bottles (avg value of $133/bottle)
o $499 for 4 (4) bottles (avg value of $125/bottle)
o $599 for 5 (5) bottles (avg value of $120/bottle)

· Enough biomarker testing and monitoring for Lengthy COVID victims doesn’t exist in the USA, and given our proprietary place with Tollovid, Todos’ CLIA/CAP-certified diagnostic lab Provista Diagnostics is nicely positioned to ascertain a Lengthy COVID biomarker panel to observe the important thing markers for Lengthy COVID affected person well being, and probably establish novel companion diagnostic biomarkers that might be used to flag sufferers for potential therapeutic intervention. Provista is within the course of of creating relationships with lab companions that supply validated Lengthy COVID biomarker testing, in addition to getting ready so as to add specialised 3CL protease (“TolloTest”) and fecal PCR testing that can permit sufferers to observe the diploma to which Lengthy COVID victims proceed to exhibit viral persistence that might be driving illness pathology.

· The information being gathered from Tollovid dietary complement clients helps inform our medical trial plans for each Tollovid and Tollovir in Lengthy COVID. 3CL intends to initially conduct observational medical research for Tollovid whereas advancing randomized, double-blind, placebo-controlled trials for Tollovir in Lengthy COVID. We count on Tollovir Lengthy COVID trials will initially be performed in Israel early in the summertime whereas the Firm establishes an Investigational New Product (IND) designation and positive aspects authorization to proceed with the pivotal Tollovir hospitalized trial in United States and Europe in addition to an IND for European trial authorization for Tollovir in Lengthy COVID.

“One of many key considerations we hear from clients and shareholders is relating to the power of Todos Medical to fund the event of 3CL Pharma. After vital debate, the Firm has retained counsel to assist 3CL Pharma file to lift capital utilizing crowdfunding Regulation CF (“Reg CF”) from non-accredited buyers and Regulation D06C (“506C”) from accredited buyers. Todos lately acquired a 3rd get together valuation for 3CL Pharma of over $1.9 billion, and in consequence, we consider we are able to increase capital at enticing valuation for each buyers and Todos that can permit 3CL Pharma to maximise its potential. We count on the choices to be available in the market in late June 2022 and we’re at present getting ready a Tollovid manufacturing run for use to reward 3CL Pharma buyers with provide of Tollovid. By elevating funding for 3CL Pharma on this approach we’re offering buyers who consider in Tollovid, Tollovir and Tollotest with a chance to instantly affect 3CL Pharma’s means to extensively distribute Tollovid, whereas additionally limiting Todos’ money burn going ahead.

“The Firm has accomplished an S-1 draft that it anticipates utilizing to execute a capital increase along side an uplisting to a significant alternate sooner or later within the second half of 2022 centered across the additional development of our PCR and Lengthy COVID testing enterprise at Provista and the commercialization of our Videssa breast most cancers blood check in 2023. As acknowledged earlier on this replace, the Firm has a crowdfunding capital elevating technique for unlocking the $1.9 billion third get together valuation we lately acquired for the primary two 3CL Pharma’s three key property. We consider initiating capital elevating instantly into 3CL Pharma through crowdfunding will characterize a significant valuation inflection occasion for Todos because the worry of great dilution can be diminished whereas the worth of 3CL Pharma’s growth will nonetheless be captured by the Firm and ultimately handed alongside in some type to shareholders.”

About Tollovid® and Tollovid Day by day™
Tollovid and Tollovid Day by day are dietary complement merchandise comprised of pure elements that assist help and keep wholesome immune operate and still have potent 3CL protease inhibition properties based mostly upon in vitro purposeful assays that present sturdy inhibition of 3CL protease exercise. Tollovid’s 3CL protease IC50 binding affinity is at the very least ten occasions (10x) as sturdy as Ivermectin’s revealed 3CL protease IC50 binding affinity. Tollovid Day by day’s 3CL protease IC50 binding affinity is at the very least two and a half occasions (2.5x) as Ivermectin. Tollovid and Tollovid Day by day bind to the lively web site (receptor binding area) of the 3CL protease. Tollovid has a 5-day dosing routine, with 4 doses of three capsules taken every day that gives most immune help. Tollovid Day by day is a each day immune help product with a dosing routine of twice each day.

About Tollovir®
Tollovir® is a 3CL protease inhibitor and anti-cytokine therapeutic candidate for the therapy of the nidovirus subcategory of coronaviruses that features SARS-CoV-2, COVID-19, SARS-CoV-1, MERS and 229E. Tollovir is comprised of all pure elements which can be certified to make sure sturdy inhibition of the 3CL protease in vitro, in addition to sturdy anti-cytokine exercise. Tollovir has efficiently accomplished a Part 2 medical trial in Israel for the therapy of sufferers hospitalized with COVID-19. Tollovir can be developed for the therapy of hospitalized COVID-19 (extreme and significant), reasonable COVID-19, long-haul COVID and probably pediatric COVID-19. Todos has licensed rights for Tollovir to T-Cell Shield Hellas S.A. for the Greek market.

About TolloTest®
TolloTest® is a 3CL protease diagnostic fluorescence platform know-how that has demonstrated medical proof of idea in hospital setting and outpatient settings in appropriately figuring out sufferers contaminated with COVID-19, together with inside 1-3 days of first publicity. TolloTest diagnostic instruments are being developed to deal with key deficiencies with present SARS-CoV-2 fast antigen and PCR applied sciences. TolloTest can present leads to lower than ten (10 minutes), and probably in as little as two (2) minutes. Knowledge generated from two research performed with TolloTest reveal that: (1) it may establish SARS-CoV-2 contaminated sufferers sooner than fast antigen testing (probably sooner than PCR testing), (2) it may establish sufferers who’re seemingly not infectious, however nonetheless check optimistic by PCR and (3) it may establish sufferers which can be nonetheless seemingly infectious, however who’ve been launched from quarantine based mostly on time from optimistic PCR check. TolloTest assay codecs are being developed for (1) point-of-care/at-home market and (2) fast mass screening in group settings (airports, faculties, places of work).

About Videssa® Breast Most cancers Blood Check
Videssa Breast is the one easy blood check to offer early and correct detection of lively breast most cancers. In these ladies who current with suspicious mammography outcomes, the choice whether or not to order extra imaging or biopsy could be troublesome. With a easy blood draw, Videssa Breast can assist information additional diagnostic procedures or present assurance that the affected person doesn’t have breast most cancers. When utilized in mixture with imaging, Videssa Breast gives the healthcare supplier extra knowledge resulting in elevated confidence and readability when medical evaluation is difficult.

About LymPro Alzheimer’s Blood Check
The Lymphocyte Proliferation Check (LymPro Check™) is a diagnostic blood check that determines the power of peripheral blood lymphocytes (PBLs) and monocytes to resist an exogenous mitogenic stimulation that induces them to enter the cell cycle. It’s believed that sure ailments, most notably Alzheimer’s illness, are the results of compromised mobile equipment that results in aberrant cell cycle re-entry by neurons, which then results in apoptosis. LymPro is exclusive in the usage of peripheral blood lymphocytes as a surrogate for neuronal cell operate, suggesting a typical relationship between PBLs and neurons within the mind.

About Todos Medical Ltd.
Based in Rehovot, Israel with places of work in New York Metropolis, Todos Medical Ltd. ( TOMDF) engineers’ life-saving diagnostic options for the early detection of a wide range of cancers. The Firm’s state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening know-how utilizing peripheral blood evaluation that deploys deep examination into most cancers’s affect on the immune system, searching for biochemical adjustments in blood mononuclear cells and plasma. Todos’ two internally developed cancer-screening checks, TMB-1 and TMB-2 have acquired a CE mark in Europe. Todos lately acquired U.S.-based medical diagnostics firm Provista Diagnostics, Inc. to achieve rights to its Alpharetta, Georgia-based CLIA/CAP licensed lab at present performing PCR COVID testing and Provista’s proprietary commercial-stage Videssa® breast most cancers blood check.

Todos can also be growing blood checks for the early detection of neurodegenerative issues, equivalent to Alzheimer’s illness. The Lymphocyte Proliferation Check (LymPro Check™) is a diagnostic blood check that determines the power of peripheral blood lymphocytes (PBLs) and monocytes to resist an exogenous mitogenic stimulation that induces them to enter the cell cycle. It’s believed that sure ailments, most notably Alzheimer’s illness, are the results of compromised mobile equipment that results in aberrant cell cycle re-entry by neurons, which then results in apoptosis. LymPro is exclusive in the usage of peripheral blood lymphocytes as a surrogate for neuronal cell operate, suggesting a typical relationship between PBLs and neurons within the mind.

Todos has entered into distribution agreements with corporations to distribute sure novel coronavirus (COVID-19) check kits. The agreements cowl a number of worldwide suppliers of PCR testing kits and associated supplies and provides, in addition to antibody testing kits from a number of producers after finishing validation of mentioned testing kits and provides in its accomplice CLIA/CAP licensed laboratory in the USA. Moreover, Todos has entered right into a three way partnership with NLC Pharma to pursue the event of diagnostic checks focusing on the 3CL protease, in addition to 3CL protease inhibitors that concentrate on a elementary reproductive mechanism of coronaviruses.

For extra data, please go to https://www.todosmedical.com/.

Ahead-looking Statements

Sure statements contained on this press launch could represent forward-looking statements. For instance, forward-looking statements are used when discussing our anticipated medical growth packages and medical trials. These forward-looking statements are based mostly solely on present expectations of administration, and are topic to vital dangers and uncertainties that would trigger precise outcomes to vary materially from these described within the forward-looking statements, together with the dangers and uncertainties associated to the progress, timing, value, and outcomes of medical trials and product growth packages; difficulties or delays in acquiring regulatory approval or patent safety for product candidates; competitors from different biotechnology corporations; and our means to acquire extra funding required to conduct our analysis, growth and commercialization actions. As well as, the next elements, amongst others, might trigger precise outcomes to vary materially from these described within the forward-looking statements: adjustments in know-how and market necessities; delays or obstacles in launching our medical trials; adjustments in laws; incapability to well timed develop and introduce new applied sciences, merchandise and purposes; lack of validation of our know-how as we progress additional and lack of acceptance of our strategies by the scientific group; incapability to retain or appeal to key workers whose information is important to the event of our merchandise; unexpected scientific difficulties that will develop with our course of; better value of ultimate product than anticipated; lack of market share and strain on pricing ensuing from the competitors; and laboratory outcomes that don’t translate to equally good leads to actual settings, all of which might trigger the precise outcomes or efficiency to vary materially from these contemplated in such forward-looking statements. Besides as in any other case required by legislation, Todos Medical doesn’t undertake any obligation to publicly launch any revisions to those forward-looking statements to replicate occasions or circumstances after the date hereof or to replicate the incidence of unanticipated occasions. For a extra detailed description of the dangers and uncertainties affecting Todos Medical, please confer with its studies filed now and again with the U.S. Securities and Trade Fee.

Todos Company Contact:
Daniel Hirsch
CFO
Todos Medical
917-983-4229 x 104
[email protected]

Todos Investor Relations Contact:
Eric Ribner
LifeSci Advisors
Electronic mail: [email protected]