New York, NY, and Tel Aviv, ISRAEL – 
(NewMediaWire) – January 5, 2022 – Todos
Medical, Ltd. (OTCQB: TOMDF), a
comprehensive medical diagnostics and related solutions company, announced that
its President & CEO Gerald Commissiong today issued a letter to shareholders
outlining the Company progresses towards a national exchange listing expected
in the first half of 2022.
Dear Valued Shareholder,
I would like to thank you
for joining us in our journey here at Todos to transform the course of the
COVID-19 pandemic and help patients with cancer and Alzheimer’s get better
access to diagnostic tools that could dramatically impact their health. I’m
going to touch on the key themes of great interest to our shareholders and hopefully
set out the key plans we have that we believe will drive shareholder value in
the months ahead.
Acquisition of NLC Pharma
Assets and Formation of 3CL Sciences
We continue to make good
progress to complete the acquisition of NLC Pharma’s assets, and have updated
the timeline expected to close the transaction to this month January 2022. As a
reminder, Todos and NLC Pharma are currently operating under our active joint
venture with NLC Pharma called COVID Antigen Test Killer (CATK) established in
Q2/2020 where Todos has been funding the development and commercialization of
3CL protease biology-related products that include Tollovid®, Tollovid Daily™,
Tollovir™ and TolloTest™. As a reminder, Dr. Dorit Arad of NLC Pharma is a
pioneer in the field of 3CL protease biology whose lab was the first to purify
the 3C and 3CL proteases in the early 2000s and is slated to become the Chief
Scientific Officer of 3CL Sciences.
Tollovid and Tollovid Daily
are dietary supplements products that have received Certificates of Free Sale
(CFS) from the US Food & Drug Administration (FDA) with 2 allowed claims:
1) Support
and maintain healthy immune function
2) 3CL
protease inhibitor (based on in vitro data)
These are important products
available for purchase now on Amazon, Alibaba and our own website www.MyTollovid.com that empower people to make decisions
now to support their immune system. We have seen record sales of Tollovid in
the last month as increasing awareness of the significant benefit of 3CL
protease inhibitors has gained international attention, and we believe we are
uniquely positioned to meet that demand given that we have 3CL protease
inhibitor products with authorized FDA claims on the market now in the United
States and a partner in Europe via T Cell Protect Hellas that is preparing to
distribute Tollovid Daily throughout Europe.
In parallel, we are developing
botanical drug candidate Tollovir for the treatment of COVID-19 in hospitalized
patients. Tollovir is a combination of herbal ingredients that have two
specific compounds (NLC-EXT-1 and NLC-EXT-2) discovered by Dr. Arad through
research under the joint venture that have 1) potent 3CL protease inhibition
via sub nanomolar binding affinity activity and 2) anti-cytokine activity. We
believe the dual mechanisms of Tollovir are critical in the hospitalized
setting because they are synergistic in reducing the hyper-inflammation that
likely drove the patient to the hospital and stopping the replication of the
virus that likely created the hyper-inflammation in the first place.
The
virus can maintain its activity at low levels for at least 3 months and
research has shown it can persist for up to 8 months 1. Efforts
aimed at reducing the hyper-inflammation and stopping the replication of the
virus that created the inflammation feedback loop should be able to quell the
cycle that causes hospitalized symptoms and death. It is very important to
stabilize patients in order to get them out of the hospital faster so we can
reduce the COVID burden on hospital systems. This time to stabilization is
actually our primary endpoint in the current study. We believe we can produce
in the tens of millions of treatment courses of Tollovir in 2022 to meet the
demand for drug-grade 3CL protease inhibitors. We will be working with our
European partners T-Cell Protect Hellas S. A. to gain Emergency Use
Authorization (EUA) in Greece, and of course 3CL Sciences itself, as an
Israel-based company, will be looking to advance EUA in Israel. We also expect
we could receive EUA in other jurisdictions depending on the need in those
jurisdictions. Given that we do not know which variant may emerge next, the
variant-independent nature of the 3CL protease inhibitor products we are
bringing forward will be a critical part of the fight against COVID-19 going
forward.
We continue to believe that
3CL protease diagnostics could represent a sea-change in the COVID diagnostics
market and TolloTest is uniquely positioned to meet that demand. On average,
lateral flow antigen tests show evidence of disease 9 days after infection well
after symptoms appear, but we expect our TolloTest to significantly cut that
time and show evidence as early as 1 to 3 days before symptoms appear. The 3CL
protease develops in the body 70 times faster than a virion, making detection
easier. We have developed prototype models for mass screening systems for
point-of-entry access to airports, schools, offices, sports arenas and other
areas where large groups of people will interact indoors and will be building
the prototype in the first half of 2022, and intend to partner the single use
point of care intellectual property to a group currently in the market looking
to differentiate their current nucleocapsid antigen testing kits by having an
additional unique marker that could identify the virus earlier than currently
available antigen tests.
COVID Testing
We have seen record demand
for PCR testing at our CLIA/CAP lab Provista Diagnostics in recent weeks, and
we are ramping up hiring to meet the substantial demand we expect will continue
in the months ahead for COVID testing. With this demand increasing, we are
seeing increasing sample flow from our reference lab clients and have received
a number of new contracts to support new testing sites that are being
established throughout the New York City area and the Atlanta area.
COVID testing at our client
labs through our Corona Diagnostics subsidiary are also seeing increasing
demand and we are looking at ways to more closely align with our labs to our
mutual benefit so we can help them further scale to meet the demands of their
local communities.
Proprietary testing:
Videssa breast cancer test and LymPro Alzheimer’s test
Todos was founded to bring
proprietary tests for immune-related disorder to market beginning with breast
cancer. To that end, our Videssa breast cancer test is the priority product
candidate to bring into the market because it will differentiate our CLIA lab
and allow us to provide a comprehensive suite of testing that will be
‘stickier’ with ordering physicians. Women with dense breasts or those
who are at high risk of cancer, will view our CLIA lab as a next generation
cancer testing lab that can screen for both breast cancer and COVID. Building
on this concept will allow us to tie together COVID testing, including monitoring
for Long COVID biology that we intend to bring online later this year, with
testing for Cancer which will also need to be monitored closely, especially
cancer patients who are post-COVID. To this end, we intend to launch a clinical
study in 2022 to meet the criteria to bring this important test into the market
and gain initial reimbursement that will allow us to drive sales in 2023. We
will be giving more detail on our Videssa strategy in the weeks ahead as Dr.
Jorge Leon, our Chief Scientific Officer of Oncology and Infectious Diseases,
makes progress in getting the study started.
In addition, we have the
second half of an ongoing clinical trial for our LymPro Alzheimer’s blood test
at the University of Leipzig in Germany that we expect to readout in the first
half of 2022. As a reminder, this clinical study is evaluating the correlation
between LymPro scores and amyloid concentrations in the brain as measured by
SUVR, and the first half of the study showed a strong statistical significance
of the correlation with p = 0.00000216 and r = 0.85. We are very hopeful that
LymPro, a dynamic functional assay that measures immune response in the blood
that mimics ongoing pathology in the brain, will become an important tool to
qualify patients who are most likely to benefit from amyloid treatment. LymPro
measures the fundamental underlying biology of Alzheimer’s disease that we
believe can be identified at the pre-symptomatic phase given that key LymPro
markers appear to be stage-independent even at the mild cognitive impairment
(MCI) stage.
Corporate Plans for
Uplist to Nasdaq
The Company has engaged an
underwriter to support our uplisting to the Nasdaq in the first half of 2022
and we expect to file the S1 needed to complete the transaction in the near future.
The S1 is already drafted, and its filing will be a major step forward towards
that objective. We expect the clinical data from the Phase 2 clinical trial of
Tollovir to be released on January 26th, 2022 and will provide further details
around the data’s release in the weeks ahead given that we are extremely close
to completing the data lock that will trigger the analysis and data report back
to the Company from the statistical analysis group our key clinical advisor Dr.
Jules Mitchel retained to execute the analysis. We believe the data will be a
revaluation event for Todos and thereafter we will strategically plan on the
best path to achieve the Nasdaq listing that has been a key stated objective
for some time.
We are very excited about
our positioning in the marketplace at the beginning of this new year. We
believe the combination of COVID testing and Tollovid/Tollovid Daily sales that
are currently driving revenues will serve as a bridge to the transformational
revenue of Tollovir. The potential of Emergency Use Authorization (EUA) in one
or more jurisdictions in the first quarter of 2022 exists and could be a boon
to revenues should we receive it. If this happens, we plan to complete the
necessary studies to expand the number of jurisdictions in which Tollovir
receives EUAs. This would have an impact in the second half of 2022 that would
multiply sales, and position the Company financially at the same point where we
expected to be in the beginning of 2023 from launching our proprietary
diagnostics initiatives. We believe this short-term (PCR Testing / Tollovid /
Tollovid Daily), medium-term (Tollovir) and longer-term (Videssa and LymPro)
revenue strategy could layer in key revenue and provide the funding needed to
drive the next leg in revenue generation.
We are very excited about
the future for Todos, and we thank you for sharing in our vision as a
shareholder of the Company.
For more information, please
visit www.todosmedical.com. For more information
on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.
About Todos Medical Ltd.
Founded in Rehovot, Israel with
offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers
life-saving diagnostic solutions for the early detection of a variety of
cancers. In 2021, Todos completed the acquisition of U.S.-based medical diagnostics
company Provista Diagnostics, Inc. to gain rights to its Alpharetta,
Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and
Provista’s proprietary commercial-stage Videssa® breast cancer blood test. The
Company’s state-of-the-art and patented Todos Biochemical Infrared Analyses
(TBIA) is a proprietary cancer-screening technology using peripheral blood
analysis that deploys deep examination into cancer’s influence on the immune
system, looking for biochemical changes in blood mononuclear cells and plasma.
Todos’ two internally-developed cancer-screening tests, TMB-1 and TMB-2, have
received a CE mark in Europe. Todos is focused on the commercialization of
Videssa and will bring the TBIA tests to market thereafter.
Todos has entered into a joint
venture with NLC Pharma targeting diagnostic and testing solutions to address
the COVID-19 pandemic. The Joint-Venture is pursuing the development of
diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors
that target a fundamental reproductive mechanism of coronaviruses. The
Company’s proprietary therapeutic candidate Tollovir™ is currently in a Phase 2
clinical trial to treat hospitalized COVID-19 patients in Israel, and is
preparing to initiate Phase 2/3 clinical trials for both hospitalized and
non-hospitalized patients in Israel.
Todos is also developing blood
tests for the early detection of neurodegenerative disorders, such as
Alzheimer’s disease. The Lymphocyte Proliferation Test (LymPro Test™) is a
diagnostic blood test that determines the ability of peripheral blood
lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic
stimulation that induces them to enter the cell cycle. It is believed that
certain diseases, most notably Alzheimer’s disease, are the result of
compromised cellular machinery that leads to aberrant cell cycle re-entry by
neurons, which then leads to apoptosis. LymPro is unique in the use of
peripheral blood lymphocytes as a surrogate for neuronal cell function,
suggesting a common relationship between PBLs and neurons in the brain.
Todos is also distributing
certain (COVID-19) testing materials and supplies to CLIA-certified labs in the
United States. The products cover multiple suppliers of PCR testing kits,
extraction kits, automation materials and supplies, as well as COVID-19
antibody and antigen testing kits.
For more information, please
visit https://www.todosmedical.com/.
Forward-looking Statements
Certain statements contained in
this press release may constitute forward-looking statements. For example,
forward-looking statements are used when discussing our expected clinical
development programs and clinical trials. These forward-looking statements are
based only on current expectations of management, and are subject to
significant risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements, including
the risks and uncertainties related to the progress, timing, cost, and results
of clinical trials and product development programs; difficulties or delays in
obtaining regulatory approval or patent protection for product candidates;
competition from other biotechnology companies; and our ability to obtain
additional funding required to conduct our research, development and
commercialization activities. In addition, the following factors, among others,
could cause actual results to differ materially from those described in the
forward-looking statements: changes in technology and market requirements;
delays or obstacles in launching our clinical trials; changes in legislation;
inability to timely develop and introduce new technologies, products and
applications; lack of validation of our technology as we progress further and
lack of acceptance of our methods by the scientific community; inability to
retain or attract key employees whose knowledge is essential to the development
of our products; unforeseen scientific difficulties that may develop with our
process; greater cost of final product than anticipated; loss of market share
and pressure on pricing resulting from competition; and laboratory results that
do not translate to equally good results in real settings, all of which could
cause the actual results or performance to differ materially from those
contemplated in such forward-looking statements. Except as otherwise required
by law, Todos Medical does not undertake any obligation to publicly release any
revisions to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. For a more detailed description of the risks and
uncertainties affecting Todos Medical, please refer to its reports filed from
time to time with the U.S. Securities and Exchange Commission.
Todos
Corporate and Investor Contact:
Richard Galterio
Todos Medical
732-642-7770
rich.g@todosmedical.com
References
1. https://assets.researchsquare.com/files/rs-1139035/v1_covered.pdf?c=1640020576